COPD (Chronic Obstructive Pulmonary Disease), Eccentric Exercise Training, Pulmonary Rehabilitation
Conditions
Brief summary
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.
Interventions
OTHEREccentric and concentric aerobic exercice versus only concentric aerobic exercice
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.
Sponsors
Universidad Europea de Madrid
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sit-to-stand test-5 (STS) | Baseline and 1 month after | 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. |
| PIM and PEM pressures | Baseline and 1 month after | The pressure gauge we use is the RP Check. To measure peak expiratory pressure (PEM), the patient places the mouthpiece in their mouth, with the bite blocks between their teeth; they inhale as much air as possible until their lungs are completely full (to total lung capacity) and then exhale with maximum effort and for as long as possible (at least 1.5 seconds). To measure peak inspiratory pressure (PIP), the patient places the mouthpiece in their mouth, exhales as much air as possible to empty their lungs to residual volume, and then inhales with maximum effort and for as long as possible (at least 1.5 seconds). We take three consecutive measurements of each pressure, allowing the patient to rest for one minute between each measurement, and record the best result. |
| Handgrip | Baseline and 1 month after | Hand Grip Dynamometer Jamar®, taking into account the dominant hand and possible upper limb injuries that may interfere with the test result |
| Quadriceps strength | Baseline and 1 month after | The measurement will be taken on the dominant leg using the MicroFET®2 Digital Handheld Dynamometer following the protocol described by Bohannon et al ( |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Dyspnea | Baseline and 1 month after | It consists of a vertical scale from 0-10 that relates the perceived exertion of physical activity to a numerical value ranging from 0 (minimal effort) to 10 (extreme effort). It does not require measuring instruments, as it is a subjective scale. |
Countries
Spain
Contacts
CONTACTTeresa Fernandez Pardo, PT, Msc, PhD
Outcome results
None listed