Physical Activity Levels and Social Cognitive Theory Correlates among Adults with Crohn's Disease: Preliminary Results from a Cross-Sectional Analysis.

There is increasing research and clinical interest in physical activity (PA) as an adjuvant therapy for improving health outcomes among persons with Crohn's disease. To date, little is known regarding PA behavior and its cognitive and behavioral correlates in Crohn's disease. Thus, we assessed self-reported PA and its social cognitive theory (SCT) correlates in a sample of persons with Crohn's disease. Data on demographic and clinical characteristics, disease activity, leisure-time PA, and SCT variables were collected from 30 participants with Crohn's disease (90% White, 60% female) through an online survey. SCT variables assessed included exercise self-efficacy, social support, outcome expectations, goal setting, and planning. Analyses involved comparing PA levels and SCT survey scores using independent sample t-tests and non-parametric bivariate correlations. The majority of participants were in clinical remission (60%) and over half (57%) were classified as physically active, yet the mean PA level was lower than normative values for adults. Females (n = 18) and participants who reported previous surgery for Crohn's disease (n = 18) were almost twice as physically active as male participants and those without a history of Crohn's disease-related surgery, respectively (p's < 0.05). Overall, participants who reported greater exercise goal setting behaviors had higher levels of PA (rs = 0.34; p < 0.05). These findings highlight lower overall levels of PA in persons with Crohn's disease, and exercise goal setting represents a potential target of behavior change interventions for increasing PA in this population.

Breast cancer survivors' exercise preferences change during an exercise intervention are associated with post-intervention physical activity.

PURPOSE: Exercise program preferences are important for designing physical activity (PA) interventions; yet may change following an intervention. Further, the relationship between preferences and PA behavior change is unclear. This study evaluated exercise program preferences among breast cancer survivors (BCS) before and after a behavioral intervention and associations between program preferences and PA change. METHODS: BCS were randomized to the BEAT Cancer intervention (n = 110) or written materials (n = 112). Questionnaires assessed exercise program preferences. Minutes per week of moderate-to-vigorous PA (MVPA) were accelerometer-measured and self-reported at baseline (M0), post-intervention (M3), and 3-month follow-up (M6). RESULTS: At M0, the majority of intervention group participants preferred exercising with others (62%) yet shifted to preferring exercising alone (59%) at M3 (p < 0.001). Furthermore, preferring exercising with others at M0 was associated with greater increases in self-reported MVPA between M0 and M6 (124.2 ± 152 vs. 53.1 ± 113.8, p = 0.014). BCS preferring facility-based exercise decreased after the BEAT Cancer intervention (14% vs. 7%, p = 0.039) and preferring exercising at home/had no preference at M0 had greater improvements in accelerometer-measured MVPA from M0 to M3 (74.3 ± 118.8 vs. -2.3 ± 78.4, p = 0.033) and M0 to M6 (44.9 ± 112.8 vs. 9.3 ± 30.4, p = 0.021). Exercise program preferences regarding mode of counseling, training supervision, and type of exercise changed from M0 to M3 but were not associated with changes in MVPA. CONCLUSION: Findings suggest BCS exercise program preferences may change after an intervention and be associated with changes in MVPA. Understanding the role of PA preferences will better inform the design and success of PA behavior change interventions. ClinicTrials.gov, ClinicalTrials.gov number: NCT00929617.

Relationships between Obesity, Exercise Preferences, and Related Social Cognitive Theory Variables among Breast Cancer Survivors.

Breast cancer survivors with obesity have an increased risk of cancer recurrence, second malignancy, and comorbidities. Though physical activity (PA) interventions are needed, investigation of the relationships between obesity and factors influencing PA program aspects among cancer survivors remain understudied. Thus, we conducted a cross-sectional study examining associations amongst baseline body mass index (BMI), PA program preferences, PA, cardiorespiratory fitness, and related social cognitive theory variables (self-efficacy, exercise barriers interference, social support, positive and negative outcome expectations) from a randomized controlled PA trial with 320 post-treatment breast cancer survivors. BMI was significantly correlated with exercise barriers interference (r = 0.131, p = 0.019). Higher BMI was significantly associated with preference to exercise at a facility (p = 0.038), lower cardiorespiratory fitness (p < 0.001), lower walking self-efficacy (p < 0.001), and higher negative outcome expectations (p = 0.024), independent of covariates (comorbidity score, Western Ontario and McMaster Universities osteoarthritis index score, income, race, education). Those with class I/II obesity reported a higher negative outcome expectations score compared with class III. Location, walking self-efficacy, barriers, negative outcome expectations, and fitness should be considered when designing future PA programs among breast cancer survivors with obesity.

Breast Cancer Survivors' Exercise Preferences Change During an Exercise Intervention and are associated with Post-Intervention Physical Activity.

Purpose Exercise program preferences are important for designing physical activity (PA) interventions; yet may change following an intervention. Further, the relationship between preferences and PA behavior change is unclear. This study evaluated exercise program preferences among breast cancer survivors (BCS) before and after a behavioral intervention and associations between program preferences and PA change. Methods BCS were randomized to the BEAT Cancer intervention (n = 110) or written materials (n = 112). Questionnaires assessed exercise program preferences. Minutes per week of moderate-to-vigorous PA (MVPA) were accelerometer-measured and self-reported at baseline (M0), post-intervention (M3), and 3-month follow-up (M6). Results At M0, the majority of intervention group participants preferred exercising with others (62%) yet shifted to preferring exercising alone (59%) at M3 ( p < 0.001). Furthermore, preferring exercising with others at M0 was associated with greater increases in self-reported MVPA between M0 and M6 (124.2 ± 152 vs. 53.1 ± 113.8, p = 0.014). BCS preferring facility-based exercise decreased after the BEAT Cancer intervention (14% vs. 7%, p = 0.039) and preferring exercising at home/had no preference at M0 had greater improvements in accelerometer-measured MVPA from M0 to M3 (74.3 ± 118.8 vs. -2.3 ± 78.4, p = 0.033) and M0 to M6 (44.9 ± 112.8 vs. 9.3 ± 30.4, p = 0.021). Exercise program preferences regarding mode of counseling, training supervision, and type of exercise changed from M0 to M3 but were not associated with changes in MVPA. Conclusion Findings suggest BCS exercise program preferences may change after an intervention and be associated with changes in MVPA. Understanding the role of PA preferences will better inform the design and success of PA behavior change interventions. ClinicTrials.gov, ClinicalTrials.gov number: NCT00929617.

Targeted exercise for African-Americans with multiple sclerosis: Project TEAAMS.

BACKGROUND: We propose a randomized controlled trial (RCT) that examines the effects of a remotely-delivered, cultrally-tailored exercise training program for immediate and sustained improvements in patient-reported outcomes (PROs) of walking dysfunction, symptoms, and health-related quality of life (HRQOL) among African-Americans with multiple sclerosis (MS). METHODS/DESIGN: The study will be conducted using a parallel group RCT design. The RCT examines the effects of a remotely-delivered, culturally-tailored exercise training program compared with an active control condition among 100 African-Americans with MS. The primary PROs focus on walking dysfunction. The secondary PROs include symptoms of fatigue, depression, anxiety, and HRQOL. The tertiary PROs include exercise behavior and mediator variables based on social cognitive theory. Participants will be randomly assigned into one of two conditions, intervention (Aerobic and Resistance Exercise Training) or active control (Stretching and Flexibility), using a random numbers sequence with concealed allocation. The conditions will be administered over four months by a trained behavioral coach who will be uninvolved in recruitment, screening, random assignment, and outcome assessment. We will monitor the outcomes of interest before and after the 4-month intervention period, and then again 4 months after intervention cessation for capturing stability of intervention effects. The data analysis will follow intent-to-treat principles with a linear mixed model. DISCUSSION: If successful, this RCT will provide initial evidence for the uptake and implementation of the program in clinics/environments providing healthcare for African-Americans with MS.

A qualitative evaluation of a clinic versus home exercise rehabilitation program for adults with multiple sclerosis: The tele-exercise and multiple sclerosis (TEAMS) study.

BACKGROUND: Substantial evidence supports therapeutic exercise for improving health and function in people with multiple sclerosis (MS). However, few studies have considered the patients' perspective. OBJECTIVE: This study explored perspectives of adults with MS following participation in a 3-month clinic- and home-based exercise rehabilitation program. METHODS: Twenty participants with MS were interviewed using a semi-structured interview guide on the design and implementation processes of the exercise programs as well as any perceived facilitators or barriers to exercise. Data analysis was conducted using a thematic analysis approach to generate themes from the transcribed interviews. RESULTS: Key facilitators of exercise for people with MS included perceived improvements in physical health and function, activity participation, and psychosocial health. Mismatched level of exercise with their stage of post-diagnosis and/or functional ability and limited human interaction emerged as barriers to exercise. CONCLUSIONS: Participation in the exercise program was a positive experience for people with MS. Despite the provision of a high level of adaptation and tailored exercise plan and delivery, self-directed exercise continued to present challenges for people with MS. Additionally, the importance of seeking cost-effective ways to maintain motivational support was implicit in participant responses. The findings provided an improved understanding of personal experiences and exercise perspectives that can inform future intervention strategies aimed at promoting sustained exercise participation.

Moderators of physical activity and quality of life response to a physical activity intervention for breast cancer survivors.

PURPOSE: Moderate-to-vigorous physical activity (MVPA) can improve the quality of life (QoL) for breast cancer survivors (BCS), yet, most do not achieve 150 + weekly minutes of MVPA. This study investigated moderators of response to a physical activity (PA) behavior change intervention for BCS. METHODS: BCS (N = 222) were randomized to the 3-month intervention (BEAT Cancer) or usual care. Measurements occurred at baseline, post-intervention, and 3 months post-intervention. Measures included accelerometry, self-reported MVPA, and Functional Assessment of Cancer Therapy (FACT-General, FACT-Breast, physical well-being (PWB), social well-being (SWB), emotional well-being (EWB), functional well-being (FWB), additional concerns (AC), and Trial Outcome Index (TOI)). RESULTS: Adjusted linear mixed-model analyses indicated individuals ≤ 24 months post-diagnosis and who were single reported smaller increases in weekly self-reported MVPA than those > 24 months (44.07 vs 111.93) and partnered (- 16.24 vs. 49.16 min), all p < 0.05. As for QoL, participants < 12 months post-diagnosis who received chemotherapy experienced smaller improvements than those ≥ 12 months in FACT-General, FACT-Breast, PWB, and SWB scores. Survivors with a history of chemotherapy had smaller improvements in FACT-General, FACT-Breast, PWB, SWB, TOI, and AC scores, all p < 0.05. CONCLUSION: These findings indicate that being < 2 years post-diagnosis, single, and prior chemotherapy may limit MVPA and QOL responses to a PA intervention. Further studies are needed to determine if and/or what additional PA supports and resources these subgroups of BCS might find beneficial and effective. TRIAL REGISTRATION: ClinicalTrials.gov number: NCT00929617.

Pasos Hacia La Salud II: study protocol for a randomized controlled trial of a theory- and technology-enhanced physical activity intervention for Latina women, compared to the original intervention.

