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Whole-body electrical muscle stimulation and high-protein diet in older adults with excess weight

Tests electrical muscle stimulation with high-protein eating in inactive older adults with overweight.

Plain-language title generated from the registry record
Registry title: 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

Key facts

Where
Maringá, BrazilSee the site

Where in Brazil

  • UniCesumar - Centro Universitário CesumarMaringá, BrazilNo longer taking part

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  2. Are travel costs paid?
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  4. What happens if I want to stop?
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Trial details

Who runs it
Universidade Cesumar (UNICESUMAR)
Trial code
NCT07859072
Record updated
5 October 2026
Original description
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.Read full original descriptionShow less

Effects of Whole-Body Electromyostimulation Combined With Nutritional Guidance for a High-Protein Diet on Body Composition, Muscle Function, Functional Performance, Psychological Outcomes, Cardiometabolic Health, Cognitive Function, Quality of Life, and Other Health Outcomes in Older Adults With Excess Adiposity: A Randomized Controlled Trial

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 $p < 0.05$.

Inclusion: Age 60 years or older (both sexes); Body Mass Index (BMI) ≥ 25 kg/m² (overweight or obese); Physically inactive (not engaged in regular structured exercise for at least 6 months prior to the study); Medical clearance to engage in progressive resistance exercise and neuromuscular electrical stimulation.

Exclusion: Current use of medications or supplements known to significantly affect protein metabolism or muscle mass; Presence of electronic implants (e.g., cardiac pacemakers, defibrillators) or metallic implants that contraindicate WB-NMES; Absolute contraindications to WB-NMES (e.g., active neoplasia, severe epilepsy, acute inflammatory diseases, severe cardiac arrhythmias, thrombosis); Severe cognitive impairment that prevents understanding instructions or questionnaires; Disabling musculoskeletal or neurological disorders that hinder exercise performance; Uncontrolled chronic diseases (e.g., uncontrolled hypertension or diabetes); Adherence below 85% in training sessions or nutritional follow-ups during the study period.

ClinicalTrials.gov NCT07859072