EFFECTIVENESS OF COMBINED CONCENTRIC AND ECCENTRIC AEROBIC EXERCISE ON A TREADMILL IN PATIENTS WITH COPD: A RANDOMIZED CLINICAL TRIAL.

N/ANot Yet RecruitingNCT07627035

Universidad Europea de Madrid40 enrolled

Overview

The aim of this study is to demonstrate the effectiveness of combined concentric and eccentric aerobic training in subjects with COPD, in terms of strength, lung capacity, functionality, and short-term health quality. A randomized, examiner-blinded clinical trial has been designed for this purpose, following the CONSORT guidelines for clinical trials and the ethical principles of the Declaration of Helsinki. A total sample of 40 subjects has been estimated. The study is aimed at patients diagnosed with mild or moderate COPD. A program of 12 group sessions will be conducted over 4 weeks. Each session will last 75 minutes and will include strength exercises and respiratory physiotherapy, common to all subjects. The interval aerobic training will depend on the assigned group: treadmill with negative and positive (or neutral) incline (experimental group), treadmill with positive incline and/or cycle ergometer (control group). The following variables will be measured on the first and last day of treatment, as well as one month after the intervention ends: thickness, cross-sectional area, and ultrasound intensity of the rectus femoris muscle; diaphragmatic excursion and thickness; 5 sit to stand test; get up and go test; Borg scale; maximum respiratory pressures; grip strength in both hands and maximum quadriceps strength; spirometric assessment of FEV1 and SF-12 health quality questionnaire.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

COPD (Chronic Obstructive Pulmonary Disease)

Interventions

Eccentric and concentric aerobic exercice versus only concentric aerobic exerciceOTHER

For the experimental group: Aerobic exercise will be performed in interval mode, alternating between treadmill walking with a negative incline of up to -6% and treadmill walking with an positive incline. For the intervention group, this will consist of a 2-minute interval at the estimated MET workload, followed by a 4-minute interval at half the intensity. The total duration will be between 20 and 30 minutes. For the control group: The aerobic exercise will be performed in interval mode, on a treadmill with an incline and/or cycle ergometer, consisting of a 2-minute interval at the estimated workload in METs, followed by another 4-minute interval at half the intensity. It will last between 20 and 30 minutes.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: • Subjects \>18 years old. * Present with dyspnea grade 2-3 on the mMRC scale. * Sufficient cognitive and functional level to understand, learn, and carry out the exercise program. * No contraindications to physical training. * Active participants. Exclusion Criteria: • Recent cardiovascular events such as congestive heart failure, angioplasty or cardiac surgery within the last four weeks, valvular abnormalities requiring surgical correction, myopericarditis, or exercise-induced ventricular arrhythmias. * Renal failure requiring dialysis. * Patients with uncontrolled bronchospasm due to intrinsic asthma. * Patients undergoing chemotherapy after surgery. * Severe exercise intolerance due to untreated cardiac arrhythmias, ischemia during low-intensity exercise (unstable angina), severe pulmonary hypertension, or heart failure (NYHA class III or IV). * Pulmonary embolism with anticoagulant therapy for less than 5 days.

Outcomes

Primary Outcomes

Sit-to-stand test-5 (STS)

It is a safe and simple test that provides a reliable and objective measure of functional capacity in patients with lung disease, allowing for a rapid interpretation of the patient's progress. It is therefore the primary variable of this study. In this test, the patient is asked to stand up from and sit down from a chair at maximum speed five times, and the time is recorded. The protocol described by Jones et al. will be followed, with a minimum reduction of 1.7 seconds considered significant improvement.