Post COVID-19 SyndromeNCT07051954
Effectiveness of Functional Respiratory Muscle Training in Post-COVID-19 Syndrome
A study testing Core Stabilization and Functional Inspiratory Muscle Training (IMT) in people with Post COVID-19 Syndrome and Functional Inspiratory Muscle Training, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Post COVID-19 Syndrome, Functional Inspiratory Muscle Training, Core Stabilization
- What is being tested?
- Core Stabilization and Functional Inspiratory Muscle Training (IMT)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Sep 2025to 30 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed with Post-COVID-19 Syndrome.
- Literate and able to understand study procedures.
- Aged between 18 and 65 years.
- Willing to voluntarily participate in the study.
- Classified as functional class 2-3 according to the Post-COVID-19 Functional Status Scale (PCFS).
- Clinically stable; comorbid conditions such as hypertension or diabetes must be controlled.
- No orthopedic or neurological conditions that would prevent assessment of peripheral muscle strength, balance, or exercise capacity.
Who cannot join
- History of recent myocardial infarction or pulmonary embolism.
- Presence of uncontrolled chronic diseases.
- Any orthopedic or neurological disorders that limit mobility.
- Neurological impairments (e.g., cerebrovascular disease) or psychiatric disorders that impair cooperation or compliance with exercise testing.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Hacettepe University
Ankara, Çankaya, 06100
Melike Sura OKSUZ CAPANOGLU, PT, +90 505 954 52 27, suramelike@gmail.com
About this study
Official title: Investigation of the Effects of Functional Respiratory Muscle Training on Respiratory Muscle Function, Exercise Capacity, Skeletal Muscle Strength, and Muscle Endurance in Individuals With Post-COVID-19 Syndrome
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.
Read more
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.
Read the detailed description
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.
- Being tested
- Core Stabilization, Functional Inspiratory Muscle Training (IMT)
- Keywords
- Post-COVID Syndrome, Trunk Muscle Endurance, Exercise Capacity, Functional Inspiratory Muscle Training (IMT), Core Stabilization
- Medical subject headings
- Post-Acute COVID-19 Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Core StabilizationOther
12-week supervised core stabilization training, 3 sessions per week, 45 minutes per session.
Functional Inspiratory Muscle Training (IMT)Other
IMT using a portable inspiratory muscle training device at 60% MIP, progressively increased over 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Core Stabilization Group | Active comparator | Participants will receive an 12-week core stabilization exercise program only. Receives: Other: Core Stabilization |
| Functional IMT Group | Experimental | Participants will receive an 12-weeks core stabilization exercise program plus functional inspiratory muscle training (IMT). Receives: Other: Core Stabilization; Other: Functional Inspiratory Muscle Training (IMT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Respiratory muscle strength
Maximal inspiratory pressure (MIP) and maximal expiratory pressure (MEP) with mouth-pressure device
Measured: 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.
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.
Measured: 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.
Measured: Baseline and after 12 weeks of intervention.
Secondary outcomes (5)
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.
Measured: Baseline and after 12 weeks of intervention.
Fatigue Perception
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.
Measured: 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).
Measured: 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
Measured: 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.
Measured: Baseline and after 12 weeks of intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jul 2025
- Study start15 Sep 2025
- Primary completion1 Dec 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post COVID-19 SyndromeStudies of the same condition, open and under way.
