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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age60+
SponsorUniversidade Cesumar (UNICESUMAR)

About this 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 $p \< 0.05$.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

  • Whole-Body Neuromuscular Electrical Stimulation (WB-NMES)

    Device

    16-week intervention, 2 sessions/week (\~25 min each). Exercises performed: leg curl, leg extension, kettlebell squat, lat pulldown, machine row, incline chest press, bench crunch. Simultaneous electrical stimulation via impulse suit: 85 Hz frequency, 400 µs pulse width, 5s ON / 5s OFF duty cycle, 0s ramp-up. Intensity adjusted progressively using OMNI-RPE scale and capped at VAS 5 for discomfort.

  • Conventional Resistance Training

    Behavioral

    16-week resistance training intervention without electrical stimulation, 2 sessions/week (\~25 min each). Participants perform the same 7 exercises (leg curl, leg extension, kettlebell squat, lat pulldown, machine row, incline chest press, bench crunch) with 2 sets of 1 min and 45s rest. Progression managed via OMNI-RPE scale (RPE 2-3 progressing to 7-8).

  • High-Protein Nutritional Guidance

    Behavioral

    Hybrid nutritional intervention (individualized in-person sessions and remote WhatsApp follow-ups). Guidance aims to achieve a daily protein intake of 1.2 to 1.5 g/kg/day, evenly distributed across main meals throughout the day.

  • Normoproteic Nutritional Guidance

    Behavioral

    Hybrid nutritional guidance focusing on general principles of healthy eating, food choices, and hydration according to national dietary guidelines, without targeting or encouraging increased protein intake.

Treatment groups

36 Participants
are divided into 4 treatment groups
Group A: WB-NMES + High-Protein DietExperimental treatment 2 interventions
Group B: WB-NMES + Normoproteic DietActive comparator 2 interventions
Group C: Conventional RT + High-Protein DietActive comparator 2 interventions
Group D: Conventional RT + Normoproteic DietActive comparator 2 interventions

Trial outcomes

Primary outcomes

1

Change in Fat-Free Mass

Change in fat-free mass (in kg) from baseline to the end of the 16-week intervention, assessed using the body composition assessment method specified in the study protocol.

Time frame
The duration of the entire program will be approximately one year, from registration through to tabulation and writing.
2

Change in Skeletal Muscle Mass

Change in skeletal muscle mass (in kg) from baseline to the end of the 16-week intervention, assessed using the body composition assessment method specified in the study protocol.

Time frame
The duration of the entire program will be approximately one year, from registration through to tabulation and writing.
3

Handgrip Strength (HGS)

Assessed by hydraulic hand dynamometry (Jamar®), measured in kilogram-force (kgf), to evaluate changes in upper-limb maximal muscle strength resulting from the interventions.

Time frame
Baseline (week 0) and post-16 weeks of intervention.

Secondary outcomes

1

Knee Extension and Flexion Peak Torque

Measured using an isokinetic dynamometer (Biodex System 4 Pro) in Newton-meters (N·m) at angular velocities of 60°/s (peak torque) and 180°/s (muscle power).

Time frame
Baseline (week 0) and post-16 weeks of intervention.
2

Distance in Medicine Ball Throw Test

Distance achieved (in meters) throwing a 2 kg medicine ball from the chest, assessing upper-body rapid force and muscle power.

Time frame
Baseline (week 0) and post-16 weeks of intervention.
3

30-Second Chair Stand Test

Total number of full repetitions of sitting and standing from a standard chair completed within 30 seconds (30-second Chair Stand Test).

Time frame
Baseline (week 0) and post-16 weeks of intervention.
4

30-Second Arm Curl Test

Total number of arm curl repetitions executed in 30 seconds using a standardized weight (Arm Curl Test).

Time frame
Baseline (week 0) and post-16 weeks of intervention.

Other outcomes

1

Body Water Distribution via Bioelectrical Impedance

Mapping of total body water (TBW), intracellular water (ICW), and extracellular water (ECW) volumes, in liters, via bioelectrical impedance analysis (InBody 570) for hydration status monitoring.

Time frame
Baseline (week 0) and post-16 weeks of intervention.
2

Participant-reported experience and acceptability of the intervention (qualitative)

Qualitative exploration of participants' experience of the 16-week intervention. Completers from all four factorial arms are invited to an individual semi-structured interview (audio-recorded, \~20-30 min) by trained interviewers not involved in delivering the sessions; modality-specific blocks (WB-EMS and nutritional guidance) are administered according to each participant's allocation, allowing contrasts across arms. Interviews are transcribed verbatim and analysed using reflexive thematic analysis (Braun \& Clarke), with a primarily deductive orientation around predefined domains: experience and acceptability of the interventions (resistance training, WB-EMS, nutritional guidance); health promotion and empowerment; and the three basic psychological needs of Self-Determination Theory (autonomy, competence, relatedness), while remaining open to additional themes. As a qualitative outcome, results are reported as constructed themes rather than a numeric metric. Conduct and reporting fol

Time frame
At the end of the 16-week intervention (post-intervention)

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

This trial is not recruiting at the moment. You can still explore other options: