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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 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.

SUBMITTER: Nobrega SR

PROVIDER: S-EPMC7257225 | biostudies-literature | 2020 May

REPOSITORIES: biostudies-literature

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

Nóbrega Sanmy Rocha SR Chachá Silvana Gama Florencio SGF Libardi Cleiton Augusto CA

Trials 20200529 1

<h4>Background</h4>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.<h4>Method ...[more]

PMID: 32471480

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Project description:BackgroundSarcopenia is accompanied by a decline in muscle mass, muscle strength, and muscle function. Resistance training is the most potential training method for the prevention and treatment of sarcopenia. However, the conventional high-load resistance training (CRT) recommended by the American College of Sports Medicine is a challenge for older people with sarcopenia. As a novel training method, low-load resistance training combined with blood flow restriction (LRT-BFR) may elicit similar muscle mass and muscle strength gains as CRT but with less effort. The objectives of this study are to assess and compare the efficacy and safety of 12-week LRT-BFR and CRT on muscle strength, muscle performance, body composition, pulmonary function, blood biomarkers, CVD risk factors, and quality of life in community-dwelling older Chinese people with sarcopenia.MethodThis is a 12-week, assessor-blinded, 3-arm randomized controlled trial with a non-exercise control group. Community-dwelling people over 65 years will be screened for sarcopenia according to the diagnostic criteria of the Asian Working Group for Sarcopenia (AWGS). Fifty-one subjects will be randomized into a LRT-BFR group (n = 17), a CRT group (n = 17), and a no-strength training control group (n = 17). The primary outcome is lower limb muscle strength. The secondary outcomes are body composition, upper limb muscle strength, pulmonary function, blood biomarkers, CVD risk factors, and quality of life. Post-intervention follow-up will be performed for 12 weeks. These indicators will be assessed at baseline (0 week), after the 12-week intervention (12 weeks), and at follow-up (24 weeks). The adverse events will also be reported. Data will be analyzed for all participants in an intent-to-treat plan.DiscussionThis study is the first RCT that will systematically measure and compare the efficacy and safety of LRT-BFR and CRT in older people with sarcopenia on muscle strength, body composition, pulmonary function, blood biomarkers (inflammatory biomarkers, hormone, and growth factors), CVD risk factors, and quality of life. This study can provide an efficient and safe method to prevent the progression of sarcopenia in older people.Trial registrationChinese Clinical Trial Registry ChiCTR2100042803 . Registered on 28 January 2021.

Project description:Background: There is growing evidence to support the use of low-load blood flow restriction (LL-BFR) exercise in musculoskeletal rehabilitation. Purpose: The purpose of this study was to evaluate the efficacy and feasibility of low-load blood flow restricted (LL-BFR) training versus conventional high mechanical load resistance training (RT) on the clinical outcomes of patient's undergoing inpatient multidisciplinary team (MDT) rehabilitation. Study design: A single-blind randomized controlled study. Methods: Twenty-eight lower-limb injured adults completed a 3-week intensive MDT rehabilitation program. Participants were randomly allocated into a conventional RT (3-days/week) or twice-daily LL-BFR training group. Outcome measurements were taken at baseline and 3-weeks and included quadriceps and total thigh muscle cross-sectional area (CSA) and volume, muscle strength [five repetition maximum (RM) leg press and knee extension test, isometric hip extension], pain and physical function measures (Y-balance test, multistage locomotion test-MSLT). Results: A two-way repeated measures analysis of variance revealed no significant differences between groups for any outcome measure post-intervention (p > 0.05). Both groups showed significant improvements in mean scores for muscle CSA/volume, 5-RM leg press, and 5-RM knee extension (p < 0.01) after treatment. LL-BFR group participants also demonstrated significant improvements in MSLT and Y-balance scores (p < 0.01). The Pain scores during training reduced significantly over time in the LL-BFR group (p = 0.024), with no adverse events reported during the study. Conclusion: Comparable improvements in muscle strength and hypertrophy were shown in LL-BFR and conventional training groups following in-patient rehabilitation. The LL-BFR group also achieved significant improvements in functional capacity. LL-BFR training is a rehabilitation tool that has the potential to induce positive adaptations in the absence of high mechanical loads and therefore could be considered a treatment option for patients suffering significant functional deficits for whom conventional loaded RT is contraindicated. Trial Registration: ISRCTN Reference: ISRCTN63585315, dated 25 April 2017.

