Coronavirus 2019 disease can cause important sequelae in the patient, being one of the main affectations of the respiratory system due to bilateral pneumonia and frequently presenting loss of strength, dyspnea, polyneuropathies and multi-organ involvement. Respiratory muscle dysfunction It is one of the most frequent sequelae of this disease. The aim of this study it to assess the effect of pulmonary rehabilitation program (PRP) for 8 weeks vs PRP supplemented with pulsed electromagnetic field therapy (PEFT) vs control group (CG) with health education in people with sequelae of COVID-19 on respiratory capacity and clinical response.
Methods: a single-blind, randomized clinical trial of parallel groups and three branches is presented. Participants will be randomly assigned to the three groups. Thrity-three participants will be randomized assigned either will receive (n=11) PR for 60 minutes, vs (n=11) PR plus PEFT vs (n=11) CG with health education program. Both groups will receive a three times-weekly 60 min exercise program for 8 weeks. Exercise training will be structured in three stages. Exercise will start with a warm-up period (4 minutes); followed by the core phase of aerobic exercises (15-18 minutes), upper and lower limb strength (9 minutes), exercises of the respiratory muscles with diaphragmatic breaths with retentions (10 minutes) and the final cooling-stretching (4 minutes) for a total 45 min, coupled with 15 minutes of breathing retraining with the Threshold Inspiratory Muscle Training® (IMT) device (Philips Respironics). Respiratory muscle training will start at 10% of the initial MIP achieved at startup and will increase by 5% every two weeks until reaching 20% of the initial MIP. The intensity of the exercise training will be at 60-75% of the maximum heart rate rate achieved in the exercise capacity test. The last group will receive PRP for 8 weeks supplemented with pulsed electromagnetic field therapy (PEFT) three times-weekly 10 min for 5 weeks. Frequency and intensity will be adjusted depending on the perception subjective of the patients. Before and after the intervention and two months later, the effects on respiratory capacity (spirometry), clinical response, symptoms (pain and dyspnea), respiratory muscle strength, respiratory symptoms, anthropometric, exercise capacity, fatigue, pain will be assessed and quality of life in people with sequelae of COVID-19.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
33
Pulsed electromagnetic field therapy is an innovative therapy. The technology is based on a high intensity electromagnetic field, which positively influences human tissue. It is a form of non-invasive treatment, with good tolerance by patients. High-intensity electromagnetic fields excite neural and muscle cells, which stimulates the human body.
This type of physiotherapy program includes: respiratory muscle training, coughing exercises, diaphragmatic training, aerobic training and strength training.
Rocío Martín-Valero
Málaga, Spain
Changes in Forced expiratory volume in the first second of expiration (FEV₁).
Pulmonary function test will be performed using the spirometry equipment Spiro USB MicroMedical® model according to the Guidelines of American Thoracic Society and the European Respiratory Society. Forced expiratory volume in the first second of expiration (FEV₁): volume of air expired during the first second of forced expiration after maximum inspiration. The normal value is ≥ 80%.
Time frame: Baseline, 8 weeks, 16 weeks.
Changes in Forced vital capacity (FVC).
Pulmonary function test will be performed using the spirometry equipment Spiro USB MicroMedical® model according to the Guidelines of American Thoracic Society and the European Respiratory Society. Forced vital capacity (FVC): It is expressed as a volume (in ml) and is considered normal when it is greater than 80% of its theoretical value.
Time frame: Baseline, 8 weeks, 16 weeks.
Changes in FEV₁ / FVC index.
Pulmonary function test will be performed using the spirometry equipment Spiro USB MicroMedical® model according to the Guidelines of American Thoracic Society and the European Respiratory Society. FEV₁ / FVC index: it is the proportion of the forced vital capacity that an individual exhales in the first second of forced expiration. It must be greater than 75%, although values of up to 70% are accepted.
Time frame: Baseline, 8 weeks, 16 weeks.
Changes in Maximal inspiratory pressures (MIP) and maximal expiratory pressures (MEP)
Change in respiratoy muscle function strength will be measured with the MicroRPM® model meter with the participant in sitting. Respiratory pressures will be measured maximum statics following SEPAR recommendations.
Time frame: Baseline, 8 weeks, 16 weeks.
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