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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40-100
SponsorVA Office of Research and Development

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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)

Trial design

Design model

Parallel

Treatments tested in this trial

  • Every Step Counts-Tai Chi

    Behavioral

    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 Care

    Other intervention

    Usual Care

Treatment groups

136 Participants
are divided into 2 treatment groups
Group A: Every Step Counts-Tai ChiExperimental treatment 1 intervention
Group B: Usual CareActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Physical Function measured by Daily Step Counts

The FitBit pedometer will objectively-measure physical activity as daily step counts.

Time frame
6 months

Secondary outcomes

1

Pain Intensity

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

Time frame
6 months
2

Dyspnea

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

Time frame
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.

Time frame
6 months
4

Dyspnea

UCSD Shortness of Breath Questionnaire with 24 items. Scores range from 0 to 120.

Time frame
6 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

VA Office of Research and Development

Lead sponsor

University of Michigan

Collaborator

Beth Israel Deaconess Medical Center

Collaborator