COPDWATCH for PainNCT05701982
The Effect of a Technology-Mediated Integrated Walking and Tai Chi Intervention on Physical Function in Veterans With COPD and Chronic Musculoskeletal Pain
A study testing Every Step Counts-Tai Chi in people with COPD and Chronic Musculoskeletal Pain, run by VA Office of Research and Development at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 40 to 100 years
- Conditions the study is for
- COPD, Chronic Musculoskeletal Pain
- What is being tested?
- Every Step Counts-Tai Chi
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 136 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Jan 2024to 31 Mar 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female participants, aged 40 and older
- Clinical diagnosis of COPD defined as history of cigarette consumption of > 10 pack-years, and either a ratio of forced expiratory volume in one second (FEV1) to forced vital capacity (FVC) < 0.70 or chest computerized tomography (CT) evidence of emphysema*
- Numeric Rating Scale pain score > 3 for > 3 months
- Self-reported ability to walk a minimum of one block, bend at the hip, and transfer weight from one leg to another
- Ability to complete 800 feet walk with Fitbit Inspire-2 recording > 90% accuracy to detect steps compared to manual counts*
- Have access to a computer or smartphone with Internet connection or willing to come to study site to use study computers
Show all 9Show fewer
- Have access to videoconferencing audio and video capabilities
- Competent to provide informed consent and willingness to make return study visits
- Different criteria are used if baseline study visit is a virtual one.
Who cannot join
- COPD exacerbation in the previous 1 month
- Clinical signs of unstable cardiovascular disease (active coronary artery disease, congestive heart failure, uncontrolled atrial fibrillation, or uncontrolled hypertension)
- Oxygen saturation < 85% recorded on baseline 4-meter walk*
- High fall risk (unable to perform 5 chair stand tests)
- Inability to ambulate
- Inability to complete questionnaires
Show all 13Show fewer
- Inability to collect at least 7 of 10 days of baseline step counts
- Active substance abuse
- Participation in a regular exercise (i.e., MOVE! or Gerofit) or Tai Chi program in the previous 3 months
- Concurrent participation in another interventional research study
- Receipt of hospice or end-of-life palliative care
- Active medical intervention that would cause a meaningful increase in pain such as surgery, chemotherapy, or radiation therapy
- Different criteria are used if baseline study visit is a virtual one.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
Boston, Massachusetts, 02130-4817
Niquel Ortega, 857-364-5669, Niquel.Ortega@va.gov
Carole L Palumbo, PhD, (857) 364-4754, Carole.Palumbo@va.gov
About this study
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.
Read the detailed description
Current physical activity (PA) interventions for persons with chronic obstructive pulmonary disease (COPD) focus primarily on reducing the debilitating symptom of dyspnea, or shortness of breath. However, over half of patients with COPD experience chronic musculoskeletal pain which limits achievement of PA goals and optimization of physical function. Low PA is associated with poor outcomes-increased risk of COPD acute exacerbations, hospitalizations, and death-independent of lung function. Funded by Rehabilitation R\&D, the investigators have developed Every Step Counts (ESC), a web-based intervention to promote PA in Veterans with COPD. ESC couples a dynamic website with a pedometer that objectively monitors daily step counts. Based on the Behavioral Theory of Self-Regulation, the website provides individualized step-count goals, iterative feedback, education on disease self-management, motivation, and an online community of social support. In RCTs, the investigators have demonstrated ESC's safety, feasibility, and efficacy to increase PA over 3-6 months. However, not all participants increased daily step counts. In secondary analyses, the investigators identified pain as a significant barrier to PA. Participants with co-occurring pain and dyspnea walked 1,200-1,400 fewer steps per day, compared to those with no symptoms. In its current form, ESC does not focus on pain management. Tai Chi (TC) is an attractive nonpharmacologic treatment for chronic musculoskeletal pain. TC improves neuromuscular function, core strength, and lower limb proprioception. Importantly, the mindfulness embedded in TC uniquely addresses cognitive and psycho-emotional processes critical for pain management (i.e., "extinction of fear conditioning, acceptance-based coping strategies, increased ability to self-regulate affective appraisal of nociceptive input," and reduced pain-related distress and catastrophizing). The investigators have shown that persons with COPD can safely engage with TC delivered via either in-person classes or video instruction. The investigators propose to integrate ESC and TC to target biopsychosocial mechanisms of pain to break the chronic pain cycle and improve physical function in persons with COPD. The investigators will adapt ESC with pain management content, an online TC video library, and synchronous TC classes led by an instructor via teleconference. The investigators will randomize participants 1:1 to ESC-TC or usual care for 6 months. Assessments of outcomes will occur at baseline, 2, 4, and 6 months in all participants, and at 12 months in a subset who enroll early. Aim 1: Determine the efficacy of the ESC-TC intervention in 136 persons with COPD and chronic musculoskeletal pain to improve the primary outcome of physical function, measured by daily step count, compared to usual care at 6 months. Aim 2: Evaluate the effect of the ESC-TC intervention on secondary outcomes of (a) pain intensity and interference, (b) dyspnea, (c) health-related quality of life, (d) mobility, (e) depression, (f) exercise self-efficacy, (g) kinesiophobia, (h) pain catastrophizing, and (i) sleep quality. Aim 3: Explore the long-term effects of ESC-TC on symptoms and risk of acute exacerbations and COPD-related hospitalizations at 12 months in approximately 96 participants. The innovative multimodal, web-based, non-pharmacologic intervention to treat chronic musculoskeletal pain has potential to expand access to exercise as a rehabilitation strategy.
