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Integrated Walking + Tai Chi for COPD (WATCH for Pain Trial)
N/A
Recruiting
Led By Marilyn L. Moy, MD
Research Sponsored by VA Office of Research and Development
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
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
Must not have
Inability to collect at least 7 of 10 days of baseline step counts
COPD exacerbation in the previous 1 month
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights
No Placebo-Only Group
Summary
This trial will look into whether an intervention of walking & Tai Chi can help improve physical function in Veterans with COPD & chronic musculoskeletal pain, improving their quality of life. #veterans #COPD #chronicpain
Who is the study for?
This trial is for Veterans aged 40+ with COPD who have smoked more than the equivalent of 10 packs of cigarettes a year and suffer from chronic musculoskeletal pain. They must be able to walk, use a computer or smartphone, and not be in another exercise program or dealing with unstable heart conditions.
What is being tested?
The study tests if walking combined with Tai Chi (Every Step Counts-Tai Chi), facilitated by technology, can improve physical function compared to usual care in those suffering from both COPD and chronic musculoskeletal pain.
What are the potential side effects?
Since this intervention involves walking and Tai Chi exercises, potential side effects may include muscle soreness or strain. However, these activities are generally considered low-risk for most people.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with COPD, smoked more than 10 pack-years, and have specific breathing test results or CT scan findings.
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I have had pain rated above 3 for more than 3 months.
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I can walk 800 feet and use a Fitbit Inspire-2 accurately.
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I can walk a block, bend, and shift my weight between legs.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I can't provide step counts for at least 7 out of 10 days.
Select...
I have had a worsening of my COPD in the last month.
Select...
My oxygen levels drop below 85% when I walk.
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I cannot walk on my own.
Select...
I do not have active heart problems like uncontrolled high blood pressure or heart failure.
Select...
I am currently receiving end-of-life care.
Select...
I am at high risk of falling and cannot do 5 chair stand tests.
Select...
I am undergoing treatment that increases my pain.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Physical Function measured by Daily Step Counts
Secondary study objectives
Dyspnea
Pain Intensity
Pain Interference
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Every Step Counts-Tai ChiExperimental Treatment1 Intervention
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.
Group II: Usual CareActive Control1 Intervention
Usual Care
Find a Location
Who is running the clinical trial?
VA Office of Research and DevelopmentLead Sponsor
1,666 Previous Clinical Trials
3,765,673 Total Patients Enrolled
6 Trials studying Chronic Musculoskeletal Pain
4,785 Patients Enrolled for Chronic Musculoskeletal Pain
University of MichiganOTHER
1,862 Previous Clinical Trials
6,441,331 Total Patients Enrolled
1 Trials studying Chronic Musculoskeletal Pain
104 Patients Enrolled for Chronic Musculoskeletal Pain
Beth Israel Deaconess Medical CenterOTHER
861 Previous Clinical Trials
12,932,690 Total Patients Enrolled
Marilyn L. Moy, MDPrincipal InvestigatorVA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
3 Previous Clinical Trials
269 Total Patients Enrolled
1 Trials studying Chronic Musculoskeletal Pain
13 Patients Enrolled for Chronic Musculoskeletal Pain
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I can't provide step counts for at least 7 out of 10 days.You are not able to fill out the surveys and questionnaires.I have been diagnosed with COPD, smoked more than 10 pack-years, and have specific breathing test results or CT scan findings.I have had a worsening of my COPD in the last month.I have had pain rated above 3 for more than 3 months.I can walk 800 feet and use a Fitbit Inspire-2 accurately.My oxygen levels drop below 85% when I walk.You have participated in a regular exercise or Tai Chi program in the last 3 months.I cannot walk on my own.I do not have active heart problems like uncontrolled high blood pressure or heart failure.I am 40 years old or older.I am currently receiving end-of-life care.I can walk a block, bend, and shift my weight between legs.You are currently using drugs or alcohol excessively.I am at high risk of falling and cannot do 5 chair stand tests.I am undergoing treatment that increases my pain.
Research Study Groups:
This trial has the following groups:- Group 1: Usual Care
- Group 2: Every Step Counts-Tai Chi
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.