Clinical trial NCT06680271: Exercise Prescription Via Telerehabilitation for Older Adults With Cardiopulmonary Disease in Antioquia, Colombia
Official title: Exercise Prescription Via Telerehabilitation for Older Adults With Cardiopulmonary Disease in Antioquia, Colombia
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Telerehabilitation
Exercise
Noncommunicable Disease
Keywords: Telerehabilitation
Physical Activity
Lead sponsor: Fundacion Universitaria Maria Cano
Sponsor class: OTHER
First posted: 2024-11-08
Enrollment: 50
Sex: ALL
Minimum age (years): 60
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention 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.
Primary purpose: TREATMENT

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.
* 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.

Primary outcomes:
measure: Quality of Life - BREF (WHOQOL-BREF)
timeFrame: Month 1 vs Month 3
Secondary outcomes:
measure: Frailty SPPB (Short Physical Performance Battery)
timeFrame: Month 1 vs Month 3
measure: Senior Fitness Test- Physical Condition
timeFrame: Month 1 vs Month 3
Other outcomes:
Locations:
city: Envigado
country: Colombia
facility: Silvia Betancur
state: Antioquia
Study officials:
References: