Diaphragmatic Breathing Exercises With KOTS Currents in Patients With Long COVID
KOTS-LC
Effects of Diaphragmatic Breathing Exercises Combined With Diaphragmatic Electrostimulation Using KOTS Currents in Patients With Long COVID: A Pilot Randomized Controlled Trial
1 other identifier
interventional
10
1 country
1
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jun 2026
Shorter than P25 for not_applicable
1 active site
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
CompletedStudy Start
First participant enrolled
June 1, 2026
CompletedFirst Posted
Study publicly available on registry
June 2, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2026
CompletedJune 4, 2026
June 1, 2026
1 month
May 27, 2026
June 2, 2026
Conditions
Keywords
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
EXPERIMENTALParticipants 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.
Diaphragmatic Breathing Exercises
ACTIVE COMPARATORParticipants 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.
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.
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.
Eligibility Criteria
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
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sara Perpiña-Martínez
Pontifical University of Salamanca
Central Study Contacts
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
- 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.