Integrated Walking + Tai Chi for COPD

(WATCH for Pain Trial)

Recruiting in Palo Alto (17 mi)

Overseen by Marilyn L Moy, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: VA Office of Research and Development

Disqualifiers: Unstable cardiovascular, High fall risk, others

No Placebo Group

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?

Persons with COPD benefit from being physically active, but they are often limited by chronic musculoskeletal pain. This project will determine whether a non-pharmacologic, integrated, technology-mediated walking and Tai Chi mindfulness intervention can improve physical function in Veterans with COPD and chronic musculoskeletal pain. The proposed research addresses VA Rehabilitation R\&D Service's high priority area of improving health-related quality of life by reducing disease burden and maximizing function in Veterans with chronic disease.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your healthcare provider.

What data supports the effectiveness of the treatment Every Step Counts-Tai Chi, Tai Chi, Tai Chi Qigong for COPD?

Research shows that Tai Chi can help improve exercise capacity and quality of life for people with COPD. Studies found that Tai Chi participants had better walking distances and reported less fatigue compared to those receiving usual care. ^{1 2 3 4 5}

Is Tai Chi safe for people with COPD?

Research shows that Tai Chi, including its variations like Tai Chi Qigong, is generally safe for people, including those with COPD. Studies have not reported significant adverse events, suggesting it is a safe exercise option. ^{5 6 7 8 9}

How does the treatment 'Every Step Counts-Tai Chi' differ from other treatments for COPD?

The 'Every Step Counts-Tai Chi' treatment is unique because it combines Tai Chi, a traditional Chinese mind-body exercise, with walking to improve lung function, exercise capacity, and quality of life in COPD patients. Unlike standard drug treatments, this approach focuses on physical movement and mental relaxation, offering a holistic alternative to enhance both physical and mental health. ^{3 4 9 10 11}

Eligibility Criteria

This trial is for Veterans aged 40+ with COPD who have smoked more than the equivalent of 10 packs of cigarettes a year and suffer from chronic musculoskeletal pain. They must be able to walk, use a computer or smartphone, and not be in another exercise program or dealing with unstable heart conditions.

Inclusion Criteria

I have been diagnosed with COPD, smoked more than 10 pack-years, and have specific breathing test results or CT scan findings.

Have access to a computer or smartphone with Internet connection or willing to come to study site to use study computers

I have had pain rated above 3 for more than 3 months.

Exclusion Criteria

I can't provide step counts for at least 7 out of 10 days.

You are not able to fill out the surveys and questionnaires.

I have had a worsening of my COPD in the last month.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the ESC-TC intervention, a web-based platform to promote walking combined with pain management content, an online Tai Chi video library, and synchronous Tai Chi classes led by an instructor via teleconference

6 months

Assessments at baseline, 2, 4, and 6 months

Follow-up

Participants are monitored for long-term effects of the ESC-TC intervention on symptoms and risk of acute exacerbations and COPD-related hospitalizations

6 months

Assessment at 12 months for a subset of participants

Treatment Details

Interventions

• Every Step Counts-Tai Chi (Behavioural Intervention)

Trial Overview The study tests if walking combined with Tai Chi (Every Step Counts-Tai Chi), facilitated by technology, can improve physical function compared to usual care in those suffering from both COPD and chronic musculoskeletal pain.

Participant Groups

Group I: Every Step Counts-Tai Chi Experimental Treatment 1 Intervention

The intervention is ESC-TC which is a web-based platform (Every Step Counts) to promote walking combined with pain management content, an online Tai Chi video library, and synchronous Tai Chi classes led by an instructor via teleconference. The intervention is delivered remotely.

Group II: Usual Care Active Control 1 Intervention

Usual Care

Every Step Counts-Tai Chi is already approved in China, United States, European Union for the following indications:

🇨🇳 Approved in China as Tai Chi for:

• General health and wellness
• Chronic obstructive pulmonary disease (COPD)
• Musculoskeletal pain management

🇺🇸 Approved in United States as Tai Chi for:

• General health and wellness
• Chronic obstructive pulmonary disease (COPD)
• Musculoskeletal pain management
• Rehabilitation

🇪🇺 Approved in European Union as Tai Chi for:

• General health and wellness
• Chronic obstructive pulmonary disease (COPD)
• Musculoskeletal pain management
• Rehabilitation

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA Boston, MA

Who Is Running the Clinical Trial?

VA Office of Research and Development Lead Sponsor

University of Michigan Collaborator

Beth Israel Deaconess Medical Center Collaborator

References

1. England pubmed.ncbi.nlm.nih.gov

Long-term Exercise After Pulmonary Rehabilitation (LEAP): a pilot randomised controlled trial of Tai Chi in COPD. [2023] 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.

2. United States pubmed.ncbi.nlm.nih.gov

Traditional Chinese exercises for pulmonary rehabilitation: evidence from a systematic review. [2022] Qigong (QG) and tai chi (TC), alternative forms of exercise based on traditional Chinese medicine, are reported to be beneficial to patients with chronic obstructive pulmonary disease (COPD). This systematic review analyzed the evidence and made recommendations for clinical applications and future research.

3. England pubmed.ncbi.nlm.nih.gov

Exploring Tai Chi Exercise and Mind-Body Breathing in Patients with COPD in a Randomized Controlled Feasibility Trial. [2022] 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 .

