Integrated Walking + Tai Chi for COPD

(WATCH for Pain Trial)

Overseen By Marilyn L Moy, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: VA Office of Research and Development

Disqualifiers: Unstable cardiovascular, High fall risk, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 14

Duration: 6 months

136 Participants Needed

Trial Summary

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}

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.

Research Team

Marilyn L Moy, MD

Principal Investigator

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

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.

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

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

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

University of Michigan

Collaborator

Trials

1,891

Recruited

6,458,000+

Beth Israel Deaconess Medical Center

Collaborator

Trials

872

Recruited

12,930,000+

Findings from Research

In a pilot study involving 91 participants with COPD, Tai Chi showed a small but positive effect on exercise capacity compared to usual care, with 64% of Tai Chi participants improving their 6-minute walk test distance after 24 weeks.

Tai Chi also led to significant improvements in specific quality of life measures, such as fatigue and mastery, compared to usual care, suggesting it may be a beneficial strategy for maintaining rehabilitation gains in COPD patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term Exercise After Pulmonary Rehabilitation (LEAP): a pilot randomised controlled trial of Tai Chi in COPD. Moy, ML., Wayne, PM., Litrownik, D., et al.[2023]

Qigong (QG) and tai chi (TC) have been shown to significantly improve lung function and exercise capacity in patients with chronic obstructive pulmonary disease (COPD), with notable gains in forced expiratory volume and 6-Minute Walk Test distances compared to both conventional exercise and no exercise groups.

The review analyzed 12 randomized controlled trials, indicating that while QG and TC are beneficial, the overall quality of the studies was moderate, suggesting the need for further research to strengthen the evidence base.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Traditional Chinese exercises for pulmonary rehabilitation: evidence from a systematic review. Ng, BH., Tsang, HW., Ng, BF., et al.[2022]

In a pilot study involving 92 participants with moderate to severe COPD, tai chi showed greater short-term improvements in depressive symptoms, walking distance, and functional capacity compared to a mindful breathing intervention over 12 weeks.

Both tai chi and mindful breathing were feasible interventions for COPD patients, but only tai chi led to significant benefits in mood and social support, with some improvements maintained at 24 weeks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exploring Tai Chi Exercise and Mind-Body Breathing in Patients with COPD in a Randomized Controlled Feasibility Trial. Kraemer, KM., Litrownik, D., Moy, ML., et al.[2022]

Tai Chi significantly improves exercise capacity and health-related quality of life in COPD patients, as shown by a meta-analysis of 11 studies involving 824 participants, with notable increases in six-minute walking distance and improvements in quality of life scores.

Compared to non-exercise groups, Tai Chi led to a meaningful enhancement in walking distance and a reduction in respiratory-related quality of life scores, suggesting it can be an effective alternative in pulmonary rehabilitation programs.

NCBI (Pubmed)

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. Wu, W., Liu, X., Wang, L., et al.[2018]

In a randomized controlled trial with 206 COPD patients, a 3-month Tai chi Qigong program significantly improved exercise capacity, with walking distance increasing by 17% from 298 to 349 meters by the sixth month.

The Tai chi Qigong group also showed notable improvements in lung function, with forced expiratory volume increasing by 11%, while the control group experienced a decline, highlighting Tai chi Qigong as a beneficial exercise for COPD patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The sustaining effects of Tai chi Qigong on physiological health for COPD patients: a randomized controlled trial. Chan, AW., Lee, A., Lee, DT., et al.[2022]

Tai chi (TC) is generally safe, with no serious adverse events reported in a review of 153 randomized controlled trials, primarily involving older adults, although minor musculoskeletal issues like knee and back pain were noted.

Only 33% of the trials reported adverse events, and just 12% had a clear protocol for monitoring them, indicating that the inconsistent reporting limits our understanding of TC's safety profile.

NCBI (Pubmed)

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. Wayne, PM., Berkowitz, DL., Litrownik, DE., et al.[2022]

This systematic review aims to comprehensively analyze existing systematic reviews on the adverse events associated with Qigong and related therapies, highlighting the need for better understanding of their safety.

The findings will provide valuable insights for clinicians, practitioners, and patients regarding the safe application of Qigong in clinical and daily life settings, while also guiding future research in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of Qigong: Protocol for an overview of systematic reviews. Guo, Y., Xu, MM., Huang, Y., et al.[2022]

In a study involving 226 patients with moderate to severe COPD, Tai Chi training significantly reduced the rate of acute exacerbations and improved health-related quality of life compared to standard treatment alone over a 52-week follow-up period.

While lung function did not show significant improvement in either group, both the Tai Chi and control groups experienced notable decreases in anxiety and depression symptoms, indicating that Tai Chi may also support mental well-being in COPD patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Tai Chi on patients with moderate to severe COPD in stable phase. Luo, C., Jiang, H., Li, H., et al.[2023]

A modified 6-form Tai Chi routine was developed specifically for patients with COPD, allowing them to learn it in about 3 hours and showing high adherence (86%) without any negative incidents during practice.

The modified Tai Chi significantly improved lung function (FEV1%), exercise capacity (6-minute walking distance), and health status (COPD Assessment Test scores) compared to a control group, making it a safe and effective exercise therapy for COPD patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A modified 6-form Tai Chi for patients with COPD. Zhu, S., Shi, K., Yan, J., et al.[2018]

Tai Chi significantly improved lung function and overall health in patients with chronic obstructive pulmonary disease (COPD), as evidenced by better forced volume capacity and forced expiratory volume, along with enhanced exercise capacity measured by the 6-minute walking distance.

The study, which included 1,096 participants across 16 trials, suggests that Tai Chi can be a beneficial addition to standard rehabilitation programs, although it remains unclear if it is superior to traditional pulmonary rehabilitation exercises.

NCBI (Pubmed)

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. Guo, C., Xiang, G., Xie, L., et al.[2022]

Tai chi has been shown to significantly improve lung function (measured by FEV1), exercise capacity (6-minute walk distance), anxiety levels, and overall quality of life in patients with chronic obstructive pulmonary disease (COPD), based on a review of 20 randomized controlled trials involving 1430 participants.

While tai chi demonstrated benefits for several health-related outcomes, it did not show significant effects on other measures like FEV1%, FEV1/FVC ratio, depression, or social support, suggesting its specific therapeutic impact may be limited to certain areas.

NCBI (Pubmed)

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. Yang, Y., Yang, L., Yang, X., et al.[2023]

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]

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

Traditional Chinese exercises for pulmonary rehabilitation: evidence from a systematic review. [2022]

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]

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]

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]

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]

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

Safety of Qigong: Protocol for an overview of systematic reviews. [2022]

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

Effects of Tai Chi on patients with moderate to severe COPD in stable phase. [2023]

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

A modified 6-form Tai Chi for patients with COPD. [2018]

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]

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]