TelerehabilitationNCT06680271
Exercise Prescription Via Telerehabilitation for Older Adults With Cardiopulmonary Disease in Antioquia, Colombia
A study testing Remote exercise and Home exercise in people with Telerehabilitation and Exercise, run by Fundacion Universitaria Maria Cano at 1 site in Colombia.
Trial summary
Objective: To evaluate the effects of telerehabilitation with physical exercise in older adults with cardiorespiratory disease in Antioquia, Colombia. Methods: This study will be a single controlled trial conducted at a single center. A sample of 50 older adults with cardiorespiratory diseases will be included. Read more about this study
- Who is it for?
- Ages 60 to 100 years
- Conditions the study is for
- Telerehabilitation, Exercise, Noncommunicable Disease
- What is being tested?
- Remote exercise and Home exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteColombia
- Study dates
- 1 Mar 2025to 30 Nov 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Voluntarily agree to participate in the study.
- Inclusion will be considered for individuals with specific chronic medical conditions, including Chronic Obstructive Pulmonary Disease (COPD), which will be diagnosed according to the guidelines established in the widely used Global Initiative for Chronic Obstructive Lung Disease (GOLD) guide in clinical and research contexts. Similarly, asthma will be included, identified according to the criteria outlined in the Global Initiative for Asthma (GINA) guide. Heart failure will also be included, categorized based on the New York Heart Association (NYHA) functional classification previously validated in Colombian populations. Additionally, metabolic syndrome will be included, with confirmation based on criteria defined by the World Health Organization (WHO).
- The patient's diagnosis must be confirmed through medical history.
- These specific criteria will guide the selection of participants who meet the established requirements for this study.
- Must be able to communicate verbally or in writing.
- Must be in a stable phase of their illness, supported by medical history.
- A minimum of 3 months of illness for the condition to be considered chronic.
- Patients with Type II Diabetes Mellitus must have a glucose level lower than 200 mg/dL during the tele-rehabilitation session.
Who cannot join
- Dementia.
- Epilepsy or a history of seizures.
- Patient who has recently undergone surgery.
- Delirium.
- Acute myocardial infarction or recent unstable angina.
- Uncontrolled atrial or ventricular arrhythmias.
Show all 17Show fewer
- Dissecting aortic aneurysm.
- Severe aortic stenosis.
- Acute endocarditis/pericarditis.
- Uncontrolled hypertension.
- Acute thromboembolic disease.
- Severe acute heart failure.
- Severe acute respiratory failure.
- Uncontrolled orthostatic hypotension.
- Diabetes mellitus with acute decompensation or uncontrolled hypoglycemia.
- Recent fracture (within the last month, strength training).
- Any other circumstance deemed by the evaluator or the subject that prevents physical activity.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Objective: To evaluate the effects of telerehabilitation with physical exercise in older adults with cardiorespiratory disease in Antioquia, Colombia.
Methods: This study will be a single controlled trial conducted at a single center. A sample of 50 older adults with cardiorespiratory diseases will be included. The intervention group will consist of 25 subjects receiving a multicomponent physical exercise intervention (aerobic, strength, flexibility, and neuromotor) delivered by a physical therapist via the Microsoft Teams platform. The control group will consist of 25 subjects receiving traditional physical therapy at home from a physical therapist. The intervention will be pre-registered on "ClinicalTrials.gov".
Expected Results: An improvement in quality of life, measured by the WHOQOL-Bref (World Health Organization Quality of Life), an increase in physical condition assessed with the Senior Fitness Test battery, and a reduction in frailty measured by the Short Physical Performance Battery (SPPB) are expected. Additionally, the development of a cardiopulmonary telerehabilitation protocol is anticipated.
Read the detailed description
This study will explore the effects of prescribing physical exercise through telerehabilitation for older adults with cardiorespiratory diseases in Antioquia, Colombia. It will aim to determine which exercise prescriptions are most beneficial and feasible for this population within a telerehabilitation model, taking into account the specific conditions they face.
The study will address three main questions. First, it will identify which types of physical exercises are most suitable for older adults with various cardiorespiratory conditions when delivered via telerehabilitation. Second, it will examine how to best implement these exercises to ensure safety, engagement, and effectiveness through remote guidance. Finally, the study will evaluate the benefits of telerehabilitation-prescribed physical exercises, particularly regarding improvements in quality of life for older adults managing these health conditions.
