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

NCT05984823 | Terminated

• 1 other identifier: HomeBFR-COPD
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

Chronic obstructive pulmonary disease; Blood flow restriction; Home-based exercise; Tele-health; Body weight strength exercise; Feasibility

Outcome Measures

Primary Outcomes (6)

• Recruitment and retention rates

  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

  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)

  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)

  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

  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

  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 Outcomes (15)

• Aerobic exercise capacity (VO2peak)

  At baseline visit (week 0) and follow up visit (week 7).

• Lower limb function

  At baseline visit (week 0) and follow up visit (week 7).

• Quadriceps muscles strength

  At baseline visit (week 0) and follow up visit (week 7).

• Chronic Respiratory Questionnaire (CRQ)

  At baseline visit (week 0) and follow up visit (week 7).

• COPD Assessment Tool (CAT)

  At baseline visit (week 0) and follow up visit (week 7).

Study Arms (2)

Intervention group

EXPERIMENTAL

Body weight exercise with blood flow restriction

Other: Home based body weight type exercises with blood flow restriction

Exercise only group

ACTIVE COMPARATOR

Body weight exercise only

Other: Home based body weight type exercises

Interventions

Home based body weight type exercises with blood flow restriction OTHER

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.

Intervention group

Home based body weight type exercises OTHER

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.

Exercise only group

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mrs Hanoof Aljohani: lead
• University Hospitals, Leicester: collaborator

Study Sites (1)

NIHR Leicester Biomedical Research Centre - Respiratory

Leicester, Leicestershire, LE39QP, United Kingdom

Location

Related Publications (8)

• Hughes L, Paton B, Rosenblatt B, Gissane C, Patterson SD. Blood flow restriction training in clinical musculoskeletal rehabilitation: a systematic review and meta-analysis. Br J Sports Med. 2017 Jul;51(13):1003-1011. doi: 10.1136/bjsports-2016-097071. Epub 2017 Mar 4.

  PMID: 28259850 BACKGROUND

• Clarkson MJ, Conway L, Warmington SA. Blood flow restriction walking and physical function in older adults: A randomized control trial. J Sci Med Sport. 2017 Dec;20(12):1041-1046. doi: 10.1016/j.jsams.2017.04.012. Epub 2017 Apr 21.

  PMID: 28483555 BACKGROUND

• Patterson SD, Hughes L, Head P, Warmington S, Brandner C. Blood flow restriction training: a novel approach to augment clinical rehabilitation: how to do it. Br J Sports Med. 2017 Dec;51(23):1648-1649. doi: 10.1136/bjsports-2017-097738. Epub 2017 Jun 22. No abstract available.

  PMID: 28642225 BACKGROUND

• Patterson SD, Hughes L, Warmington S, Burr J, Scott BR, Owens J, Abe T, Nielsen JL, Libardi CA, Laurentino G, Neto GR, Brandner C, Martin-Hernandez J, Loenneke J. Blood Flow Restriction Exercise: Considerations of Methodology, Application, and Safety. Front Physiol. 2019 May 15;10:533. doi: 10.3389/fphys.2019.00533. eCollection 2019.

  PMID: 31156448 BACKGROUND

• Pereira-Neto EA, Johnston KN, Lewthwaite H, Boyle T, Fon A, Williams MT. Title: Blood flow restricted exercise training: Perspectives of people with chronic obstructive pulmonary disease and health professionals. Chron Respir Dis. 2021 Jan-Dec;18:14799731211056092. doi: 10.1177/14799731211056092.

  PMID: 34823382 BACKGROUND

• Maltais F, Decramer M, Casaburi R, Barreiro E, Burelle Y, Debigare R, Dekhuijzen PN, Franssen F, Gayan-Ramirez G, Gea J, Gosker HR, Gosselink R, Hayot M, Hussain SN, Janssens W, Polkey MI, Roca J, Saey D, Schols AM, Spruit MA, Steiner M, Taivassalo T, Troosters T, Vogiatzis I, Wagner PD; ATS/ERS Ad Hoc Committee on Limb Muscle Dysfunction in COPD. An official American Thoracic Society/European Respiratory Society statement: update on limb muscle dysfunction in chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 2014 May 1;189(9):e15-62. doi: 10.1164/rccm.201402-0373ST.

  PMID: 24787074 BACKGROUND

• Swallow EB, Reyes D, Hopkinson NS, Man WD, Porcher R, Cetti EJ, Moore AJ, Moxham J, Polkey MI. Quadriceps strength predicts mortality in patients with moderate to severe chronic obstructive pulmonary disease. Thorax. 2007 Feb;62(2):115-20. doi: 10.1136/thx.2006.062026. Epub 2006 Nov 7.

  PMID: 17090575 BACKGROUND

• Madarame H, Kurano M, Fukumura K, Fukuda T, Nakajima T. Haemostatic and inflammatory responses to blood flow-restricted exercise in patients with ischaemic heart disease: a pilot study. Clin Physiol Funct Imaging. 2013 Jan;33(1):11-7. doi: 10.1111/j.1475-097X.2012.01158.x. Epub 2012 Jul 30.

  PMID: 23216760 BACKGROUND

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Thomas Ward, MBBS, PhD

  University Hospitals, Leicester

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The lead researcher performed baseline assessments prior to randomisation and was therefore blinded to group allocation. Participants were then randomised (1:1) by an independent researcher using a computer-generated sequence. Follow-up assessments were conducted by the same researcher, who was not blinded at that stage due to involvement in intervention delivery.
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Lead Investigator

Model Details: Intervention group and control group

Study Record Dates

• First Submitted: July 13, 2023
• First Posted: August 9, 2023
• Study Start: January 26, 2024
• Primary Completion: November 4, 2024
• Study Completion: November 30, 2024
• Last Updated: August 7, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• 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.
• 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.

Locations

GB (1)