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Набор скоро начнётся NCT07561879

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

Без фазы С лечением Aged Exercise Therapy Physical Performance

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Multicomponent training program, Elastic band training program.
Кому может быть актуально
Состояния в реестре: Aged, Exercise Therapy, Physical Performance. Базовые параметры: от 60 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Список центров уточняется — проверьте первичный протокол.
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

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.

Обзор

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

Подробное описание

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.

Вмешательства

  • Поведенческое Multicomponent training program
    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 1
  • Поведенческое Elastic band training program
    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 th

Первичные конечные точки

  • Physical fitness [Срок оценки: 16 weeks]
  • Go/No-Go task [Срок оценки: 16 weeks]
  • Cognitive status [Срок оценки: 16 weeks]
Вторичные конечные точки (3)
  • body weight [Срок оценки: 16 week]
  • Postural balance [Срок оценки: 16 weeks]
  • Health-related quality of life [Срок оценки: 16 weeks]

Критерии участия

Критерии включения

  • 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.

Критерии исключения

  • 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Тройное слепое
Основная цель
Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07561879 · (No. 29-2022)

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