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
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.
Status | Recruiting |
Enrollment | 48 |
Est. completion date | April 2021 |
Est. primary completion date | March 2021 |
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 |
Country | Name | City | State |
---|---|---|---|
Hong Kong | Haven of Hope Hospital | Hong Kong |
Lead Sponsor | Collaborator |
---|---|
Hospital Authority, Hong Kong |
Hong Kong,
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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.
Centner C, Wiegel P, Gollhofer A, König D. Effects of Blood Flow Restriction Training on Muscular Strength and Hypertrophy in Older Individuals: A Systematic Review and Meta-Analysis. Sports Med. 2019 Jan;49(1):95-108. doi: 10.1007/s40279-018-0994-1. Erratum in: Sports Med. 2018 Nov 9;:. — View Citation
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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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. Review. — View Citation
Jeong M, Kang HK, Song P, Park HK, Jung H, Lee SS, Koo HK. Hand grip strength in patients with chronic obstructive pulmonary disease. Int J Chron Obstruct Pulmon Dis. 2017 Aug 9;12:2385-2390. doi: 10.2147/COPD.S140915. eCollection 2017. — View Citation
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Kroemer KH, Marras WS. Towards an objective assessment of the "maximal voluntary contraction" component in routine muscle strength measurements. Eur J Appl Physiol Occup Physiol. 1980;45(1):1-9. — View Citation
Loenneke JP, Wilson JM, Marín 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
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The change of maximal voluntary isometric contraction (MVIC) of knee extension of the dominant leg | 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 | The change of scores of Short physical performance Battery (SPPB) | Gait speed with 4m distance, Balance test & repeated chair stands test | through study completion in 3 weeks (after 10-12 sessions of training) | |
Secondary | The change of hand grip strength | 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) | |
Secondary | The change of health related quality of life: Chinese version of COPD assessment test (CAT) | Self-administered Chinese version of COPD assessment test (CAT) | through study completion in 3 weeks (after 10-12 sessions of training) | |
Secondary | Acceptability of Blood flow restriction resistance 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; | |
Secondary | Reasons of drop-out of Blood flow restriction resistance exercise | Examination the reasons of drop-out in those discontinuing the training | through study completion in 3 weeks (after 10-12 sessions of training) | |
Secondary | Feasibility of Blood flow restriction resistance exercise | Examination of drop-out rate | through study completion in 3 weeks (after 10-12 sessions of training) | |
Secondary | Unplanned readmission rate within 1 month of discharge for COPDAE | Unplanned readmission rate within 1 month of discharge for COPDAE | 1 month after the discharge of patients in the study | |
Secondary | 6-minute walk test | 6-minute walk test | through study completion in 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 |
Acceptance scale will be assessed immediately after the program after 3 (after 10-12 sessions of training) |
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