Home-based Body Weight Exercise With Blood Flow Restriction (BFR): Feasibility of a Novel Rehabilitation Intervention in COPD Patients (HomeBFR-COPD) (HomeBFR-COPD)

August 3, 2025 updated by: Mrs Hanoof Aljohani

Home-based Body Weight Exercise With Blood Flow Restriction (BFR): Feasibility of a Novel Rehabilitation Intervention in COPD Patients

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 intervention.

Participants:

40 Eligible participants will be identified and approached by their own clinical team at routine clinical appointments or at the point of referral to pulmonary rehabilitation (PR). In addition, potential participants who didn't attend PR or are on the waiting list and individuals who have previously provided written consent to be contacted about future research studies will be contacted via post. If interested, a researcher will explain the study and provide the Participant Information Sheet. All participants will be given at least 48 hours to consider taking part and written informed consent will be obtained before any study procedure.

Experimental protocol:

Patients will be randomised (1:1 intervention: control ratio) matched for age and lung function to a home-based body weight exercise intervention including sitting knee extensions, standing knee raise, heel-toe raises, bilateral mini-squat behind a chair, and chair rise/sit to stand either with or without the blood flow restriction (n=20 in each group).

Baseline outcome measures will be conducted over the first visits to the clinic.

Initial two training sessions will be directly supervised in the research centre (visits 2 & 3) to ensure all exercises are performed correctly and safely and the patient become familiar with the trial equipment and related mobile application for exercise guidance and session recording (digital training). During both sessions, physiological measurements will be made frequently venous blood samples to assess markers of inflammation, immune and vascular health will be obtained. A brief survey to assess exercise experience will e completed at the end of visit 3.

Patients will then be asked to carry on by performing the same exercises three times per week at home for the next five weeks. The programme will start at a quite easy level and gradually increase in intensity every two weeks depending on how the participant gets on. Progression will incorporate an increase in the number of repetitions and sets every two weeks.

After the intervention phase, patients will return to the research centre for post-intervention assessment visit (visit 4) where post-intervention outcome measures (including a post-training resting blood sample) will be conducted over the same time-course as the baseline measures. at the end of the visit, a brief survey to assess exercise experience will be completed. In addition, half of the participants will be interviewed, within four weeks of completion of the study, to qualitatively assess perceived expectations, benefits, motives, and barriers to the intervention.

Study Type

Interventional

Enrollment (Actual)

27

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Leicestershire
      • Leicester, Leicestershire, United Kingdom, LE39QP
        • NIHR Leicester Biomedical Research Centre - Respiratory

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention group
Body weight exercise with blood flow restriction
Other: Home based body weight type exercises with blood flow restriction

The participant will be asked to complete blood flow restricted exercises described below three times per week for 6 weeks.

Exercise protocol: Two tourniquets will be placed around the upper part of each thigh, these tourniquets will be inflated to an individualised and maintained for the duration of each exercise (including the inter-set rest period) but deflated during the 5 min rest in between. Five Body weight Exercises will be performed: Sitting knee extensions, standing knee raise, Heel-toe raises, Bilateral, mini-squat behind a chair, and Chair rise/sit to stand.
Active Comparator: Exercise only group
Body weight exercise only
Other: Home based body weight type exercises
The participant will be asked to complete body weight exercises for three times per week for 6 weeks. These exercises include: Sitting knee extensions, standing knee raise, Heel-toe raises, Bilateral, mini-squat behind a chair, and Chair rise/sit to stand.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recruitment and retention rates
Time Frame: Through study completion, an average of 18 months
The investigators estimate a recruitment rate of 15% with 95% Confidence interval of ± 7%. A recruitment rate of 15% is in line with the referral rate for PR in stable and post-exacerbation COPD.
Through study completion, an average of 18 months
Retention rates
Time Frame: Through study completion, an average of 18 months
The investigators estimate a retention rate of 80% ± 19%. A retention rate of 80% is close to that seen in pre-pandemic PR programmes locally and is similar to that seen in our previous exercise studies.
Through study completion, an average of 18 months
Adherence to the intervention (in supervised and unsupervised sessions)
Time Frame: Through study completion, an average of 18 months
The investigators estimate that individuals would complete a mean of 14 out of 18 training sessions (78%, 95% Confidence interval ± 10%).
Through study completion, an average of 18 months
Safety (adverse events)
Time Frame: Through study completion, an average of 18 months
The investigators will monitor for potential adverse events that may be related to the intervention (venous thromboembolism, rhabdomyolysis, accelerated hypertension, altered lower limb sensation, localised bruising, clotting disorder) through specific screening questionnaires and blood pressure monitoring at study visits. Concerns about possible adverse events will result in direct referral to NHS services for further investigation and involvement in the study will be paused until these investigations have been completed.
Through study completion, an average of 18 months
Exercise experience
Time Frame: Through study completion, an average of 18 months
Brief survey upon completion of supervised training sessions and upon completion of the study. Survey items build on previous research and relate to exercise experience.
Through study completion, an average of 18 months
Acceptability
Time Frame: Through study completion, an average of 18 months

