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)
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 $p < 0.05$.
Visão geral do estudo
Status
Descrição detalhada
This is a 16-week, parallel-group, outcome-assessor-blinded randomized clinical trial (RCT), approved by the UniCesumar Ethics Committee (Opinion No. 8.718.082 / CAAE: 01410126.9.0000.5539). The study aims to investigate the effects of resistance training combined with whole-body neuromuscular electrical stimulation (WB-NMES) and nutritional guidance focused on a high-protein diet on body composition, anthropometric parameters, and quality of life in older adults with overweight and obesity residing in Maringá-PR, Brazil.
The sample will consist of 36 older adults of both sexes (age $\ge$ 60 years, BMI $\ge$ 25 $kg/m^2$, and physically inactive), randomly allocated (stratified randomization by sex in a 1:1:1:1 ratio) into four experimental groups (n = 9 per group):
RT + NOR: conventional resistance training combined with normoprotein diet guidance;
RT + PRO: conventional resistance training combined with high-protein diet guidance;
WB-NMES + RT + NOR: resistance training using WB-NMES combined with normoprotein diet guidance;
WB-NMES + RT + PRO: resistance training using WB-NMES combined with high-protein diet guidance.
Training Protocol and Electrical Stimulation: The exercise interventions will take place twice a week (sessions of approximately 25 minutes) over 16 weeks, under the supervision of qualified professionals. Participants will perform seven exercises (leg curl, leg extension, kettlebell squat, lat pulldown, seated machine row, incline bench press, and crunch on a bench), executing 2 sets of 1 minute per exercise, with a 45-second rest interval. Training intensity will be progressive and monitored by the OMNI Rating of Perceived Exertion Scale (OMNI-RPE: 2-3 in Phase 1 up to 7-8 in Phase 4, with a gradual load reduction phase in the 16th week).
In the WB-NMES groups, the exercise will be simultaneously combined with electrical current applied through a suit with integrated electrodes (frequency of 85 Hz, pulse width of 400 $\mu$s, duty cycle of 5 s on/5 s off, and a ramp-up time of 0 s). Intensity adjustments will be limited to a maximum of 5 points on the Visual Analog Scale for pain/discomfort (VAS 0-10). All participants will undergo prior familiarization sessions.
Nutritional Intervention: This will be conducted through a hybrid approach (individualized face-to-face sessions and remote monitoring via a WhatsApp group), prioritizing contextualized nutritional education. In the high-protein intake groups, the consumption goal will be 1.2 to 1.5 g of protein/kg/day, distributed evenly across meals. In the normoprotein (control) groups, the guidance will focus on general principles of healthy eating and hydration, without encouraging an increase in protein intake.
Assessments and Outcomes: Assessments will be performed at baseline (T0) and after 16 weeks (T16).
Body Composition: Assessed using multi-frequency bioelectrical impedance analysis (InBody 570) under a strict preparation protocol (lean mass, skeletal muscle mass, total and visceral body fat, body water), with reproducibility verified on two distinct days at T0.
Anthropometry: Circumferences (neck, waist, abdomen, hip, thigh, and calf) measured in duplicate by a blinded evaluator, following ISAK guidelines.
Physical and Functional Performance Assessment:
Maximal Isometric Strength (Upper Limbs): Assessed by handgrip dynamometry (Jamar®), following ASHT guidelines. The participant will perform three attempts with each hand, sitting in a standardized posture, with a 60-second rest interval. The highest value (kgf) of the dominant hand will be considered for analysis.
Localized Muscular Endurance (Senior Fitness Test):
Lower Limbs: 30-second chair stand test (maximum full repetitions in a standardized chair).
Upper Limbs: 30-second arm curl test. Using a 2 kg (women) and 4 kg (men) dumbbell, the maximum number of correct repetitions with the dominant arm will be recorded.
Muscular Power (Upper Limbs): Medicine ball throw (2 kg). The participant, seated and without feet touching the floor, will throw the ball forward explosively. Three attempts will be made (60s interval), considering the longest distance achieved.
Aerobic Endurance: 6-minute walk test (6MWT) in a 30-meter corridor, following ATS guidelines. The total distance will be recorded, along with heart rate monitoring and perceived exertion (Borg Scale) pre- and post-test.
Functional Mobility and Fall Risk: Timed Up and Go (TUG) test. Will evaluate the time (in seconds) taken to rise from a chair, walk 3 meters, return, and sit down. Two attempts will be performed, considering the shortest time.
Self-Reported Functional Capacity: Self-reported functional disability will be measured with the World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0) (36-item version), developed by the WHO, assessing difficulties in the last 30 days across six domains. Responses range on a five-point Likert scale, and the scores, calculated by simple sum, are converted to a 0 to 100 scale, where higher scores reflect greater disability. The instrument will be applied self-administered or by interview to complement objective physical data with the participants' own perception of the impact of each intervention.
Psychosocial, Motivational, and Adherence Assessments:
Basic Psychological Needs: Satisfaction in the exercise context will be assessed by the Brazilian version of the Basic Psychological Needs in Exercise Scale (BPNES) (12 items, 5-point Likert scale). The instrument covers three subscales: Autonomy, Competence, and Relatedness. Higher mean scores indicate greater satisfaction of the respective psychological need.
Motivational Regulation: Will be measured by the Brazilian version of the Behavioral Regulation in Exercise Questionnaire (BREQ-3) (23 items, 5-point Likert scale), which assesses six forms of behavioral regulation (from amotivation to intrinsic motivation). From the results, the Relative Autonomy Index (RAI) will be calculated, in which more positive values reflect a more autonomous motivational profile.
Program Adherence: Quantified by the participants' relative attendance at supervised sessions (sessions attended / scheduled sessions $\times$ 100%), with a minimum target set at 75%.
Quality of Life: Assessed using the World Health Organization Quality of Life - Old (WHOQOL-OLD) questionnaire, developed by the WHO specifically for older adults. The instrument consists of 24 questions (5-point Likert scale) distributed across six facets: Sensory Abilities; Autonomy; Past, Present and Future Activities; Social Participation; Death and Dying; and Intimacy. The questionnaire will be applied individually by trained researchers. Scores will be converted to a standardized 0 to 100 scale, where higher scores indicate a better perception of quality of life.
Statistical Analysis: Analyses will follow the intention-to-treat (ITT) principle, using Linear Mixed Models for Repeated Measures (fixed factors: Group and Time; random factor: Participants), followed by Tukey's post-hoc test (significance level set at $p < 0.05$).
Tipo de estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Contato de estudo
- Nome: Odair R de Oliveira, Esp
- Número de telefone: +5517981106069
- E-mail: odairredina.nutri@gmail.com
Locais de estudo
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Paraná
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Maringá, Paraná, Brasil, 87050-900
- UniCesumar - Centro Universitário Cesumar
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Contato:
- Odair R de Oliveira, Esp
- Número de telefone: +5517981106068
- E-mail: odairredina.nutri@gmail.com
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Contato:
- Vitor S Painelli, Dr.
- Número de telefone: +5511968117970
- E-mail: vitor.painelli@unicesumar.edu.br
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
- 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 Criteria:
- 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);
- Current use of medications or supplements known to significantly affect protein metabolism or muscle mass;
- Adherence below 85% in training sessions or nutritional follow-ups during the study period.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Dobro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Experimental: WB-NMES + High-Protein Diet
Participants will receive whole-body neuromuscular electrical stimulation (WB-NMES) combined with resistance training twice a week (~25 min/session) for 16 weeks. Current parameters: 85 Hz, 400 µs pulse width, 5s ON / 5s OFF. They will also receive nutritional guidance targeting a high-protein intake (1.2 to 1.5 g/kg/day). |
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.
Outros nomes:
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.
