Effect of Blood Flow Restriction Resistance Exercises in COPDAE In-patient Rehabilitation

July 12, 2020 updated by: LAU chung wai, Hospital Authority, Hong Kong

Effects on Muscle Strength After Blood Flow Restriction Resistance Exercise (BFR-RE) in Early In-patient Rehabilitation of Chronic Obstructive Pulmonary Disease Acute Exacerbation (COPDAE), a Single Blinded, Randomized Controlled Study

This is a randomised controlled trial of the blood flow restriction resistance exercise (BFR-RE) for early rehabilitation of chronic obstructive pulmonary disease acute exacerbation (COPDAE) in the Haven of Hope Hospital.

BFR-RE was invented by Dr. Yoshiaki Sato in Japan 40 years ago. This exercise was newly introduced to the Physiotherapy Department of Haven of Hope Hospital in March, 2020 and not a routine common training in Hospital Authority. However, currently the "BFR-device" is in its 3rd generation. Under the guidance of a certified physiotherapist, a "low load intensity" can be used for resistance training to build up muscle mass and strength by applying the device over the thigh to partially limit the blood flow to the distal limb.

BFR-RE is well studied in athletes, elderlies and patients for rehabilitation after orthopaedics surgeries. A large amount of literature reveals BFR-RE with "low load intensity" shows comparable increase of muscle mass as "high load intensity" resistance training and more increase of muscle strength than those only undergoing "low load intensity" resistance training.

The objective of this study is to investigate the additional effects of 2-week BFR-RE in patients with COPDAE on top of the conventional in-patient rehabilitation training. The primary outcome is effect on localized muscle strength. The secondary outcomes include mobility function, systemic muscle strength as reflected by handgrip strength(HGS), health related quality of life, unplanned readmission to acute hospital rate within 1 month for COPDAE.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Chronic obstructive pulmonary disease (COPD) is a prevalent disease around the world particularly in developed countries. COPD often has frequent admissions for acute exacerbation which increase the risks of mortality. Muscular dysfunction is one of extra-pulmonary morbidity of COPD.

Reduced muscle strength is associated with increased mortality in moderate to severe COPD. However, at least 70% of 1-repetition maximum (1-RM) of weight is needed to achieve muscle growth in resistance training. This might not be feasible particularly to the patients admitted for COPD acute exacerbation (COPDAE).

Blood flow restriction resistance training (BFR-RE), Kaatsu training, was developed by Dr. Yoshiaki Sato more than 40 years ago. The basic physiological mechanism of BFR-RE to increase muscle mass and strength is by metabolite accumulation, e.g. lactate. The metabolites lead to increase of serum growth hormone (GH) which promotes the collagen synthesis for tissue repair and recovery. The surge of GH leads to release of insulin-like growth factor (IGF-1) which is a protein related to muscle growth. IGF-1 contributes the muscle gain, which is a muscular anabolic process, by enhancing satellite cell proliferation.

Concerning growth of muscle mass, BFR-RE leads to a comparable increase when compared to high load resistance exercise (HL-RE). However, concerning increase of muscle strength, BFR-RE is less effective in gain than that in HL- RE but more effective than that in low load resistance exercise (LL-RE) alone. Therefore, BFR-RE can be considered when HL- RE is not advisable. (e.g. frail elderly, post-operative rehabilitation, etc.) BFR-RE is well studied among healthy adult, elderly and musculoskeletal rehabilitation patients, but not in COPDAE patients.

Standardized isotonic knee extension resistance training on alternate day with a load of 15-30% of 1-Repetition Maximum (1-RM) with "BFR-device" will be compared with the control arm having same set of exercise training without the device in COPDAE patient during 2-week of inpatient stay. Referred to previous study with 30% drop out rate estimation, 24 patients for each arm will be needed. Study period will be set to be 9 months or until expected recruitment achieved.

Though there no adverse risk responses were reported in published randomized controlled trials in clinical populations in the literature, there are some expected transient perceptual type responses, e.g. dizziness, limb numbness, perceived exertion, delayed onset muscle soreness. There are no significant risks of complications if BFR-RE is prescribed by certified trainers who have knowledge of appropriate protocols and contraindications to the use of occlusive stimuli.

The effect on muscle strength in COPDAE inpatient, which is not well studied in the literatures, will be the primary outcome of this study. The effect on mobility functions, systemic muscle strength, health related quality of life, unplanned readmission rate within 1 month of discharge for COPDAE, acceptability and feasibility of the BFR-RE will be evaluated as secondary outcomes.

Study Type

Interventional

Enrollment (Anticipated)

48

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 Contact

Study Locations

  • Hong Kong
      • Hong Kong, Hong Kong
        • Recruiting
        • Haven of Hope Hospital
        • Contact:

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. COPD acute exacerbation (COPDAE) as the primary diagnosis for hospitalization or transfer to pulmonary wards of the Haven of Hope Hospital
  2. Able to walk under supervision
  3. Understand instruction in Cantonese and can give informed consent.

