A Web-Based Mind-Body Intervention (Mindful Steps) for Promoting Walking in Chronic Cardiopulmonary Disease: Insights From a Qualitative Study.

Background: Given the deleterious effects of physical inactivity in persons with chronic obstructive pulmonary disease (COPD) and/or heart failure (HF), interventions that promote long-term daily physical activity are needed. Mindful Steps, designed to promote walking behaviors in COPD and HF, is a multicomponent intervention that integrates mind-body content with other self-regulatory components. The aim of the current qualitative study was to characterize participants' experiences with Mindful Steps and understand the perceived influence of the intervention on walking and health. Method: In the context of a pilot randomized controlled feasibility trial comparing the year-long Mindful Steps program to usual care among individuals with COPD and HF, semi-structured qualitative interviews were administered at 6- and 12-months. Interviews were audio recorded and transcribed. The constant comparative method was used to code transcripts, identify categories, and develop interrelated themes. Results: Nineteen participants (63% female; Mage = 70.2 years, SD = 6.95) who were randomized to the intervention group completed the 6-month interview and 17 completed the 12-month interview. The pedometer with feedback, live group classes, and mind-body videos were described as the most helpful intervention components. Participants learned several strategies that helped their walking (e.g., breathing regulation and awareness, body awareness, mind-body techniques, pacing), described walking as enjoyable, and identified internal reasons for walking (e.g., to feel good). They also reported several physical and mental health benefits of the intervention. Some participants reported limited influence of the intervention on walking or health. Many participants continued to use the strategies they learned in the first half of the intervention at 12-months. Conclusions: The mind-body content of Mindful Steps appeared to positively influence walking behaviors. Participants' experiences with the intervention helped to identify areas for future intervention refinement. Future quantitative work is needed to corroborate these qualitative findings and assess the efficacy of the intervention on long-term physical activity engagement. Trial Registration: This trial is registered in Clinical Trials.gov, ID number NCT01551953.

Day-night patterns in heart rate variability and complexity: differences with age and cardiopulmonary disease.

STUDY OBJECTIVES: Heart rate variability (HRV) measures provide valuable insights into physiology; however, gaps remain in understanding circadian patterns in heart rate dynamics. We aimed to explore day-night differences in heart rate dynamics in patients with chronic cardiopulmonary disease compared with healthy controls. METHODS: Using 24-hour heart rate data from patients with chronic obstructive pulmonary disease (COPD) and/or heart failure (n = 16) and healthy adult controls (older group: ≥50 years, n = 42; younger group: 20-49 years, n = 136), we compared day-night differences in conventional time and frequency domain HRV indices and a multiscale-entropy-based complexity index (CI1-20) of HRV among the 3 groups. RESULTS: Twenty-four-hour HRV showed significant day-night differences (marked with "△") among younger healthy (mean age: 34.5 years), older healthy (mean age: 61.6 years), and cardiopulmonary patients (mean age: 68.4 years), including change in percentage of adjacent intervals that differ > 50 ms (△pNN50), high frequency (△HF), normalized low frequency (△nLF), ratio (△LF/HF), and △CI1-20. Among these, △LF/HF (2.13 ± 2.35 vs 1.1 ± 2.47 vs -0.35 ± 1.25; P < .001) and △CI1-20 (0.15 ± 0.24 vs 0.02 ± 0.28 vs -0.21 ± 0.27; P < .001) were significant in each pairwise comparison following analysis of variance tests. Average CI1-20 was highest in younger healthy individuals and lowest in cardiopulmonary patients (1.37 ± 0.12 vs 1.01 ± 0.27; P < .001). Younger healthy patients showed a heart rate complexity dipping pattern (night < day), older healthy patients showed nondipping, and cardiopulmonary patients showed reverse dipping (night > day). CONCLUSIONS: As measures of 24-hour variability, traditional and complexity-based metrics of HRV exhibit large day-night differences in healthy individuals; these differences are blunted, or even reversed, in individuals with cardiopulmonary pathology. Measures of diurnal dynamics may be useful indices of reduced adaptive capacity in patients with cardiopulmonary conditions. CITATION: Ma Y, Chang M-C, Litrownik D, Wayne PM, Yeh GY. Day-night patterns in heart rate variability and complexity: differences with age and cardiopulmonary disease. J Clin Sleep Med. 2023;19(5):873-882.

Long-term Exercise After Pulmonary Rehabilitation (LEAP): a pilot randomised controlled trial of Tai Chi in COPD.

Mind-body modalities are promising strategies to maintain the benefits gained after completion of conventional pulmonary rehabilitation in persons with COPD. In this pilot randomised controlled study we examined Tai Chi in persons with COPD after completing pulmonary rehabilitation. Participants were randomised 2:2:1 to Tai Chi (TC), usual care (UC) or group walking (GW) for 24 weeks. We assessed feasibility; primary outcome was exercise capacity measured by 6-min walk test (6MWT) distance at 24 weeks. Secondary outcomes included health-related quality of life measured by Chronic Respiratory Questionnaire (CRQ), dyspnoea, mood, stress, social support, self-efficacy, physical activity and exercise engagement. Effect size estimates and estimates from generalised estimating equations were calculated. Ninety-one persons (36 TC, 37 UC, 18 GW) were enrolled, with mean age 69±6 years, 59% male, and forced expiratory volume in 1 s % predicted (FEV1 % pred) 48±19%. There was no difference in adherence and adverse events between groups. There was a small between-group effect size (ES=0.25) in change in 6MWT distance favouring TC compared to UC; 24-week comparison was nonsignificant (p=0.10). There were no differences in secondary outcomes. In exploratory analyses, there was a greater percentage of participants in TC who improved 6MWT distance at 24 weeks, compared to UC, 64% versus 39%, p=0.05. There were higher percentages of participants in TC who improved CRQ Fatigue (59% versus 31%, p=0.02) and CRQ Mastery (47% versus 20%, p=0.01) domain scores, compared to UC. For GW, there were no differences compared with TC. Tai Chi may be a feasible option to maintain the benefits gained after completing conventional pulmonary rehabilitation.

Exploring Tai Chi Exercise and Mind-Body Breathing in Patients with COPD in a Randomized Controlled Feasibility Trial.

In this pilot feasibility randomized controlled trial, participants with moderate to severe COPD were randomized to a 12-week tai chi or MBB intervention. Participants were assessed at baseline, 12 weeks, and 24 weeks. Feasibility, as assessed by intervention adherence, was the primary outcome. We also estimated preliminary between-group differences in COPD symptoms and health-related quality of life, cognitive-emotional function, and functional status across three timepoints: baseline, 12, and 24 weeks. A total of 92 participants were randomized 2:1 to tai chi (n = 61) or MBB (n = 31). The overall group adherence in the first 12 weeks was 62% in tai chi and 75% in MBB. From baseline to 12 weeks, tai chi demonstrated greater improvements in depressive symptoms (Cohen's d effect size (ES) = -.53; adj mean diff = -2.31 [-5.7, 1.07]), 6-minute walk test distance (ES = .47; adj mean diff = 62.04 [2.85, 121.22]), social support (ES = .36; adj mean diff = .19 [-0.11, 0.49]) and chair stand (ES = .44; adj mean diff = .91 [-0.05, 1.86]). Only improvements in social support were maintained at 24-week follow-up. Tai chi and MBB are feasible for individuals with COPD. Preliminary effects suggest that while our mindful breathing intervention may not be sufficient to impact outcomes, tai chi may result in short-term benefits in mood, social support and functional capacity. More work is needed to better understand mindful breathing for COPD and to examine methods for maintaining improvements from tai chi over time.Supplemental data for this article is available online at https://doi.org/10.1080/15412555.2021.1928037 .

Managing the experience of breathlessness with Tai Chi: A qualitative analysis from a randomized controlled trial in COPD.

