Resistance training combined with blood flow restriction in cirrhosis: study protocol for a randomized controlled trial

Abstract Background Patients affected by hepatic cirrhosis show reductions in muscle mass and function, with poor quality of life and functional performance. As such, resistance training with blood flow restriction (BFR-RT) could be a useful therapeutic tool for health promotion. Thus, we aim to ver...

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Main Authors: Sanmy Rocha Nóbrega, Silvana Gama Florencio Chachá, Cleiton Augusto Libardi
Format: Article
Language:English
Published: BMC 2020-05-01
Series:Trials
Subjects:
Online Access:http://link.springer.com/article/10.1186/s13063-020-04410-2
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spelling doaj-4ed07925905a4747875ee7f9a3128abf2020-11-25T03:10:56ZengBMCTrials1745-62152020-05-012111710.1186/s13063-020-04410-2Resistance training combined with blood flow restriction in cirrhosis: study protocol for a randomized controlled trialSanmy Rocha Nóbrega0Silvana Gama Florencio Chachá1Cleiton Augusto Libardi2MUSCULAB - Laboratory of Neuromuscular Adaptations to Resistance Training, Federal University of São Carlos – UFSCarDepartment of Medicine, Federal University of São Carlos – UFSCarMUSCULAB - Laboratory of Neuromuscular Adaptations to Resistance Training, Federal University of São Carlos – UFSCarAbstract Background Patients affected by hepatic cirrhosis show reductions in muscle mass and function, with poor quality of life and functional performance. As such, resistance training with blood flow restriction (BFR-RT) could be a useful therapeutic tool for health promotion. Thus, we aim to verify the effects of this intervention on muscle strength, muscle mass, fiber Pennation angle, fascicle length, functional performance, quality of life, and fall risk scores in this population. Methods Thirty participants will be randomly distributed between 1) BFR-RT and 2) control (CTRL). Assessments will occur at three time points: before the training intervention (0 W), after 12 weeks (12 W), and at follow-up (24 W). The following variables will be assessed: Child-Pugh classification; MELD score; SF-36 questionnaire; fatigue severity index; 6-min walk test; timed-up and go; 30-s sitting and rising test; dietary record; one-repetition maximum (1-RM) strength test (knee extension exercise); and vastus lateralis’ cross-sectional area, Pennation angle, and fascicle length. The BFR-RT group will undergo 12 weeks of knee extension exercise (1 × 30 repetitions and 3 × 15 repetitions at 20% 1-RM and 50% of total blood flow occlusion pressure), with two sessions per week. Data normality will be assessed using the Shapiro-Wilk test. In case of normal distribution, a one-way repeated measures analysis of variance will be implemented to test for differences in baseline values. A mixed model then will be applied for each dependent variable. In case of non-normal data distribution, a Kruskal–Wallis test will be implemented to test for differences in baseline values. Next, the Friedman test will be used to analyze repeated measures. Within- and between-group effect sizes will be calculated using Cohen’s d for each outcome. Finally, the minimal clinically important difference will be analyzed with distribution-based methods. Discussion To our knowledge, this will be the first trial to investigate BFR-RT in patients with cirrhosis and evaluate the effects on neuromuscular parameters, functional performance, disease severity, and quality of life outcomes. Trial registration Brazilian Clinical Trials Registry (ReBec): RBR-395mfw . Registered on 25 August 2018.http://link.springer.com/article/10.1186/s13063-020-04410-2End stage liver diseaseSarcopeniaPhysical activityMuscle strengthQuality of lifeHypertrophy
collection DOAJ
language English
format Article
sources DOAJ
author Sanmy Rocha Nóbrega
Silvana Gama Florencio Chachá
Cleiton Augusto Libardi
spellingShingle Sanmy Rocha Nóbrega
Silvana Gama Florencio Chachá
Cleiton Augusto Libardi
Resistance training combined with blood flow restriction in cirrhosis: study protocol for a randomized controlled trial
Trials
End stage liver disease
Sarcopenia
Physical activity
Muscle strength
Quality of life
Hypertrophy
author_facet Sanmy Rocha Nóbrega
Silvana Gama Florencio Chachá
Cleiton Augusto Libardi
author_sort Sanmy Rocha Nóbrega
title Resistance training combined with blood flow restriction in cirrhosis: study protocol for a randomized controlled trial
title_short Resistance training combined with blood flow restriction in cirrhosis: study protocol for a randomized controlled trial
title_full Resistance training combined with blood flow restriction in cirrhosis: study protocol for a randomized controlled trial
title_fullStr Resistance training combined with blood flow restriction in cirrhosis: study protocol for a randomized controlled trial
title_full_unstemmed Resistance training combined with blood flow restriction in cirrhosis: study protocol for a randomized controlled trial
title_sort resistance training combined with blood flow restriction in cirrhosis: study protocol for a randomized controlled trial
publisher BMC
series Trials
issn 1745-6215
publishDate 2020-05-01
description Abstract Background Patients affected by hepatic cirrhosis show reductions in muscle mass and function, with poor quality of life and functional performance. As such, resistance training with blood flow restriction (BFR-RT) could be a useful therapeutic tool for health promotion. Thus, we aim to verify the effects of this intervention on muscle strength, muscle mass, fiber Pennation angle, fascicle length, functional performance, quality of life, and fall risk scores in this population. Methods Thirty participants will be randomly distributed between 1) BFR-RT and 2) control (CTRL). Assessments will occur at three time points: before the training intervention (0 W), after 12 weeks (12 W), and at follow-up (24 W). The following variables will be assessed: Child-Pugh classification; MELD score; SF-36 questionnaire; fatigue severity index; 6-min walk test; timed-up and go; 30-s sitting and rising test; dietary record; one-repetition maximum (1-RM) strength test (knee extension exercise); and vastus lateralis’ cross-sectional area, Pennation angle, and fascicle length. The BFR-RT group will undergo 12 weeks of knee extension exercise (1 × 30 repetitions and 3 × 15 repetitions at 20% 1-RM and 50% of total blood flow occlusion pressure), with two sessions per week. Data normality will be assessed using the Shapiro-Wilk test. In case of normal distribution, a one-way repeated measures analysis of variance will be implemented to test for differences in baseline values. A mixed model then will be applied for each dependent variable. In case of non-normal data distribution, a Kruskal–Wallis test will be implemented to test for differences in baseline values. Next, the Friedman test will be used to analyze repeated measures. Within- and between-group effect sizes will be calculated using Cohen’s d for each outcome. Finally, the minimal clinically important difference will be analyzed with distribution-based methods. Discussion To our knowledge, this will be the first trial to investigate BFR-RT in patients with cirrhosis and evaluate the effects on neuromuscular parameters, functional performance, disease severity, and quality of life outcomes. Trial registration Brazilian Clinical Trials Registry (ReBec): RBR-395mfw . Registered on 25 August 2018.
topic End stage liver disease
Sarcopenia
Physical activity
Muscle strength
Quality of life
Hypertrophy
url http://link.springer.com/article/10.1186/s13063-020-04410-2
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