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This study aims to investigate the effects of core stabilization exercises and functional inspiratory muscle training (IMT) on various physiological and psychological parameters in individuals with post-COVID-19 syndrome. Participants diagnosed with post-COVID-19 syndrome will be randomly assigned to two groups using stratified computer-assisted randomization. One group will undergo an 8-week core stabilization training, while the other will receive combined core stabilization and IMT training. Exercise training will be conducted three times a week, with each session lasting 50 minutes.
Comprehensive pre- and post-intervention assessments will be conducted, including exercise capacity, respiratory and peripheral muscle strength, trunk endurance, balance, anxiety, depression, and fatigue levels. The primary outcome measures are respiratory muscle strength and trunk endurance.
Participants must be aged 18-65 years, have at least a primary education level, speak Turkish, and be classified as level 2-3 on the Post-COVID-19 Functional Status Scale (PCFS). Eligible participants will be referred by the Internal Medicine Department at Hacettepe University.
The study will utilize various assessment tools, including maximal inspiratory/expiratory pressure (MIP/MEP) tests, Functional Movement Screen (FMS), plank and Sorenson endurance tests, the Timed Up and Go Test for balance, handgrip and knee extension strength tests, body composition analysis, and the SF-36 quality of life questionnaire.
This study aims to investigate the effects of core stabilization programs supported by core stabilization exercises and functional inspiratory muscle training (IMT) on various physiological and psychological parameters in individuals with post-COVID-19 syndrome.
Participants to be included in the study will consist of individuals diagnosed with post-COVID syndrome and will be divided into two groups with a computer-aided stratified randomization method.
After the patients are randomly separated, one group will receive 8 weeks of core stabilization training and the other group will receive functional IMT (IMT combined with core stabilization) training. The exercise program is designed to last 8 weeks in total, and the training program for both groups will be carried out on certain days (3 days) per week, and each session will last 50 minutes.
A comprehensive assessment will be applied to both groups at the beginning and end of the study. These assessments are; exercise capacity, respiratory muscle strength, peripheral muscle strength, trunk muscle endurance, balance, anxiety and depression levels, and fatigue level parameters. The primary outcome measure of the study will be respiratory muscle strength and trunk muscle endurance.
Individuals who meet the inclusion criteria will be included in the study. The study will be conducted with individuals between the ages of 18-65, with at least primary school education, and whose local language is Turkish. Participants diagnosed with Post-COVID-19 Syndrome and who are in class 2-3 according to the Post-COVID-19 Functional Status Scale (PCFS) will be included in the study. Participants who are eligible for the study will be directed to the Cardiopulmonary Rehabilitation Unit of the Hacettepe University Faculty of Physical Therapy and Rehabilitation by the relevant physicians of the Department of General Internal Medicine of the Hacettepe University Department of Internal Medicine.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Core Stabilization Group | Active Comparator | Participants will receive an 12-week core stabilization exercise program only. |
|
| Functional IMT Group | Experimental | Participants will receive an 12-weeks core stabilization exercise program plus functional inspiratory muscle training (IMT). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Core Stabilization | Other | 12-week supervised core stabilization training, 3 sessions per week, 45 minutes per session. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Respiratory muscle strength | Maximal inspiratory pressure (MIP) and maximal expiratory pressure (MEP) with mouth-pressure device | Baseline and after 12 weeks of intervention. |
| Plank Endurance Test | Plank Test: Plank time is a common test to evaluate core stability. The patient is given a plank position and the maximum endurance time they can hold this position is measured. | Baseline and after 12 weeks of intervention. |
| Sorenson Endurance Test | Sorenson Test (Extensor Endurance Test): In this test, the person lies horizontally on the end of a table and is asked to keep their body in a fixed position outside the table. The endurance time in this position is evaluated to measure core stability. | Baseline and after 12 weeks of intervention. |
| Side Bridge Endurance Test | Side Bridge Test: It is an endurance test based on time in the side plank position. The difference between the times on the right and left sides can provide information about core stabilization. | Baseline and after 12 weeks of intervention. |
| Measure | Description | Time Frame |
|---|---|---|
| Health Status | The Short-Form-36 is a quality of life questionnaire consisting of 11 sections and 36 questions in total. The minimum and maximum scores range between 0 and 100. Higher score indicate a more favorable health status. | Baseline and after 12 weeks of intervention. |
| Fatigue Perception |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ebru Calik, PhD | Contact | +905442850087 | ecalik85@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| EBRU CALIK, Professor | Hacettepe University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hacettepe University | Recruiting | Ankara | Çankaya | 06100 | Turkey (Türkiye) |
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| ID | Term |
|---|---|
| D000094024 | Post-Acute COVID-19 Syndrome |
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
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The study includes two groups: one group performing core stabilization exercises and the other performing both core stabilization and functional inspiratory muscle training.
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| Functional Inspiratory Muscle Training (IMT) | Other | IMT using a portable inspiratory muscle training device at 60% MIP, progressively increased over 12 weeks. |
|
Fatigue Severity Scale consists of 9 questions that indicate severity of fatigue in daily life. The total score 4 and more indicate the presence of severe fatigue and ranges between 0-7. |
| Baseline and after 12 weeks of intervention. |
| Dynamic respiratory muscle strength | In the dynamic method, respiratory muscle strength index (S index) and peak inspiratory flow rate (PIF) will be assessed using the portable POWERbreathe K5 device (PowerBreathe K5, HaB International Ltd, Warwickshire, England). | Baseline and after 12 weeks of intervention. |
| Exercise motivation | Patients' exercise motivation levels and attitudes will be assessed with the Exercise Motivation Attitude Questionnaire. The Exercise Motivation Attitude Scale consists of 20 items and three subscales. The total score that can be obtained from the scale ranges from 20 to 140 (minimum 20, maximum 140). The score varies depending on the number of items in the subscales. Higher scores indicate better exercise motivation | Baseline and after 12 weeks of intervention. |
| Patient satisfaction and improvement | Global Rating of Change Scale will be used for patient satisfaction and to quantify a patient's improvement or deterioration over time to determine the effect of training. Minimally clinically important change is 2 points on 11 point scale. | Baseline and after 12 weeks of intervention. |
| 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 |