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NCT Number: NCT07561879

Comparative Effects of Multicomponent Training Concerning Elastic Band Training on Physical Fitness, Postural Balance, and Health-related Quality of Life in Older Women

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

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Key information

Conditions

Aged Exercise Therapy Physical Performance

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Multicomponent training program

Behavioral

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.

Elastic band training program

Behavioral

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

Primary outcomes

  1. Physical fitness

    Time frame: 16 weeks

    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

  2. Go/No-Go task

    Time frame: 16 weeks

    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

  3. Cognitive status

    Time frame: 16 weeks

    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.

Secondary outcomes

  1. body weight

    Time frame: 16 week

    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

  2. Postural balance

    Time frame: 16 weeks

    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

  3. Health-related quality of life

    Time frame: 16 weeks

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Pablo Valdés, PhD

CONTACT

[email protected]

+56953646566

Sponsors and collaborators

Lead sponsor

Universidad Católica del Maule

Other

Collaborators

  • University of Talca

Registry information

Official study title

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.

Acronym: RCT

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
May 1, 2026
Registry last updated
May 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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