The Effect of a Technology-Mediated Integrated Walking and Tai Chi Intervention on Physical Function in Veterans With COPD and Chronic Musculoskeletal Pain
Recruiting · NCT05701982 · Interventional (participants receive a specific treatment) · Lead sponsor: VA Office of Research and Development
View the official record on ClinicalTrials.gov →Interventions studied
Every Step Counts-Tai ChiUsual Care
What this trial is about
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.
Who can take part
Age range
40 Years to 100 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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.
Where it is running
1 location listed across 1 US state.
- VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA - Boston, Massachusetts, United States