NCT06493877 Respiratory Rehabilitation Based on Eccentric Exercice on Treadmill After Thoracic Surgery
| NCT ID | NCT06493877 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Universidad Europea de Madrid |
| Condition | Thoracic Surgery |
| Study Type | INTERVENTIONAL |
| Enrollment | 57 participants |
| Start Date | 2024-09 |
| Primary Completion | 2025-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 57 participants in total. It began in 2024-09 with a primary completion date of 2025-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Contact & Investigator
Teresa Fernandez Pardo, Msc
STUDY DIRECTOR
Universidad Europea de Madrid
Frequently Asked Questions
Who can join the NCT06493877 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Thoracic Surgery. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06493877 currently recruiting?
Yes, NCT06493877 is actively recruiting participants. Contact the research team at teresa.fernandez@universidadeuropea.es for enrollment information.
Where is the NCT06493877 trial being conducted?
This trial is being conducted at Madrid, Spain.
Who is sponsoring the NCT06493877 clinical trial?
NCT06493877 is sponsored by Universidad Europea de Madrid. The principal investigator is Teresa Fernandez Pardo, Msc at Universidad Europea de Madrid. The trial plans to enroll 57 participants.