- Conditions
- Telerehabilitation, Exercise, Noncommunicable Disease
- Being tested
- Remote exercise, Home exercise
- Keywords
- Telerehabilitation, Physical Activity
- Medical subject headings
- Motor Activity, Noncommunicable Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remote exerciseOther
The intervention group will consist of 25 subjects receiving a multicomponent physical exercise intervention (aerobic, strength, flexibility, and neuromotor) delivered by a physical therapist via the Microsoft Teams platform
Home exerciseOther
The control group will consist of 25 subjects receiving traditional physical therapy at home from a physical therapist.
| Study group | Role | What they receive |
|---|---|---|
| Telehealth interventions | Experimental | The intervention group will consist of 25 subjects receiving a multicomponent physical exercise intervention (aerobic, strength, flexibility, and neuromotor) delivered by a physical therapist via the Microsoft Teams platform. Receives: Other: Remote exercise |
| Home Intervention | Active comparator | The control group will consist of 25 subjects receiving traditional physical therapy at home from a physical therapist Receives: Other: Home exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of Life - BREF (WHOQOL-BREF)
The WHOQOL-BREF is a 26-item questionnaire covering four domains: physical health (7 items), psychological health (6 items), social relationships (3 items), and environmental health (8 items), along with items on overall quality of life and general health. Each item is rated on a 5-point ordinal scale, and scores are linearly transformed to a 0-100 scale.
Measured: Month 1 vs Month 3
Secondary outcomes (2)
Frailty SPPB (Short Physical Performance Battery)
The SPPB will assess lower limb function through five tests covering balance, strength, and mobility. Balance tests will have three progressively challenging stages (feet together, semi-tandem, and full tandem), aiming for 10 seconds unaided at each stage. Gait speed will be measured with a portable gait analysis system. For the "five times sit-to-stand" test, participants will begin seated and, after demonstrating one sit-to-stand, will complete five repetitions as quickly as possible, with feet flat on the floor. Scores will reflect performance, with a maximum score of 12; lower scores indicate greater frailty in older adults.
Measured: Month 1 vs Month 3
Senior Fitness Test- Physical Condition
The Senior Fitness Test evaluates various physical fitness components for older adults:
Lower Body Strength - Chair Stand Test (30 seconds): Measures leg strength by counting how many times a person can rise from a chair in 30 seconds. More repetitions are better.
Upper Body Strength - Arm Curl Test: Counts how many arm curls can be completed in a set time (30 seconds). More repetitions are better.
Aerobic Endurance - 6-Minute Walk Test: Assesses walking endurance over 6 minutes, measured in meters. More meters walked are better.
Upper Body Flexibility - Back Scratch Test: Measures shoulder flexibility by attempting to touch hands behind the back. Greater reach is better.
Lower Body Flexibility - Chair Sit and Reach Test: Assesses flexibility of the hamstrings and lower back, measured in centimeters. Greater reach is better.
Measured: Month 1 vs Month 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2024
- Study start1 Mar 2025 (estimated)
- Primary completion30 Sep 2025 (estimated)
- Study completion30 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TelerehabilitationStudies 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
- Non-randomised
- Intervention model
- Single group
- Model description
- The intervention group will consist of 25 subjects receiving a multicomponent physical exercise intervention (aerobic, strength, flexibility, and neuromotor) delivered by a physical therapist via the Microsoft Teams platform.
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundacion Universitaria Maria Cano
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Silvia Patricia Betancur Bedoya, Universidad Iberoamericana A.C., Mexico
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06680271
- Sponsor's protocol ID
- CR-222
- Status last verified
- Dec 2024
- First submitted
- 6 Nov 2024
- Last updated
- 18 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data obtained through this study may be provided to qualified researchers with academic interest in telerehabilitation
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exercise Prescription Via Telerehabilitation for Older Adults With Cardiopulmonary Disease in Antioquia, Colombia
- ClinicalTrials.gov ID
- NCT06680271
- Acronym / sponsor ID
- CR-222
- Conditions
- Telerehabilitation, Exercise, Noncommunicable Disease
- Keywords
- Telerehabilitation, Physical Activity
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Fundacion Universitaria Maria CanoUniversity, hospital or other
- Study start
- 1 Mar 2025 (estimated)
- Primary completion
- 30 Sep 2025 (estimated)
- Study completion
- 30 Nov 2025 (estimated)
- First posted
- 8 Nov 2024 (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.
Objective: To evaluate the effects of telerehabilitation with physical exercise in older adults with cardiorespiratory disease in Antioquia, Colombia.
