Home-based exercise with blood flow restriction for COPD patients
Home-based Body Weight Exercise With Blood Flow Restriction (BFR): Feasibility of a Novel Rehabilitation Intervention in COPD Patients
This study is testing if low-intensity home exercises with blood flow restriction can be safe and helpful for people with COPD.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 40 Years and up |
| Sex | All |
| Sponsor | Loughborough University Academic / other |
| Locations | 1 site (Leicester, Leicestershire) |
| Trial ID | NCT05984823 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the feasibility and acceptability of low-intensity home-based body weight exercises combined with blood flow restriction (BFR) in patients with Chronic Obstructive Pulmonary Disease (COPD). A total of 40 participants will be randomly assigned to either an exercise group with BFR or a control group without BFR. The study will assess functional and physiological outcomes over a 6-week intervention period, with initial training sessions supervised to ensure safety and proper technique. The goal is to determine if this exercise modality is tolerable and safe for COPD patients, providing data for future larger-scale trials.
Who should consider this trial
Good fit: Ideal candidates are adults aged 40 and above with a diagnosis of COPD who meet specific lung function and health criteria.
Not a fit: Patients with acute exacerbations of COPD or those unable to comply with the exercise protocol may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could enhance rehabilitation options for COPD patients, improving their physical function and quality of life.
How similar studies have performed: While the approach of using blood flow restriction in exercise for COPD is relatively novel, similar studies in other populations have shown promising results.
Eligibility criteria
Show full inclusion / exclusion criteria
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 risk because of participation in the study, or may influence the result of the study, or the participant's ability to participate in the study including (but not limited to): Any clotting disorder Any bleeding disorder (e.g., haemophilia) Recent (\<3 months) venous thromboembolism, vascular (artery or vein) surgery to the legs, skin graft to the legs, and or arteriovenous fistula in the legs. Had one or both legs immobilisation in the last 4 weeks (e.g., prolonged bed rest, or recent orthopaedic intervention) Taking any anticoagulant medication Significant peripheral neuropathy * Current or within the last 3 months (or maximum relevant wash out period, whichever is longer), participation in an investigational medicinal product (IMP) or device trial at the time of screening. * Current or within the last 6 months (or maximum relevant wash out period, whichever is longer), participation in pulmonary rehabilitation or in another research study involving exercise training. * Scheduled elective surgery or other procedures requiring general anaesthesia during the study. * Female participants who are pregnant, lactating, or planning pregnancy during the course of the study.
Where this trial is running
Leicester, Leicestershire
- NIHR Leicester Biomedical Research Centre - Respiratory — Leicester, Leicestershire, United Kingdom (Recruiting)
Study contacts
- Principal investigator: Thomas Ward, MBBS, PhD — University Hospitals, Leicester
- Study coordinator: Hanoof A Aljohani, MSc
- Email: H.aljohani@lboro.ac.uk
- Phone: +447498721896
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.