PURPOSE: Chronic obstructive pulmonary disease (COPD) is associated with dyspnea, decreased physical activity, and reduced quality-of-life. While pulmonary rehabilitation is helpful, maintenance of physical activity afterwards is problematic. We sought to explore qualitatively the multi-dimensional, biopsychosocial experience of patients with COPD who participated in Tai Chi (TC) vs. group walking to facilitate physical activity after pulmonary rehabilitation). METHODS: We analyzed semi-structured qualitative exit interviews (N = 81) from a randomized controlled trial comparing 6-months TC with a time-matched group walking intervention and usual care control (UC). Transcripts were reviewed by at least 2 independent reviewers utilizing a social constructivist framework and theoretical sampling approach. An in-depth analysis of an exemplar subset was performed to thematic saturation and captured emergent themes within and between groups. RESULTS: Focused analysis was conducted on 54 transcripts (N = 21 TC, N = 16 Walking, N = 17 UC). Participants were characterized by mean age 68.5 (±8.3) years, GOLD Stage = 3.0 (IQR 2.0-3.0), baseline FEV1 percent predicted 48.8% (±16.4), and 48.2% female. We identified predominant themes of breathlessness, and associated fear and embarrassment that limited physical activity across all groups. In both TC and walking, participants reported improvements in energy and endurance. Those in TC additionally shared improvements in breathing, mobility, and capacity for daily activities facilitated by body and breath awareness, emotional control and regulation of breathing, and an adaptive reframing of breathlessness. CONCLUSION: TC promoted physical and mental wellbeing by diminishing fear and embarrassment associated with breathlessness. Results highlight the multimodal characteristics of TC that may facilitate continued physical activity and improvement in quality of life.

Development of a Novel Intervention (Mindful Steps) to Promote Long-Term Walking Behavior in Chronic Cardiopulmonary Disease: Protocol for a Randomized Controlled Trial.

BACKGROUND: Despite current rehabilitation programs, long-term engagement in physical activity remains a significant challenge for patients with chronic obstructive pulmonary disease (COPD) and heart failure (HF). Novel strategies to promote physical activity in these populations are greatly needed. Emerging literature on the benefits of both mind-body interventions and web-based interventions provide the rationale for the development of the Mindful Steps intervention for increasing walking behavior. OBJECTIVE: This study aims to develop a novel multimodal mind-body exercise intervention through adaptation of an existing web-based physical activity intervention and incorporation of mind-body exercise, and to pilot test the delivery of the new intervention, Mindful Steps, in a randomized controlled feasibility trial in older adults with COPD and/or HF. METHODS: In phase 1, guided by a theoretical conceptual model and review of the literature on facilitators and barriers of physical activity in COPD and HF, we convened an expert panel of researchers, mind-body practitioners, and clinicians to inform development of the novel, multimodal intervention. In phase 2, we are conducting a pilot randomized controlled feasibility trial of the Mindful Steps intervention that includes in-person mind-body exercise classes, an educational website, online mind-body videos, and a pedometer with step-count feedback and goals to increase walking behavior in patients with COPD and/or HF. Outcomes include feasibility measures as well as patient-centered measures. RESULTS: The study is currently ongoing. Phase 1 intervention development was completed in March 2019, and phase 2 data collection began in April 2019. CONCLUSIONS: Through the integration of components from a web-based physical activity intervention and mind-body exercise, we created a novel, multimodal program to impact long-term physical activity engagement for individuals with COPD and HF. This developmental work and pilot study will provide valuable information needed to design a future clinical trial assessing efficacy of this multimodal approach. TRIAL REGISTRATION: ClinicalTrials.gov NCT03003780; https://clinicaltrials.gov/ct2/show/NCT03003780. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/27826.

The impact of Tai Chi and mind-body breathing in COPD: Insights from a qualitative sub-study of a randomized controlled trial.

