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

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

Interventions

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.

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.

Sponsors & Collaborators

• University Hospitals, Leicester

  collaborator OTHER

• Mrs Hanoof Aljohani

  lead OTHER

Principal Investigators

• Thomas Ward, MBBS, PhD · University Hospitals, Leicester

Study Design

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

40 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-01-26

Primary Completion

2024-11-04

Completion

2024-11-30

Countries

• United Kingdom

Study Locations