Comparative Effects of Multicomponent Training Concerning Elastic Band Training on Physical Fitness, Postural Balance, and Health-related Quality of Life in Older Women (RCT)
24 de abril de 2026 atualizado por: Pablo Valdés-Badilla, Universidad Católica del Maule
Comparative Effects of Multicomponent Training Concerning Elastic Band Training on Physicalfunctional Fitness, Postural Balance, and Health-related Quality of Life in Older Womean: a Randomized Controlled Trial.
Objective: To compare the effects of MCT versus EBT on functional fitness, postural balance, and HRQoL in older women.
Methods: Single-blind, parallel-group randomized controlled trial lasting 16 weeks (2 sessions/week, 60 min).
Twenty
Visão geral do estudo
Status
Ainda não está recrutando
Intervenção / Tratamento
Descrição detalhada
This study was a single-blind (assessors), randomized controlled trial with parallel groups, comparing the effects of MCT and EBT.
Both groups participated in structured physical activity interventions following a quantitative methodological approach.
Participant allocation (ratio 1:1) was performed using an online randomization tool (https://www.randomizer.org)
by an investigator not involved in assessments.
The methodology followed the CONSORT (Consolidated Standards of Reporting Trials) guidelines for randomized clinical trials (Turner et al., 2012).
The study was registered in the U.S. ClinicalTrials.gov
(registration ID: NCT0678002).
The interventions lasted 16 weeks and were conducted twice per week on non-consecutive days: Mondays and Wednesdays for the EBT group, and Tuesdays and Thursdays for the MCT group.
Each session lasted 60 minutes.
The assessed outcomes included general physical fitness (Chair stand, Arm curl, 2-minute step test, Chair sit-and-reach, Back scratch, TUG, and MIHS for dominant and non-dominant sides), postural balance variables (energy and center of pressure velocity in medio-lateral and antero-posterior directions) under eyes-open and eyes-closed conditions and HRQoL.
All assessments were performed in the afternoon (between 4:00 p.m. and 6:00 p.m.) in a temperature-controlled laboratory, using standardized evaluators to ensure consistency between pre- and post-intervention measurements.
During the intervention period, no participants experienced musculoskeletal or cardiorespiratory injuries, and no pain was reported either prior to the assessments or during the training sessions.
Tipo de estudo
Intervencional
Inscrição (Estimado)
40
Estágio
- Não aplicável
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Contato de estudo
- Nome: Pablo Valdés, PhD
- Número de telefone: +56953646566
- E-mail: e.maximiliano@live.cl
Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Não
Descrição
Inclusion Criteria:
- individuals over 70 - 75 years of age;
- the ability to understand and follow contextually appropriate instructions through simple commands
- independence, defined as a score of at least 43 points on the Preventive Medical Examination for Older People from the Chilean Ministry of Health (in Spanish, EMPAM) (MINSAL, 2012)
- the ability to comply with at least 85% attendance of the scheduled intervention sessions.
Exclusion Criteria:
- having any form of disability
- having musculoskeletal injuries or being under physical rehabilitation that would prevent participation in usual physical activities
- being permanently or temporarily unable to engage in physical activity.
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Triplo
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Comparador Ativo: Elastic band training program
EBT was implemented based on previous studies demonstrating its safety and effectiveness for older women.
The elastic bands (Ultimate Elastic Resistance Band System Elite, country) was used during the intervention.
The elastic bands were color-coded (yellow, red, green, and black), with each color representing a different resistance level used to prescribe and adjust training load.
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The training program included resistance exercises targeting the major muscle groups of both the upper and lower limbs.
Upper-limb exercises consisted of let pulldown, scapular retraction, shoulder abduction, biceps curl, triceps extension, and upright row.
Lower-limb exercises included leg press, ankle eversion, ankle dorsiflexion, knee extension, knee flexion, and hip flexion.
Participants initiated the program using the lowest resistance level, with progressive increases in training volume throughout the intervention.
The progression of training volume followed the same periodization used in the MCT group.
During weeks 1 to 4, participants performed three sets of 10 repetitions per exercise with 2-minute rest intervals between sets.
Between weeks 5 and 8, volume increased to four sets of 10 repetitions, maintaining the same rest interval.
During weeks 9 to 12, participants performed four sets of 12 repetitions, and during weeks 13 to 16, the same volume (4 × 12 repetitions) was main
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Experimental: Multicomponent training program
The MCT main phase consisted of a strength training circuit targeting the major muscle groups of the upper limbs (biceps, triceps, deltoids, and latissimus dorsi) and lower limbs (quadriceps, hamstrings, gluteus, and gastrocnemius).
The circuit also incorporated exercises designed to improve cardiorespiratory fitness, agility, and postural balance, including both static and dynamic balance tasks.
Exercises were performed using body weight and external implements, such as dumbbells, kettlebells, poles, and medicine balls.
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During weeks 1 to 4, participants performed three sets of 10 repetitions per exercise with a 2-minute rest interval between sets.
Movements were executed at a controlled tempo of approximately 2 seconds during the concentric phase and 4 seconds during the eccentric phase.
