NCT07299786

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2024

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 30, 2024

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2024

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 10, 2025

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 28, 2025

Completed
25 days until next milestone

First Posted

Study publicly available on registry

December 23, 2025

Completed
Last Updated

December 23, 2025

Status Verified

November 1, 2025

Enrollment Period

5 months

First QC Date

November 28, 2025

Last Update Submit

December 17, 2025

Conditions

Keywords

telerehabilitationMulticomponent ExerciseMultiple Chronic Conditions

Outcome Measures

Primary Outcomes (2)

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

    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.

    Baseline and 12 weeks post-intervention

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

    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

    Baseline and 12 weeks post-intervention

Secondary Outcomes (1)

  • Change in Quality of Life Measured by the WHOQOL-BREF Questionnaire

    Baseline and 12 weeks post-interventio

Other Outcomes (1)

  • Participant Satisfaction with the Telerehabilitation Program

    At the end of the 12-week intervention

Study Arms (2)

Telerehabilitation Group (TRG)

EXPERIMENTAL

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.

Behavioral: Multicomponent Exercise via Telerehabilitation

Home-Based Physiotherapy Group (HBG)

ACTIVE COMPARATOR

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.

Behavioral: Home-Based Physiotherapy

Interventions

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.

Also known as: HBG
Home-Based Physiotherapy Group (HBG)

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.

Also known as: TRG
Telerehabilitation Group (TRG)

Eligibility Criteria

Age60 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fundación Universitaria María Cano

Envigado, Antioquia, 055420, Colombia

Location

MeSH Terms

Conditions

Multiple Chronic Conditions

Condition Hierarchy (Ancestors)

Chronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
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.
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 28, 2025

First Posted

December 23, 2025

Study Start

January 30, 2024

Primary Completion

June 30, 2024

Study Completion

October 10, 2025

Last Updated

December 23, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

Individual participant data (IPD) will not be shared due to institutional and ethical restrictions. Only aggregated and anonymized data will be published in scientific reports and peer-reviewed journals.

Locations