Chronic Obstructive Pulmonary DiseaseHomeBFR-COPDNCT05984823
Home-based Body Weight Exercise With Blood Flow Restriction (BFR): Feasibility of a Novel Rehabilitation Intervention in COPD Patients (HomeBFR-COPD)
A study testing Home based body weight type exercises with blood flow restriction and Home based body weight type exercises in people with Chronic Obstructive Pulmonary Disease, run by Mrs Hanoof Aljohani at 1 site in United Kingdom.
Trial 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). Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- Home based body weight type exercises with blood flow restriction and Home based body weight type exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 26 Jan 2024to 30 Nov 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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).
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- 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.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
NIHR Leicester Biomedical Research Centre - Respiratory
Leicester, Leicestershire, LE39QP
About this study
Official title: 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.
Read more
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.
Read the 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.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- Home based body weight type exercises with blood flow restriction, Home based body weight type exercises
- Keywords
- Chronic obstructive pulmonary disease, Blood flow restriction, Home-based exercise, Tele-health, Body weight strength exercise, Feasibility
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home based body weight type exercises with blood flow restrictionOther
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.
Home based body weight type exercisesOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Body weight exercise with blood flow restriction Receives: Other: Home based body weight type exercises with blood flow restriction |
| Exercise only group | Active comparator | Body weight exercise only Receives: Other: Home based body weight type exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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%).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Through study completion, an average of 18 months
Secondary outcomes (15)
Aerobic exercise capacity (VO2peak)
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.
Measured: At baseline visit (week 0) and follow up visit (week 7).
Lower limb function
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).
Measured: At baseline visit (week 0) and follow up visit (week 7).
Quadriceps muscles strength
Maximal isometric and isokinetic quadriceps strength of both legs using an isokinetic dynamometer.
Measured: At baseline visit (week 0) and follow up visit (week 7).
Chronic Respiratory Questionnaire (CRQ)
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.
Measured: At baseline visit (week 0) and follow up visit (week 7).
COPD Assessment Tool (CAT)
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).
Measured: At baseline visit (week 0) and follow up visit (week 7).
Hemodynamic response to exercise
Heart rate (beats per minute) will be monitored throughout exercise using chest strap heart rate sensor (Polar H10)
Measured: At visit 2 and 3 (week 1) of supervised training sessions.
Hemodynamic response to exercise
Systolic and diastolic blood pressure (millimetres of mercury) will be continuously assessed during exercise using an ambulatory blood pressure monitor (The Oscar 2™)
Measured: At visit 2 and 3 (week 1) of supervised training sessions.
Hemodynamic response to exercise
Oxygen saturations (%O2sat) will be monitored throughout exercise using Nonin 3150 WristOx2 Pulse Oximeter.
Measured: At visit 2 and 3 (week 1) of supervised training sessions.
Muscle soreness
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".
Measured: At visit 2 and 3 (week 1) of supervised training sessions.
Exercise intensity
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.
Measured: At visit 2 and 3 (week 1) of supervised training sessions.
Concentration of skeletal muscle damage biomarker (CK)
Venous blood samples will be obtained for measurement of skeletal muscle damage biomarker (CK).
Measured: 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.
Venous blood samples will be obtained for measurement of inflammation biomarkers (CRP, interleukin-6, immune and endothelial cell-expressed soluble adhesion molecules).
Measured: 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).
Venous blood samples will be obtained for measurement of endothelial function biomarker (bradykinin).
Measured: 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
Venous blood samples will be obtained for measurement of cardiac cell injury and stretch biomarkers (troponin I and BNP).
Measured: 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
Venous blood samples will be obtained for measurement of the presence of endothelial progenitor cells.
Measured: 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).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2023
- Study start26 Jan 2024
- Primary completion4 Nov 2024
- Study completion30 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Intervention group and control group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mrs Hanoof Aljohani
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospitals, Leicester
- Responsible party
- Sponsor-investigator, Mrs Hanoof Aljohani, Loughborough University
- Investigators
- Thomas Ward, MBBS, PhD, Principal investigator, University Hospitals, Leicester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05984823
- Sponsor's protocol ID
- HomeBFR-COPD
- Acronym
- HomeBFR-COPD
- Status last verified
- Jul 2026
- First submitted
- 13 Jul 2023
- Last updated
- 24 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data are held under REC-approved governance arrangements (23/EE/0069) restricting access to the named study team; no external data-sharing mechanism was included in the approved protocol or participant consent.
Publications
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.
PubMed 28259850Clarkson 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.
PubMed 28483555Patterson 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.
PubMed 28642225Patterson 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.
PubMed 31156448Pereira-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.
PubMed 34823382Maltais 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.
PubMed 24787074Swallow 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.
PubMed 17090575Madarame 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.
PubMed 23216760
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Home-based Body Weight Exercise With Blood Flow Restriction (BFR): Feasibility of a Novel Rehabilitation Intervention in COPD Patients
- ClinicalTrials.gov ID
- NCT05984823
- Acronym / sponsor ID
- HomeBFR-COPD / HomeBFR-COPD
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- Chronic obstructive pulmonary disease, Blood flow restriction, Home-based exercise, Tele-health, Body weight strength exercise, Feasibility
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Mrs Hanoof AljohaniUniversity, hospital or other
- Collaborators
- University Hospitals, Leicester
- Study start
- 26 Jan 2024 (actual)
- Primary completion
- 4 Nov 2024 (actual)
- Study completion
- 30 Nov 2024 (actual)
- First posted
- 9 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Intervention group and control group
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Other: Home based body weight type exercises with blood flow restrictionBody weight exercise with blood flow restriction |
| Exercise only group | Active comparator | Other: Home based body weight type exercisesBody weight exercise only |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (13 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Home based body weight type exercises with blood flow restrictionThe 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. | Other | Intervention group |
| Home based body weight type exercisesThe 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. | Other | Exercise only group |
Primary outcome
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.
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.
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%).
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.
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.
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.
15 secondary outcomes
Aerobic exercise capacity (VO2peak)
Time frame: 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).
Quadriceps muscles strength
Time frame: 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).
COPD Assessment Tool (CAT)
Time frame: 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.
Hemodynamic response to exercise
Time frame: 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.
Muscle soreness
Time frame: 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.
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).
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).
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).
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).
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2026.
- Background: PubMed 28259850Hughes 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.
- Background: PubMed 28483555Clarkson 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.
- Background: PubMed 28642225Patterson 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.
- Background: PubMed 31156448Patterson 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.
- Background: PubMed 34823382Pereira-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.
- Background: PubMed 24787074Maltais 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.
- Background: PubMed 17090575Swallow 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.
- Background: PubMed 23216760Madarame 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.
- Individual participant dataSharing planned: No. Data are held under REC-approved governance arrangements (23/EE/0069) restricting access to the named study team; no external data-sharing mechanism was included in the approved protocol or participant consent.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas Ward, MBBS, PhD principal investigator
University Hospitals, Leicester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Home based body weight type exercises with blood flow restriction and Home based body weight type exercises in people with Chronic Obstructive Pulmonary Disease, run by Mrs Hanoof Aljohani at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment and retention rates (time frame: Through study completion, an average of 18 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05984823, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2026; AzTrials last refreshed its copy on 1 Nov 2026.