Qualitatively with in-depth, semi-structured, one-to-one exit interviews of 50% of participants (randomly chosen) 1 - 4 weeks after completion of the final follow-up assessment.Topics will focus on patients' perceived expectations, benefits, motives, and barriers to the intervention.

- Examining reasons for declining to participate amongst eligible patients, reasons for non-adherence to the exercise intervention, and reasons for dropout amongst discontinuing patients.
Through study completion, an average of 18 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Aerobic exercise capacity (VO2peak)
Time Frame: At baseline visit (week 0) and follow up visit (week 7).
VO2peak (ml/kg/min), will be assessed using an incremental-cycle-exercise test on a cycle ergometer which has a high precision for VO2peak confirmation and is well tolerated by patients.
At baseline visit (week 0) and follow up visit (week 7).
Lower limb function
Time Frame: At baseline visit (week 0) and follow up visit (week 7).
Short Physical Performance Battery (SPPB) will be performed consisting of tests of gait speed, standing balance, and chair stand tests. The SPPB consists of 3 individual sub-tests - standing balance, 4-meter gait speed (4mGS) and 5-repetition sit-to-stand (5STS).
At baseline visit (week 0) and follow up visit (week 7).
Quadriceps muscles strength
Time Frame: At baseline visit (week 0) and follow up visit (week 7).
Maximal isometric and isokinetic quadriceps strength of both legs using an isokinetic dynamometer.
At baseline visit (week 0) and follow up visit (week 7).
Chronic Respiratory Questionnaire (CRQ)
Time Frame: At baseline visit (week 0) and follow up visit (week 7).
A valuable health related quality of life (HRQL) tool that it incorporates patient perceptions of both physical and emotional health. Four aspects of HRQL are evaluated: dyspnoea, fatigue, emotional function, and mastery. Each domain includes 4 to 7 items, with each item graded on 7-point Likert scale; item scores within a domain are summated to provide a total score for each domain. Higher scores indicate better HRQL.
At baseline visit (week 0) and follow up visit (week 7).
COPD Assessment Tool (CAT)
Time Frame: At baseline visit (week 0) and follow up visit (week 7).
CAT questionnaire consists of eight items on a 1-to-5-point scale assessing various manifestations of COPD. It provides a simple quantified measure of health related quality of life (HRQL) focusing on cough, phlegm, chest tightness, breathlessness, limited activities, and confidence leaving home, sleeplessness, and energy. The total score is correlated with the impact level of COPD on health status and is interpreted as low (<10), medium (10-20), high (21-30) and very high (>30).
At baseline visit (week 0) and follow up visit (week 7).
Hemodynamic response to exercise
Time Frame: At visit 2 and 3 (week 1) of supervised training sessions.
Heart rate (beats per minute) will be monitored throughout exercise using chest strap heart rate sensor (Polar H10)
At visit 2 and 3 (week 1) of supervised training sessions.
Hemodynamic response to exercise
Time Frame: At visit 2 and 3 (week 1) of supervised training sessions.
Systolic and diastolic blood pressure (millimetres of mercury) will be continuously assessed during exercise using an ambulatory blood pressure monitor (The Oscar 2™)
At visit 2 and 3 (week 1) of supervised training sessions.
Hemodynamic response to exercise
Time Frame: At visit 2 and 3 (week 1) of supervised training sessions.
Oxygen saturations (%O2sat) will be monitored throughout exercise using Nonin 3150 WristOx2 Pulse Oximeter.
At visit 2 and 3 (week 1) of supervised training sessions.
Muscle soreness
Time Frame: At visit 2 and 3 (week 1) of supervised training sessions.
Muscle soreness will be assessed using a visual analog scale. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no soreness" and "extreme soreness".
At visit 2 and 3 (week 1) of supervised training sessions.
Exercise intensity
