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Clinical Trials/NCT07299786
NCT07299786
Completed
Not Applicable

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

Fundacion Universitaria Maria Cano1 site in 1 country34 target enrollmentStarted: January 30, 2024Last updated:

Overview

Phase
Not Applicable
Status
Completed
Enrollment
34
Locations
1
Primary Endpoint
Change in Physical Performance Measured by the Short Physical Performance Battery (SPPB)

Overview

Brief Summary

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

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Other
Masking
Double (Participant, Outcomes Assessor)

Masking Description

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.

Eligibility Criteria

Ages
60 Years to 100 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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.

Outcomes

Primary Outcomes

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

Time Frame: 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)

Time Frame: 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

Secondary Outcomes

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

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Silvia Patricia Betancur Bedoya

Principal Investigator

Fundacion Universitaria Maria Cano

Study Sites (1)

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