PURPOSE: Chronic obstructive pulmonary disease (COPD) is associated with multiple psychosocial and behavioral factors. Prior research suggests that mind-body interventions may support the development and maintenance of healthy behaviors and improve health-related quality-of-life in such patients. We sought to qualitatively explore cognitive, psychosocial, and behavioral changes in patients with COPD who participated in two different mind-body interventions compared to an education control. METHODS: We analyzed semi-structured qualitative exit interviews from a prospective, randomized pilot trial (N = 123) investigating 12-weeks of Tai Chi (TC) vs. mind-body breathing (MBB) vs. education (EDU) control in patients with moderate-severe COPD. TC involved traditional movements, that integrate meditative breathing, while MBB focused mainly on meditative breathing techniques alone. Interviews were audio-recorded and transcribed verbatim. Qualitative analysis of randomly selected transcripts was performed by two independent reviewers using an iterative process to identify emergent themes informed by grounded theory methods until thematic saturation was reached. RESULTS: A total of 66 transcripts were reviewed (N = 22 TC, N = 22 MBB, N = 22 EDU). Participants were mean age = 68.1 years, GOLD Stage = 2.3, baseline FEV11 percent predicted mean (SD): 58% (13.4), 42.4% female. We identified six frequently mentioned themes: 1) overall awareness and understanding, 2) self-care knowledge, skills and behaviors, 3) behavior-related neurocognitive concepts, 4) physical function, 5) psychological well-being, and 6) social support/social function. Compared to EDU, more participants in TC and MBB noted improvements in awareness of self and the mind-body connection (e.g., body and breath awareness), knowledge of breathing techniques and integration of self-care skills with daily activities, self-efficacy for symptom management (particularly managing anxiety and dyspnea), acceptance of disease, physical function improvements (e.g., endurance, dyspnea, fatigue), and psychological well-being (particularly relaxation, emotion regulation and decreased reactivity). Compared to MBB, those in TC shared more intention to continue with self-care behaviors, physical activity self-efficacy, and improved flexibility. All three groups, including EDU, noted increased social support and knowledge of disease. Those in EDU, however, had fewer mentions of processes related to behavior change, and less concrete changes in neurocognitive, psychological, and physical function domains. CONCLUSIONS: Mind-body interventions including meditative breathing may impact behavior-related neurocognitive and emotional factors that improve self-care management and support positive behavioral changes in patients with COPD. TRIAL REGISTRATION: This trial is registered in Clinical Trials.gov, ID number NCT01551953.

BEAM study (Breathing, Education, Awareness, Movement): a randomised controlled feasibility trial of tai chi exercise in patients with COPD.

BACKGROUND: Despite therapeutic advances, the management of chronic obstructive pulmonary disease (COPD) remains complex. There is growing interest in multidimensional, mind-body exercises to improve both physical and psychosocial aspects of COPD burden. Few US data are available in this population on tai chi (TC) a mind-body exercise incorporating physical activity, breathing and mindful awareness. We explored feasibility and preliminary efficacy of TC in COPD in an US academic medical setting. METHODS: Patients with COPD Global Obstructive Lung Disease (GOLD) stages 2-4 were randomised to a 12-week TC programme or education control. At 12 weeks, those in TC were randomised again to continue in maintenance classes or not to further explore optimal duration. All groups were followed to 24 weeks. Feasibility/safety parameters were analysed descriptively. Preliminary between-group differences were estimated in symptoms (dyspnoea, fatigue), health-related quality-of-life (Chronic Respiratory Questionnaire CRQ), cognitive-emotional measures (mood, COPD self-efficacy) and functional status (6 min walk test, lower body strength, flexibility, physical activity). RESULTS: Ninety-two subjects were randomised (N=61 TC, N=31 education). Mean age was 68±8 years, 66% male, mean forced expiratory volume in 1 s % predicted 57±13, 28% were GOLD stage 3-4. Overall retention was 85%. Nineteen adverse events occurred, most being study-unrelated COPD exacerbations. From baseline to 12 weeks, there were between-group improvements favouring TC, in CRQ-total (Cohen's d effect size (ES)=0.46; adj mean diff (AMD)=0.31), CRQ-emotion (ES=0.54; AMD=0.49), Centre for Epidemiologic Studies Depression (ES=-0.37; AMD=2.39) and Patient-Reported Outcome Measurement Information System (PROMIS)-fatigue (ES=-0.34; AMD=-0.17). From baseline to 24 weeks, there was an improvement favouring TC in CRQ-dyspnoea (ES=0.41; AMD=0.46). Among TC participants, there was a positive effect of maintenance classes on self-efficacy (ES=-0.69; AMD=-0.40), 6 min walk (ES=0.56; AMD=49.26 feet), PROMIS-fatigue (ES=-0.41; AMD=-0.28) and chair stand (0.43; AMD=0.56). CONCLUSION: TC in patients with COPD is feasible and safe. Preliminary analyses support a potential modest role in improving quality-of-life, cognitive-emotional health and function that should be further studied. TRIAL REGISTRATION NUMBER: NCT01551953. IRB REFERENCE: BIDMC 2010P-000412; VA 2540.