- Conditions
- COPD, Chronic Musculoskeletal Pain
- Being tested
- Every Step Counts-Tai Chi, Usual Care
- Keywords
- physical activity, mindful movement, videoconference
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Every Step Counts-Tai ChiBehavioural
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.
Usual CareOther
Usual Care
| Study group | Role | What they receive |
|---|---|---|
| Every Step Counts-Tai Chi | Experimental | 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. Receives: Behavioral: Every Step Counts-Tai Chi |
| Usual Care | Active comparator | Usual Care Receives: Other: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical Function measured by Daily Step Counts
The FitBit pedometer will objectively-measure physical activity as daily step counts.
Measured: 6 months
Secondary outcomes (4)
Pain Intensity
The 11-point Numeric Rating Scale (0=no pain; 10=worst pain imaginable) will assess pain intensity.
Measured: 6 months
Dyspnea
Dyspnea will be assessed using the mMRC scale (responses 0-4 with 4 being the most dyspneic).
Measured: 6 months
Pain Interference
The Interference subscale of the West Haven-Yale Multidimensional Pain Inventory will assess pain-related interference, with higher scores representing greater interference.
Measured: 6 months
Dyspnea
UCSD Shortness of Breath Questionnaire with 24 items. Scores range from 0 to 120.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2023
- Study start3 Jan 2024
- Primary completion30 Sep 2027 (estimated)
- Study completion31 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPDStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The intervention is ESC-TC which is delivered remotely. It 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 investigators will randomize participants 1:1 to ESC-TC or usual care for 6 months.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 136 participants (estimated)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Collaborators
- University of Michigan, Beth Israel Deaconess Medical Center
- Responsible party
- Sponsor
- Investigators
- Marilyn L. Moy, MD, Principal investigator, VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05701982
- Sponsor's protocol ID
- F4225-R
- Acronym
- WATCH for Pain
- Status last verified
- Jan 2026
- First submitted
- 5 Jan 2023
- Last updated
- 22 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: A Final De-identified, Anonymized Dataset will be created and shared upon request.
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of a Technology-Mediated Integrated Walking and Tai Chi Intervention on Physical Function in Veterans With COPD and Chronic Musculoskeletal Pain
- ClinicalTrials.gov ID
- NCT05701982
- Acronym / sponsor ID
- WATCH for Pain / F4225-R
- Conditions
- COPD, Chronic Musculoskeletal Pain
- Keywords
- physical activity, mindful movement, videoconference
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 136 participants (estimated)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Collaborators
- University of Michigan, Beth Israel Deaconess Medical Center
- Study start
- 3 Jan 2024 (actual)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- 31 Mar 2028 (estimated)
- First posted
- 27 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Current physical activity (PA) interventions for persons with chronic obstructive pulmonary disease (COPD) focus primarily on reducing the debilitating symptom of dyspnea, or shortness of breath. However, over half of patients with COPD experience chronic musculoskeletal pain which limits achievement of PA goals and optimization of physical function. Low PA is associated with poor outcomes-increased risk of COPD acute exacerbations, hospitalizations, and death-independent of lung function. Funded by Rehabilitation R\&D, the investigators have developed Every Step Counts (ESC), a web-based intervention to promote PA in Veterans with COPD. ESC couples a dynamic website with a pedometer that objectively monitors daily step counts. Based on the Behavioral Theory of Self-Regulation, the website provides individualized step-count goals, iterative feedback, education on disease self-management, motivation, and an online community of social support. In RCTs, the investigators have demonstrated ESC's safety, feasibility, and efficacy to increase PA over 3-6 months. However, not all participants increased daily step counts. In secondary analyses, the investigators identified pain as a significant barrier to PA. Participants with co-occurring pain and dyspnea walked 1,200-1,400 fewer steps per day, compared to those with no symptoms. In its current form, ESC does not focus on pain management. Tai Chi (TC) is an attractive nonpharmacologic treatment for chronic musculoskeletal pain. TC improves neuromuscular function, core strength, and lower limb proprioception. Importantly, the mindfulness embedded in TC uniquely addresses cognitive and psycho-emotional processes critical for pain management (i.e., "extinction of fear conditioning, acceptance-based coping strategies, increased ability to self-regulate affective appraisal of nociceptive input," and reduced pain-related distress and catastrophizing). The investigators