Clinical trial NCT06493877: Respiratory Rehabilitation Based on Eccentric Exercice on Treadmill After Thoracic Surgery
Official title: Respiratory Rehabilitation Based on Eccentric Exercice on Treadmill After Thoracic Surgery: a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Thoracic Surgery
Breathing
Muscle
Keywords: "thoracic surgery"
"eccentric training"
"pulmonary rehabilitation"
Lead sponsor: Universidad Europea de Madrid
Sponsor class: OTHER
First posted: 2024-07-10
Enrollment: 57
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Thoracic surgeries are frequent and pulmonary rehabilitation is essential, since one of the problems that these patients present is dyspnea when performing aerobic exercise, which limits improvement and in some cases causes them to abandon physical exercise. Thanks to carrying out a correct effort retraining program, combining respiratory physiotherapy with therapeutic exercise, patients with respiratory pathologies manage to improve lung capacity and ventilatory mechanics, increase muscle strength and aerobic resistance, prevent long- term complications, reduce fatigue and, ultimately, improve your quality of life.

Likewise, it is important to find the most appropriate type of muscular work that produces more benefits in the short and medium term to optimize our resources.The objective of the study is to demonstrate the effectiveness of eccentric training in patients who have undergone thoracic surgery, in terms of strength, lung capacity, functionality and quality of health in the short and medium term.

For this purpose, a randomized clinical trial has been designed, with a blinded examiner, following the CONSORT guideline for clinical trials and the ethical principles of the Declaration of Helsinki. A total sample of 57 subjects has been estimated. The study is aimed at patients after scheduled thoracic surgery. A program of 12 group sessions spread over 4 weeks will be carried out. Each of them will last 75 minutes and will include strength and respiratory physiotherapy exercises, common to all subjects.

Aerobic interval training will depend on the group assigned: treadmill with negative slope (experimental group), treadmill with positive slope (control group 1) or cycle ergometer (control group 2). On the first and last day of treatment, as well as one month after completing the intervention, the following variables will be measured: thickness, cross-sectional area and ultrasound intensity of the rectus femoris; diaphragmatic excursion and thickness; 6 minute walk test; Borg scale; maximum respiratory pressures; sit-to-stand test; grip strength in both hands; spirometric assessment of FEV1 and SF-12 health quality questionnaire. a


Eligibility criteria: Inclusion Criteria:

* Subjects \>18 years.
* Thoracic surgery in the previous 75 days
* Present dyspnea grade 2 - 3 on the mMRC scale.
* Cognitive and functional level sufficient to understand, learn and carry out the exercise program.
* Not have contraindications to perform physical training.
* Active collaborators.

Exclusion Criteria:

* Severe intolerance to exertion due to untreated cardiac arrhythmias, ischemia during low intensity exercise (anginas unstable), severe pulmonary hypertension, heart failure (NYHA III or IV)
* Pulmonary embolism with anticoagulant treatment less than 5 days.
* Recent cardiovascular events such as congestive heart failure, angioplasties or cardiac surgeries of less than four weeks' duration, valvular alterations requiring surgical correction, myopericarditis, ventricular arrhythmias caused by exercise.
* Kidney failure requiring dialysis.
* Patients with uncontrolled bronchospasm due to intrinsic asthma.
* Patients undergoing post-surgery chemotherapy treatment.
* Adverse effects that occurred during the development of the treatment.

Primary outcomes:
measure: Rectus femoral thickness
timeFrame: Baseline, 3 weeks, 2 months
measure: Diaphragmatic excursion
timeFrame: Baseline, 3 weeks, 2 months
measure: Diaphragm thickness
timeFrame: Baseline, 3 weeks, 2 months
measure: 6MWT
timeFrame: Baseline, 3 weeks, 2 months
measure: Perceived effort
timeFrame: Baseline, 3 weeks, 2 months
measure: Measurement of maximum respiratory pressures (MIP and PEM).
timeFrame: Baseline, 3 weeks, 2 months
measure: Functional capacity
timeFrame: Baseline, 3 weeks, 2 months
measure: Grip strength measurement in both hands
timeFrame: Baseline, 3 weeks, 2 months
measure: Spirometric assessment of FEV1
timeFrame: Baseline, 3 weeks, 2 months
measure: Life quality
timeFrame: Baseline, 3 weeks, 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Hospital Universitario Ramon y Cajal
Study officials:
affiliation: Universidad Europea de Madrid
name: Teresa Fernandez Pardo, Msc
role: STUDY_DIRECTOR
References: