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临床试验/NCT07299786
NCT07299786已完成不适用

Multicomponent Exercise Prescription Through Telerehabilitation for Older Adults With Multiple Chronic Conditions in Antioquia, Colombia

Fundacion Universitaria Maria Cano2 个研究点 分布在 1 个国家目标入组 34 人开始时间: 2024年1月30日最近更新:

试验速览

阶段
不适用
状态
已完成
入组人数
34
试验地点
2
主要终点
Change in Physical Performance Measured by the Short Physical Performance Battery (SPPB)

研究概览

简要总结

The goal of this clinical trial is to learn if a multicomponent exercise program delivered through telerehabilitation improves physical fitness and quality of life in older adults with multiple chronic conditions living in Antioquia, Colombia.

The main questions it aims to answer are:

Does telerehabilitation with multicomponent exercise improve physical performance compared to home-based physiotherapy provided in person by a physiotherapist?

Does this program enhance participants' quality of life and functional independence?

Participants will:

Join a 12-week exercise program with two 45-minute online sessions per week, led by a physiotherapist through Microsoft Teams.

Perform exercises including aerobic, strength, flexibility, and balance training, adapted to their health condition.

Complete pre- and post-intervention assessments of physical function (Senior Fitness Test, SPPB) and quality of life (WHOQOL-BREF).

Researchers will compare the telerehabilitation group to a home-based physiotherapy group, in which physiotherapists visit participants at their homes, to determine whether the online multicomponent exercise intervention is effective, safe, and feasible for older adults with multiple chronic conditions.

详细描述

This study is a randomized, single-blind, parallel-group controlled clinical trial designed to evaluate the implementation and effects of a multicomponent exercise program delivered through synchronous telerehabilitation in older adults with multiple chronic conditions living in Antioquia, Colombia.

Population aging has led to a growing prevalence of multimorbidity, characterized by the coexistence of cardiovascular, respiratory, metabolic, and musculoskeletal conditions. This clinical complexity is commonly associated with declines in physical function, increased frailty, loss of independence, and reduced quality of life. Although exercise-based rehabilitation is a key component of chronic disease management, access to supervised programs remains limited for many older adults due to geographic barriers, mobility restrictions, and resource constraints, particularly in low- and middle-income settings.

Telerehabilitation, defined as the remote delivery of rehabilitation services through information and communication technologies, has emerged as an alternative approach to improve access to physiotherapy services while maintaining professional supervision. Multicomponent exercise programs that integrate aerobic, resistance, flexibility, and balance training have demonstrated benefits for physical and functional health in older populations. However, there is limited evidence regarding the use of supervised telerehabilitation models for older adults with multimorbidity in Colombia.

Participants are allocated in a 1:1 ratio to either a Telerehabilitation Group or a Home-Based Physiotherapy Group. Randomization is stratified by sex and primary diagnosis to promote balance between groups. Outcome assessors are blinded to group allocation.

The telerehabilitation intervention consists of a structured, supervised multicomponent exercise program delivered in real time using videoconferencing technology. Sessions are conducted twice weekly over a 12-week period and follow a standardized format that includes warm-up activities, aerobic conditioning, resistance exercises using body weight or elastic bands, flexibility training, balance exercises, and cool-down. Exercise intensity and progression are individualized based on functional capacity, health status, and participant tolerance. All sessions are supervised synchronously by a licensed physiotherapist, who provides guidance, monitors responses to exercise, and applies predefined safety procedures.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Double (Participant, Outcomes Assessor)

盲法说明

This study was conducted as a single-blind trial. Both participants and outcome assessors were blinded to group allocation. Participants were informed that they would take part in one of two exercise-based physiotherapy programs, without being told which one was the experimental (telerehabilitation) or the control (home-based physiotherapy) intervention. Outcome assessors responsible for pre- and post-intervention evaluations were also blinded to participant allocation to minimize assessment bias. The physiotherapists who delivered the interventions were not blinded due to the nature of the procedures.

入排标准

年龄范围
60 Years 至 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adults aged 60 years or older.
  • Diagnosed with a chronic cardiorespiratory condition (e.g., chronic obstructive pulmonary disease, asthma, heart failure, or ischemic heart disease).
  • May present other stable chronic comorbidities (e.g., metabolic or musculoskeletal diseases).
  • Medically stable and cleared by a physician to participate in moderate exercise.
  • Able to stand and walk independently, with or without assistive devices.
  • Have access to a device with an internet connection (computer, tablet, or smartphone) for online sessions.
  • Cognitive ability to follow instructions and communicate with the physiotherapist.
  • Willingness to provide informed consent and comply with the study procedures.

排除标准

  • Severe dementia or cognitive impairment preventing participation.
  • Uncontrolled epilepsy or recent seizure history.
  • Recent major surgery (within the past 3 months).
  • Delirium or acute confusional state.
  • Recent acute myocardial infarction or unstable angina.
  • Uncontrolled arrhythmias. -Dissecting aortic aneurysm.-
  • Severe aortic stenosis.
  • Acute endocarditis or pericarditis.
  • Uncontrolled hypertension. -Acute thromboembolic disease.- Any medical condition or instability that, in the investigator's judgment, would make participation unsafe or inappropriate.

结局指标

主要结局

Change in Physical Performance Measured by the Short Physical Performance Battery (SPPB)

时间窗: Baseline and 12 weeks post-intervention

The Short Physical Performance Battery (SPPB) is a standardized test that assesses lower extremity function through three components: balance, gait speed, and chair stand performance. Each component is scored from 0 to 4, with a total score ranging from 0 to 12, where higher scores indicate better physical performance. The SPPB has been validated as a predictor of functional capacity, frailty, and disability in older adults. In this study, the SPPB will be used to evaluate changes in physical performance before and after the 12-week intervention in both groups.

Change in Physical Fitness Measured by the Senior Fitness Test (SFT)

时间窗: Baseline and 12 weeks post-intervention

The Senior Fitness Test (SFT) is a standardized battery designed to assess physical fitness in older adults across multiple components of functional capacity. It includes six subtests evaluating lower-body strength, upper-body strength, aerobic endurance, flexibility, agility, and dynamic balance: chair stand, arm curl, 2-minute step, chair sit-and-reach, back scratch, and 8-foot up-and-go. Each subtest is scored independently using performance-based measures. There is no single composite score for the SFT. The minimum and maximum values for each subtest are as follows: Chair Stand Test: number of repetitions completed in 30 seconds (minimum = 0 repetitions; no fixed maximum). Arm Curl Test: number of repetitions completed in 30 seconds (minimum = 0 repetitions; no fixed maximum). 2-Minute Step Test: number of steps completed in 2 minutes (minimum = 0 steps; no fixed maximum). Chair Sit-and-Reach Test: distance reached in centimeters relative to the toes (negative values indicate

次要结局

  • Change in Quality of Life Measured by the WHOQOL-BREF Questionnaire(Baseline and 12 weeks post-interventio)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Silvia Patricia Betancur Bedoya

Principal Investigator

Fundacion Universitaria Maria Cano

研究点 (2)

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