Reporting of Protocol Rationale and Content Validity in Randomized Clinical Trials of T'ai Chi: A Systematic Evaluation.

BACKGROUND: Mind-body exercise interventions are typically multimodal, complex, and pluralistic, and few have been developed with the goal of therapeutically targeting a specific medical population. It is thus important that clinical trials evaluating mind-body interventions provide some justification for the use of the specific protocol being evaluated. OBJECTIVES: This article reports the results of a systematic review of the quality of reporting of protocol rationale and content validity for using a specific t'ai chi protocol in a randomized controlled trial (RCT). METHODS: Electronic literature searches were conducted using PubMed/MEDLINE, EBSCOhost, and the Cochrane Library from inception through June 2015. Search terms were Tai Chi, Taiji, Tai Chi Chuan; searches were limited to English-language RCTs. Inclusion and exclusion of trials were reported in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. The authors assessed the level of reporting with respect to t'ai chi protocol validation using a 5-point grading system based on whether (1) a specific protocol was mentioned, (2) rationale for the specific protocol was stated and supported, and (3) formal evaluation for content validity was conducted. RESULTS: There was significant heterogeneity in the quality of reporting related to protocol rationale and content validity. A total of 171 publications were identified. Studies met between 0 and 4 validity criteria (of possible 5, more indicating better quality), with a mean of 2.52 (±SD 1.2) and median of 3. Twenty (12%) trials did not mention a specific t'ai chi protocol, 10 (6%) trials met 0 of 5 criteria, and 47 (31%) studies met 4 of 5 criteria. Formal validity assessments were employed in only one trial. CONCLUSIONS: The poor quality of protocol rationale and content validity reporting limits our ability to accurately evaluate the evidence of t'ai chi as a therapeutic intervention. The development of formal guidelines for developing and reporting intervention validity for multimodal mind-body exercises like t'ai chi may improve the quality and interpretability of research.

Long-term Exercise After Pulmonary Rehabilitation (LEAP): Design and rationale of a randomized controlled trial of Tai Chi.

BACKGROUND: Persons with chronic obstructive pulmonary disease (COPD) have reduced exercise capacity and levels of physical activity. Supervised, facility-based pulmonary rehabilitation programs improve exercise capacity and reduce dyspnea, but novel long-term strategies are needed to maintain the benefits gained. Mind-body modalities such as Tai Chi which combine aerobic activity, coordination of breathing, and cognitive techniques that alleviate the physical inactivity, dyspnea, and anxiety and depression that are the hallmarks of COPD are promising strategies. METHODS/DESIGN: We have designed a randomized controlled study to examine whether Tai Chi will maintain exercise capacity in persons with COPD who have recently completed a supervised pulmonary rehabilitation program, compared to standard care. The primary outcome is 6-min walk test distance at 6 months. Secondary outcomes include health-related quality of life, dyspnea, mood, occurrence of acute exacerbations, engagement in physical activity, exercise self-efficacy, and exercise adherence. Simultaneously, we are conducting a pilot study of group walking. We will enroll 90 persons who will be randomized to one of three arms in a 2:2:1 ratio: Tai Chi, standard care, or group-based walking. DISCUSSION: The Long-term Exercise After Pulmonary Rehabilitation (LEAP) study is a novel and clinically relevant trial. We will enroll a well-characterized cohort of persons with COPD and will comprehensively assess physiological and psychosocial outcomes. Results of this study will provide the evidence base for persons with COPD to engage in Tai Chi as a low-cost, long-term modality to sustain physical activity in persons who have completed a standard short-term pulmonary rehabilitation program. TRIAL REGISTRATION: This trial is registered in Clinical Trials.gov, with the ID number of NCT01998724.

