Clinical trial NCT05379517: Pulmonary Rehabilitation Program With Pulsed Electromagnetic Field Therapy in Patients With Post-covid Sequelae.
Official title: Effects of a Pulmonary Rehabilitation Program (PRP) Versus PRP Plus Pulsed Electromagnetic Field Therapy in Patients With Post-covid Sequelae: A Randomized Clinical Trial Project
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: COVID-19
Keywords: Covid-19
Pulmonary rehabilitation program
Respiratory rehabilitation
Pulmonary function
Exercise capacity
Pulsed electromagnetic field therapy
Lead sponsor: University of Malaga
Sponsor class: OTHER
First posted: 2022-05-18
Enrollment: 33
Sex: ALL
Minimum age (years): 45
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Changes in Forced expiratory volume in the first second of expiration (FEV₁).
timeFrame: Baseline, 8 weeks, 16 weeks.
measure: Changes in Forced vital capacity (FVC).
timeFrame: Baseline, 8 weeks, 16 weeks.
measure: Changes in FEV₁ / FVC index.
timeFrame: Baseline, 8 weeks, 16 weeks.
Secondary outcomes:
measure: Changes in Maximal inspiratory pressures (MIP) and maximal expiratory pressures (MEP)
timeFrame: Baseline, 8 weeks, 16 weeks.
Other outcomes:
measure: Changes in Body composition
timeFrame: Baseline, 8 weeks, 16 weeks.
measure: Changes in The Short Performance Physical Battery (SPPB)
timeFrame: Baseline, 8 weeks, 16 weeks.
measure: Changes in The six meter walking test (6-MWT)
timeFrame: Baseline, 8 weeks, 16 weeks.
measure: Changes in Fatigue (Fatigue assessment scale FAS)
timeFrame: Baseline, 8 weeks, 16 weeks.
measure: Changes in The 36 items Quality of Life Questionnaire
timeFrame: Baseline, 8 weeks, 16 weeks.
measure: Changes in Perception of dyspnea, Medical Research Council (mMRC)
timeFrame: Baseline, through study completion, 16 weeks.
measure: Changes in Pain, Visual Analogic Scale (VAS)
timeFrame: Baseline, through study completion, 16 weeks.
Locations:
city: Málaga
country: Spain
facility: Rocío Martín-Valero
Study officials:
affiliation: University of Malaga
name: Rocío Martín-Valero, PhD
role: STUDY_DIRECTOR
References: