Radiofrequency in Patients Post Covid 19 With Respiratory Sequelae.

NCT07184372 | Completed

• 1 other identifier: ART-GLB-RF-RESP-COVID
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

Brief Summary

The sequelae that occur in post-COVID-19 patients are multiple and, at a therapeutic level, these represent a new challenge within the general context of the pandemic that the world is suffering. The virus has managed to end thousands of lives today and many other cases are being charged as directly responsible for a multiplicity of multisystem damages that need to be diagnosed and treated. Among the most relevant, are those that can affect to respiratory levels in patients without previous pahologies, and in patients at risk who already had a pathology prior to infection. On the other hand, signs and symptoms have been observed characteristic in the organ systems described above in post-contagion patients, directly associated with sequelae SARV-CoV2. The radiofrequency (RF) of electromagnetic waves represents a technology of proven efficacy and safety in multiple fields of both human and veterinary medicine. These include neurological pathologies, respiratory disease and very especially those that affect the locomotor system. In therapeutics there are different RF modalities depending on the modality, polarity, type of signal and frequency, which in turn translate into different therapeutic profiles, clinical indications, efficacy and safety. Among the RF technologies most used today and that have a greater scientific background, is the one known as Resistive Capacitive Monopolar RadioFrequency at 448 kHz (INDIBA®) (RFMCR). This study aims to assess the efficacy and safety of RFMCR in the treatment of respiratory sequelae in patients presenting this type of pathologies that appear after contagion by COVID-19. Through this non-invasive technique, the investigators want to show that RF can help the physical rehabilitation of these patients through metabolic stimulation, increased vascularization and oxygenation of directly affected tissues, effects of deep hyperthermia generated by the interaction of the current with the treated biological substrate, as well as the activationof tissue regeneration, the result of subthermal action. It is thus intended to improve signs such as lung capacity, dyspnea, neuropathies and global muscle capacity, which are essential for the recovery of the post-COVID-19 patients. The hypothesis of this study is that current post-COVID-19 treatments can be significantly improved in order to prevent complications and ensure the patients' well-being.

Conditions

COVID-19; Respiratory Disease; Dyspnea; Cough

Keywords

dyspnea; post covid 19; radiofrequency 448khz; respiratory sequelae; cough

Outcome Measures

Primary Outcomes (1)

• Spirometry

  spirometry tests were performed in the same manner: the patient was seated with their feet flat on the floor and a nose clip was placed on the patient and they were asked to take two normal breaths, and on the third, to take a maximum inhalation and a maximum exhalation. We obteined the following parameters: FVC (Forced Vital Capacity), FEV1 (Forced Expiratory Volume in 1 Second), FVC/FEV1 (Ratio of FVC to volume expired in 1 second), PEF (Peak Expiratory Flow), PEFT (Peak Expiratory Flow Time), FEF50% (Forced expiratory flow at 50% of expiration), FEF25% - FEF75% (Forced expiratory flow between 25% and 75% of expiration), FEF50%/FIF50 (Ratio of forced expiratory flow at 50% of expiration to forced inspiratory flow at 50% of inspiration) and FEV1/FEV0.5 (Ratio of forced expiratory volume in 1 second to forced expiratory volume in the first 0.5 s

  3 months

Secondary Outcomes (3)

• Sadoul Dyspnea Scale

  3 months

• Leiscester Test

  3 months

• Chest measurements

  3 months

Study Arms (3)

Placebo group

PLACEBO COMPARATOR

The radiofrequency is turn off during the treatment

Other: Placebo

Conventional Group

ACTIVE COMPARATOR

Manual tecniques are applied to improve lung capacity

Other: Manual tecniques

Experimental Group

EXPERIMENTAL

Manual tecniques and radiofrequency are applied to improve lung capacity

Other: Radiofrequency and manual tecniques

Interventions

Radiofrequency and manual tecniques OTHER

We apply manual tecniques while we use the radiofrequency, the treatment is divided into 3 phases: * PHASE 1: With the patient in the supine position, treatment was performed along the diaphragm for 10 minutes, of which 5 minutes were spent with the capacitive electrode and the other 5 minutes with the resistive electrode. The plate was placed on the back at the level of the diaphragm. * PHASE 2: The patient was placed in the lateral decubitus position on their right side and 3 minutes were spent with the capacitive electrode and 7 minutes with the resistive electrode. The patient was asked to breathe costal-diaphragmatically throughout the entire duration of the resistive electrode. The plate was placed on the right side, at lung level. * PHASE 3: The same procedure was performed as in the second phase, only this time on the contralateral side, i.e., on the left side.

Experimental Group

Manual tecniques OTHER

Manual techniques are used to increase inspiratory capacity, working on the diaphragm and rib cage to increase their mobility along with breathing exercises.

Conventional Group

Placebo OTHER

The radiofrequency is turn off

Placebo group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• have passed covid 19
• have respiratory sequelae after covid 19 during more than a month
• have dyspnea, cough or fatigue

You may not qualify if:

• be pregnant
• have pacemaker
• have or had passes thrombosis
• have a respiratory disease before covid

Sponsors & Collaborators

• Clinica Gema Leon: lead

Study Sites (1)

Clinica de Fisioterapia Gema Leon

Córdoba, Cordoba, 14012, Spain

Location

MeSH Terms

Conditions

COVID-19; Respiration Disorders; Dyspnea; Cough

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; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Gema León Bravo, Fisioterapia

  Gema León Physiotherapy and Rehabilitation Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Gema León Bravo

Model Details: Longitudinal and experimental

Study Record Dates

• First Submitted: September 17, 2025
• First Posted: September 19, 2025
• Study Start: June 16, 2021
• Primary Completion: June 21, 2022
• Study Completion: July 20, 2022
• Last Updated: September 19, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)