New treatment option for COPD
Official title The Effect of a Technology-Mediated Integrated Walking and Tai Chi Intervention on Physical Function in Veterans With COPD and Chronic Musculoskeletal Pain
ClinicalTrials.gov ID: NCT05701982
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 40 to 100
You may be able to join 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...
- 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\
You likely can't join 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...
- 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
See the full eligibility 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...
- 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.
- 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 treatment 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.
The study team makes the final eligibility decision.
Where it's taking place
- Boston, Massachusetts, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 40 years to 100 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Boston, Massachusetts, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.