The Effect of a Technology-Mediated Integrated Walking and Tai Chi Intervention on Physical Function in Veterans With COPD and Chronic Musculoskeletal Pain
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 40 Years to 100 Years
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
- Time periods mentioned: 6 months
Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.
Show the study's own words
- "The investigators will randomize participants 1:1 to ESC-TC or usual care for 6 months."
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests whether a walking and Tai Chi program supported by technology can help Veterans move and do daily tasks better. It is for Veterans with COPD, a long-term lung disease, and lasting muscle, bone, or joint pain. The program includes mindfulness, or paying attention to the present moment.
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Be age 40 or older. Men and women can join.
- Have diagnosed COPD, a smoking history of more than 10 pack-years (such as one pack a day for 10 years), and either a breathing test ratio below 0.70 or a chest CT scan showing emphysema, a type of lung damage. Different rules apply if the first study visit is online.
- Have a pain score above 3 on a number scale for more than 3 months.
- Report being able to walk at least one block, bend at the hips, and shift weight from one leg to the other.
- Walk 800 feet while a Fitbit Inspire-2 counts steps with more than 90% accuracy compared with a hand count. Different rules apply if the first study visit is online.
- Have a computer or smartphone with internet, or be willing to use study computers at the study site.
- Have access to video calls with both sound and video.
- Be able to understand and agree to join the study, and be willing to return for study visits.
Who can't join
- Have had a COPD flare-up in the past month, or have unstable heart or blood pressure problems.
- Have a blood oxygen level below 85% during the first 4-meter walk test. Different rules apply if the first study visit is online.
- Cannot walk, or have a high risk of falling because you cannot complete five chair stands.
- Cannot complete questionnaires or record steps on at least 7 of the first 10 days.
- Currently misuse alcohol or drugs.
- Have taken part in a regular exercise or Tai Chi program in the past 3 months, or are in another study that tests a treatment or program.
- Receive hospice or comfort care at the end of life.
- Are getting medical treatment that would greatly increase pain, such as surgery, chemotherapy, or radiation.
Simplified for readability. The official criteria below are what the study team uses.
Official 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.
Study sites (1)
MA
- VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA · Boston, MA 02130-4817Niquel Ortega · Study contact · 857-364-5669 · Niquel.Ortega@va.govCarole L Palumbo, PhD · Study contact · (857) 364-4754 · Carole.Palumbo@va.govMarilyn L. Moy, MD · Principal investigatorMore trials in Boston