跳至主要内容
临床试验/NCT06680271
NCT06680271Enrolling By Invitation不适用

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

Fundacion Universitaria Maria Cano1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2025年3月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
Enrolling By Invitation
入组人数
50
试验地点
1
主要终点
Quality of Life - BREF (WHOQOL-BREF)

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
60 Years 至 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •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.

排除标准

  • •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.

研究组 & 干预措施

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.

干预措施: Remote exercise (Other)

Home Intervention

Active Comparator

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

干预措施: Home exercise (Other)

结局指标

主要结局

Quality of Life - BREF (WHOQOL-BREF)

时间窗: 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.

次要结局

  • Frailty SPPB (Short Physical Performance Battery)(Month 1 vs Month 3)
  • Senior Fitness Test- Physical Condition(Month 1 vs Month 3)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Silvia Patricia Betancur Bedoya

Professor

Universidad Iberoamericana A.C., Mexico

研究点 (1)

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