BACKGROUND: Latinas are at increased risk for many lifestyle-related chronic diseases and are one of the least physically active populations in the US Innovative strategies are needed to help Latinas achieve the health benefits associated with physical activity (PA). This manuscript describes the study protocol of the Pasos Hacia La Salud II Study, which builds upon our previous research to test an enhanced individually-tailored, text-message and website-delivered, Spanish-language intervention (enhanced intervention), in comparison to the original web-based Pasos Hacia La Salud Intervention (original intervention). METHODS: Sedentary Latinas between the ages of 18-65 will be recruited and will complete an orientation and baseline assessments. Participants will be subsequently randomized to the original intervention, or the Enhanced Intervention, which has greater targeting of theoretical constructs such as self-efficacy, enjoyment, and social support, and which uses text messages and more dynamic and refined website features to encourage increased website use. Using a linear mixed effects regression model, we will simultaneously estimate the intervention effects on mean accelerometer-measured hours/week of moderate-to-vigorous PA (MVPA) at 6, 12, 18, and 24 months, with a subject-specific intercept (intent-to-treat sample). Change in self-reported MVPA, measured via the 7-day Physical Activity Recall, will be assessed as a secondary outcome using a similar model. We will investigate potential mediators of the intervention effect using a multiple mediation approach, and potential moderators by evaluating potential interactions. As an exploratory outcome, we will study the differences (among both study arms) in cost, in US dollars, per minute increases in weekly mean MVPA. DISCUSSION: The original Pasos PA intervention showed efficacy in helping Latinas increase PA; we expect the Enhanced Intervention to help a larger proportion of participants to increase and maintain their PA long term. This web- and text-based enhanced intervention could have great reach and dissemination potential, which could be capitalized on in the future to help to advance health equity. Adaptations made in response to the COVID-19 pandemic are also described in this manuscript. TRIAL REGISTRATION: Clinical Trial Number: NCT03491592 . First posted April 9, 2018.

Correction: Pekmezi et al. Rationale and Methods for a Randomized Controlled Trial of a Dyadic, Web-Based, Weight Loss Intervention among Cancer Survivors and Partners: The DUET Study. Nutrients 2021, 13, 3472.

The authors would like to correct errors in their prior publication [...].

Test/Retest Reliability and Validity of Remote vs. In-Person Anthropometric and Physical Performance Assessments in Cancer Survivors and Supportive Partners.

(1) Background: Anthropometric and physical performance testing is commonly done in lifestyle research and is traditionally performed in-person. To expand the scalability of lifestyle interventions among cancer survivors, in-person assessments were adapted to remote means and evaluated for feasibility, safety, validity, and reliability. (2) Methods: Cancer survivors and supportive partners were approached to participate in three anthropometric and physical performance testing sessions (two remote/one in-person). Correlations, concordance, and differences between testing modes were evaluated. (3) Results: 110-of-112 individuals approached for testing participated (98% uptake); the sample was 78% female, 64% non-Hispanic White, of mean age 58 years and body mass index = 32.4 kg/m2. ICCs for remote assessments ranged from moderate (8' walk = 0.47), to strong (8' get-up-and-go = 0.74), to very strong (30 s chair stand = 0.80; sit-and-reach = 0.86; 2 min step test = 0.87; back scratch = 0.90; weight = 0.93; waist circumference = 0.98) (p-values < 0.001). Perfect concordance (100%) was found for side-by-side and semi-tandem balance, and 87.5-90.3% for tandem balance. No significant differences between remote and in-person assessments were found for weight, 8' walk, and 8' get-up-and-go. No adverse events occurred and 75% indicated no preference or preferred virtual testing to in-person. (4) Conclusions: Remote anthropometric and physical performance assessments are reliable, valid, acceptable, and safe among cancer survivors and supportive partners.

Physical activity outcomes from a randomized trial of a theory- and technology-enhanced intervention for Latinas: the Seamos Activas II study.

