Coronavirus 2019 disease can cause important sequelae in the patient, being one of themain affectations of the respiratory system due to bilateral pneumonia and frequentlypresenting 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) vscontrol group (CG) with health education in people with sequelae of COVID-19 onrespiratory 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.
Device: Pulsed ectromagnetid field therapy
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.
Other: Pulmonary rehabilitation program (PRP)
This type of physiotherapy program includes: respiratory muscle training, coughing
exercises, diaphragmatic training, aerobic training and strength training.
Inclusion Criteria:
- People between 45 and 65 years old who have overcome COVID-19 and continue with
sequelae (fatigue, dyspnea and/or muscle pain) two months after overcoming the
illness.
- People with limiting dyspnea of less than grade 2 according to the modified Medical
Research Council (mMRC) scale.
- People with diagnostic criteria for COVID-19 according to regulations SEPAR and meet
the criteria defined in said regulations for care medical and nursing in a
specialized unit (susceptible etiology of specific treatment, who suffered
mild-moderate infection and/or repeated exacerbations).
Exclusion Criteria:
- Pregnant people.
- People with pacemakers.
- People who present bleeding.
- People with tumor problems.
- Traumatological, neurological or cardiovascular diseases that prevent patients from
performing the training.
- People who present glaucoma, retinal detachment and/or recent cataract surgery.
- People with psychiatric or behavioral disorders condition collaboration with the
program.
Rocío Martín-Valero
Málaga, Spain
Investigator: Rocío Martín Valero, PhD
Contact: 34 951 95 28 58
rovalemas@uma.es
Investigator: Rocío Martín-Valero, PhD
Rocío Martín-Valero, PhD
34 951 952 858
rovalemas@uma.es
Rocío Martín-Valero, PhD, Study Director
University of Malaga