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Diaphragmatic Breathing Exercises With KOTS Currents in Patients With Long COVID (KOTS-LC)

27 maggio 2026 aggiornato da: Sara Perpiñá, Universidad Pontificia de Salamanca

Effects of Diaphragmatic Breathing Exercises Combined With Diaphragmatic Electrostimulation Using KOTS Currents in Patients With Long COVID: A Pilot Randomized Controlled Trial

This study will evaluate the effects of diaphragmatic breathing exercises combined with diaphragmatic electrostimulation using KOTS currents in patients with Long COVID. Participants will be randomly assigned to one of two groups. The control group will perform diaphragmatic breathing exercises, while the intervention group will perform diaphragmatic breathing exercises combined with diaphragmatic electrostimulation using KOTS currents. The intervention will last three weeks, with two sessions per week. The study will assess respiratory function, quality of life, physical function, dyspnea, fatigue, and basal oxygen saturation.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

Long COVID is a multifactorial condition that may affect respiratory function, physical capacity, fatigue, dyspnea, and quality of life. Respiratory rehabilitation strategies, including diaphragmatic breathing exercises, may help improve breathing patterns and respiratory function in this population. KOTS currents, also known as Russian currents, are medium-frequency alternating currents used in physiotherapy to stimulate muscle contraction. Their application to the diaphragm may be a complementary therapeutic approach in patients with Long COVID.

This study is designed as a pilot randomized controlled trial with two parallel arms. Participants diagnosed with Long COVID will be randomly assigned to a control group or an intervention group. The control group will perform diaphragmatic breathing exercises. The intervention group will perform diaphragmatic breathing exercises combined with diaphragmatic electrostimulation using KOTS currents. The treatment period will last three weeks, with two sessions per week. Assessments will be performed at baseline and after completion of the intervention.

The primary outcome will be forced vital capacity. Secondary outcomes will include forced expiratory volume in one second, peak expiratory flow, the FEV1/FVC ratio, basal oxygen saturation, physical function assessed with the 30-second Sit-to-Stand test, dyspnea assessed with the modified Medical Research Council scale, quality of life assessed with the SF-36 questionnaire, and fatigue assessed with the DePaul Symptom Questionnaire.

Tipo di studio

Interventistico

Iscrizione (Stimato)

10

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

  • Nome: Sara Perpiña-Martinez
  • Numero di telefono: (+34) 910053661
  • Email: sperpinama@upsa.es

Luoghi di studio

  • Spagna
    • Madrid
      • Madrid, Madrid, Spagna, 28015
        • Clínica Universitaria Salus Infirmorum, Universidad Pontificia de Salamanca
        • Contatto:

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

Inclusion Criteria:

  • Men and women aged 18 to 65 years.
  • Medical diagnosis of Long COVID.
  • At least 2 months since SARS-CoV-2 infection.
  • Ability and willingness to provide informed consent.
  • Ability to participate in the assigned intervention and assessment procedures.

Exclusion Criteria:

  • Presence of a pacemaker.
  • History of epilepsy.
  • Pregnancy.
  • History of acute cardiac arrest.
  • Severe respiratory distress.
  • Use of a wheelchair.
  • Blurred vision.
  • Cyanosis.
  • Refusal to perform part or all of the treatment.
  • Incomplete or incorrectly completed questionnaires.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Separare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Diaphragmatic Breathing Exercises Plus KOTS Currents
Participants assigned to this arm will perform diaphragmatic breathing exercises combined with diaphragmatic electrostimulation using KOTS currents. The intervention will be delivered twice per week for three weeks. KOTS currents will be applied as medium-frequency alternating current stimulation, with stimulation intensity adjusted according to participant tolerance.
Dispositivo: Diaphragmatic Electrostimulation Using KOTS Currents
Diaphragmatic electrostimulation will be applied using KOTS currents, a medium-frequency alternating current stimulation. Electrodes will be placed over the seventh and eighth rib region along the mammillary line. Stimulation will be delivered in trains of 4 seconds of stimulation followed by 8 seconds of rest, with a carrier frequency of 2,500 Hz. The standard treatment duration will be 15 minutes: 10 minutes at 30 Hz followed by 5 minutes at 70 Hz. Stimulation intensity will be adjusted according to participant tolerance. The intervention will be delivered twice per week for three weeks, together with diaphragmatic breathing exercises.
Altri nomi:
  • KOTS Currents
  • Russian Currents
Comportamentale: Diaphragmatic Breathing Exercises
Participants will perform diaphragmatic breathing exercises in a supine position with the knees flexed. One hand will be placed on the chest and the other hand below the sternum. Participants will be instructed to inhale through the nose while expanding the abdomen with minimal thoracic movement, and to exhale slowly through pursed lips. The breathing pattern will include a 4-second inspiration and a 6-second expiration. Exercises will be performed twice per week for three weeks.
Altri nomi:
  • Respirazione diaframmatica
Comparatore attivo: Diaphragmatic Breathing Exercises
Participants assigned to this arm will perform diaphragmatic breathing exercises twice per week for three weeks. Exercises will be performed in a supine position, with slow nasal inspiration and abdominal expansion followed by slow exhalation through pursed lips.
Comportamentale: Diaphragmatic Breathing Exercises
Participants will perform diaphragmatic breathing exercises in a supine position with the knees flexed. One hand will be placed on the chest and the other hand below the sternum. Participants will be instructed to inhale through the nose while expanding the abdomen with minimal thoracic movement, and to exhale slowly through pursed lips. The breathing pattern will include a 4-second inspiration and a 6-second expiration. Exercises will be performed twice per week for three weeks.
Altri nomi:
  • Respirazione diaframmatica