Latina women report disproportionately high and increasing prevalence of chronic health conditions (obesity, diabetes) related to low physical activity levels. Efforts to date at addressing high rates of physical inactivity in this at-risk population have shown modest success. The original Seamos Saludables (sample size N = 266) was a culturally and linguistically adapted, print-based physical activity intervention that showed significant increases in moderate to vigorous physical activity (MVPA) from baseline to 6 months. However, only 11% of intervention participants reached the national PA guidelines of ≥ 150 min/week of aerobic MVPA. The current study tests the original Seamos Saludables intervention (Original Intervention) against an enhanced iteration Seamos Activas II (Enhanced Intervention). Study aims and intervention refinements focus on increasing the percentage of Latinas meeting national aerobic PA guidelines. For the current study (Seamos Activas II), a randomized controlled trial with (N = 199 participants) of two PA interventions (original intervention, N = 102; vs. enhanced intervention, N = 97) was conducted. Intervention refinements involved further targeting key constructs of the Social Cognitive Theory and incorporating text-message-based strategies for self-monitoring, in response to participant feedback for greater interactivity and accountability. PA assessments were conducted at baseline and 6 months. The sample was predominantly Mexican American (89%) with average age of 43.8 years (SD = 10.11) and mean BMI at baseline was 30.6 (SD = 7.56). There were significant within group increases in MVPA from baseline to 6 months (p < .05) in both Original and Enhanced Intervention arms. However, quantile regression models did not indicate significant differences in 6-month outcomes between conditions controlling for baseline, p = 0.73. There were significant differences between conditions with respect to meeting national guidelines for aerobic MVPA at 6 months, with 57% of Enhanced Intervention participants meeting guidelines compared to 44% of Original Intervention participants, OR = 1.66, 95% CI: 1.09 -2.89. Models suggest trends favoring the enhanced condition for improvements in biomarkers over 6 months. Findings indicate that the intervention enhancements likely helped more Latinas achieve nationally recommended, health enhancing PA levels than the original intervention and showed promise for improving physiological response to exercise.Trial Registration ClinicalTrials.Gov; NCT02630953. Registered 14 December 2015. https://clinicaltrials.gov/ct2/show/NCT02630953 .

Physical Activity in Adults With Crohn's Disease: A Scoping Review.

Background: As it becomes increasing clear that managing Crohn's disease (CD) requires more than medical treatment alone, further research to identify second-line approaches for managing CD and its symptoms such as physical activity (PA) are necessary to address this public health concern. Methods: We conducted a scoping review of descriptive, cross-sectional, and experimental studies to synthesize evidence regarding PA rates, determinants, health consequences, and interventions specifically in adults with CD. Adhering to the Preferred Items for Systematic Reviews and Meta-Analyses extension for scoping reviews (PRISMA-ScR) guidelines, published literature was searched to identify articles that examined PA or exercise in adults with CD. Results: Twenty-eight articles met inclusion criteria: 13 included a cross-sectional design, 4 a case-control design, 2 cohort designs, and 9 intervention designs. Adults with CD appear to be similar to somewhat less physically active than the general population, though self-report and objective rates of PA vary widely by geographical location. PA may be associated with the reduced risk of future active disease in adults with CD in clinical remission, as well as improve health-related quality of life, fatigue, cardiorespiratory fitness, and depression. Preliminary findings from interventional studies demonstrate that moderate-intensity PA is feasible, safe, and may have beneficial effects on disease activity. Conclusions: Overall, the benefits that can be accrued from regular PA are quite diverse; however, a substantially larger body of evidence is needed to provide firmer conclusions on the health benefits of PA that might underlie exercise-related changes in function and disease activity in adults with CD.

Rationale and Methods for a Randomized Controlled Trial of a Dyadic, Web-Based, Weight Loss Intervention among Cancer Survivors and Partners: The DUET Study.

Scalable, effective interventions are needed to address poor diet, insufficient physical activity, and obesity amongst rising numbers of cancer survivors. Interventions targeting survivors and their friends and family may promote both tertiary and primary prevention. The design, rationale, and enrollment of an ongoing randomized controlled trial (RCT) (NCT04132219) to test a web-based lifestyle intervention for cancer survivors and their supportive partners are described, along with the characteristics of the sample recruited. This two-arm, single-blinded RCT randomly assigns 56 dyads (cancer survivor and partner, both with obesity, poor diets, and physical inactivity) to the six-month DUET intervention vs. wait-list control. Intervention delivery and assessment are remotely performed with 0-6 month, between-arm tests comparing body weight status (primary outcome), and secondary outcomes (waist circumference, health indices, and biomarkers of glucose homeostasis, lipid regulation and inflammation). Despite COVID-19, targeted accrual was achieved within 9 months. Not having Internet access was a rare exclusion (<2%). Inability to identify a support partner precluded enrollment of 42% of interested/eligible survivors. The enrolled sample is diverse: ages 23-81 and 38% racial/ethnic minorities. Results support the accessibility and appeal of web-based lifestyle interventions for cancer survivors, though some cancer survivors struggled to enlist support partners and may require alternative strategies.

