- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06804317
Effectiveness of a Supervised Multicomponent Exercise-Based Telerehabilitation Intervention on Physical Performance in Older Patients with Multiple Chronic Conditions in Colombia
January 27, 2025 updated by: Catalina Lopera Muñetón, Fundacion Universitaria Maria Cano
Currently, the older adult population faces an increase in the prevalence of cardiopulmonary diseases, which negatively impact their quality of life by limiting their ability to perform daily activities and affecting their physical and emotional well-being.
In particular, cardiovascular and respiratory diseases are among the leading causes of morbidity and mortality among older adults in Colombia.
Despite advances in pharmacological treatment and medical care, physical rehabilitation remains an essential component in the management of these diseases, with physical exercise serving as one of its fundamental pillars.
However, access to physical rehabilitation programs for the older adult population, particularly in rural or hard-to-reach areas, continues to pose a significant challenge.
Telemedicine and Information and Communication Technologies (ICT) have emerged as viable solutions to overcome this barrier, enabling the remote prescription and monitoring of physical exercises, facilitating the inclusion of more patients in rehabilitation programs, and improving their quality of life.
Therefore, this study aims to evaluate the effectiveness of a multicomponent ICT-mediated intervention in terms of improving physical condition, reducing frailty, adherence, satisfaction, and quality of life in older adults with cardiopulmonary diseases.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
41
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Medellín, Colombia
- Fundación Universitaria María Cano
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria
- Diagnosis of a non-communicable disease.
- Ability to communicate verbally or in writing.
- Stable disease status confirmed by clinical history.
- Condition present for at least three months to qualify as chronic.
- For patients with type II diabetes mellitus: glucose levels below 200 mg/dL during tele-rehabilitation sessions.
Exclusion Criteria
- Requirement for assistance with walking.
- History of disease exacerbation within the past six months.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: NCD´s Telerehabilitation
41 participants enrolled in a tele-rehabilitation program with Exercise-based interventions conducted twice weekly for three months via videoconferencing on Microsoft Teams
|
Exercise-based interventions were conducted twice weekly for three months via videoconferencing on Microsoft Teams. The program included various components: Aerobic and strength training, Flexibility, Balance and coordination |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Short Physical Performance Battery
Time Frame: Baseline and at 1 month postest
|
This battery includes tests for usual walking speed over 4 meters, five-chair stands, and balance.
Each task receives a score (0-4) based on the time required to perform five sit-to-stand repetitions, standing balance, and walking speed over 4 meters.
The total score (0-12) is calculated by summing individual scores, with higher scores indicating better lower-body function.
|
Baseline and at 1 month postest
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Six-minute walk test
Time Frame: Baseline and at 1 month postest
|
Conducted on a straight, level, hard surface, ideally 30 meters long, with a minimum acceptable length of 20 meters.
The track was marked every 3 meters, with cones at the ends and bright tape at the start.
Variables recorded included meters (m), which represent the total distance covered by the individual during the six-minute period.
|
Baseline and at 1 month postest
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 1, 2024
Primary Completion (Actual)
November 14, 2024
Study Completion (Actual)
December 30, 2024
Study Registration Dates
First Submitted
January 15, 2025
First Submitted That Met QC Criteria
January 27, 2025
First Posted (Actual)
March 25, 2025
Study Record Updates
Last Update Posted (Actual)
March 25, 2025
Last Update Submitted That Met QC Criteria
January 27, 2025
Last Verified
January 1, 2025
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 013008018-2023
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.