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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.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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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
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
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  • 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
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  • 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.

Marilyn L Moy, MD contact

(857) 203-6622

Marilyn.Moy@va.gov

United States1 site, 1 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

    Recruiting

Other trials in United States

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.

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 groups in NCT05701982
Study groupRoleWhat they receive
Every Step Counts-Tai ChiExperimentalThe 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 CareActive comparatorUsual Care
Receives: Other: Usual Care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)
  1. Pain Intensity

    The 11-point Numeric Rating Scale (0=no pain; 10=worst pain imaginable) will assess pain intensity.

    Measured: 6 months

  2. Dyspnea

    Dyspnea will be assessed using the mMRC scale (responses 0-4 with 4 being the most dyspneic).

    Measured: 6 months

  3. 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

  4. 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.

  1. First posted27 Jan 2023
  2. Study start3 Jan 2024
  3. Primary completion30 Sep 2027 (estimated)
  4. Study completion31 Mar 2028 (estimated)

Resources

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)
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.

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.

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