Outros nomes:
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Comparador Ativo: WB-NMES + Normoproteic Diet
Participants will receive whole-body neuromuscular electrical stimulation (WB-NMES) combined with resistance training twice a week (~25 min/session) for 16 weeks. Current parameters: 85 Hz, 400 µs pulse width, 5s ON / 5s OFF. They will also receive general healthy eating guidance without protein supplementation (normoproteic intake). |
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.
Outros nomes:
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.
Outros nomes:
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Comparador Ativo: Conventional RT + High-Protein Diet
Participants will perform conventional resistance training (RT) twice a week (~25 min/session) for 16 weeks, without electrical stimulation. They will also receive nutritional guidance targeting a high-protein intake (1.2 to 1.5 g/kg/day). |
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.
Outros nomes:
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).
Outros nomes:
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Comparador Ativo: Conventional RT + Normoproteic Diet
Participants will perform conventional resistance training (RT) twice a week (~25 min/session) for 16 weeks, without electrical stimulation. They will also receive general healthy eating guidance without protein supplementation (normoproteic intake). |
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.
Outros nomes:
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).
Outros nomes:
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Change in Fat-Free Mass
Prazo: The duration of the entire program will be approximately one year, from registration through to tabulation and writing.
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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. |
The duration of the entire program will be approximately one year, from registration through to tabulation and writing.
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Change in Skeletal Muscle Mass
Prazo: The duration of the entire program will be approximately one year, from registration through to tabulation and writing.
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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. |
The duration of the entire program will be approximately one year, from registration through to tabulation and writing.
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Handgrip Strength (HGS)
Prazo: Baseline (week 0) and post-16 weeks of intervention.
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Assessed by hydraulic hand dynamometry (Jamar®), measured in kilogram-force (kgf), to evaluate changes in upper-limb maximal muscle strength resulting from the interventions. |
Baseline (week 0) and post-16 weeks of intervention.
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Knee Extension and Flexion Peak Torque
Prazo: Baseline (week 0) and post-16 weeks of intervention.
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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). |
Baseline (week 0) and post-16 weeks of intervention.
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Distance in Medicine Ball Throw Test
Prazo: Baseline (week 0) and post-16 weeks of intervention.
|
Distance achieved (in meters) throwing a 2 kg medicine ball from the chest, assessing upper-body rapid force and muscle power. |
Baseline (week 0) and post-16 weeks of intervention.
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30-Second Chair Stand Test
Prazo: Baseline (week 0) and post-16 weeks of intervention.
|
Total number of full repetitions of sitting and standing from a standard chair completed within 30 seconds (30-second Chair Stand Test). |
Baseline (week 0) and post-16 weeks of intervention.
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30-Second Arm Curl Test
Prazo: Baseline (week 0) and post-16 weeks of intervention.
|
Total number of arm curl repetitions executed in 30 seconds using a standardized weight (Arm Curl Test). |
Baseline (week 0) and post-16 weeks of intervention.
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Time in Timed Up and Go (TUG) Test
Prazo: Baseline (week 0) and post-16 weeks of intervention.
|
Time in seconds required to stand up from a chair, walk 3 meters, turn, walk back, and sit down again. |
Baseline (week 0) and post-16 weeks of intervention.
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WHODAS 2.0 Functional Disability Score
Prazo: Baseline (week 0) and post-16 weeks of intervention.
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Global score of the World Health Organization Disability Assessment Schedule 2.0 (36-item version), measuring the level of limitation in daily activities. The score ranges from 0 to 100, with higher scores indicating greater disability and worse functioning. |
Baseline (week 0) and post-16 weeks of intervention.
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Relative Body Fat
Prazo: Baseline (week 0) and post-16 weeks of intervention.
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Percentage of body fat (%) determined by multi-frequency bioelectrical impedance analysis (InBody 570). |
Baseline (week 0) and post-16 weeks of intervention.
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Body Girths (Waist, Abdomen, Hip, Thigh, and Calf)
Prazo: Baseline (week 0) and post-16 weeks of intervention.
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Anthropometric measurements in centimeters (cm) following ISAK standards (neck, waist, abdomen, hip, medial thigh, and calf). |
Baseline (week 0) and post-16 weeks of intervention.
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Lipid Panel and Apolipoproteins
Prazo: Baseline (week 0) and post-16 weeks of intervention.
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Plasma levels in mg/dL of total cholesterol, HDL-c, LDL-c, VLDL-c, triglycerides, and apolipoproteins measured in fasting blood samples. |
Baseline (week 0) and post-16 weeks of intervention.
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Inflammatory Cytokines (IL-6 and IL-1beta)
Prazo: Baseline (week 0) and post-16 weeks of intervention.
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Plasma concentrations of Interleukin-6 (IL-6) and Interleukin-1beta (IL-1beta), expressed in pg/mL. |
Baseline (week 0) and post-16 weeks of intervention.
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Gastrointestinal Gut Peptides and Leptin
Prazo: Baseline (week 0) and post-16 weeks of intervention
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Fasting plasma concentrations of appetite-regulating hormones, including Glucagon-Like Peptide-1 (GLP-1), Peptide YY (PYY), Gastrin, and Leptin, all expressed in pg/mL. |
Baseline (week 0) and post-16 weeks of intervention
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Plasma BDNF Concentration
Prazo: Baseline (week 0) and post-16 weeks of intervention.
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Plasma concentration of Brain-Derived Neurotrophic Factor (BDNF), expressed in picograms per milliliter (pg/mL). |
Baseline (week 0) and post-16 weeks of intervention.
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Finger-Toe Pulse Wave Velocity (PWV)
Prazo: Baseline (week 0) and post-16 weeks of intervention.
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Pulse Wave Velocity, assessment via applanation tonometry to estimate arterial stiffness, expressed in meters per second (m/s). |
Baseline (week 0) and post-16 weeks of intervention.
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Binge Eating
Prazo: Baseline (week 0) and post-16 weeks of intervention.
|
Binge eating will be estimated from the Binge Eating Scale (BES), adapted from the University of Rhode Island Change Assessment (URICA). URICA ranges from 0-46 points, with higher scores indicating greater binge eating severity. |
Baseline (week 0) and post-16 weeks of intervention.
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Basic Psychological Needs in Exercise
Prazo: Baseline (week 0) and post-16 weeks of intervention
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Basic Psychological Needs will be monitored through the Basic Psychological Needs in Exercise Scale (BPNES). The BPNES ranges from 18-90 points, with higher scores indicating greater satisfaction of basic psychological needs in exercise. |
Baseline (week 0) and post-16 weeks of intervention
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Motivational Regulation
Prazo: Baseline (week 0) and post-16 weeks of intervention
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The motivational regulation will be assessed through the Behavioral Regulation in Exercise Questionnaire-3 (BREQ-3). The BREQ-3 assesses six motivational regulations, each scored from 0-4. |
Baseline (week 0) and post-16 weeks of intervention
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Fasting glucose
Prazo: Baseline (week 0) and post-16 weeks of intervention.
|
Fasting blood glucose concentration, measured in milligrams per deciliter (mg/dL). |
Baseline (week 0) and post-16 weeks of intervention.
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Fasting insulin
Prazo: Baseline (week 0) and post-16 weeks of intervention.
|
Fasting blood insulin concentration, measured in microinternational units per milliliter (µIU/mL). |
Baseline (week 0) and post-16 weeks of intervention.
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C-peptide
Prazo: Baseline (week 0) and post-16 weeks of intervention.
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Fasting blood C-peptide concentration, measured in nanograms per milliliter (ng/mL). |
Baseline (week 0) and post-16 weeks of intervention.
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Homeostatic Model Assessment of Insulin Resistance (HOMA-IR)
Prazo: Baseline (week 0) and post-16 weeks of intervention.
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Insulin resistance will be estimated using the Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) index, calculated from fasting blood glucose and fasting insulin concentrations. HOMA-IR is a dimensionless index, with higher values indicating greater insulin resistance. |
Baseline (week 0) and post-16 weeks of intervention.
