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Impact of resistance exercise rehabilitation and whey protein supplementation in elderly patients with heart failure with preserved ejection fraction with sarcopenia: a study protocol for a randomised controlled trial.

BMJ open
January 1, 1970
Mo Zhou et al. (10 authors)
Clinical Trial ProtocolJournal ArticleResearch Support, Non-U.S. Gov'tHuman StudyClinical
Study Details

Study Goal

The researchers aimed to evaluate the effects of resistance training (RT) and whey protein supplementation (WPS) on 6-minute walking distance, muscle status, cardiac function, and quality of life in elderly HFpEF patients with sarcopenia.

Results Summary

The study will assess changes in 6-minute walking distance (primary outcome) and secondary outcomes like muscle status, cardiac function, and quality of life after 12 weeks of RT with or without WPS, but results are not yet reported in the abstract.

Population

Elderly patients with heart failure with preserved ejection fraction (HFpEF) and sarcopenia.

Effective Dosage

Not specified (daily WPS mentioned but no dosage details provided).

Duration

12 weeks

Interactions

None mentioned

Extracted Claims (3)
InterventionDirectionEndpointPopulationDosageImpactClaim #
Resistance training (RT) or resistance exercise rehabilitation (RER)
decrease
physiological function and mortality
elderly HFpEF patients with sarcopenia
-
may have benefits
#1
Whey protein supplementation (WPS)
increase
strength and muscle mass
-
-
may increase the effects of exercise
#2
Whey protein supplementation (WPS)
increase
heart function and quality of life (QoL)
-
-
promoting
#3
Abstract

INTRODUCTION: Heart failure with preserved ejection fraction (HFpEF) affects more than half of the patients with heart failure. HFpEF and sarcopenia can interact with each other and contribute to reduced physiological function and increased mortality in elderly patients. Resistance training (RT) or resistance exercise rehabilitation (RER) may have benefits for elderly HFpEF patients with sarcopenia. Whey protein supplementation (WPS) may increase the effects of exercise on strength and muscle mass, in addition to promoting heart function and quality of life (QoL). However, studies are needed to evaluate effects of RER and WPS in patients with HFpEF with sarcopenia. METHODS AND ANALYSIS: This is a prospective, randomised, controlled clinical trial in which patients with HFpEF with sarcopenia will be randomly allocated to three groups, control, RT and RT+WP. Participants in all groups will receive basic intervention including standard medicine treatment, home-based aerobic exercise and basic nutritional intervention. The RT group will undergo resistance exercise programmes, and the RT+WP group will receive daily WPS apart from resistance exercise. The study variables will be evaluated at baseline and 12 weeks. Primary outcome measure is the change of 6 min walking distance. Secondary outcomes include parameters of muscle status, cardiac function, nutritional status, QoL and major adverse cardiovascular events. The primary efficacy analysis will follow the intention-to-treat principle. ETHICS AND DISSEMINATION: This study was approved by Ethics Committee of China-Japan Friendship Hospital for Clinical Research (No. 2022-KY-003). The results of this study will be disseminated via peer-reviewed publications and presentations at conferences. TRIAL REGISTRATION NUMBER: ChiCTR2200061069.

Medical Subject Headings (MeSH)
HumansAgedSarcopeniaHeart FailureResistance TrainingQuality of LifeWhey ProteinsStroke VolumeProspective StudiesExercise TherapyDietary SupplementsRandomized Controlled Trials as Topic
Study Links
Quality Scores
SafetyNot Assessed
Efficacy75/10
Quality85/10
Citation Metrics
Total Citations2
Citations/Year0.7
Relative Citation Ratio0.24
NIH Percentile12.1%
Research Impact Scores
APT Score0.50
Weight Score1.54
Normalized Score0.67
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