Respiratory Rehabilitation Based on Eccentric Exercice on Treadmill After Thoracic Surgery

NCT ID: NCT06493877

Last Updated: 2024-07-11

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 57 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-30
• Study Completion Date: 2027-09-30

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

Conditions

Thoracic Surgery; Breathing; Muscle

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Aerobic exercice on a treadmill with a negative slope

The aerobic exercise will be developed in interval mode, on a treadmill with a negative slope of up to -6% for the intervention group, performing a 2-minute interval with the workload estimated in METS, followed by another 4-minute interval with half the work intensity. It will last between 20 and 30 minutes. The intensity or workload will be individualized (between low and medium), according to the functional status of each participant and will be gradually increased depending on their tolerance. The working heart rate will be between 60% and 80% of the theoretical maximum HR, the oxygen saturation. It should never go below 90% and the subjective perception of effort according to the modified Borg scale will have its objective between 4 and 6 maximum. The treadmill used is the Commercial X22i model from Nordictrack, with a maximum slope of -6º.

Group Type: EXPERIMENTAL

Retraining program after thoracic surgery

Intervention Type: OTHER

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 repetitions of each one. It will begin with a warm-up and then a cool down with stretching. We will apply respiratory physiotherapy techniques to promote ventilation and drainage of secretions.

Next, the aerobic work is carried out according to the assigned group: treadmill with a positive slope (experimental group), treadmill with a negative slope (control 1) or cycle ergometer (group 2).

Aerobic exercice on a treadmill with a positive slope

The aerobic exercise will be carried out in interval mode, on a treadmill with a positive slope, performing a 2-minute interval with the workload estimated in METS, followed by another 4-minute interval with half the work intensity. It will last between 20 and 30 minutes. The intensity or workload will be individualized (between low and medium), according to the functional status of each participant and will be gradually increased depending on their tolerance. The working heart rate will be between 60% and 80% of the theoretical maximum HR, the oxygen saturation It should never go below 90% and the subjective perception of effort according to the modified Borg scale will have its objective between 4 and 6 maximum. The treadmill used is the Commercial X22i model from Nordictrack, with a maximum slope of 40º

Group Type: ACTIVE_COMPARATOR

Retraining program after thoracic surgery

Intervention Type: OTHER

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 repetitions of each one. It will begin with a warm-up and then a cool down with stretching. We will apply respiratory physiotherapy techniques to promote ventilation and drainage of secretions.

Next, the aerobic work is carried out according to the assigned group: treadmill with a positive slope (experimental group), treadmill with a negative slope (control 1) or cycle ergometer (group 2).

Aerobic exercice on a cycle ergometer

The aerobic exercise will be carried out in interval mode, on a cycle ergometer, performing a 2-minute interval with the estimated workload in watts, followed by another 4-minute interval with half the work intensity. It will last between 20 and 30 minutes. The intensity or workload will be individualized (between low and medium), according to the functional status of each patient and will be gradually increased depending on her tolerance. The working heart rate will be between 60% and 80% of the theoretical maximum HR, the oxygen saturation should never drop below 90% and the subjective perception of effort according to the modified Borg scale will have its objective between 4 and 6. maximum.

Group Type: ACTIVE_COMPARATOR

Retraining program after thoracic surgery

Intervention Type: OTHER

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 repetitions of each one. It will begin with a warm-up and then a cool down with stretching. We will apply respiratory physiotherapy techniques to promote ventilation and drainage of secretions.

Next, the aerobic work is carried out according to the assigned group: treadmill with a positive slope (experimental group), treadmill with a negative slope (control 1) or cycle ergometer (group 2).

Interventions

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 repetitions of each one. It will begin with a warm-up and then a cool down with stretching. We will apply respiratory physiotherapy techniques to promote ventilation and drainage of secretions.

Next, the aerobic work is carried out according to the assigned group: treadmill with a positive slope (experimental group), treadmill with a negative slope (control 1) or cycle ergometer (group 2).

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universidad Europea de Madrid

OTHER

Sponsor Role: lead

Responsible Party

Teresa Fernandez Pardo

Msc

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Teresa Fernandez Pardo, Msc

Role: STUDY_DIRECTOR

Universidad Europea de Madrid

Locations

Hospital Universitario Ramon y Cajal

Madrid, , Spain

Site Status: RECRUITING

Countries

Spain

Central Contacts

Teresa Fernandez-Pardo

Role: CONTACT

teresa.fernandez@universidadeuropea.es

00.34 913 36 80 00

Facility Contacts

Teresa Fernandez Pardo, Msc

Role: primary

teresa.fernandez@universidadeuropea.es

0034 913 36 80 00

Other Identifiers

082/24

Identifier Type: -

Identifier Source: org_study_id