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

Chronic Obstructive Pulmonary Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04448236
• Other study ID #: BFR-RE in COPDAE
• Status: Completed
• Phase: N/A
• Start date: June 10, 2020
• Est. completion date: December 9, 2020

Study information

• Verified date: January 2024
• Source: Hospital Authority, Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 53
• Est. completion date: December 9, 2020
• Est. primary completion date: December 9, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Exacerbation of COPD
• Chronic Obstructive Pulmonary Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

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

Locations

Country	Name	City	State
Hong Kong	Haven of Hope Hospital	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Authority, Hong Kong

Country where clinical trial is conducted

Hong Kong, 

References & Publications (21)

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Brandner, C. R., May, A. K., Clarkson, M. J., & Warmington, S. A. Reported Side-effects and Safety Considerations for the Use of Blood Flow Restriction During Exercise in Practice and Research. Techniques in Orthopaedics. 2018; 33(2), 114-121.

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Cook SB, LaRoche DP, Villa MR, Barile H, Manini TM. Blood flow restricted resistance training in older adults at risk of mobility limitations. Exp Gerontol. 2017 Dec 1;99:138-145. doi: 10.1016/j.exger.2017.10.004. Epub 2017 Oct 5. — View Citation

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Loenneke JP, Wilson JM, Marin PJ, Zourdos MC, Bemben MG. Low intensity blood flow restriction training: a meta-analysis. Eur J Appl Physiol. 2012 May;112(5):1849-59. doi: 10.1007/s00421-011-2167-x. Epub 2011 Sep 16. — View Citation

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* Note: There are 21 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of Maximal Voluntary Isometric Contraction (MVIC) of Knee Extension of the Dominant Leg in 3 Weeks	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.	baseline and 3 weeks (after 10-12 sessions of training)
Secondary	Change of Scores of Short Physical Performance Battery (SPPB) in 3 Weeks	SPPB is the sum of the points from the following 3 measures, high the point, better performance; Time needed to walk 4m distance: less than 4.82s=4 points, 4.82-6.2s=3 points, 6.21-8.7s=2 points, >8.7s=1 point; if unable to do the walk=0 point; Balance test: can hold side by side stand 10s= 1 point; semi-tandem stand 10s=1 point; tandem stand 10s=2 point; tandem stand 3-9.99s=1 point; if unable to do the stand=0 point; Repeated chair stands test:; Participant unable to complete 5 chair stands or completes stands in >60s =0 point; If chair stand time is 16.70s or more= 1 point; If chair stand time is 13.70 to 16.69s = 2 points; If chair stand time is 11.20 to 13.69s=3 points; If chair stand time is 11.19s or less= 4 points; Minimum score=0 Maximum score=12(best performance)	baseline and 3 weeks (after 10-12 sessions of training)
Secondary	Change of Hand Grip Strength in 3 Weeks	a non-invasive marker of systemic skeletal muscle strength and function, is assessed by handheld grip dynamometer of dominant hand	baseline and 3 weeks (after 10-12 sessions of training)
Secondary	Change of Health Related Quality of Life in 3 Weeks	Self-administered Chinese version of Chronic obstructive pulmonary disease(COPD) assessment test (CAT) It contains 8 questions and 6 points each (0 to 5). Higher score means worse health status. The Minimal clinical important difference of CAT score was 2 to 3.; Minimum score=0 Maximum score=40 (worst health status)	baseline and 3 weeks (after 10-12 sessions of training)
Secondary	Average Pain Score of Each Training	Visual analog scale (0-10) for before, immediate and 5-minute post exercise. least pain=0 ; most severe pain=10	pain score before, immediate and 5-minute post exercise;
Secondary	Reasons of Drop-out of Blood Flow Restriction Resistance Exercise	Examination the reasons of drop-out in those discontinuing the training	baseline to 3 weeks (after 10-12 sessions of training)
Secondary	Feasibility of BFR Exercise	Examination of drop-out rate	baseline and 3 weeks (after 10-12 sessions of training)
Secondary	Unplanned Readmission Rate on 1 Month Post Discharge	Unplanned readmission rate within 1 month of discharge for Chronic Obstructive Pulmonary Disease Acute Exacerbation (COPDAE)	1 month after the discharge of patients in the study
Secondary	6-minute Walk Test Distance Gain	the distance can achieved in 6-minute walk test	baseline and 3 weeks (after 10-12 sessions of training)
Secondary	Acceptability of Blood Flow Restriction Resistance Exercise	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 Lowest score=1 Highest score=5(Higher score means better acceptance)	Acceptance scale will be assessed immediately after the program after 3 (after 10-12 sessions of training)