Time Frame: At visit 2 and 3 (week 1) of supervised training sessions.
Rate of perceived exertion will be continuously assessed during exercise using Modified Borg Dyspnoea Scale which uses a scale from 0 to 10, where 0 represents no dyspnea and 10 represents maximal dyspnea.
At visit 2 and 3 (week 1) of supervised training sessions.
Concentration of skeletal muscle damage biomarker (CK)
Time Frame: Before, 1 hour after, and 48 hours after exercise at visit 2 of supervised training session (week 1) and at baseline of visit 4 (week 7).
Venous blood samples will be obtained for measurement of skeletal muscle damage biomarker (CK).
Before, 1 hour after, and 48 hours after exercise at visit 2 of supervised training session (week 1) and at baseline of visit 4 (week 7).
Concentration of inflammation biomarkers including, CRP, interleukin-6, immune and endothelial cell-expressed soluble adhesion molecules.
Time Frame: Before, 1 hour after, and 48 hours after exercise at visit 2 of supervised training session (week 1) and at baseline of visit 4 (week 7).
Venous blood samples will be obtained for measurement of inflammation biomarkers (CRP, interleukin-6, immune and endothelial cell-expressed soluble adhesion molecules).
Before, 1 hour after, and 48 hours after exercise at visit 2 of supervised training session (week 1) and at baseline of visit 4 (week 7).
Concentration of endothelial function biomarker (bradykinin).
Time Frame: Before, 1 hour after, and 48 hours after exercise at visit 2 of supervised training session (week 1) and at baseline of visit 4 (week 7).
Venous blood samples will be obtained for measurement of endothelial function biomarker (bradykinin).
Before, 1 hour after, and 48 hours after exercise at visit 2 of supervised training session (week 1) and at baseline of visit 4 (week 7).
Concentration of cardiac cell injury and stretch biomarkers troponin I and BNP
Time Frame: Before, 1 hour after, and 48 hours after exercise at visit 2 of supervised training session (week 1) and at baseline of visit 4 (week 7).
Venous blood samples will be obtained for measurement of cardiac cell injury and stretch biomarkers (troponin I and BNP).
Before, 1 hour after, and 48 hours after exercise at visit 2 of supervised training session (week 1) and at baseline of visit 4 (week 7).
The presence of endothelial progenitor cells
Time Frame: Before, 1 hour after, and 48 hours after exercise at visit 2 of supervised training session (week 1) and at baseline of visit 4 (week 7).
Venous blood samples will be obtained for measurement of the presence of endothelial progenitor cells.
Before, 1 hour after, and 48 hours after exercise at visit 2 of supervised training session (week 1) and at baseline of visit 4 (week 7).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mrs Hanoof Aljohani

Collaborators

University Hospitals, Leicester

Investigators

  • Principal Investigator: Thomas Ward, MBBS, PhD, University Hospitals, Leicester

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 26, 2024

Primary Completion (Actual)

November 4, 2024

Study Completion (Actual)

November 30, 2024

Study Registration Dates

First Submitted

July 13, 2023

First Submitted That Met QC Criteria

August 2, 2023

First Posted (Actual)

August 9, 2023

Study Record Updates

Last Update Posted (Actual)

August 7, 2025

Last Update Submitted That Met QC Criteria

August 3, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HomeBFR-COPD

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All individual patient data (IPD) that underlie results in a publication

IPD Sharing Time Frame

Data requests can be submitted starting 6 months after article publication and the data will be made accessible for up to 24 months. Extensions will be considered on a case-by-case basis.

IPD Sharing Access Criteria

Access to trial IPD can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of research chief investigator and/or principal investigator.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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