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

NCT07561879 | Not Yet Recruiting

• 1 other identifier: (No. 29-2022)
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Aged; Exercise Therapy; Physical Performance

Keywords

Postural Balance; cognitive function; Quality of Life

Outcome Measures

Primary Outcomes (3)

• Physical fitness

  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

  16 weeks

• Go/No-Go task

  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

  16 weeks

• Cognitive status

  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.

  16 weeks

Secondary Outcomes (3)

• body weight

  16 week

• Postural balance

  16 weeks

• Health-related quality of life

  16 weeks

Study Arms (2)

Elastic band training program

ACTIVE COMPARATOR

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.

Behavioral: Elastic band training program

Multicomponent training program

EXPERIMENTAL

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.

Behavioral: Multicomponent training program

Interventions

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.

Multicomponent training program

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

Elastic band training program

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad Católica del Maule: lead
• University of Talca: collaborator

Central Study Contacts

Pablo Valdés, PhD

CONTACT

+56953646566; e.maximiliano@live.cl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: This study was a single-blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Model Details: randomized controlled trial

Study Record Dates

• First Submitted: April 24, 2026
• First Posted: May 1, 2026
• Study Start: April 1, 2026
• Primary Completion: May 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: May 1, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share