Isoinertial Training in Patients With COPD

Official title

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

Overview

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.

Detailed description

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.

Interventions

• Device 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
• Other 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

Primary outcome measures

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

Secondary outcome measures (6)

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

Eligibility criteria

Inclusion criteria

• 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

Exclusion criteria

• 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

Colombia · 2 centers

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

Identifiers

NCT: NCT07605117 · DCTAFD24 23

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