Exclusion Criteria:

  1. Concomitant acute cardiac event
  2. Severe hypertension (BP > 180/100)
  3. History of venous thromboembolism
  4. History of peripheral vascular disease
  5. Absence of posterior tibial or dorsalis pedal pulse
  6. History of revascularization of the extremity
  7. History of lymphectomies
  8. Extremities with dialysis access
  9. Vascular grafting
  10. Current extremity infection
  11. Active malignancy
  12. Open fracture / soft tissue injuries
  13. Amputation to the lower extremity
  14. Expected hospitalization less than 2 weeks on admission
  15. Medications known to increase clotting risks

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: BFR-RE intervention group

The participants will have the standardised 2 week resistance training with "BFR-device" with details as follows:

  • Cuff size: medium
  • Restriction time: 5- 10 mins (stop after finishing 4 sets of training or terminating by Physiotherapists)
  • Applied location: alternate quadriceps in consecutive day
  • Applied pressure: 80% limb occlusion pressure (LOP)
Device: Blood flow restriction resistance exercise
Application the "Blood flow restriction device" over the proximal thigh to have 80% of the limb occlusion pressure to accumulate the metabolite generated during knee extension
No Intervention: Control group
Same standardized 2-week in-patient rehabilitation and same amount of the above-mentioned resistance training without the "BFR device".

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The change of maximal voluntary isometric contraction (MVIC) of knee extension of the dominant leg
Time Frame: through study completion in 3 weeks (after 10-12 sessions of training)

To measure the change of the force-producing capabilities of a muscle group objectively during its isometric contraction condition which means muscle group under contraction with a constant velocity of joint motion and muscle length.

Computer dynamometer will be used to measure the MVIC of the isometric knee extension of the dominant leg.
through study completion in 3 weeks (after 10-12 sessions of training)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The change of scores of Short physical performance Battery (SPPB)
Time Frame: through study completion in 3 weeks (after 10-12 sessions of training)
Gait speed with 4m distance, Balance test & repeated chair stands test
through study completion in 3 weeks (after 10-12 sessions of training)
The change of hand grip strength
Time Frame: through study completion in 3 weeks (after 10-12 sessions of training)
a non-invasive marker of systemic skeletal muscle strength and function, is assessed by handheld grip dynamometer of dominant hand
through study completion in 3 weeks (after 10-12 sessions of training)
The change of health related quality of life: Chinese version of COPD assessment test (CAT)
Time Frame: through study completion in 3 weeks (after 10-12 sessions of training)
Self-administered Chinese version of COPD assessment test (CAT)
through study completion in 3 weeks (after 10-12 sessions of training)
Acceptability of Blood flow restriction resistance exercise
Time Frame: pain score before, immediate and 5-minute post exercise;

Measure pain score by visual analog scale (0-10) before, immediate and 5-minute post exercise.

least pain=0 ; most severe pain=10
pain score before, immediate and 5-minute post exercise;
Reasons of drop-out of Blood flow restriction resistance exercise
Time Frame: through study completion in 3 weeks (after 10-12 sessions of training)
Examination the reasons of drop-out in those discontinuing the training
through study completion in 3 weeks (after 10-12 sessions of training)
Feasibility of Blood flow restriction resistance exercise
Time Frame: through study completion in 3 weeks (after 10-12 sessions of training)
Examination of drop-out rate
through study completion in 3 weeks (after 10-12 sessions of training)
Unplanned readmission rate within 1 month of discharge for COPDAE
Time Frame: 1 month after the discharge of patients in the study
Unplanned readmission rate within 1 month of discharge for COPDAE
1 month after the discharge of patients in the study
6-minute walk test
Time Frame: through study completion in 3 weeks (after 10-12 sessions of training)
6-minute walk test
through study completion in 3 weeks (after 10-12 sessions of training)
Acceptability of Blood flow restriction resistance exercise
Time Frame: Acceptance scale will be assessed immediately after the program after 3 (after 10-12 sessions of training)

Measure the patient's acceptance by a 5-point categorical scale after the whole program.

1=very dislike, 2=dislike,3=no comment, 4= like, 5=very like
Acceptance scale will be assessed immediately after the program after 3 (after 10-12 sessions of training)

Collaborators and Investigators

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

Sponsor

Hospital Authority, Hong Kong

Investigators

  • Principal Investigator: chung wai LAU, MBBS, Hospital Authority, Hong Kong

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)

June 10, 2020

Primary Completion (Anticipated)

March 1, 2021

Study Completion (Anticipated)

April 1, 2021

Study Registration Dates

First Submitted

June 13, 2020

First Submitted That Met QC Criteria

June 24, 2020

First Posted (Actual)

June 25, 2020

Study Record Updates

Last Update Posted (Actual)

July 14, 2020

Last Update Submitted That Met QC Criteria

July 12, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BFR-RE in COPDAE

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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