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Geriatric Depression Scale-15 (GDS-15) Total Score
Prazo: Baseline (week 0) and post-16 weeks of intervention.
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Total score on the Geriatric Depression Scale-15 (GDS-15), a 15-item screening scale for depressive symptoms in older adults. Scores range from 0 to 15, with higher scores indicating greater severity of depressive symptoms. |
Baseline (week 0) and post-16 weeks of intervention.
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Beck Depression Inventory-II (BDI-II) Total Score
Prazo: Baseline (week 0) and post-16 weeks of intervention.
|
Total score on the Beck Depression Inventory-II (BDI-II), a 21-item self-report measure of depressive symptoms. Scores range from 0 to 63, with higher scores indicating greater severity of depressive symptoms. |
Baseline (week 0) and post-16 weeks of intervention.
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Generalized Anxiety Disorder-7 (GAD-7) Total Score
Prazo: Baseline (week 0) and post-16 weeks of intervention.
|
Total score on the Generalized Anxiety Disorder-7 (GAD-7), a 7-item self-report scale assessing symptoms of generalized anxiety. Scores range from 0 to 21, with higher scores indicating greater severity of anxiety symptoms. |
Baseline (week 0) and post-16 weeks of intervention.
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World Health Organization Quality of Life-OLD (WHOQOL-OLD) Total Score
Prazo: Baseline (week 0) and post-16 weeks of intervention.
|
Total score of the World Health Organization Quality of Life-OLD (WHOQOL-OLD), an instrument designed to assess quality of life in older adults. Scores range from 0 to 100, with higher scores indicating better quality of life. |
Baseline (week 0) and post-16 weeks of intervention.
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Pittsburgh Sleep Quality Index (PSQI) Global Score
Prazo: Baseline (week 0) and post-16 weeks of intervention.
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Global score of the Pittsburgh Sleep Quality Index (PSQI), a self-report instrument assessing sleep quality and sleep disturbances. Scores range from 0 to 21, with higher scores indicating worse sleep quality. |
Baseline (week 0) and post-16 weeks of intervention.
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Appraisal of Self-Care Agency Scale (ASA-A) Total Score
Prazo: Baseline (week 0) and post-16 weeks of intervention.
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Total score of the Appraisal of Self-Care Agency Scale (ASA-A), assessing an individual's self-care agency. Scores range from 24 to 120, with higher scores indicating greater self-care agency. |
Baseline (week 0) and post-16 weeks of intervention.
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Outras medidas de resultado
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Body Water Distribution via Bioelectrical Impedance
Prazo: Baseline (week 0) and post-16 weeks of intervention.
|
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. |
Baseline (week 0) and post-16 weeks of intervention.
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Participant-reported experience and acceptability of the intervention (qualitative)
Prazo: At the end of the 16-week intervention (post-intervention)
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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 |
At the end of the 16-week intervention (post-intervention)
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Vitor S Painelli, Dr., UniCesumar - Centro Universitário Cesumar
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Estimado)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
- Distúrbios Nutricionais
- Supernutrição
- Peso corporal
- Condições Patológicas, Sinais e Sintomas
- Doenças Nutricionais e Metabólicas
- Sinais e sintomas
- Excesso de peso
- Obesidade
- Atividade motora
- Movimento
- Fenômenos fisiológicos musculoesqueléticos
- Fenômenos fisiológicos musculoesqueléticos e neurais
- Terapêutica
- Modalidades de fisioterapia
- Dieta, comida e nutrição
- Fenômenos fisiológicos
- Fenômenos fisiológicos nutricionais
- Atendimento ao paciente
- Terapia de exercícios
- Reabilitação
- Cuidados posteriores
- Continuidade do atendimento ao paciente
- Dieta terapia
- Terapia nutricional
- Dieta
- Condicionamento físico, humano
- Exercício
- Treinamento de resistência
- Dieta, alta proteína
Outros números de identificação do estudo
- 01410126.9.0000.5539
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Descrição do plano IPD
All IPD that underlie results in a publication.
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