have shown that persons with COPD can safely engage with TC delivered via either in-person classes or video instruction. The investigators propose to integrate ESC and TC to target biopsychosocial mechanisms of pain to break the chronic pain cycle and improve physical function in persons with COPD. The investigators will adapt ESC with pain management content, an online TC video library, and synchronous TC classes led by an instructor via teleconference. The investigators will randomize participants 1:1 to ESC-TC or usual care for 6 months. Assessments of outcomes will occur at baseline, 2, 4, and 6 months in all participants, and at 12 months in a subset who enroll early. Aim 1: Determine the efficacy of the ESC-TC intervention in 136 persons with COPD and chronic musculoskeletal pain to improve the primary outcome of physical function, measured by daily step count, compared to usual care at 6 months. Aim 2: Evaluate the effect of the ESC-TC intervention on secondary outcomes of (a) pain intensity and interference, (b) dyspnea, (c) health-related quality of life, (d) mobility, (e) depression, (f) exercise self-efficacy, (g) kinesiophobia, (h) pain catastrophizing, and (i) sleep quality. Aim 3: Explore the long-term effects of ESC-TC on symptoms and risk of acute exacerbations and COPD-related hospitalizations at 12 months in approximately 96 participants. The innovative multimodal, web-based, non-pharmacologic intervention to treat chronic musculoskeletal pain has potential to expand access to exercise as a rehabilitation strategy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- The intervention is ESC-TC which is delivered remotely. It 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 investigators will randomize participants 1:1 to ESC-TC or usual care for 6 months.
| Arm | Type | Receives |
|---|---|---|
| Every Step Counts-Tai Chi | Experimental | Behavioral: Every Step Counts-Tai ChiThe 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. |
| Usual Care | Active comparator | Other: Usual CareUsual Care |
Who may qualify
- Ages
- 40 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Male and female participants, aged 40 and older
- Clinical diagnosis of COPD defined as history of cigarette consumption of > 10 pack-years, and either a ratio of forced expiratory volume in one second (FEV1) to forced vital capacity (FVC) < 0.70 or chest computerized tomography (CT) evidence of emphysema*
- Numeric Rating Scale pain score > 3 for > 3 months
- Self-reported ability to walk a minimum of one block, bend at the hip, and transfer weight from one leg to another
- Ability to complete 800 feet walk with Fitbit Inspire-2 recording > 90% accuracy to detect steps compared to manual counts*
Key exclusion criteria (13 listed)
- COPD exacerbation in the previous 1 month
- Clinical signs of unstable cardiovascular disease (active coronary artery disease, congestive heart failure, uncontrolled atrial fibrillation, or uncontrolled hypertension)
- Oxygen saturation < 85% recorded on baseline 4-meter walk*
- High fall risk (unable to perform 5 chair stand tests)
- Inability to ambulate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Every Step Counts-Tai ChiThe 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. | Behavioural | Every Step Counts-Tai Chi |
| Usual CareUsual Care | Other | Usual Care |
Primary outcome
Physical Function measured by Daily Step Counts
Time frame: 6 months
The FitBit pedometer will objectively-measure physical activity as daily step counts.
4 secondary outcomes
Pain Intensity
Time frame: 6 months
Dyspnea
Time frame: 6 months
Pain Interference
Time frame: 6 months
Dyspnea
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2026.
- Individual participant dataSharing planned: Yes. A Final De-identified, Anonymized Dataset will be created and shared upon request.
Related trials for COPD
Active, not recruiting
Symptoms and Functions in Patients With COPD and Chronic Bronchitis Switching From CIG to THS
COPD, Smoking
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Not yet recruiting
The Aim of the Study is to Decipher the Alterations in Signalling Pathways of Skeletal Muscle Stem Cells (Satellite Cells (SCs)) in Individuals With COPD, as Well as to Examine the Effect of Exercise Training on SCs.
COPD (Chronic Obstructive Pulmonary Disease), Sarcopenia in Elderly
Not yet recruitingPhase 2
Study of Treprostinil Administered Via Soft Mist Inhaler (SMI) in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Active, not recruitingPhase 1
A Study for GSK3862995B in Healthy Participants and Participants With Chronic Obstructive Pulmonary Disease
Pulmonary Disease, Chronic Obstructive
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Marilyn L. Moy, MD principal investigator
VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Every Step Counts-Tai Chi in people with COPD and Chronic Musculoskeletal Pain, run by VA Office of Research and Development at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marilyn L Moy, MD ((857) 203-6622, Marilyn.Moy@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physical Function measured by Daily Step Counts (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2026.