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.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 40
- 主要终点
- Physical fitness
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Care Provider, Investigator, Outcomes Assessor)
盲法说明
This study was a single-blind
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Elastic band training program (Behavioral)
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.
干预措施: Multicomponent training program (Behavioral)
结局指标
主要结局
Physical fitness
时间窗: 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
Go/No-Go task
时间窗: 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
Cognitive status
时间窗: 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.
次要结局
- body weight(16 week)
- Postural balance(16 weeks)
- Health-related quality of life(16 weeks)
研究者
Pablo Valdés-Badilla
PhD
Universidad Católica del Maule