Prevention of Chemotherapy-Induced Peripheral Neuropathy With PRESIONA, a Therapeutic Exercise and Blood Flow Restriction Program: A Randomized Controlled Study Protocol.

OBJECTIVE: This trial will analyze the acute and cumulative effects of a tailored program called PRESIONA that combines therapeutic exercise and blood flow restriction to prevent chemotherapy-induced peripheral neuropathy (CIPN) in individuals with early breast cancer undergoing neoadjuvant chemotherapy. METHODS: PRESIONA will be a physical therapist-led multimodal exercise program that uses blood flow restriction during low-load aerobic and strength exercises. For the acute study, only 1 session will be performed 1 day before the first taxane cycle, in which 72 women will be assessed before intervention and 24 hours post intervention. For the cumulative study, PRESIONA will consist of 24 to 36 sessions for 12 weeks following an undulatory prescription. At least 80 women will be randomized to the experimental group or control group. Feasibility will be quantified based on the participant recruitment to acceptance ratio; dropout, retention, and adherence rates; participant satisfaction; tolerance; and program security. In the efficacy study, the main outcomes will be CIPN symptoms assessed with a participant-reported questionnaire (EORTC QLQ-CIPN20). In addition, to determine the impact on other participant-reported health and sensorimotor and physical outcomes, the proportion of completed scheduled chemotherapy sessions will be examined at baseline (t0), after anthracycline completion (t1), after intervention (t2), and at the 2-month (t3) and 1-year follow-ups (t4). CONCLUSION: The proposed innovative approach of this study could have a far-reaching impact on therapeutic options, and the physical therapist role could be essential in the oncology unit to improve quality of life in individuals with cancer and reduce side effects of cancer and its treatments. IMPACT: Physical therapists in the health care system could be essential to achieve the planned doses of chemotherapy to improve survival and decrease the side effects of individuals with breast cancer. The prevention of CIPN would have an impact on the quality of life in these individuals, and this protocol potentially could provide an action guide that could be implemented in any health care system.

A Web-Based Exercise System (e-CuidateChemo) to Counter the Side Effects of Chemotherapy in Patients With Breast Cancer: Randomized Controlled Trial.

BACKGROUND: Breast cancer patients have to face a high-risk state during chemotherapy, which involves deterioration of their health including extensive physical deterioration. Face-to-face physical exercise programs have presented low adherence rates during medical treatment, and telehealth systems could improve these adherence rates. OBJECTIVE: This study aimed to evaluate the effectiveness of a Web-based exercise program (e-CuidateChemo) to mitigate the side effects of chemotherapy on the physical being, anthropometric aspects, and body composition. METHODS: A total of 68 patients diagnosed with breast cancer, who were undergoing chemotherapy, were enrolled. The patients were categorized into two groups: e-CuidateChemo (n=34) and controls (n=34). The e-CuidateChemo group participated in an adapted 8-week tailored exercise program through a Web-based system. A blinded, trained researcher assessed functional capacity, strength, anthropometric parameters, and body composition. The intervention effects were tested using analysis of covariance and Cohen d tests. RESULTS: Functional capacity improved significantly in the e-CuidateChemo group compared to the control group (6-minute walk test: 62.07 [SD 130.09] m versus -26.34 [SD 82.21] m; 6-minute walk test % distance predicted: 10.81% [SD 22.69%] m versus -4.60% [SD 14.58%]; between-group effect: P=.015 for both). The intervention group also showed significantly improved secondary outcomes such as between-group effects for abdominal (24.93 [SD 26.83] s vs -18.59 [SD 38.69] s), back (12.45 [SD 10.20] kg vs 1.39 [10.72] kg), and lower body (-2.82 [SD 3.75] s vs 1.26 [SD 2.84] s) strength; all P<.001 compared to the control group. CONCLUSIONS: This paper showed that a Web-based exercise program was effective in reversing the detriment in functional capacity and strength due to chemotherapy. TRIAL REGISTRATION: ClinicalTrials.gov NCT02350582; https://clinicaltrials.gov/ct2/show/NCT02350582.

