Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Diaphragmatic Electrostimulation Using KOTS Currents | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Forced Expiratory Volume in One Second | 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 3 weeks |
| Peak Expiratory Flow |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sara Perpiña-Martinez | Contact | (+34) 910053661 | sperpinama@upsa.es |
| Name | Affiliation | Role |
|---|---|---|
| Sara Perpiña-Martínez | Pontifical University of Salamanca | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clínica Universitaria Salus Infirmorum, Universidad Pontificia de Salamanca | Madrid | Madrid | 28015 | Spain |
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D000094024 | Post-Acute COVID-19 Syndrome |
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
Not provided
Not provided
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.
Not provided
Not provided
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.
|
|
| Diaphragmatic Breathing Exercises | Behavioral | 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. |
|
|
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 3 weeks |
| FEV1/FVC Ratio | 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 3 weeks |
| Basal Oxygen Saturation | 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 3 weeks |
| Physical Function | 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 3 weeks |
| Dyspnea | 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 3 weeks |
| Quality of Life with SF-36 questionnaire | 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 3 weeks |
| Fatigue | Fatigue will be assessed using the DePaul Symptom Questionnaire. Higher scores indicate greater fatigue. | Baseline and 3 weeks |
| D007239 |
| Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D000094025 | Post-Infectious Disorders |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |