Non Communicable Chronic DiseasesNCT06804317
Effectiveness of a Supervised Multicomponent Exercise-Based Telerehabilitation Intervention on Physical Performance in Older Patients with Multiple Chronic Conditions in Colombia
A study testing telerehabilitation in people with Non Communicable Chronic Diseases, run by Fundacion Universitaria Maria Cano at 1 site in Colombia.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 60 to 100 years
- Conditions the study is for
- Non Communicable Chronic Diseases
- What is being tested?
- telerehabilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteColombia
- Study dates
- 1 Feb 2024to 30 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Requirement for assistance with walking.
- History of disease exacerbation within the past six months.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Non Communicable Chronic Diseases
- Being tested
- telerehabilitation
- Keywords
- Exercise Therapy, elderly, telerehabilitation
- Medical subject headings
- Noncommunicable Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
telerehabilitationOther
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
| Study group | Role | What they receive |
|---|---|---|
| NCD´s Telerehabilitation | Experimental | 41 participants enrolled in a tele-rehabilitation program with Exercise-based interventions conducted twice weekly for three months via videoconferencing on Microsoft Teams Receives: Other: telerehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Short Physical Performance Battery
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.
Measured: Baseline and at 1 month postest
Secondary outcomes (1)
Six-minute walk test
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.
Measured: Baseline and at 1 month postest
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2025
- Study start1 Feb 2024
- Primary completion14 Nov 2024
- Study completion30 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non Communicable Chronic DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundacion Universitaria Maria Cano
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Catalina Lopera Muñetón, Fundacion Universitaria Maria Cano
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06804317
- Sponsor's protocol ID
- 013008018-2023
- Status last verified
- Jan 2025
- First submitted
- 15 Jan 2025
- Last updated
- 3 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Supervised Multicomponent Exercise-Based Telerehabilitation Intervention on Physical Performance in Older Patients with Multiple Chronic Conditions in Colombia
- ClinicalTrials.gov ID
- NCT06804317
- Acronym / sponsor ID
- 013008018-2023
- Conditions
- Non Communicable Chronic Diseases
- Keywords
- Exercise Therapy, elderly, telerehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Fundacion Universitaria Maria CanoUniversity, hospital or other
- Study start
- 1 Feb 2024 (actual)
- Primary completion
- 14 Nov 2024 (actual)
- Study completion
- 30 Dec 2024 (actual)
- First posted
- 3 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NCD´s Telerehabilitation | Experimental | Other: telerehabilitation41 participants enrolled in a tele-rehabilitation program with Exercise-based interventions conducted twice weekly for three months via videoconferencing on Microsoft Teams |
Who may qualify
- Ages
- 60 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (2 listed)
- Requirement for assistance with walking.
- History of disease exacerbation within the past six months.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| telerehabilitationExercise-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 | Other | NCD´s Telerehabilitation |
Primary outcome
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.
1 secondary outcome
Six-minute walk test
Time frame: Baseline and at 1 month postest
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing telerehabilitation in people with Non Communicable Chronic Diseases, run by Fundacion Universitaria Maria Cano at 1 site in Colombia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Colombia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Short Physical Performance Battery (time frame: Baseline and at 1 month postest). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2025.