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Clinical Trial Protocol
Journal Article
Research Support, Non-U.S. Gov't
Comparing the efficacy of low-load resistance exercise combined with blood flow restriction versus conventional-load resistance exercise in Chinese community-dwelling older people with sarcopenic obesity: a study protocol for a randomised controlled trial.
BMC Geriatrics 2023 December 20
INTRODUCTION: Sarcopenic obesity (SO) is characterised by decreased muscle mass, diminished muscle strength and/or reduced physical performance and a high percentage of body fat (PBF). Conventional-load resistance exercise (CRE) may be difficult for older people with SO owing to their declining physical functions. Low-load resistance exercise (LRE) combined with blood flow restriction (BFR; LRE-BFR) is a viable alternative to CRE for improving muscle mass and strength and potential exercise mode for managing SO. This study has two objectives: (1) to comprehensively evaluate the efficacy of CRE and LRE-BFR in improving body composition, muscle strength, physical performance, haematological parameters, cardiovascular disease (CVD) risk factors and quality of life and (2) to compare the efficacy of CRE and LRE-BFR and explore their potential mechanisms.
METHODS AND ANALYSIS: This work is a 12-week assessor-blinded randomised clinical trial that will be conducted thrice a week. Sarcopenia will be defined using the Asian Working Group for Sarcopenia 2019, and obesity will be determined using the criteria developed by the World Health Organization. Community-dwelling older people aged ≥ 65 years will be screened as the participants using inclusion and exclusion criteria. A total of 33 participants will be randomised into a CRE group (n = 11), an LRE-BFR group (n = 11) and a control group that will be given only health education (n = 11). The primary outcomes will be knee extensor strength and PBF, and the secondary outcomes will be body composition, anthropometric measurements, muscle strength of upper limbs, physical performance, haematological parameters, CVD risk factors and quality of life. The outcomes will be measured at the baseline (week 0), end of the intervention (week 12) and follow up (week 24). All the collected data will be analysed following the intention-to-treat principle.
ETHICS AND DISSEMINATION: The Ethics Research Committee has approved this study (approval No. CMEC-2022-KT-51). Changes or developments in this study will be reported at www.chictr.org.cn .
TRIAL REGISTRATION: ChiCTR2300067296 (3 January 2023).
METHODS AND ANALYSIS: This work is a 12-week assessor-blinded randomised clinical trial that will be conducted thrice a week. Sarcopenia will be defined using the Asian Working Group for Sarcopenia 2019, and obesity will be determined using the criteria developed by the World Health Organization. Community-dwelling older people aged ≥ 65 years will be screened as the participants using inclusion and exclusion criteria. A total of 33 participants will be randomised into a CRE group (n = 11), an LRE-BFR group (n = 11) and a control group that will be given only health education (n = 11). The primary outcomes will be knee extensor strength and PBF, and the secondary outcomes will be body composition, anthropometric measurements, muscle strength of upper limbs, physical performance, haematological parameters, CVD risk factors and quality of life. The outcomes will be measured at the baseline (week 0), end of the intervention (week 12) and follow up (week 24). All the collected data will be analysed following the intention-to-treat principle.
ETHICS AND DISSEMINATION: The Ethics Research Committee has approved this study (approval No. CMEC-2022-KT-51). Changes or developments in this study will be reported at www.chictr.org.cn .
TRIAL REGISTRATION: ChiCTR2300067296 (3 January 2023).
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