Project description:"Nonspecific shoulder pain" encompasses various non-traumatic musculoskeletal shoulder disorders, diverging from diagnostic terminologies that refer to precise tissue-oriented clinical diagnosis. Blood flow restriction (BFR) training, involving partial arterial inflow and complete venous outflow restriction, has exhibited acute hypoalgesic effects primarily in healthy populations by increasing their pain thresholds. This study aims to examine whether a single BFR session with low-load exercises can alleviate pain perception among nonspecific shoulder pain patients. Conducted as a single-blind crossover randomised clinical trial, 48 adults (age range: 18 to 40) presenting with nonspecific shoulder pain will partake in two trial sessions. Random assignment will place participants into BFR or sham BFR groups and ask them to perform one exercise with BFR. Subsequently, participants will complete a shoulder girdle loading regimen comprising six exercises. The second session will involve participants switching treatment groups. Pain pressure thresholds (PPTs), shoulder pain and disability via the shoulder pain and disability index (SPADI), maximal voluntary isometric contraction (MVIC) of shoulder external rotators, pain during active abduction, and peak pain during shoulder external rotation will be evaluated using the numeric pain rating scale (NPRS). Immediate post-exercise assessments will include patient-perceived pain changes using the global rating of change scale (GROC) and participant-rated perceived exertion (RPE), employing a modified Borg's scale (Borg CR10) post-BFR or sham BFR exercise session. Each session will encompass three assessment periods, and a combination of mixed-effect models and descriptive statistics will underpin the analysis. This protocol was approved by Cyprus National Bioethics Committee (ΕΕΒΚ/2023/48), and was registered in ClinicalTrials.gov (Registration number: NCT05956288). Conclusion: The anticipated outcomes of this study illuminated the acute effects of BFR training on pain perception within the context of nonspecific shoulder pain, potentially advancing strategies for managing pain intensity using BFR techniques.

Project description:BackgroundThe effectiveness of blood flow restriction training (BFR) in elderly with knee osteoarthritis (OA) is comparable to performing high-intensity protocols (70 to 80% of 1 RM [repetition maximum]) that are known to be effective for improving the muscle strength of knee extensors, with the advantage of generating less particular rating of perceived exertion and pain immediately after training. However, despite being a promising alternative, little is known about the best way to apply the BFR, such as level of pressure and combination or not with other therapeutic modalities. The purpose of this study is to evaluate whether different levels of blood flow restriction with low load (BFR + LL) and no load (BFR + rest) are non-inferior to high-intensity resistance exercise (HIRE+BFRplacebo) for pain reduction in patients with knee OA.Methods/designThis clinical trial is a non-inferiority, five-arm, randomized, active-controlled, single trial which will be carried out in 165 patients of both sexes with knee OA, aged 50 years and older. Participants will be randomly allocated into 5 exercise groups (40% of BFR + LL; 80% of BFR + LL; 40% of BFR + rest; 80% BFR + rest, and HIRE+BFR placebo). A mixed linear model will be used to examine the effect of group-by-time interaction on pain intensity on the WOMAC subscale (primary outcome) and on disease severity, physical functional data, balance data, quality of life, global perceived effect scale, and muscle strength (secondary outcomes). Participants will be analyzed for intention-to-treat, and the statistical assessor blinded to the groups. The collection of outcomes 72 h after completion of the 16 weeks of interventions will be the primary measurement point. Follow-up secondary timepoints will be collected at 20, 28, 40, 52, and 64 weeks after the end of interventions, except for pain during the training, which will be measured immediately at the end of each session. Only the comparison of the primary outcome between the HIRE group with each BFR group will be analyzed in the non-inferiority framework, the other comparisons between the BFR groups for the primary outcome, and all secondary outcomes will be interpreted in the superiority framework.DiscussionThe results of this clinical trial can point out more clearly to ways to optimize the BFR training with the minimum of pain immediately after training, which will allow the offer of an effective and more adherent strengthening training to patients with knee OA.Trial registrationRegistro Brasileiro de Ensaios Clínicos, RBR-93rx9q . Registered on 23 July 2020. Version 1.0.

Project description:BACKGROUND:During aging, a significant loss of muscle mass, strength, and power is associated with a decline in daily functional capacities. Traditionally, resistance training is prescribed to prevent or reverse the skeletal muscle weakness, but the required training intensity may be too demanding for older people with poor physical performance. Resistance exercise with blood flow moderation (KAATSU training), originally developed in Japan, combines resistance exercise with blood flow restriction. It has been reported that KAATSU training enhances muscle hypertrophy in many populations. However, few studies have evaluated the effects of resistance exercises with blood flow restriction in elderly people and how this affects vascular structure and function. OBJECTIVE:The aim of this study was to evaluate (1) the acute and chronic effects of resistance exercise with blood flow restriction on vascular health in elderly people with low gait speed and (2) whether low-load resistance training with blood flow restriction elicits similar strength and gait speed gains to those elicited by conventional resistance training without blood flow restriction. METHODS:This is an ongoing randomized controlled trial in elderly people with low gait speed. Overall, two study arms of 13 participants each perform resistance exercise with and without blood flow restriction. The 2 groups are as follows: the control group will perform conventional resistance exercise (60% of 1 repetition maximum) and the KAATSU group will perform the low-load resistance exercise with blood flow restriction (20% of 1 repetition maximum) for 12 weeks. Pulse wave velocity, venous occlusion plethysmography, and flow-mediated dilation are used to assess arterial stiffness, muscle blood flow, and endothelial function, respectively. The secondary outcomes are gait speed, strength, and quality of life. All measures will be performed before and after the training program. RESULTS:This research study is in progress. Recruitment has started, and data collection is expected to finish in August 2020. CONCLUSIONS:The findings of this study will have important implications for the rehabilitation of elderly people. TRIAL REGISTRATION:ClinicalTrials.gov NCT03272737; https://clinicaltrials.gov/ct2/show/NCT03272737. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID):DERR1-10.2196/14691.

Project description:BackgroundPatellar instability is a common and understudied condition that disproportionally affects athletes and military personnel. The rate of post-traumatic osteoarthritis that develops following a patellar dislocation can be up to 50% of individuals 5-15 years after injury. Conservative treatment is the standard of care for patellar instability however, there are no evidence-informed rehabilitation guidelines in the scientific literature. The purpose of this study is to assess the effectiveness of blood-flow restriction training (BFRT) for patellar instability. Our hypotheses are that this strategy will improve patient-reported outcomes and accelerate restoration of symmetric strength and knee biomechanics necessary to safely return to activity.Methods/designThis is a parallel-group, superiority, randomized, double-blinded, placebo-controlled clinical trial at the University of Kentucky, sports medicine clinic that aims to recruit 78 patients with acute patellar dislocations randomly allocated into two groups: (1) sham BFRT and (2) BFRT. Both groups will receive the current standard of care physical therapy 3 times per week for up to 9 weeks. Physical therapy sessions will consist of typical standard of care treatment followed by BFRT or sham BFRT. Primary outcomes include the Norwich Patellar Instability Scale, quadriceps strength, and imaging and biochemical biomarkers of cartilage degradation.DiscussionThe current standard of care for non-operative treatment of patellar instability is highly variable does not adequately address the mechanisms necessary to restore lower extremity function and protect the long-term health of articular cartilage following injury. This proposed novel intervention strategy uses an easily implementable therapy to evaluate if BFRT significantly improves patient-reported outcomes, function, and joint health over the first year of recovery.Trial registrationBlood Flow Restriction Training, Aspiration, and Intraarticular Normal Saline (BRAINS) NCT04554212 . Registered on 18 September 2020.

Dataset Information

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

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

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