- More trials run by Hacettepe UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study includes two groups: one group performing core stabilization exercises and the other performing both core stabilization and functional inspiratory muscle training.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ebru Calik Kutukcu, Hacettepe University
- Investigators
- EBRU CALIK, Professor, Principal investigator, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07051954
- Sponsor's protocol ID
- 2024/12-16
- Status last verified
- Jan 2026
- First submitted
- 3 Jul 2025
- Last updated
- 14 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effects of Functional Respiratory Muscle Training on Respiratory Muscle Function, Exercise Capacity, Skeletal Muscle Strength, and Muscle Endurance in Individuals With Post-COVID-19 Syndrome
- ClinicalTrials.gov ID
- NCT07051954
- Acronym / sponsor ID
- 2024/12-16
- Keywords
- Post-COVID Syndrome, Trunk Muscle Endurance, Exercise Capacity, Functional Inspiratory Muscle Training (IMT), Core Stabilization
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 15 Sep 2025 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 4 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- The study includes two groups: one group performing core stabilization exercises and the other performing both core stabilization and functional inspiratory muscle training.
| Arm | Type | Receives |
|---|---|---|
| Core Stabilization Group | Active comparator | Other: Core StabilizationParticipants will receive an 12-week core stabilization exercise program only. |
| Functional IMT Group | Experimental | Other: Core Stabilization, Other: Functional Inspiratory Muscle Training (IMT)Participants will receive an 12-weeks core stabilization exercise program plus functional inspiratory muscle training (IMT). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Diagnosed with Post-COVID-19 Syndrome.
- Literate and able to understand study procedures.
- Aged between 18 and 65 years.
- Willing to voluntarily participate in the study.
- Classified as functional class 2-3 according to the Post-COVID-19 Functional Status Scale (PCFS).
Key exclusion criteria (4 listed)
- History of recent myocardial infarction or pulmonary embolism.
- Presence of uncontrolled chronic diseases.
- Any orthopedic or neurological disorders that limit mobility.
- Neurological impairments (e.g., cerebrovascular disease) or psychiatric disorders that impair cooperation or compliance with exercise testing.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Core Stabilization12-week supervised core stabilization training, 3 sessions per week, 45 minutes per session. | Other | Core Stabilization Group, Functional IMT Group |
| Functional Inspiratory Muscle Training (IMT)IMT using a portable inspiratory muscle training device at 60% MIP, progressively increased over 12 weeks. | Other | Functional IMT Group |
Primary outcome
Respiratory muscle strength
Time frame: Baseline and after 12 weeks of intervention.
Maximal inspiratory pressure (MIP) and maximal expiratory pressure (MEP) with mouth-pressure device
Plank Endurance Test
Time frame: Baseline and after 12 weeks of intervention.
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.
Sorenson Endurance Test
Time frame: Baseline and after 12 weeks of intervention.
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.
Side Bridge Endurance Test
Time frame: Baseline and after 12 weeks of intervention.
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.
5 secondary outcomes
Health Status
Time frame: Baseline and after 12 weeks of intervention.
Fatigue Perception
Time frame: Baseline and after 12 weeks of intervention.
Dynamic respiratory muscle strength
Time frame: Baseline and after 12 weeks of intervention.
Exercise motivation
Time frame: Baseline and after 12 weeks of intervention.
Patient satisfaction and improvement
Time frame: Baseline and after 12 weeks of intervention.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2026.
- Individual participant dataSharing planned: No
Related trials for Post COVID-19 Syndrome
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
Recruiting
Whole-body Cryotherapy in Those With Chronic Fatigue: A Feasibility Study
ME/CFS, Fibromyalgia (FM)
Not yet recruitingPhase 3
The Study of Brave-LC LDN Treatment Trial
Post-acute COVID-19 Syndrome
Active, not recruitingObservational study
Epigenetic Changes in Long COVID Patients
Long COVID-19 Syndrome, Long COVID Symptoms
Enrolling by invitationPhase 2
Immunotherapy for Neurological Post-Acute Sequelae of SARS-CoV-2
Systemic Inflammation, Neuroinflammation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
EBRU CALIK, Professor principal investigator
Hacettepe University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Core Stabilization and Functional Inspiratory Muscle Training (IMT) in people with Post COVID-19 Syndrome and Functional Inspiratory Muscle Training, run by Hacettepe University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ebru Calik, PhD (+905442850087, ecalik85@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Respiratory muscle strength (time frame: Baseline and after 12 weeks of intervention.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2026.