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

Last updated: February 11, 2025
Sponsor: VA Office of Research and Development
Overall Status: Active - Recruiting

Phase

N/A

Condition

Chronic Musculoskeletal Pain

Acute Pain

Muscle Pain

Treatment

Usual Care

Every Step Counts-Tai Chi

Clinical Study ID

NCT05701982
F4225-R
  • Ages 40-100
  • All Genders

Study 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

Inclusion Criteria:

  • Male and female participants, aged 40 and older

  • Clinical diagnosis of COPD defined as history of cigarette consumption of > 10pack-years, and either a ratio of forced expiratory volume in one second (FEV1) toforced vital capacity (FVC) < 0.70 or chest computerized tomography (CT) evidence ofemphysema*

  • Numeric Rating Scale pain score > 3 for > 3 months

  • Self-reported ability to walk a minimum of one block, bend at the hip, and transferweight from one leg to another

  • Ability to complete 800 feet walk with Fitbit Inspire-2 recording > 90% accuracy todetect steps compared to manual counts*

  • Have access to a computer or smartphone with Internet connection or willing to cometo 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

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 uncontrolledhypertension)

  • 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 inthe 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 assurgery, chemotherapy, or radiation therapy

  • Different criteria are used if baseline study visit is a virtual one.

Study Design

Total Participants: 136
Treatment Group(s): 2
Primary Treatment: Usual Care
Phase:
Study Start date:
January 03, 2024
Estimated Completion Date:
March 31, 2028

Study 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.

Connect with a study center

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

    Boston, Massachusetts 02130-4817
    United States

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.