NCT05701982 The Effect of a Technology-Mediated Integrated Walking and Tai Chi Intervention on Physical Function in Veterans With COPD and Chronic Musculoskeletal Pain
| NCT ID | NCT05701982 |
| Status | Recruiting |
| Phase | — |
| Sponsor | VA Office of Research and Development |
| Condition | COPD |
| Study Type | INTERVENTIONAL |
| Enrollment | 136 participants |
| Start Date | 2024-01-03 |
| Primary Completion | 2027-09-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 136 participants in total. It began in 2024-01-03 with a primary completion date of 2027-09-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Eligibility Criteria
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.
Contact & Investigator
Marilyn L. Moy, MD
PRINCIPAL INVESTIGATOR
VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
Frequently Asked Questions
Who can join the NCT05701982 clinical trial?
This trial is open to participants of all sexes, aged 40 Years or older, up to 100 Years, studying COPD. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05701982 currently recruiting?
Yes, NCT05701982 is actively recruiting participants. Contact the research team at Marilyn.Moy@va.gov for enrollment information.
Where is the NCT05701982 trial being conducted?
This trial is being conducted at Boston, United States.
Who is sponsoring the NCT05701982 clinical trial?
NCT05701982 is sponsored by VA Office of Research and Development. The principal investigator is Marilyn L. Moy, MD at VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA. The trial plans to enroll 136 participants.
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