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

NCT05701982 | Recruiting DMC

• 1 other identifier: F4225-R
• Study Type: interventional
• Target: 136
• Locations: 1 country
• Sites: 1

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.

Conditions

COPD; Chronic Musculoskeletal Pain

Keywords

physical activity; mindful movement; videoconference

Outcome Measures

Primary Outcomes (1)

• Physical Function measured by Daily Step Counts

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

  6 months

Secondary Outcomes (4)

• Pain Intensity

  6 months

• Dyspnea

  6 months

• Pain Interference

  6 months

• Dyspnea

  6 months

Study Arms (2)

Every Step Counts-Tai Chi

EXPERIMENTAL

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

Usual Care

ACTIVE COMPARATOR

Usual Care

Other: Usual Care

Interventions

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.

Every Step Counts-Tai Chi

Usual Care OTHER

Usual Care

Usual Care

Eligibility Criteria

• Age: 40 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• VA Office of Research and Development: lead
• University of Michigan: collaborator
• Beth Israel Deaconess Medical Center: collaborator

Study Sites (1)

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

Boston, Massachusetts, 02130-4817, United States

RECRUITING

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Motor Activity

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavior

Study Officials

• Marilyn L. Moy, MD

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marilyn L Moy, MD

CONTACT

(857) 203-6622; Marilyn.Moy@va.gov

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The PI and study staff who conduct follow-up visits for outcome assessments will be blinded to each participant's randomization group.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: January 5, 2023
• First Posted: January 27, 2023
• Study Start: January 3, 2024
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): March 31, 2028
• Last Updated: January 22, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share

Locations

US (1)