Factors that Explain the Cancer-Related Insomnia.

A better understanding of cancer related insomnia and its relationship with other associated factors is necessary to improve its management. To clarify the relationship between insomnia and treatment related variables, sociodemographic data, health related fitness, pain, anxiety, and depression in breast cancer patients. One hundred twenty-three patients participated in this cross-sectional study. As a primary variable was insomnia using The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 version. Other variables included: stage of treatment, type of treatment, multiple sit to stand test, trunk curl test, 6-min walk test, back muscle strength test, the Brief Pain Inventory short form and the Hospital Anxiety and Depression Scale. Insomnia was negatively associated with the treatment stage (p = 0.01), the 6-min walk test (p = 0.01) and the back muscle strength test (p = 0.01), while it was positively associated with the type of treatment (p = 0.01) and the multiple sit-to-stand test (p = 0.05). In addition, higher levels of insomnia were associated with higher scores on the Brief Pain Inventory short form (p = 0.01) and the Hospital Anxiety and Depression Scale (p = 0.01). Anxiety, type of treatment, back muscle strength, pain severity and stage of treatment were predictors of insomnia, and when they were combined they explained 51.2% of insomnia in our sample. The variability in insomnia related breast cancer is explained by anxiety, type of treatment, pain, treatment stage, and back muscle strength. Clinicians should take these results into account when generating cancer care programs to control pain and health-related-fitness (Registration of Trials NCT01801527).

Telehealth system: A randomized controlled trial evaluating the impact of an internet-based exercise intervention on quality of life, pain, muscle strength, and fatigue in breast cancer survivors.

BACKGROUND: The chronicity status of breast cancer survivors suggests a growing need for cancer rehabilitation. Currently, the use of technology is a promising strategy for providing support, as reflected in the emergence of research interest in Web-based interventions in cancer survivorship. METHODS: A randomized controlled trial was conducted that included a total of 81 participants who had completed adjuvant therapy (except hormone treatment) for stage I to IIIA breast cancer. Participants were randomly assigned to an 8-week Internet-based, tailored exercise program (n = 40) or to a control group (n = 41).The instruments used at baseline, 8 weeks, and 6-month follow-up were the European Organization for Research and Treatment of Cancer Quality-of-Life Questionnaire Core 30 and its breast cancer module, the Brief Pain Inventory, the handgrip dynamometer, the isometric abdominal test, the back dynamometer, the multiple sit-to-stand test, and the Piper Fatigue Scale. RESULTS: After the intervention, the telerehabilitation group had significantly improved scores for global health status, physical, role, cognitive functioning, and arm symptoms (all P < .01) as well as pain severity (P = .001) and pain interference (P = .045) compared with the control group. Significant improvements also were observed favoring the telerehabilitation group for affected and nonaffected side handgrip (both P = .006), abdominal, back and lower body strength (all P < .01), and total fatigue (P < .001). These findings were maintained after 6 months of follow-up, except for role functioning, pain severity, and nonaffected side handgrip. Analysis was based on an intention-to-treat principle. CONCLUSIONS: This program may improve adverse effects and maintain benefits in breast cancer survivors. The results of this study have encouraging implications for cancer care. Cancer 2016;122:3166-74. © 2016 American Cancer Society.

The Six-Minute Walk Test as a Measure of Health in Breast Cancer Patients.

This study examined the relationship between the 6-min walk test (6MWT) and fitness, psychological and physiologic states, quality of life, cancer-related symptoms, and body composition of 87 women with breast cancer. The assessment included the 6MWT and evaluations of Cancer Quality of Life (EORTC C-30 and EORTC BR-23), cognitive performance (Trail Making Test), the Hospital Anxiety and Depression Scale, body composition, health-related fitness (abdominal test, multiple sit-to-stand test, trunk dynamometry), and pain (Brief Pain Inventory). We observed the following correlations: moderate between 6MWT and pain interference; modest for cognitive and social functioning and the multiple sit-to-stand test; fair for several items on the Cancer Quality of Life, for anxiety, lean body mass, trunk dynamometry and pain intensity; and weak for role functioning, loss of appetite, cognitive performance and depression. Thus, the 6MWT could be used as a measure of the major components of global health in women with breast cancer.

Depressed mood in breast cancer survivors: associations with physical activity, cancer-related fatigue, quality of life, and fitness level.

PURPOSE: One out of five cancer survivors suffer from depression after oncology treatment. The aim of this study was to examine the relationship between depression and quality of life (QoL), cancer-related symptoms, physical activity level, health-related fitness, and salivary flow rate in breast cancer survivors. METHOD: 108 breast cancer survivors in the year after the conclusion of treatment were included in this cross-sectional study. Demographic and clinically relevant information, cancer-related fatigue (Piper Fatigue Scale), QoL (QLQ-Br23 module), pain intensity VAS scale, salivary flow rate, physical activity level (Minnesota Leisure Time Physical Activity Questionnaire), and health-related fitness were assessed in all participants. Depressed mood was measured with the Profile of Mood States (POMS) Depression subscale. RESULTS: Significant positive correlations between depressed mood and fatigue, systemic side effects, perceived shoulder pain, and breast-arms symptoms (r ranged between .57 and .28, P < .01) were found. In addition, significant negative correlations between depressed mood and body image, future perspective, force handgrip, and physical activity level (r ranged between -.41 and -.19; p < .05) were found. Regression analyses revealed that cancer-related fatigue, physical activity level, systemic side effects, and body image were significant predictors of depressed mood, and when combined, they explained 39.6% of the variance in depressed mood. CONCLUSIONS: Cancer-related fatigue, physical activity level, and QoL partially explain the variability of depressed mood in breast cancer survivors. This paper facilitates a better understanding of the relationship between depressed mood and possible factors associated with it.

Telehealth system (e-CUIDATE) to improve quality of life in breast cancer survivors: rationale and study protocol for a randomized clinical trial.

BACKGROUND: Breast cancer survivors suffer physical impairment after oncology treatment. This impairment reduces quality of life (QoL) and increase the prevalence of handicaps associated to unhealthy lifestyle (for example, decreased aerobic capacity and strength, weight gain, and fatigue). Recent work has shown that exercise adapted to individual characteristics of patients is related to improved overall and disease-free survival. Nowadays, technological support using telerehabilitation systems is a promising strategy with great advantage of a quick and efficient contact with the health professional. It is not known the role of telerehabilitation through therapeutic exercise as a support tool to implement an active lifestyle which has been shown as an effective resource to improve fitness and reduce musculoskeletal disorders of these women. METHODS / DESIGN: This study will use a two-arm, assessor blinded, parallel randomized controlled trial design. People will be eligible if: their diagnosis is of stages I, II, or IIIA breast cancer; they are without chronic disease or orthopedic issues that would interfere with ability to participate in a physical activity program; they had access to the Internet and basic knowledge of computer use or living with a relative who has this knowledge; they had completed adjuvant therapy except for hormone therapy and not have a history of cancer recurrence; and they have an interest in improving lifestyle. Participants will be randomized into e-CUIDATE or usual care groups. E-CUIDATE give participants access to a range of contents: planning exercise arranged in series with breathing exercises, mobility, strength, and stretching. All of these exercises will be assigned to women in the telerehabilitation group according to perceived needs. The control group will be asked to maintain their usual routine. Study endpoints will be assessed after 8 weeks (immediate effects) and after 6 months. The primary outcome will be QoL measured by The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 version 3.0 and breast module called The European Organization for Research and Treatment of Cancer Breast Cancer-Specific Quality of Life questionnaire. The secondary outcomes: pain (algometry, Visual Analogue Scale, Brief Pain Inventory short form); body composition; physical measurement (abdominal test, handgrip strength, back muscle strength, and multiple sit-to-stand test); cardiorespiratory fitness (International Fitness Scale, 6-minute walk test, International Physical Activity Questionnaire-Short Form); fatigue (Piper Fatigue Scale and Borg Fatigue Scale); anxiety and depression (Hospital Anxiety and Depression Scale); cognitive function (Trail Making Test and Auditory Consonant Trigram); accelerometry; lymphedema; and anthropometric perimeters. DISCUSSION: This study investigates the feasibility and effectiveness of a telerehabilitation system during adjuvant treatment of patients with breast cancer. If this treatment option is effective, telehealth systems could offer a choice of supportive care to cancer patients during the survivorship phase. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT01801527.