Tai chi mind-body exercise in patients with COPD: study protocol for a randomized controlled trial.

BACKGROUND: Chronic obstructive pulmonary disease (COPD) is a chronic, progressively debilitating condition that is prevalent in the US and worldwide. Patients suffer from progressive dyspnea and exercise intolerance. Physical exercise is beneficial, but conventional pulmonary rehabilitation programs are underutilized. There remains a need for novel interventions that improve symptoms, quality-of-life, and functional capacity. Tai chi is an increasingly popular mind-body exercise that includes physical exercise, breathing training, mindful awareness, and stress management--components that are essential to the self-management of COPD. There are, however, limited data on the effectiveness of tai chi as a therapeutic intervention in this population. METHODS/DESIGN: The Primary Aims are to evaluate the efficacy, safety, and feasibility of a 12-week tai chi program for patients with COPD. We utilize a randomized controlled trial design, with participants assigned in a 2:1 ratio to either a group tai chi program (N = 63) or a time/attention-matched education control (N = 31). Our primary outcomes are COPD-specific quality-of-life and exercise capacity. Secondary outcomes include dyspnea, mood, functional status, self-efficacy, and lung function. Cardiopulmonary exercise testing is done in a subset of patients (N = 50). To explore optimal training duration, a subgroup of patients in tai chi are randomly assigned to complete an additional 12 weeks training (total 24 weeks) (Exploratory Aim 1). To explore the impact of a simplified seated intervention including only a subset of tai chi's training components, a third randomly assigned group (N = 31) receives a 12- week mind-body breathing program (N = 31) (Exploratory Aim 2). DISCUSSION: Results of the BEAM study (Breathing, Education, Awareness, Movement) will provide preliminary evidence regarding the value of tai chi for improving quality of life and exercise capacity in patients with COPD, including information regarding optimal duration. They will also inform the feasibility and potential benefit of an alternative mind-body breathing intervention, and provide insight regarding how isolated mind-body exercise components contribute to the overall effects of tai chi. Should the results be positive, tai chi and related mind-body practices may offer a novel exercise option that is potentially accessible to a large proportion of patients with COPD. TRIAL REGISTRATION: This trial is registered in Clinical Trials.gov, ID number NCT01551953. Date of Registration March 1 2012.

What do we really know about the safety of tai chi?: A systematic review of adverse event reports in randomized trials.

OBJECTIVE: To systematically review the frequency and quality of adverse event (AE) reports in randomized controlled trials (RCTs) of tai chi (TC). DATA SOURCES: Electronic searches of PubMed/MEDLINE and additional databases from inception through March 2013 of English-language RCTs. Search terms included tai chi, taiji, and tai chi chuan. Data were independently extracted by 2 investigators. STUDY SELECTION: We included all available RCTs that were published in English and used TC as an intervention. Inclusion and exclusion criteria of studies were reported in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. DATA EXTRACTION: Eligible RCTs were categorized with respect to AE reporting: no mention of protocol for monitoring AEs or reports of AEs, and reports of AEs either with or without explicit protocol for monitoring AEs. DATA SYNTHESIS: There were 153 eligible RCTs identified; most targeted older adults. Only 50 eligible trials (33%) included reporting of AEs; of these, only 18 trials (12% overall) also reported an explicit AE monitoring protocol. Protocols varied with respect to the rigor of systematic monitoring in both the TC and comparison groups. Reported AEs were typically minor and expected and primarily musculoskeletal related (eg, knee and back pain); no intervention-related serious AEs were reported. CONCLUSIONS: TC is unlikely to result in serious AEs, but it may be associated with minor musculoskeletal aches and pains. However, poor and inconsistent reporting of AEs greatly limits the conclusions that can be drawn regarding the safety of TC.