Pulmonary Rehabilitation Program With Pulsed Electromagnetic Field Therapy in Patients With Post-covid Sequelae.

NCT05379517 | Unknown

• 1 other identifier: UMA_RP COVID_2022
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

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.

Conditions

COVID-19

Keywords

Covid-19; Pulmonary rehabilitation program; Respiratory rehabilitation; Pulmonary function; Exercise capacity; Pulsed electromagnetic field therapy

Outcome Measures

Primary Outcomes (3)

• 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%.

  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.

  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.

  Baseline, 8 weeks, 16 weeks.

Secondary Outcomes (1)

• Changes in Maximal inspiratory pressures (MIP) and maximal expiratory pressures (MEP)

  Baseline, 8 weeks, 16 weeks.

Other Outcomes (7)

• Changes in Body composition

  Baseline, 8 weeks, 16 weeks.

• Changes in The Short Performance Physical Battery (SPPB)

  Baseline, 8 weeks, 16 weeks.

• Changes in The six meter walking test (6-MWT)

  Baseline, 8 weeks, 16 weeks.

Study Arms (3)

Control Group (CG)

NO INTERVENTION

Patients in the control group will receive a booklet with general information on a health education program where they will be taught global stretching exercises to be performed themselves at least twice a week at home for 20 minutes. In addition, hygienic postural care will be included.

Experimental group 1

EXPERIMENTAL

People will receive a three times-weekly 60 min pulmonary rehabilitation program (PRP) 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.

Other: Pulmonary rehabilitation program (PRP)

Experimental group 2

EXPERIMENTAL

Patients will receive a pulmonary rehabilitation program (PRP) supplemented with pulsed electromagnetic field therapy. The latter will be applied for 5 weeks, a total of 3 sessions per week. The BTL-6000 Super Inductive System (SIS) will be used with the 'focus field' type manual applicator. The parameters will be: intensity of the magnetic field up to 2.5 Tesla (T), the frequency range to achieve the analgesic effect will vary between 10-20 Hz and, finally, an adjustable relative intensity up to 100%, depending on the perception subjective of the patients. Sessions will last 10 minutes. The parameters and procedure of therapy follow the manufacturer's recommendations. The SIS will be applied in the area where the patient presents the highest level of pain.

Device: Pulsed ectromagnetid field therapy; Other: Pulmonary rehabilitation program (PRP)

Interventions

Pulsed ectromagnetid field therapy DEVICE

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.

Experimental group 2

Pulmonary rehabilitation program (PRP) OTHER

This type of physiotherapy program includes: respiratory muscle training, coughing exercises, diaphragmatic training, aerobic training and strength training.

Experimental group 1; Experimental group 2

Eligibility Criteria

• Age: 45 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Malaga: lead

Study Sites (1)

Rocío Martín-Valero

Málaga, Spain

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Rocío Martín-Valero, PhD

  University of Malaga

  STUDY DIRECTOR

Central Study Contacts

Rocío Martín-Valero, PhD

CONTACT

34 951 952 858; rovalemas@uma.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The study is planned as simple blind since the person who performs evaluation is external to participant recruitment and intervention.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 11, 2022
• First Posted: May 18, 2022
• Study Start: September 15, 2022
• Primary Completion: November 30, 2022
• Study Completion: December 30, 2022
• Last Updated: May 18, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)