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Forced Vital Capacity
Lasso di tempo: Baseline and after 3 weeks
Forced vital capacity will be assessed using spirometry. The outcome will evaluate the change in forced vital capacity from baseline to after the three-week intervention.
Baseline and after 3 weeks

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Forced Expiratory Volume in One Second
Lasso di tempo: Baseline and after 3 weeks
Forced expiratory volume in one second will be assessed using spirometry. The outcome will evaluate the change in FEV1 from baseline to after the three-week intervention.
Baseline and after 3 weeks
Peak Expiratory Flow
Lasso di tempo: Baseline and after 3 weeks
Peak expiratory flow will be assessed using spirometry. The outcome will evaluate the change in PEF from baseline to after the three-week intervention.
Baseline and after 3 weeks
FEV1/FVC Ratio
Lasso di tempo: Baseline and after 3 weeks
The FEV1/FVC ratio will be calculated from spirometry measurements. The outcome will evaluate the change in the FEV1/FVC ratio from baseline to after the three-week intervention.
Baseline and after 3 weeks
Basal Oxygen Saturation
Lasso di tempo: Baseline and after 3 weeks
Basal oxygen saturation will be measured using a finger pulse oximeter. The outcome will evaluate the change in basal oxygen saturation from baseline to after the three-week intervention
Baseline and after 3 weeks
Physical Function
Lasso di tempo: Baseline and after 3 weeks
Physical function will be assessed using the 30-second Sit-to-Stand test. The outcome will evaluate the change in the number of completed sit-to-stand repetitions from baseline to after the three-week intervention
Baseline and after 3 weeks
Dyspnea
Lasso di tempo: Baseline and after 3 weeks
Dyspnea will be assessed using the modified Medical Research Council scale. The outcome will evaluate the change in perceived dyspnea from baseline to after the three-week intervention. Lower scores indicate lower dyspnea.
Baseline and after 3 weeks
Quality of Life with SF-36 questionnaire
Lasso di tempo: Baseline and after 3 weeks
Quality of life will be assessed using the SF-36 questionnaire. The outcome will evaluate the change in quality-of-life dimensions from baseline to after the three-week intervention. Higher scores indicate better quality of life.
Baseline and after 3 weeks
Fatigue
Lasso di tempo: Baseline and after 3 weeks
Fatigue will be assessed using the DePaul Symptom Questionnaire. Higher scores indicate greater fatigue.
Baseline and after 3 weeks

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Universidad Pontificia de Salamanca

Investigatori

  • Investigatore principale: Sara Perpiña-Martínez, Pontifical University of Salamanca

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

1 giugno 2026

Completamento primario (Stimato)

1 luglio 2026

Completamento dello studio (Stimato)

1 luglio 2026

Date di iscrizione allo studio

Primo inviato

27 maggio 2026

Primo inviato che soddisfa i criteri di controllo qualità

27 maggio 2026

Primo Inserito (Effettivo)

2 giugno 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

2 giugno 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

27 maggio 2026

Ultimo verificato

1 maggio 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • UPSA-KOTS-LC-2025

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Descrizione del piano IPD

Individual participant data will not be shared because the study involves health-related data from a small sample of participants. Data will be pseudonymized and handled in accordance with applicable data protection regulations and the informed consent approved for the study.

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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