Isoinertial Training in Patients With COPD

Официальное название

Effect of Isoinertial Training on Muscle Strength and Functional Capacity in Patients With Chronic Obstructive Pulmonary Disease (COPD): A Randomized Controlled Clinical Trial

Обзор

Isoinertial training is emerging as a potentially effective strategy to improve strength and functionality in older people diagnosed with chronic obstructive pulmonary disease (COPD), due to its influence on muscle mass and neuromuscular efficiency. COPD is characterized by systemic alterations, including peripheral muscle dysfunction; which contributes to patient functional limitation, and reduces patients' quality of life. Isoinertial training may improve the physiological response to effort, and also promote functional performance in this population. Hence, the aim of this study is to evaluate the effect of an isoinertial training program on muscle strength and functional capacity in patients with COPD during an 8-week intervention.

Подробное описание

To assess the effects of an isoinertial training programme on muscle strength and functional capacity in older people diagnosed with chronic obstructive pulmonary disease (COPD), in a randomized controlled clinical trial. Thirty participants diagnosed with moderate to severe COPD, over 50 years (50% men, 50% women), will be included to analyze possible differences in the training response compared to the control group. Participants will sign the informed consent and randomly assign to the intervention or control group. The intervention consists in a supervised isoinertial training program, while the control group will continue with the usual pulmonary rehabilitation program. Patients will be subjected to an initial assessment that include the application of tests of functional capacity, muscle strength, as well as clinical parameters and sociodemographic characteristics. The intervention will last 8 weeks, with a frequency of 2 to 3 sessions per week. The training program will include exercises aimed at strengthening the upper and lower limbs, using a isoinertial device with controlled load progression.

Вмешательства

• Устройство Isoinertial training
  Supervised isoinertial training: * Participants will perform a supervised isoinertial training program during 8 weeks of follow-up * The intervention will have a frequency of 2 to 3 weekly sessions * The program will include exercises aimed at strengthening the upper and lower limbs using a isoinertial device * The training load will be progressive to each participant and adjusted according to the individual response. * The program will be carried out in combination with usual pulmonary rehabil
• Другое Traditional rehabilitation (control group)
  Traditional treatment (control group) * Participants involved in the usual pulmonary rehabilitation program during 8 weeks with a frequency of 2-3 sessions per week. * This program includes low- to moderate-intensity aerobic exercise, joint mobility activities and general strengthening exercises using conventional resources according to the clinic's rehabilitation protocol. * No isoinertial training

Первичные конечные точки

• Change in upper limb muscle strength using the Hand Grip Test (HGT) [Срок оценки: Baseline and 8-week follow-up]
• Change in functional capacity by 6-minute walk test (6MWT) [Срок оценки: Baseline and 8-week follow-up]
• Lower limb functional performance [Срок оценки: Baseline and 8-week follow-up]
• Change in functional mobility using the Timed Up and Go Test (TUG) [Срок оценки: Baseline and 8-week follow-up]
• Change in muscle quality index (MQI) [Срок оценки: Baseline and 8-week follow-up]

Вторичные конечные точки (6)

• Change in functional performance using 5 Times Sit-to-Stand Test (5STS) [Срок оценки: Baseline and 8-week follow-up]
• Change in health-related quality of life through The Saint George's Respiratory Questionnaire (SGRQ) [Срок оценки: Baseline and 8-week follow-up]
• Changes in Body Mass Index (BMI) [Срок оценки: Baseline and 8-week follow-up]
• Changes in heart rate [Срок оценки: Baseline and 8-week follow-up]
• Changes in blood pressure [Срок оценки: Baseline and 8-week follow-up]
• Changes in oxygen saturation (SpO2) [Срок оценки: Baseline and 8 week follow-up]

Критерии участия

Критерии включения

• People between 50 - 80 years of age diagnosed with moderate or severe COPD
• No acute exacerbations in the last 4 weeks
• Sufficient functional capacity to exercise
• Signed informed consent

Критерии исключения

• Presence of neurological, musculoskeletal, or cardiovascular diseases that significantly limit exercise performance or compromise participant safety; including uncontrolled hypertension, recent myocardial infarction, unstable angina, severe osteoarthritis, stroke sequelae, or Parkinson's disease.
• Contraindications to exercise participation according to medical evaluation.
• Recent surgeries in the past 3 months
• Simultaneous participation in other exercise programs
• Cognitive disorders

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Колумбия · 2 центра

• Universidad Manuela Beltrán — Bogotá
• Pulsar Unidad de Neumologia y Rehabilitación Pulmonar — Ibague

Идентификаторы

NCT: NCT07605117 · DCTAFD24 23

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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