4. New Zealand pubmed.ncbi.nlm.nih.gov

Effects of Tai Chi on exercise capacity and health-related quality of life in patients with chronic obstructive pulmonary disease: a systematic review and meta-analysis. [2018] Tai Chi is a traditional Chinese mind-body exercise that has been widely practiced in the People's Republic of China for many centuries. This exercise has also been applied as a training modality in pulmonary rehabilitation programs for stable chronic obstructive pulmonary disease (COPD). This systematic review and meta-analysis aimed to assess the effects of Tai Chi on exercise capacity and health-related quality of life (HRQoL) in COPD patients.

5. Scotland pubmed.ncbi.nlm.nih.gov

The sustaining effects of Tai chi Qigong on physiological health for COPD patients: a randomized controlled trial. [2022] To evaluate the sustaining effects of Tai chi Qigong in improving the physiological health for COPD patients at sixth month.

6. United States pubmed.ncbi.nlm.nih.gov

What do we really know about the safety of tai chi?: A systematic review of adverse event reports in randomized trials. [2022] To systematically review the frequency and quality of adverse event (AE) reports in randomized controlled trials (RCTs) of tai chi (TC).

7. United States pubmed.ncbi.nlm.nih.gov

Safety of Qigong: Protocol for an overview of systematic reviews. [2022] Qigong, as one of the essential elements of Traditional Chinese exercises, has been used to improve physical and psychological health and combat diseases in China for thousands of years. In recent years, the beneficial effects of Qigong on different medical conditions are becoming more accepted by both patients and health care providers. Although it is a common impression that Qigong and related therapies are generally safe procedures, but the current understanding of its adverse events is fragmented. Thus, we conducted this overview to synthesize comprehensively existing systematic reviews on adverse events associated with Qigong and related therapies, and our findings can be used to informing clinicians, Qigong practitioner, and patients alike on applying such treatments or interventions in clinical treatment and daily life training mindful manner, and provide a guideline for researchers in future.

8. United States pubmed.ncbi.nlm.nih.gov

Effects of Tai Chi on patients with moderate to severe COPD in stable phase. [2023] This study was designed to investigate the effects of Tai Chi training on moderate to severe Chronic obstructive pulmonary disease (COPD) in the stable phase. This was a 2-arm randomized clinical trial. A total of 226 COPD patients with moderate to severe in the stable phase were allocated to either the control group or the observation group. The observation of the frequency of acute exacerbation for both groups lasted for at least 52 weeks follow-up. Changes in lung function and symptom scores of health-related quality of life (St George's Respiratory Questionnaire score) were also compared between the 2 groups. The accompanying anxiety and depressive symptoms of the patients were evaluated using the Self-Rating Depression Scale and Self-Rating Anxiety Scale prior to the procedure and 52 weeks later. Patients with moderate to severe COPD in China were divided into the Tai Chi group (n = 116) or control group (n = 110). After excluding 10 patients who fell off, 108 patients were enrolled in each group. Evidently, the matched group had higher exacerbation rate than the Tai Chi group (P .05) but showed significant improvement in morbidity of acute exacerbation and quality of life (P

9. Scotland pubmed.ncbi.nlm.nih.gov

A modified 6-form Tai Chi for patients with COPD. [2018] 24-form Tai Chi is a traditional exercise popular among old people in China, but it has some complex movements beyond of capabilities of patients with COPD. This study was to modify and simplify 24-form Tai Chi and evaluate effects of the modified Tai Chi on lung function, exercise capacity, dyspnea symptom and health status in patients with COPD.

10. China pubmed.ncbi.nlm.nih.gov

Effects of Tai Chi training on the physical and mental health status in patients with chronic obstructive pulmonary disease: a systematic review and meta-analysis. [2022] Tai Chi is a systematic whole body movement developed in ancient China. It plays an increasingly important role in the field of pulmonary rehabilitation for patients with chronic obstructive pulmonary disease (COPD). Our review aimed to explore the impact of Tai Chi on the physical and mental health of patients with COPD.

11. United States pubmed.ncbi.nlm.nih.gov

Effects of Tai Chi on Lung Function, Exercise Capacity and Psychosocial Outcomes in Patients With Chronic Obstructive Pulmonary Disease: Systematic Review and Meta-analysis of Randomized Controlled Trials. [2023] Objectives: To explore whether tai chi can improve lung function, exercise capacity, and health-related outcomes in patients with chronic obstructive pulmonary disease (COPD). Methods: The PubMed, Embase, Cochrane Central Register of Controlled Trials, Chinese National Knowledge Infrastructure (CNKI), Wanfang, and China Science and Technology Journal Database (VIP) databases were searched from inception to January 5, 2023. The methodological quality of the included studies was evaluated according to the Cochrane Handbook for Systematic Reviews of Interventions criteria. Results: A total of 1430 participants from 20 randomized controlled trials were included in this review. The results indicated significant effects of tai chi on FEV1, 6WMD, anxiety, and quality of life (p < 0.01), but not on FEV1%, FEVI/FVC, depression, and social support. Conclusions: Tai chi might be a potential alternative therapy to improve FEV1, 6WMD, anxiety, and quality of life for patients with COPD.