Exercise Prescription Via Telerehabilitation for Older Adults With Cardiopulmonary Disease in Antioquia, Colombia

NCT06680271 | Enrolling By Invitation

• 1 other identifier: CR-222
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Telerehabilitation; Exercise; Noncommunicable Disease

Keywords

Telerehabilitation; Physical Activity

Outcome Measures

Primary Outcomes (1)

• 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.

  Month 1 vs Month 3

Secondary Outcomes (2)

• Frailty SPPB (Short Physical Performance Battery)

  Month 1 vs Month 3

• Senior Fitness Test- Physical Condition

  Month 1 vs Month 3

Study Arms (2)

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.

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

Other: Home exercise

Interventions

Remote exercise OTHER

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

Telehealth interventions

Home exercise OTHER

The control group will consist of 25 subjects receiving traditional physical therapy at home from a physical therapist.

Home Intervention

Eligibility Criteria

• Age: 60 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Voluntarily agree to participate in the study.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fundacion Universitaria Maria Cano: lead

Study Sites (1)

Silvia Betancur

Envigado, Antioquia, Colombia

Location

MeSH Terms

Conditions

Motor Activity; Noncommunicable Diseases

Condition Hierarchy (Ancestors)

Behavior; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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.

Study Record Dates

• First Submitted: November 6, 2024
• First Posted: November 8, 2024
• Study Start: March 1, 2025
• Primary Completion: September 30, 2025
• Study Completion: November 30, 2025
• Last Updated: December 18, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Data requests can be submitted starting 12 months after article publication and the data will be made accessible for up to 24 months.
• Access Criteria: Access to trial Individual Patient Data (IPD) is available to qualified researchers conducting independent scientific research. Requests will be granted after review and approval of a research proposal. For more information or to submit a request, please contact principal researcher.

Locations

CO (1)