Home-based Body Weight Exercise With Blood Flow Restriction (BFR): Feasibility of a Novel Rehabil… (NCT05984823) | Clinical Trial Compass
CompletedNot Applicable
Home-based Body Weight Exercise With Blood Flow Restriction (BFR): Feasibility of a Novel Rehabilitation Intervention in COPD Patients (HomeBFR-COPD)
United Kingdom27 participantsStarted 2024-01-26
Plain-language summary
The primary aim of this randomised controlled trial is to investigate the feasibility and acceptability of low-intensity exercise with blood flow restriction (BFR) in patients with Chronic Obstructive Pulmonary disease (COPD).
The investigators will also collect functional and physiological outcome data to explore potential mechanisms and provide data for a power calculation to be used in a future randomised controlled trial (RCT) to ensure that subsequent full scale clinical RCT has maximum reach and benefit.
The primary experimental hypothesis that underpins these aims is:
• Low-intensity exercise with BFR is a tolerable, acceptable, and safe exercise modality in COPD patients.
40 patients attending clinics at University Hospitals of Leicester (UHL) National Health Service (NHS) Trust with diagnosed COPD will be randomly allocated to a home-based body weight exercise intervention either with or without the blood flow restriction (n=20 in each group). The body weight exercise will consist of five body weight exercises including: sitting knee extensions, standing knee raise, heel-toe raises, bilateral mini-squat behind a chair, and chair rise/sit to stand.
In addition to the pre and post intervention visits, the initial two training sessions for both groups will be directly supervised in the research centre. These sessions are to ensure all exercises are performed correctly and safely and the patient become familiar with the exercises and BFR equipment and mobile application, which provides exercise guidance and session recording.
Who can participate
Age range
40 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Male or Female
* Aged 40 years or above
* Diagnosed with COPD as per GOLD criteria (Forced expiratory volume(FEV1)/forced vital capacity(FVC) \<0.7)
* FEV1 ≤ 80% predicted
* Medical Research Council (MRC) dyspnoea scale ≥2
* BMI \<= 35
* Willing and able to give informed consent for participation in the study.
* Stable dose of current regular medication for at least 4 weeks prior to study entry.
* Clinically acceptable ECG at enrolment.
* Able (in the investigators opinion) and willing to comply with all study requirements.
* Willing to allow his or her General Practitioner and consultant, if appropriate, to be notified of participation in the study.
Exclusion Criteria:
* Unable to communicate sufficiently in English
* Unable to give informed consent or comply with testing and training protocol for any reason.
* Acute exacerbation in the preceding 4 weeks (would become eligible 4 weeks following recovery).
* Unable to undertake exercise due to physical or psychological barriers.
* Contraindication to exercise training (American College of Sports Medicine guidelines)
* Any major or uncontrolled comorbidity that would impair the participant's ability to exercise or would mean exercise was unsafe (e.g., uncontrolled diabetes, hypertension BP\>160/100, muscle or joint injuries which would limit ability to exercise).
* Any other significant disease, disorder, or medical condition which, in the opinion of the Investigator, may either put the participants at…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Recruitment and retention rates
Timeframe: Through study completion, an average of 18 months
2
Retention rates
Timeframe: Through study completion, an average of 18 months
3
Adherence to the intervention (in supervised and unsupervised sessions)
Timeframe: Through study completion, an average of 18 months
4
Safety (adverse events)
Timeframe: Through study completion, an average of 18 months
5
Exercise experience
Timeframe: Through study completion, an average of 18 months
6
Acceptability
Timeframe: Through study completion, an average of 18 months