Methods: This study will be a single controlled trial conducted at a single center. A sample of 50 older adults with cardiorespiratory diseases will be included. The intervention group will consist of 25 subjects receiving a multicomponent physical exercise intervention (aerobic, strength, flexibility, and neuromotor) delivered by a physical therapist via the Microsoft Teams platform. The control group will consist of 25 subjects receiving traditional physical therapy at home from a physical therapist. The intervention will be pre-registered on "ClinicalTrials.gov".
Expected Results: An improvement in quality of life, measured by the WHOQOL-Bref (World Health Organization Quality of Life), an increase in physical condition assessed with the Senior Fitness Test battery, and a reduction in frailty measured by the Short Physical Performance Battery (SPPB) are expected. Additionally, the development of a cardiopulmonary telerehabilitation protocol is anticipated.
Detailed description
This study will explore the effects of prescribing physical exercise through telerehabilitation for older adults with cardiorespiratory diseases in Antioquia, Colombia. It will aim to determine which exercise prescriptions are most beneficial and feasible for this population within a telerehabilitation model, taking into account the specific conditions they face.
The study will address three main questions. First, it will identify which types of physical exercises are most suitable for older adults with various cardiorespiratory conditions when delivered via telerehabilitation. Second, it will examine how to best implement these exercises to ensure safety, engagement, and effectiveness through remote guidance. Finally, the study will evaluate the benefits of telerehabilitation-prescribed physical exercises, particularly regarding improvements in quality of life for older adults managing these health conditions.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The intervention group will consist of 25 subjects receiving a multicomponent physical exercise intervention (aerobic, strength, flexibility, and neuromotor) delivered by a physical therapist via the Microsoft Teams platform.
| Arm | Type | Receives |
|---|---|---|
| Telehealth interventions | Experimental | Other: Remote exerciseThe intervention group will consist of 25 subjects receiving a multicomponent physical exercise intervention (aerobic, strength, flexibility, and neuromotor) delivered by a physical therapist via the Microsoft Teams platform. |
| Home Intervention | Active comparator | Other: Home exerciseThe control group will consist of 25 subjects receiving traditional physical therapy at home from a physical therapist |
Who may qualify
- Ages
- 60 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Voluntarily agree to participate in the study.
- Inclusion will be considered for individuals with specific chronic medical conditions, including Chronic Obstructive Pulmonary Disease (COPD), which will be diagnosed according to the guidelines established in the widely used Global Initiative for Chronic Obstructive Lung Disease (GOLD) guide in clinical and research contexts. Similarly, asthma will be included, identified according to the criteria outlined in the Global Initiative for Asthma (GINA) guide. Heart failure will also be included, categorized based on the New York Heart Association (NYHA) functional classification previously validated in Colombian populations. Additionally, metabolic syndrome will be included, with confirmation based on criteria defined by the World Health Organization (WHO).
- The patient's diagnosis must be confirmed through medical history.
- These specific criteria will guide the selection of participants who meet the established requirements for this study.
- Must be able to communicate verbally or in writing.
Key exclusion criteria (17 listed)
- Dementia.
- Epilepsy or a history of seizures.
- Patient who has recently undergone surgery.
- Delirium.
- Acute myocardial infarction or recent unstable angina.
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 |
|---|---|---|
| Remote exerciseThe intervention group will consist of 25 subjects receiving a multicomponent physical exercise intervention (aerobic, strength, flexibility, and neuromotor) delivered by a physical therapist via the Microsoft Teams platform | Other | Telehealth interventions |
| Home exerciseThe control group will consist of 25 subjects receiving traditional physical therapy at home from a physical therapist. | Other | Home Intervention |
Primary outcome
Quality of Life - BREF (WHOQOL-BREF)
Time frame: Month 1 vs Month 3
The WHOQOL-BREF is a 26-item questionnaire covering four domains: physical health (7 items), psychological health (6 items), social relationships (3 items), and environmental health (8 items), along with items on overall quality of life and general health. Each item is rated on a 5-point ordinal scale, and scores are linearly transformed to a 0-100 scale.
2 secondary outcomes
Frailty SPPB (Short Physical Performance Battery)
Time frame: Month 1 vs Month 3
Senior Fitness Test- Physical Condition
Time frame: Month 1 vs Month 3
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2024.
- Individual participant dataSharing planned: Yes. Data obtained through this study may be provided to qualified researchers with academic interest in telerehabilitation
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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.
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 Remote exercise and Home exercise in people with Telerehabilitation and Exercise, 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 8 inclusion and 17 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: enrolling by invitation, as of the sponsor's last update on 18 Dec 2024. 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?
This study is still under way. Results are not available in the source record yet.
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?
Quality of Life - BREF (WHOQOL-BREF) (time frame: Month 1 vs Month 3). 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 18 Dec 2024.