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

Overview

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

Interventions

• Other Retraining program after thoracic surgery
  An effort retraining program will be carried out, with respiratory physiotherapy, muscle strengthening exercises and aerobic exercise, for four weeks, every other day, with a duration of 75 minutes each session. Both the control and experimental groups will receive a common treatment: Muscle strength and aerobic resistance exercises will be performed following the F.I.T.T principle, working the main muscle groups against resistance (between 40% and 60% RM) performing three sets of ten repetition

Primary outcome measures

• Rectus femoral thickness [Time frame: Baseline, 3 weeks, 2 months]
• Diaphragmatic excursion [Time frame: Baseline, 3 weeks, 2 months]
• Diaphragm thickness [Time frame: Baseline, 3 weeks, 2 months]
• 6MWT [Time frame: Baseline, 3 weeks, 2 months]
• Perceived effort [Time frame: Baseline, 3 weeks, 2 months]
• Measurement of maximum respiratory pressures (MIP and PEM). [Time frame: Baseline, 3 weeks, 2 months]
• Functional capacity [Time frame: Baseline, 3 weeks, 2 months]
• Grip strength measurement in both hands [Time frame: Baseline, 3 weeks, 2 months]
• Spirometric assessment of FEV1 [Time frame: Baseline, 3 weeks, 2 months]
• Life quality [Time frame: Baseline, 3 weeks, 2 months]

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.

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

Spain · 1 center

• Hospital Universitario Ramon y Cajal — Madrid

Identifiers

NCT: NCT06493877 · 082/24

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