Long COVID Syndrome, Post-Acute COVID-19 Syndrome
Conditions
Keywords
Diaphragmatic Breathing, KOTS Currents, Russian Currents, Diaphragmatic Electrostimulation, Quality of Life, Respiratory Rehabilitation, Spirometry
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.
Detailed description
Long COVID is a multifactorial condition that may be associated with persistent respiratory symptoms, reduced physical capacity, fatigue, dyspnea, and impaired quality of life. Respiratory rehabilitation strategies may contribute to improving breathing patterns and functional recovery in this population. Diaphragmatic breathing exercises are commonly used to promote respiratory control and diaphragmatic activation. In addition, KOTS currents, also known as Russian currents, are medium-frequency alternating currents used in physiotherapy to elicit muscle contraction and may be applied as a complementary strategy to stimulate the diaphragm. This pilot randomized controlled trial will compare diaphragmatic breathing exercises alone with diaphragmatic breathing exercises combined with diaphragmatic electrostimulation using KOTS currents in patients diagnosed with Long COVID. Participants will be randomly allocated to either the control group or the intervention group. Both groups will receive a three-week intervention consisting of two sessions per week. The control group will perform diaphragmatic breathing exercises, whereas the intervention group will perform the same breathing exercises combined with diaphragmatic electrostimulation. Assessments will be conducted before and after the intervention period. The study is intended to explore whether adding diaphragmatic electrostimulation to a respiratory exercise program may provide additional benefits compared with diaphragmatic breathing exercises alone in this population.
Interventions
DEVICEDiaphragmatic 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.
BEHAVIORALDiaphragmatic 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.
Sponsors
Universidad Pontificia de Salamanca
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
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.
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Forced Vital Capacity | Baseline and 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Forced Expiratory Volume in One Second | Baseline and 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. |
| Peak Expiratory Flow | Baseline and 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. |
| FEV1/FVC Ratio | Baseline and 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. |
| Basal Oxygen Saturation | Baseline and 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 |
| Physical Function | Baseline and 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 |
| Dyspnea | Baseline and 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. |
| Quality of Life with SF-36 questionnaire | Baseline and 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. |
| Fatigue | Baseline and 3 weeks | Fatigue will be assessed using the DePaul Symptom Questionnaire. Higher scores indicate greater fatigue. |
Countries
Spain
Contacts
CONTACTSara Perpiña-Martinez
PRINCIPAL_INVESTIGATORSara Perpiña-Martínez
Pontifical University of Salamanca
Outcome results
None listed