Features That Middle-aged and Older Cancer Survivors Want in Web-Based Healthy Lifestyle Interventions: Qualitative Descriptive Study.

BACKGROUND: With the increasing number of older cancer survivors, it is imperative to optimize the reach of interventions that promote healthy lifestyles. Web-based delivery holds promise for increasing the reach of such interventions with the rapid increase in internet use among older adults. However, few studies have explored the views of middle-aged and older cancer survivors on this approach and potential variations in these views by gender or rural and urban residence. OBJECTIVE: The aim of this study was to explore the views of middle-aged and older cancer survivors regarding the features of web-based healthy lifestyle programs to inform the development of a web-based diet and exercise intervention. METHODS: Using a qualitative descriptive approach, we conducted 10 focus groups with 57 cancer survivors recruited from hospital cancer registries in 1 southeastern US state. Data were analyzed using inductive thematic and content analyses with NVivo (version 12.5, QSR International). RESULTS: A total of 29 male and 28 female urban and rural dwelling Black and White survivors, with a mean age of 65 (SD 8.27) years, shared their views about a web-based healthy lifestyle program for cancer survivors. Five themes emerged related to program content, design, delivery, participation, technology training, and receiving feedback. Cancer survivors felt that web-based healthy lifestyle programs for cancer survivors must deliver credible, high-quality, and individually tailored information, as recommended by health care professionals or content experts. Urban survivors were more concerned about information reliability, whereas women were more likely to trust physicians' recommendations. Male and rural survivors wanted information to be tailored to the cancer type and age group. Privacy, usability, interaction frequency, and session length were important factors for engaging cancer survivors with a web-based program. Female and rural participants liked the interactive nature and visual appeal of the e-learning sessions. Learning from experts, an attractive design, flexible schedule, and opportunity to interact with other cancer survivors in Facebook closed groups emerged as factors promoting program participation. Low computer literacy, lack of experience with web program features, and concerns about Facebook group privacy were important concerns influencing cancer survivors' potential participation. Participants noted the importance of technology training, preferring individualized help to standardized computer classes. More rural cancer survivors acknowledged the need to learn how to use computers. The receipt of regular feedback about progress was noted as encouragement toward goal achievement, whereas women were particularly interested in receiving immediate feedback to stay motivated. CONCLUSIONS: Important considerations for designing web-based healthy lifestyle interventions for middle-aged and older cancer survivors include program quality, participants' privacy, ease of use, attractive design, and the prominent role of health care providers and content experts. Cancer survivors' preferences based on gender and residence should be considered to promote program participation.

Do Wearable Activity Trackers Increase Physical Activity Among Cardiac Rehabilitation Participants? A SYSTEMATIC REVIEW AND META-ANALYSIS.

PURPOSE: The objective of this study was to review randomized controlled trials (RCT), which included a wearable activity tracker in an intervention to promote physical activity among cardiac rehabilitation (CR) participants, and to conduct a meta-analysis for the outcomes of step counts and aerobic capacity (V˙o2max). METHODS: Eight databases were searched for RCTs that included an activity tracker, enrolled adults eligible for CR, and reported outcomes of step count or aerobic capacity. Mean differences were calculated for outcomes in the meta-analyses. RESULTS: Nineteen RCTs with 2429 participants were included in the systematic review and 10 RCTs with 891 participants were included in the meta-analysis. Meta-analysis of three RCTs using a pedometer or accelerometer demonstrated a significant increase in daily step count compared with controls (n = 211, 2587 steps/d [95% CI, 916-5257]; I2 = 74.6% and P = .002). Meta-analysis of three RCTs using a pedometer or accelerometer intervention demonstrated a significant increase in V˙o2max compared with controls (n = 260, 2.6 mL/min/kg [95% CI, 1.6-3.6]; I2 = 0.0% and P < .0001). Meta-analysis of four RCTs using a heart rate monitor demonstrated a significant increase in V˙o2max compared with controls (n = 420, 1.4 mL/min/kg [95% CI, 0.4-2.3]; I2 = 0.0% and P = .006). CONCLUSIONS: Use of activity trackers among CR participants was associated with significant increases in daily step count and aerobic capacity when compared with controls. However, study size was small and variability in intervention supports the need for larger trials to assess use of activity trackers in CR.

Still striding toward social justice? Redirecting physical activity research in a post-COVID-19 world.

The COVID-19 crisis and parallel Black Lives Matter movement have amplified longstanding systemic injustices among people of color (POC). POC have been differentially affected by COVID-19, reflecting the disproportionate burden of ongoing chronic health challenges associated with socioeconomic inequalities and unhealthy behaviors, including a lack of physical activity. Clear and well-established benefits link daily physical activity to health and well-being-physical, mental, and existential. Despite these benefits, POC face additional barriers to participation. Thus, increasing physical activity among POC requires additional considerations so that POC can receive the same opportunities to safely participate in physical activity as Americans who are White. Framed within the Ecologic Model of Physical Activity, this commentary briefly describes health disparities in COVID-19, physical activity, and chronic disease experienced by POC; outlines underlying putative mechanisms that connect these disparities; and offers potential solutions to reduce these disparities. As behavioral medicine leaders, we advocate that solutions must redirect the focus of behavioral research toward community-informed and systems solutions.

Wearable Technology To Reduce Sedentary Behavior And CVD Risk In Older Adults: A Pilot Randomized Clinical Trial.

BACKGROUND: Physical exercise is associated with decreased cardiovascular disease (CVD) risk, but recent large-scale trials suggest that exercise alone is insufficient to reduce CVD events in high-risk older adults. PURPOSE: This pilot randomized clinical trial aimed to collect critical data on feasibility, safety, and protocol integrity necessary to design a fully powered randomized controlled trial (RCT) and evaluate the impact of combining structured exercise with an intervention designed to enhance non-exercise physical activity (EX+NEPA) compared to EX alone. METHODS: Forty participants aged ≥60 years with moderate-to-high risk of coronary heart disease events were randomly assigned to either the EX+NEPA or EX groups and followed for 20 weeks. Both groups underwent a twice-weekly, 8-week center-based exercise intervention with aerobic and resistance exercises. EX+NEPA group also received a wearable activity tracking device along with behavioral monitoring and feedback throughout the study. Study outcomes were evaluated at 8 and 20 weeks. RESULTS: Data are presented as adjusted mean change of the differences over time with 95% confidence intervals at 20 weeks. Relative to EX, the change in steps/day at 20 weeks was 1994 (-40.27, 4028) higher for EX+NEPA. For sedentary time at close-out, the EX+NEPA group was -6.8 (-45.2, 31.6) min/day relative to EX. The between-group differences for systolic and diastolic blood pressure were -9.9 (-19.6, -0.3) and -1.8 (-6.9, 3.3) mmHg, respectively. CONCLUSION: The addition of wearable technology intervention appeared to positively influence daily activity patterns and changes in blood pressure - potentially improving risk factors for CVD. A fully powered randomized trial is needed to ultimately test this hypothesis.

Rationale and design of a Scale-Up Project Evaluating Responsiveness to Home Exercise And Lifestyle Tele-Health (SUPER-HEALTH) in people with physical/mobility disabilities: a type 1 hybrid design effectiveness trial.

