NCT07621588

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 27, 2026

Completed
5 days until next milestone

Study Start

First participant enrolled

June 1, 2026

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 2, 2026

Completed
29 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2026

Completed
Last Updated

June 4, 2026

Status Verified

June 1, 2026

Enrollment Period

1 month

First QC Date

May 27, 2026

Last Update Submit

June 2, 2026

Conditions

Keywords

Diaphragmatic BreathingKOTS CurrentsRussian CurrentsDiaphragmatic ElectrostimulationQuality of LifeRespiratory RehabilitationSpirometry

Outcome Measures

Primary Outcomes (1)

  • Forced Vital Capacity

    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 3 weeks

Secondary Outcomes (8)

  • Forced Expiratory Volume in One Second

    Baseline and 3 weeks

  • Peak Expiratory Flow

    Baseline and 3 weeks

  • FEV1/FVC Ratio

    Baseline and 3 weeks

  • Basal Oxygen Saturation

    Baseline and 3 weeks

  • Physical Function

    Baseline and 3 weeks

  • +3 more secondary outcomes

Study Arms (2)

Diaphragmatic Breathing Exercises Plus KOTS Currents

EXPERIMENTAL

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.

Device: Diaphragmatic Electrostimulation Using KOTS CurrentsBehavioral: Diaphragmatic Breathing Exercises

Diaphragmatic Breathing Exercises

ACTIVE COMPARATOR

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.

Behavioral: Diaphragmatic Breathing Exercises

Interventions

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.

Also known as: KOTS Currents, Russian Currents
Diaphragmatic Breathing Exercises Plus KOTS Currents

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.

Also known as: Diaphragmatic Breathing
Diaphragmatic Breathing ExercisesDiaphragmatic Breathing Exercises Plus KOTS Currents

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clínica Universitaria Salus Infirmorum, Universidad Pontificia de Salamanca

Madrid, Madrid, 28015, Spain

Location

MeSH Terms

Conditions

Post-Acute COVID-19 Syndrome

Condition Hierarchy (Ancestors)

COVID-19Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesPost-Infectious DisordersChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Sara Perpiña-Martínez

    Pontifical University of Salamanca

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sara Perpiña-Martinez

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
The outcomes assessor was masked to group allocation. Participants were assigned to either diaphragmatic breathing exercises alone or diaphragmatic breathing exercises combined with diaphragmatic electrostimulation using KOTS currents.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants will be randomly assigned to one of two parallel groups: diaphragmatic breathing exercises alone or diaphragmatic breathing exercises combined with diaphragmatic electrostimulation using KOTS currents.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator and Professor of Physiotherapy

Study Record Dates

First Submitted

May 27, 2026

First Posted

June 2, 2026

Study Start

June 1, 2026

Primary Completion

July 1, 2026

Study Completion

July 1, 2026

Last Updated

June 4, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

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.

Locations