COVID-19NCT05379517
Pulmonary Rehabilitation Program With Pulsed Electromagnetic Field Therapy in Patients With Post-covid Sequelae.
A study testing Pulsed ectromagnetid field therapy and Pulmonary rehabilitation program (PRP) in people with COVID-19, run by University of Malaga at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 to 65 years
- Conditions the study is for
- COVID-19
- What is being tested?
- Pulsed ectromagnetid field therapy and Pulmonary rehabilitation program (PRP)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteSpain
- Study dates
- 15 Sep 2022to 30 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Rocío Martín-Valero
Málaga
Rocío Martín Valero, PhD, 34 951 95 28 58, rovalemas@uma.es
Rocío Martín-Valero, PhD
About this study
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
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.
Read the 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.
- Conditions
- COVID-19
- Being tested
- Pulsed ectromagnetid field therapy, Pulmonary rehabilitation program (PRP)
- Keywords
- Covid-19, Pulmonary rehabilitation program, Respiratory rehabilitation, Pulmonary function, Exercise capacity, Pulsed electromagnetic field therapy
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulsed ectromagnetid field therapyDevice
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.
Pulmonary rehabilitation program (PRP)Other
This type of physiotherapy program includes: respiratory muscle training, coughing exercises, diaphragmatic training, aerobic training and strength training.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Pulsed ectromagnetid field therapy; Other: Pulmonary rehabilitation program (PRP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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%.
Measured: 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.
Measured: 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.
Measured: Baseline, 8 weeks, 16 weeks.
Secondary outcomes (1)
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.
Measured: Baseline, 8 weeks, 16 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2022
- Study start15 Sep 2022 (estimated)
- Primary completion30 Nov 2022 (estimated)
- Study completion30 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 33 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Malaga
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rocío Martín Valero, University of Malaga
- Investigators
- Rocío Martín-Valero, PhD, Study director, University of Malaga
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05379517
- Sponsor's protocol ID
- UMA_RP COVID_2022
- Status last verified
- May 2022
- First submitted
- 11 May 2022
- Last updated
- 18 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05379517
- Acronym / sponsor ID
- UMA_RP COVID_2022
- Conditions
- COVID-19
- Keywords
- Covid-19, Pulmonary rehabilitation program, Respiratory rehabilitation, Pulmonary function, Exercise capacity, Pulsed electromagnetic field therapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 33 participants (estimated)
- Lead sponsor
- University of MalagaUniversity, hospital or other
- Study start
- 15 Sep 2022 (estimated)
- Primary completion
- 30 Nov 2022 (estimated)
- Study completion
- 30 Dec 2022 (estimated)
- First posted
- 18 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 | Other: Pulmonary rehabilitation program (PRP)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. |
| Experimental group 2 | Experimental | Device: Pulsed ectromagnetid field therapy, Other: Pulmonary rehabilitation program (PRP)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. |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pulsed ectromagnetid field therapyPulsed 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. | Device | Experimental group 2 |
| Pulmonary rehabilitation program (PRP)This type of physiotherapy program includes: respiratory muscle training, coughing exercises, diaphragmatic training, aerobic training and strength training. | Other | Experimental group 1, Experimental group 2 |
Primary outcome
Changes in Forced expiratory volume in the first second of expiration (FEV₁).
Time frame: Baseline, 8 weeks, 16 weeks.
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%.
Changes in Forced vital capacity (FVC).
Time frame: Baseline, 8 weeks, 16 weeks.
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.
Changes in FEV₁ / FVC index.
Time frame: Baseline, 8 weeks, 16 weeks.
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.
1 secondary outcome
Changes in Maximal inspiratory pressures (MIP) and maximal expiratory pressures (MEP)
Time frame: Baseline, 8 weeks, 16 weeks.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rocío Martín-Valero, PhD study director
University of Malaga
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pulsed ectromagnetid field therapy and Pulmonary rehabilitation program (PRP) in people with COVID-19, run by University of Malaga at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rocío Martín-Valero, PhD (34 951 952 858, rovalemas@uma.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Forced expiratory volume in the first second of expiration (FEV₁). (time frame: Baseline, 8 weeks, 16 weeks.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2022.