Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Clinical Trial

WB-EMS Combined With Nutritional Guidance for a High-Protein Diet on Body Composition, Muscle Function, Psychological and Functional Outcomes in Older Adults With Excess Adiposity

NCT: NCT07859072 · NOT_YET_RECRUITING

NCT IDNCT07859072
StatusNOT_YET_RECRUITING
Start Date2026-10-02
Completion2027-06-20
SponsorUniversidade Cesumar (UNICESUMAR) (OTHER)
First posted
Last updated

Brief Summary

This is a 16-week randomized controlled trial (RCT) with outcome assessor blinding. The objective is to investigate the effects of resistance training (RT) combined with whole-body neuromuscular electrical stimulation (WB-NMES) and a high-protein diet on body composition, anthropometry, and quality of life. Sample and Group Allocation The sample will comprise 36 older adults (≥ 60 years), physically inactive, and with overweight or obesity (BMI ≥ 25 kg/m²). They will be randomized (stratified by sex) into four groups of 9 participants: RT + NOR: Resistance training + normal-protein diet. RT + PRO: Resistance training + high-protein diet. WB-NMES + RT + NOR: Resistance training with electrical stimulation + normal-protein diet. WB-NMES + RT + PRO: Resistance training with electrical stimulation + high-protein diet. Intervention Protocol Exercise (2x/week, 25 min/session): Seven exercises (2 sets of 1 min execution with 45s of rest). Progressive intensity controlled by the OMNI-RPE Scale. Electrical Stimulation (WB-NMES Groups): Simultaneous use of an electrode suit (85 Hz, 400 µs pulse width, 5s on/5s off duty cycle), with intensity capped at a maximum of 5/10 on the pain/discomfort Visual Analog Scale (VAS). Nutrition (In-person + Remote): High-protein (PRO) groups will focus on an intake of 1.2 to 1.5 g of protein/kg/day. Normal-protein (NOR) groups will receive general healthy eating guidelines, without encouraging an increase in protein intake. Assessments and Outcomes (Conducted at T0 and T16) Body Composition and Anthropometry: Multi-frequency bioelectrical impedance (InBody 570) and circumference measurements following ISAK guidelines. Physical and Functional Performance: Handgrip strength (dynamometry). Muscular endurance (30-second chair stand and arm curl tests). Upper limb power (2 kg medicine ball throw). Aerobic endurance (6-Minute Walk Test). Mobility and fall risk (Timed Up and Go - TUG). Questionnaires and Scales: Self-reported functional disability (WHODAS 2.0). Basic psychological needs satisfaction (BPNES). Motivational regulation in exercise (BREQ-3). Quality of life specific for older adults (WHOQOL-OLD). Adherence: Minimum attendance goal of 75% for the sessions. Statistical Analysis The analysis will follow the intention-to-treat (ITT) principle. Data will be analyzed using Linear Mixed Models for Repeated Measures (fixed factors: Group and Time), followed by Tukey's post-hoc test, adopting a significance level of $p \< 0.05$.

Frequently Asked Questions

What is WB-EMS Combined With Nutritional Guidance for a High-Protein Diet on Body Composition, Muscle Function, Psychological and Functional Outcomes in Older Adults With Excess Adiposity?

WB-EMS Combined With Nutritional Guidance for a High-Protein Diet on Body Composition, Muscle Function, Psychological and Functional Outcomes in Older Adults With Excess Adiposity is a clinical trial registered under NCT07859072. Current status: NOT_YET_RECRUITING.

What is the status of NCT07859072?

The current status of NCT07859072 (WB-EMS Combined With Nutritional Guidance for a High-Protein Diet on Body Composition, Muscle Function, Psychological and Functional Outcomes in Older Adults With Excess Adiposity) is: NOT_YET_RECRUITING.

When did WB-EMS Combined With Nutritional Guidance for a High-Protein Diet on Body Composition, Muscle Function, Psychological and Functional Outcomes in Older Adults With Excess Adiposity start?

WB-EMS Combined With Nutritional Guidance for a High-Protein Diet on Body Composition, Muscle Function, Psychological and Functional Outcomes in Older Adults With Excess Adiposity started on 2026-10-02.

Related Devices

Official Source

View on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov API. For the most current status, refer to the official record.

↑