Home-based Body Weight Exercise With Blood Flow Restriction (BFR): Feasibility of a Novel Rehabilitation Intervention in COPD Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 27
- 试验地点
- 2
- 主要终点
- Recruitment and retention rates
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Single (Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Exercise only group
Body weight exercise only
干预措施: Home based body weight type exercises (Other)
Intervention group
Body weight exercise with blood flow restriction
干预措施: Home based body weight type exercises with blood flow restriction (Other)
结局指标
主要结局
Recruitment and retention rates
时间窗: 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
时间窗: 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)
时间窗: 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)
时间窗: 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
时间窗: 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
时间窗: 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.
次要结局
- 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).)
- COPD Assessment Tool (CAT)(At baseline visit (week 0) and follow up visit (week 7).)
- Concentration 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).)
- 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).)
- Muscle soreness(At visit 2 and 3 (week 1) of supervised training sessions.)
- Exercise intensity(At visit 2 and 3 (week 1) of supervised training sessions.)
- Concentration 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).)
- Hemodynamic response to exercise(At visit 2 and 3 (week 1) of supervised training sessions.)
- Concentration 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).)
- 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).)
- Concentration of inflammation biomarkers including, 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).)
研究者
Mrs Hanoof Aljohani
Lead Investigator
Loughborough University