Respiratory Rehabilitation Based on Eccentric Exercice on Treadmill After Thoracic Surgery
NCT Number: NCT06493877
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Thoracic Surgery|Breathing|Muscle
Interventions: OTHER: Retraining program after thoracic surgery
Sponsor: Universidad Europea de Madrid
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 57
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-09
Completion Date: 2027-09
Locations: Hospital Universitario Ramon y Cajal, Madrid, 28034, Spain

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

Primary Outcome Measures: Rectus femoral thickness, The dominant quadriceps (defined by the leg that is usually used to climb stairs or kick a ball) is measured, with the patient's starting position being supine with the knee completely extended and relaxed. While previous studies suggested a minimum of 30 minutes of rest before performing the ultrasound, more recent studies indicate that 5 minutes after adopting the supine position, measurements normalize. There is no consensus on the measurement point, but it is proposed to place the probe at the midpoint of the muscle length (50% rule), taking the greater trochanter and proximal edge of the patella as reference. It is also advisable to place the probe midway between the medial and lateral edges of the muscle. Once the placement point of the probe has been determined, it is placed as perpendicular as possible to the skin using a generous amount of transducer gel and exerting the minimum possible pressure to avoid compression of the dermal surface and muscle distortion., Baseline, 3 weeks, 2 months|Diaphragmatic excursion, A convex probe of 2.5 to 3.5 MHz is used. In obese subjects, to have better visibility, the frequency chosen is 1.5 MHz.

The subjects are in a supine position, with the head of the stretcher flat and their legs bent at 30-45º. The probe is positioned firmly below the right costal arch and on the line drawn corresponding to the middle of the clavicle, orienting it cranially. At that point, the dome of the right hemidiaphragm is visualized, appearing as a thick hyperechoic line. The highest diaphragmatic position is sought, which is the part of the diaphragm that produces the most craniocaudal excursion, and the transducer is kept firmly in position during the phases of the respiratory cycle and measurements of tidal volume breathing. The M mode modality is then activated, which provides us with the diaphragmatic movement pattern, placing the M beam line around 30º in the posterior part of the cranio-caudal midline: cranio-caudal diaphragmatic excursions., Baseline, 3 weeks, 2 months|Diaphragm thickness, The measurement of the thickness of the diaphragm is taken in the right hemidiaphragm since it is more accessible than the left through its hepatic window. To evaluate the thickness, a linear probe at 10-12MHz is used, placing it perpendicular to the intercostal space between the 9th and 10th rib, in the anterior part of the axillary line. At this level, 3 parallel layers with different echogenicity are observed corresponding to the pleura, the diaphragm and the peritoneum. The measurement is carried out with M mode, where the image is frozen in an unforced expiration (representing the functional residual capacity) and in a maximum inspiration. The distance between the inner edge of the pleural line and the inner edge of the peritoneal line is measured. The measurement is carried out three times and the average of the three is taken., Baseline, 3 weeks, 2 months|6MWT, In this test, the patient is asked to walk the maximum possible distance along a minimally traveled 30-meter corridor for a period of 6 minutes following a standardized protocol. The primary outcome will be the distance walked in 6 minutes measured in meters, with several reference equations that allow normality values to be calculated. It is essential to follow a standardized 6MWT methodology to obtain reproducible and reliable results, which is why the indications of the SEPAR Manual of Procedures are followed., Baseline, 3 weeks, 2 months|Perceived effort, It is measured through the Borg scale, which consists of a vertical scale from 0-10 that relates the perceived effort when making physical effort with a numerical value that ranges from 0 (minimal effort) to 10 (extreme effort)., Baseline, 3 weeks, 2 months|Measurement of maximum respiratory pressures (MIP and PEM)., The pressure gauge we use is the RP Check. To measure PEM, the patient must insert the mouthpiece into his or her mouth, with the bite blocks between the teeth; You should inhale as much air as possible until you completely fill your lungs (to full lung capacity) and then exhale as hard as possible and for as long as possible (1.5 seconds minimum). To measure PIM, the patient must insert the mouthpiece into his mouth, exhale as much air as possible to empty his lungs until reaching the residual volume, and then inhale with as much effort as possible and for as long as possible (minimum 1.5 seconds). We perform three consecutive measurements of each one, allowing the patient to rest one minute between each one, and we note the best result., Baseline, 3 weeks, 2 months|Functional capacity, Through the 30-second sit to stand test. We previously measured basal oxygen saturation and heart rate; The patient performs the test with his arms crossed over his chest; We time 30 seconds and write down the result. Next, we measure the saturation of oxygen and heart rate., Baseline, 3 weeks, 2 months|Grip strength measurement in both hands, With the Hand Grip Dynamometer Kern Map Version 1.2 dynamometer, taking into account the dominant hand and possible injuries to the upper limbs that may interfere with the test result., Baseline, 3 weeks, 2 months|Spirometric assessment of FEV1, We performed three consecutive measurements with the Vitalograph copd-6™. You need to enter your age, height and gender. The patient must inhale completely, hold the breath, gently bite the mouthpiece and then blow as hard as they can for 6 seconds, allowing them to rest for a minute between each one and we will record the best result., Baseline, 3 weeks, 2 months|Life quality, SF-12 Health Questionnaire, Baseline, 3 weeks, 2 months