Water versus land-based multimodal exercise program effects on body composition in breast cancer survivors: a controlled clinical trial.

GOALS OF WORK: Our aim was to compare the effects of land versus water multimodal exercise programs on body composition and breast cancer-specific quality of life in breast cancer survivors. PATIENTS AND METHODS: Ninety-eight breast cancer survivors were assigned to three groups: control, land exercise, and water exercise. Both exercise groups participated in an 8-week multimodal program. Adiposity was measured by anthropometry (body mass index, waist circumference) and bioelectrical impedance (body fat and muscle lean body mass). Incidence of clinically significant secondary lymphedema was also assessed. Finally, specific quality of life was assessed using the European Organization for Research and Treatment of Cancer Quality of Life BR-23. MAIN RESULTS: Using ANCOVA, significant group × time interactions for body fat percentage (F = 3.376; P = 0.011) and lean body mass (F = 3.566; P = 0.008) were found. Breast cancer survivors in the land exercise group exhibited a greater decrease in percentage of body fat than those in the water exercise (P < 0.001) and control (P = 0.002) groups. The ANCOVA revealed a significant group × time interaction for waist circumference (F = 4.553; P = 0.002): breast cancer survivors in the control group showed a greater waist circumference when compared to water (P = 0.003) and land (P < 0.001) exercise groups. A significant group × time interaction was also found for breast symptoms (F = 9.048; P < 0.001): participants in the water exercise group experienced a greater decrease of breast symptoms than those in the land exercise (P < 0.01) and control (P < 0.05) groups. CONCLUSION: Land exercise produced a greater decrease in body fat and an increase in lean body mass, whereas water exercise was better for improving breast symptoms.

Psychophysiological effects of preperformance massage before isokinetic exercise.

Sports massage provided before an activity is called pre-event massage. The hypothesized effects of pre-event massage include injury prevention, increased performance, and the promotion of a mental state conducive to performance. However, evidence with regard to the effects of pre-event massage is limited and equivocal. The exact manner in which massage produces its hypothesized effects also remains a topic of debate and investigation. This randomized single-blind placebo-controlled crossover design compared the immediate effects of pre-event massage to a sham intervention of detuned ultrasound. Outcome measures included isokinetic peak torque assessments of knee extension and flexion; salivary flow rate, cortisol concentration, and α-amylase activity; mechanical detection thresholds (MDTs) using Semmes-Weinstein monofilaments and mood state using the Profile of Mood States (POMS) questionnaire. This study showed that massage before activity negatively affected subsequent muscle performance in the sense of decreased isokinetic peak torque at higher speed (p < 0.05). Although the study yielded no significant changes in salivary cortisol concentration and α-amylase activity, it found a significant increase in salivary flow rate (p = 0.03). With the massage intervention, there was a significant increase in the MDT at both locations tested (p < 0.01). This study also noted a significant decrease in the tension subscale of the POMS for massage as compared to placebo (p = 0.01). Pre-event massage was found to negatively affect muscle performance possibly because of increased parasympathetic nervous system activity and decreased afferent input with resultant decreased motor-unit activation. However, psychological effects may indicate a role for pre-event massage in some sports, specifically in sportspeople prone to excessive pre-event tension.