Loading
Life sciences · Interventional Study
ClinicalTrials.gov · October 5, 2026
No summary has been generated for this record yet. What follows is drawn from its source metadata only.
Interventional Study.
No findings were extractable from the material analysed.
Safety was not reported in the material analysed. Check the source before drawing any conclusion about harm.
The source did not state who this applies to in practice.
Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.
This record has not been graded across any dimension yet. Treat the label above as provisional and read the source.
What is missing. This record has no bottom line, key findings, reported figures, evidence dimensions. That is a gap in the analysis, not a judgement about the study.
Registry record from ClinicalTrials.gov (NCT07859072). This is a study registration, not published results. Lead sponsor: Universidade Cesumar (UNICESUMAR). Recruitment status: NOT_YET_RECRUITING. Phase: NA. Study type: INTERVENTIONAL. Enrollment: 36 participants (ESTIMATED). Conditions: Overweight (BMI > 25), Obesity & Overweight, Aging. Interventions: DEVICE: Whole-Body Neuromuscular Electrical Stimulation (WB-NMES); BEHAVIORAL: Conventional Resistance Training; BEHAVIORAL: High-Protein Nutritional Guidance; BEHAVIORAL: Normoproteic Nutritional Guidance. Primary outcome measures: Change in Fat-Free Mass , The duration of the entire program will be approximately one year, from registration through to tabulation and writing.; Change in Skeletal Muscle Mass , The duration of the entire program will be approximately one year, from registration through to tabulation and writing.; Handgrip Strength (HGS) , Baseline (week 0) and post-16 weeks of intervention.. 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 $p \< 0.05$.