The Effect of a Technology-Mediated Integrated Walking and Tai Chi Intervention on Physical Function in Veterans With COPD and Chronic Musculoskeletal Pain (WATCH for Pain)

January 20, 2026 updated by: VA Office of Research and Development
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
136

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02130-4817
        • Recruiting
        • VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
        • Principal Investigator:
          • Marilyn L. Moy, MD
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

40 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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
  • 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.

Exclusion Criteria:

  • 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
  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Every Step Counts-Tai Chi
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.
Behavioral: Every Step Counts-Tai Chi
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.
Active Comparator: Usual Care
Other: Usual Care
Usual Care

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Physical Function measured by Daily Step Counts
Time Frame: 6 months
The FitBit pedometer will objectively-measure physical activity as daily step counts.
6 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Pain Intensity
Time Frame: 6 months
The 11-point Numeric Rating Scale (0=no pain; 10=worst pain imaginable) will assess pain intensity.
6 months
Dyspnea
Time Frame: 6 months
Dyspnea will be assessed using the mMRC scale (responses 0-4 with 4 being the most dyspneic).
6 months
Pain Interference
Time Frame: 6 months
The Interference subscale of the West Haven-Yale Multidimensional Pain Inventory will assess pain-related interference, with higher scores representing greater interference.
6 months
Dyspnea
Time Frame: 6 months
UCSD Shortness of Breath Questionnaire with 24 items. Scores range from 0 to 120.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
VA Office of Research and Development

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Beth Israel Deaconess Medical Center
University of Michigan

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Marilyn L. Moy, MD, VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 3, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 30, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 31, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 5, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 18, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 27, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 22, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 20, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • F4225-R

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

A Final De-identified, Anonymized Dataset will be created and shared upon request.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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