INTRODUCTION: Rates of physical inactivity among people with physical disabilities are substantially higher than in the general population and access to home-based tailored exercise programmes is almost non-existent. Using a theory-driven eHealth platform, an innovative exercise programme referred to as movement-to-music (M2M) will be delivered as a customised, home-based exercise intervention for adults with mobility disabilities. METHODS AND ANALYSIS: Participants are being recruited for this type 1 hybrid design based effectiveness trial through outpatient clinics at a large rehabilitation centre and randomised to one of three groups: (1) M2M, (2) M2M plus social networking (M2Mplus) and (3) attention control (AC). The intervention includes a 12-week adoption phase, 12-week transition phase and 24-week maintenance phase, at which the collection of objective measures on exercise, fitness and self-reported measures on health will be obtained at the start of each phase and at follow-up. The study compares the effectiveness of M2M and M2Mplus in increasing physical activity (primary outcome), adherence, fitness and physical functioning compared with the AC group and examines the mediators and moderators of the treatment effect. ETHICS AND DISSEMINATION: The Institutional Review Board of The University of Alabama at Birmingham granted full approval: (IRB-160923002). Dissemination of findings will include publication in peer-reviewed journals, presentations at regional, national and/or international meetings, and the National Center on Health, Physical Activity and Disability (NCHPAD, www.nchpad.org). This study will strengthen our understanding of the potential benefits of eHealth exercise interventions for people with physical disabilities and build on strategies that aim to recruit larger samples in exercise trials. TRIAL REGISTRATION NUMBER: NCT03024320; Pre-results.

Promotion of physical activity and exercise in multiple sclerosis: Importance of behavioral science and theory.

There is an obvious disconnect between evidence of benefits and rates of participation in exercise and physical activity among people living with multiple sclerosis (MS). We propose that the problem with exercise behavior in MS (i.e. lack of broad or increasing participation by people with MS despite evidence of meaningful benefits) might be ameliorated through the inclusion of behavior change theory in the design of exercise programs and promotion efforts, as has been undertaken in other populations such as breast cancer survivors. This paper reviews Social Cognitive Theory as an example approach for informing interventions for increasing exercise and physical activity behavior outside of MS and provides an overview of current knowledge regarding the application of this theory for physical activity in MS. We then outline future research necessary for informing trials that design, implement, and test theory-based interventions for physical activity promotion in MS. If theories of behavior change are adopted for informing exercise and physical activity research in MS, we can take a major step forward in addressing the problem of exercise and physical activity participation that has plagued the field for more than 25 years.

Telehealth intervention for Latina breast cancer survivors: A pilot.

AIM: This study was a pilot test of the Latina Breast Cancer Survivorship Intervention, a survivorship self-management intervention delivered via telephone. MATERIALS AND METHODS: This study used a wait-list control design with random assignment to either (1) support and early education or (2) support and delayed education. Latina breast cancer survivors were recruited through the Florida Cancer Data System Registry. Latinas with stage I-III breast cancer who completed primary cancer treatment 3 years prior to study enrollment were eligible. The Latina Breast Cancer Survivorship Intervention consisted of three education sessions delivered weekly via telephone and six telephone support calls, both delivered by a native Spanish speaker. Primary outcome variables included physical well-being, emotional well-being, fatigue, pain, and depressive symptoms. Data collection occurred at baseline, 3 months, and 6 months. RESULTS: In total, 40 Latina breast cancer survivors who were middle-aged to older, married, with health insurance, and Spanish as preferred language enrolled in the Latina Breast Cancer Survivorship Intervention. Data were analyzed using mean change scores. Overall, physical and emotional well-being remained similar over time with well-being scores poorer compared with the general population. Pain levels improved over 6 months and showed a high effect size. Fatigue scores improved at 3 months and showed a moderate effect size. Depressive symptoms remained elevated but were not clinically significant. CONCLUSION: Telephone-based Latina Breast Cancer Survivorship Intervention reached Latina breast cancer survivors for survivorship education and support. Self-management of pain and fatigue showed improvement over time.