Status:
TERMINATED
Home-based Body Weight Exercise With Blood Flow Restriction (BFR): Feasibility of a Novel Rehabilitation Intervention in COPD Patients (HomeBFR-COPD)
Lead Sponsor:
Mrs Hanoof Aljohani
Collaborating Sponsors:
University Hospitals, Leicester
Conditions:
Chronic Obstructive Pulmonary Disease
Eligibility:
All Genders
40+ years
Phase:
NA
Brief 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...
Detailed Description
Experimental design: This is a randomised, controlled, assessor blind, single centre, clinical trial. Outcome measurements will be assessed at baseline and following the 6-week home-based interventio...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 26 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 30 2024
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT05984823
Start Date
January 26 2024
End Date
November 30 2024
Last Update
August 7 2025
Active Locations (1)
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1
NIHR Leicester Biomedical Research Centre - Respiratory
Leicester, Leicestershire, United Kingdom, LE39QP