Between weeks 5 and 8, training volume increased to four sets of 10 repetitions per exercise, maintaining the same rest interval.
During weeks 9 to 12, participants performed four sets of 12 repetitions.
Finally, during weeks 13 to 16, the training volume (4 × 12 repetitions) was maintained while the rest interval was reduced to 90 seconds in order to increase the training stimulus.
Strength training intensity was monitored using the OMNI-Resistance Exercise Scale of Perceived Exertion (Lagally & Robertson, 2006; Petro et al., 2025), with participants maintaining perceived exertion values between 5 and 8, corresponding to moderate-to-vigorous intensity.
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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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Physical fitness
Prazo: 16 weeks
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The Senior Fitness Test was assessed, which provides an evaluation with excellent reliability and easy application.
The tests were performed in the following order.
The chair stand test was conducted as the initial test in the battery to determine lower limb muscle strength, and the number of repetitions completed in 30 seconds was recorded.
The second test was the arm curl test, which measured upper limb muscle strength by counting the number of repetitions completed in 30 seconds while holding a 1.4 kg (3 lb) dumbbell.
Then, the 2-minute step test was performed to assess cardiorespiratory fitness, counting the number of knee elevations achieved by each participant, reaching at least a 70-degree angle at the hip joint.
Lower limb flexibility was measured in centimeters during the chair sit-and-reach test.
The back scratch test was conducted to measure upper limb flexibility, recorded in centimeters.
The TUG test was performed to assess agility and dynamic balanc
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16 weeks
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Go/No-Go task
Prazo: 16 weeks
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Motor inhibition was assessed using a computerized Go/No-Go task administered individually in a quiet, temperature-controlled laboratory environment with standardized lighting conditions.
Participants wore noise-cancelling headphones to minimize external distractions.
The task was implemented using OpenSesame software and presented on a monitor positioned approximately 60 cm from the participant.
Visual stimuli consisted of colored circles (blue and yellow) displayed randomly within a fixed central area on the screen.
Participants were instructed to respond as quickly as possible to Go stimuli by pressing the space bar on a keyboard and to withhold their response when a No-Go stimulus appeared.
The stimulus-response mapping was counterbalanced across participants to control for potential color-related biases.
Feedback for incorrect responses was provided through a brief visual signal displayed at the center of the screen.
The task comprised a total of 160 trials
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16 weeks
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Cognitive status
Prazo: 16 weeks
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Cognitive status was evaluated using the memory, phonetic fluency, and temporal-spatial orientation (by its Spanish acronym, MEFO) survey, a brief and clinically validated screening instrument designed to assess global cognitive status in older people .
The MEFO comprises three core domains: episodic memory, assessed through delayed recall tasks; verbal fluency, typically evaluated via category-based word generation; and temporal-spatial orientation, which examines awareness of time-related information.
These components are integrated into a composite score that reflects overall cognitive status.
Higher scores indicate better cognitive functioning.
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16 weeks
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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body weight
Prazo: 16 week
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was used to measure body weight, and a stadiometer (Seca 220, Germany; accuracy 0.1 cm) was used to measure bipedal height.
In accordance with the guidelines of the International Society for the Advancement of Kinanthropometry (ISAK), all assessments were conducted by a level II anthropometrist certified by ISAK
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16 week
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Postural balance
Prazo: 16 weeks
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Static postural balance was objectively assessed using a posturographic platform (Artoficio, model Rev0610, Chile), which incorporates load sensors to quantitatively record center of pressure (COP) oscillations.
The sampling rate was set to 40 Hz.
The following postural balance variables were analyzed: energy, medio-lateral center-of-pressure velocity (ML speed), and antero-posterior center-of-pressure velocity (AP speed), each assessed under eyes-open (EO) and eyes-closed (EC) conditions.
Participants were instructed to step onto the platform and maintain a stable foot position without adjusting their stance throughout each trial.
Foot position was standardized across participants.
Individuals were instructed to stand barefoot with feet placed parallel and hip-width apart (approximately at the level of the anterior superior iliac spines), with heels aligned along a predefined reference line marked on the platform surface.
The assessment consisted of three consecutive 30-second condit
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16 weeks
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Health-related quality of life
Prazo: 16 weeks
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This questionnaire was applied using the Short Form Health Survey (SF-36) second version.
It evaluates eight health dimensions: physical function, physical role, body pain, general health, vitality, social function, emotional role, and mental health.
The score is obtained by summing the responses, ranging from 0, representing the poorest health status, to 100, representing the best health status
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16 weeks
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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Colaboradores
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Estimado)
1 de abril de 2026
Conclusão Primária (Estimado)
1 de maio de 2026
Conclusão do estudo (Estimado)
1 de junho de 2026
Datas de inscrição no estudo
Enviado pela primeira vez
24 de abril de 2026
Enviado pela primeira vez que atendeu aos critérios de CQ
24 de abril de 2026
Primeira postagem (Real)
1 de maio de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
1 de maio de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
24 de abril de 2026
Última verificação
1 de abril de 2026
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Outros números de identificação do estudo
- (No. 29-2022)
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
NÃO
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .