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

NCT04448236 | Completed Results

• 1 other identifier: BFR-RE in COPDAE
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Chronic Obstructive Pulmonary Disease; Acute Exacerbation of COPD

Keywords

muscle strength; COPDAE; BFRRE; isometric knee extension

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Change of Scores of Short Physical Performance Battery (SPPB) in 3 Weeks

  baseline and 3 weeks (after 10-12 sessions of training)

• Change of Hand Grip Strength in 3 Weeks

  baseline and 3 weeks (after 10-12 sessions of training)

• Change of Health Related Quality of Life in 3 Weeks

  baseline and 3 weeks (after 10-12 sessions of training)

• Average Pain Score of Each Training

  pain score before, immediate and 5-minute post exercise;

• Reasons of Drop-out of Blood Flow Restriction Resistance Exercise

  baseline to 3 weeks (after 10-12 sessions of training)

Study Arms (2)

BFR-RE intervention group

EXPERIMENTAL

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

Control group

NO INTERVENTION

Same standardized 2-week in-patient rehabilitation and same amount of the above-mentioned resistance training without the "BFR device".

Interventions

Blood flow restriction resistance exercise DEVICE

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

BFR-RE intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Concomitant acute cardiac event
• Severe hypertension (BP \> 180/100)
• History of venous thromboembolism
• History of peripheral vascular disease
• Absence of posterior tibial or dorsalis pedal pulse
• History of revascularization of the extremity
• History of lymphectomies
• Extremities with dialysis access
• Vascular grafting
• Current extremity infection
• Active malignancy
• Open fracture / soft tissue injuries
• Amputation to the lower extremity
• Expected hospitalization less than 2 weeks on admission
• Medications known to increase clotting risks

Sponsors & Collaborators

• Hospital Authority, Hong Kong: lead

Study Sites (1)

Haven of Hope Hospital

Hong Kong, Hong Kong

Location

Related Publications (22)

• American College of Sports Medicine. American College of Sports Medicine position stand. Progression models in resistance training for healthy adults. Med Sci Sports Exerc. 2009 Mar;41(3):687-708. doi: 10.1249/MSS.0b013e3181915670.

  PMID: 19204579 BACKGROUND

• 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.

  BACKGROUND

• Centner C, Wiegel P, Gollhofer A, Konig 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.

  PMID: 30306467 BACKGROUND

• 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.

  PMID: 28987643 BACKGROUND

• 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.

  PMID: 28259850 BACKGROUND

• Manini TM, Clark BC. Blood flow restricted exercise and skeletal muscle health. Exerc Sport Sci Rev. 2009 Apr;37(2):78-85. doi: 10.1097/JES.0b013e31819c2e5c.

  PMID: 19305199 BACKGROUND

• Sato, Y. The history and future of KAATSU Training. International Journal of KAATSU Training Research. 2005; 1(1): 1-5.

  BACKGROUND

• Swallow EB, Reyes D, Hopkinson NS, Man WD, Porcher R, Cetti EJ, Moore AJ, Moxham J, Polkey MI. Quadriceps strength predicts mortality in patients with moderate to severe chronic obstructive pulmonary disease. Thorax. 2007 Feb;62(2):115-20. doi: 10.1136/thx.2006.062026. Epub 2006 Nov 7.

  PMID: 17090575 BACKGROUND

• Van't Hul A, Harlaar J, Gosselink R, Hollander P, Postmus P, Kwakkel G. Quadriceps muscle endurance in patients with chronic obstructive pulmonary disease. Muscle Nerve. 2004 Feb;29(2):267-74. doi: 10.1002/mus.10552.

  PMID: 14755493 BACKGROUND

• 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. doi: 10.1007/BF00421195.

  PMID: 7191799 BACKGROUND

• Robles PG, Mathur S, Janaudis-Fereira T, Dolmage TE, Goldstein RS, Brooks D. Measurement of peripheral muscle strength in individuals with chronic obstructive pulmonary disease: a systematic review. J Cardiopulm Rehabil Prev. 2011 Jan-Feb;31(1):11-24. doi: 10.1097/HCR.0b013e3181ebf302.

  PMID: 20724932 BACKGROUND

• Bernabeu-Mora R, Medina-Mirapeix F, Llamazares-Herran E, Garcia-Guillamon G, Gimenez-Gimenez LM, Sanchez-Nieto JM. The Short Physical Performance Battery is a discriminative tool for identifying patients with COPD at risk of disability. Int J Chron Obstruct Pulmon Dis. 2015 Dec 3;10:2619-26. doi: 10.2147/COPD.S94377. eCollection 2015.

  PMID: 26664110 BACKGROUND

• Hicks RW, Denholm B. Implementing AORN recommended practices for care of patients undergoing pneumatic tourniquet-assisted procedures. AORN J. 2013 Oct;98(4):383-93; quiz 394-6. doi: 10.1016/j.aorn.2013.08.004.

  PMID: 24075334 BACKGROUND

• Kearon C, Ageno W, Cannegieter SC, Cosmi B, Geersing GJ, Kyrle PA; Subcommittees on Control of Anticoagulation, and Predictive and Diagnostic Variables in Thrombotic Disease. Categorization of patients as having provoked or unprovoked venous thromboembolism: guidance from the SSC of ISTH. J Thromb Haemost. 2016 Jul;14(7):1480-3. doi: 10.1111/jth.13336. Epub 2016 Jun 7. No abstract available.

  PMID: 27428935 BACKGROUND

• 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.

  PMID: 28848339 BACKGROUND

• Kanada Y, Sakurai H, Sugiura Y, Arai T, Koyama S, Tanabe S. Estimation of 1RM for knee extension based on the maximal isometric muscle strength and body composition. J Phys Ther Sci. 2017 Nov;29(11):2013-2017. doi: 10.1589/jpts.29.2013. Epub 2017 Nov 24.

  PMID: 29200647 BACKGROUND

• 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.

  PMID: 21922259 BACKGROUND

• van Melick N, Meddeler BM, Hoogeboom TJ, Nijhuis-van der Sanden MWG, van Cingel REH. How to determine leg dominance: The agreement between self-reported and observed performance in healthy adults. PLoS One. 2017 Dec 29;12(12):e0189876. doi: 10.1371/journal.pone.0189876. eCollection 2017.

  PMID: 29287067 BACKGROUND

• Patterson SD, Hughes L, Warmington S, Burr J, Scott BR, Owens J, Abe T, Nielsen JL, Libardi CA, Laurentino G, Neto GR, Brandner C, Martin-Hernandez J, Loenneke J. Blood Flow Restriction Exercise: Considerations of Methodology, Application, and Safety. Front Physiol. 2019 May 15;10:533. doi: 10.3389/fphys.2019.00533. eCollection 2019.

  PMID: 31156448 BACKGROUND

• Takeichi N, Ishizaka S, Nishiyama M, et al. Prediction of 1 repetition maximum strength from isometric strength using Hand-Held Dynamometer for the knee extenser. Gen Rehabil, 2012; 40: 1005-1009.

  BACKGROUND

• Yu R, Ong S, Cheung O, Leung J, Woo J. Reference Values of Grip Strength, Prevalence of Low Grip Strength, and Factors Affecting Grip Strength Values in Chinese Adults. J Am Med Dir Assoc. 2017 Jun 1;18(6):551.e9-551.e16. doi: 10.1016/j.jamda.2017.03.006. Epub 2017 Apr 29.

  PMID: 28465129 BACKGROUND

• Lau CW, Leung SY, Wah SH, Yip CW, Wong WY, Chan KS. Effect on muscle strength after blood flow restriction resistance exercise in early in-patient rehabilitation of post-chronic obstructive pulmonary disease acute exacerbation, a single blinded, randomized controlled study. Chron Respir Dis. 2023 Jan-Dec;20:14799731231211845. doi: 10.1177/14799731231211845.

  PMID: 37976375 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dr. Lau Chung Wai
• Organization: Haven of Hope hospital, Hospital Authority

lcw431@ha.org.hk

27038888

Study Officials

• chung wai LAU, MBBS

  Hospital Authority, Hong Kong

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The Assessor for the primary outcome (maximum voluntary isometric contraction, MVIC) of knee extension, functional outcomes(6-minute walk test, Short Physical Performance Battery), will be blinded to the allocated study group.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: Participants are randomized into one of the two treatment groups by drawing enclosed envelops which contain the random allocation of participants to intervention group (training with "BFR-device" and control group (training without the device). The envelopes are opened after inclusion for the individual participant only. Stratification of participants into two groups by maximum voluntary isometric contraction (MVIC) at baseline before randomization will be done. The cutoff for the stratification will be determined from the data in the recent service.

Study Record Dates

• First Submitted: June 13, 2020
• First Posted: June 25, 2020
• Study Start: June 10, 2020
• Primary Completion: December 9, 2020
• Study Completion: December 9, 2020
• Last Updated: June 17, 2024
• Results First Posted: June 17, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)