Telerehabilitation With Multicomponent Exercise for Older Adults With Multiple Chronic Conditions

NCT ID: NCT07299786

Last Updated: 2025-12-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-30

Study Completion Date

2025-10-10

Brief Summary

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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.

Detailed Description

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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.

The comparison group receives an equivalent multicomponent exercise program delivered face-to-face in the participant's home by a physiotherapist over the same intervention period. Session structure, exercise components, and progression principles are comparable between groups, with the primary difference being the mode of delivery. Both groups receive standardized educational guidance related to physical activity, healthy aging, and self-management strategies.

Assessments are conducted at baseline and immediately after completion of the intervention period. Study procedures include monitoring adherence, documenting attendance, and recording any adverse events occurring during supervised exercise sessions. These elements are used to evaluate feasibility, acceptability, and safety of the intervention in both delivery modalities.

Ethical approval was obtained from the Research Ethics Committee of Fundación Universitaria María Cano. All participants provided written informed consent prior to enrollment. Participant confidentiality and data protection are ensured in accordance with institutional protocols and national regulations, including secure management of digital platforms used for telerehabilitation.

This trial aims to generate context-specific evidence on the use of supervised telerehabilitation as a strategy to deliver physiotherapy services to older adults with multiple chronic conditions, supporting future integration of digital rehabilitation models into clinical practice and public health initiatives in Colombia.

Conditions

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Multiple Comorbidity

Keywords

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telerehabilitation Multicomponent Exercise Multiple Chronic Conditions

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This study follows a parallel-group design with two intervention arms: a Telerehabilitation Group (TRG) and a Conventional Home-Based Physiotherapy Group (HBG). Participants will be randomly assigned in a 1:1 ratio, stratified by primary diagnosis and sex, to ensure balanced distribution between groups. Each participant will remain in the same group throughout the 12-week intervention period.
Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Outcome Assessors
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.

Study Groups

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Telerehabilitation Group (TRG)

Participants in the Telerehabilitation Group (TRG) will take part in a 12-week multicomponent exercise program delivered online through Microsoft Teams. Sessions will be held twice per week, lasting 45 minutes each, and will include aerobic, strength, flexibility, and balance exercises. Intensity will be individually adjusted according to perceived exertion and functional status. A physiotherapist will conduct the sessions in real time, providing continuous supervision, feedback, and safety monitoring.

Group Type EXPERIMENTAL

Multicomponent Exercise via Telerehabilitation

Intervention Type BEHAVIORAL

A supervised multicomponent exercise program delivered remotely through Microsoft Teams. The program includes aerobic, strength, flexibility, and balance exercises performed twice per week for 12 weeks, under real-time supervision by a physiotherapist. The exercises are individualized according to each participant's health status and physical capacity.

Home-Based Physiotherapy Group (HBG)

Participants in the Home-Based Physiotherapy Group (HBG) received a 12-week in-home physiotherapy program conducted by a physiotherapist who visited the participants' homes twice per week. Each session lasted approximately 45 minutes and included aerobic, strength, flexibility, and balance exercises, following the same structure as the telerehabilitation protocol. The exercises were individualized according to the participant's clinical condition and physical capacity. Progress and safety were monitored directly during each home session.

Group Type ACTIVE_COMPARATOR

Home-Based Physiotherapy

Intervention Type BEHAVIORAL

A physiotherapist-led multicomponent exercise program conducted in person at the participant's home. The intervention includes aerobic, strength, flexibility, and balance exercises, delivered twice per week for 12 weeks. The physiotherapist provides individualized progression, monitors adherence, and ensures participant safety during each home session.

Interventions

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Multicomponent Exercise via Telerehabilitation

A supervised multicomponent exercise program delivered remotely through Microsoft Teams. The program includes aerobic, strength, flexibility, and balance exercises performed twice per week for 12 weeks, under real-time supervision by a physiotherapist. The exercises are individualized according to each participant's health status and physical capacity.

Intervention Type BEHAVIORAL

Home-Based Physiotherapy

A physiotherapist-led multicomponent exercise program conducted in person at the participant's home. The intervention includes aerobic, strength, flexibility, and balance exercises, delivered twice per week for 12 weeks. The physiotherapist provides individualized progression, monitors adherence, and ensures participant safety during each home session.

Intervention Type BEHAVIORAL

Other Intervention Names

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TRG HBG

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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.
Minimum Eligible Age

60 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universidad Iberoamericana A.C., Mexico

OTHER

Sponsor Role collaborator

Fundacion Universitaria Maria Cano

OTHER

Sponsor Role lead

Responsible Party

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Silvia Patricia Betancur Bedoya

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Fundación Universitaria María Cano

Envigado, Antioquia, Colombia

Site Status

Countries

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Colombia

Other Identifiers

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013008001-2024311

Identifier Type: -

Identifier Source: org_study_id