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NCT Number: NCT07545499

Physical Functions and Lifestyle Behaviours in Post-COVID-19 Syndrome Based on Circadian Rhythms

Post-COVID-19 syndrome is associated with persistent symptoms such as fatigue, reduced physical activity, and impaired respiratory function. Circadian rhythm differences (chronotype) may influence lifestyle behaviors including physical activity, nutrition, and sleep patterns.

This observational cross-sectional study aims to compare respiratory muscle strength, physical activity levels, and nutritional habits among individuals with post-COVID-19 syndrome according to their chronotype (morning, intermediate, and evening types).

Additionally, genetic analysis of the CLOCK gene polymorphism will be performed to support objective evaluation of circadian rhythm differences. The findings of this study may help to better understand the role of circadian rhythm in post-COVID-19 syndrome and contribute to the development of individualized rehabilitation and lifestyle interventions.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hacettepe University Faculty of Physical Therapy and Rehabilitation

Ankara, Altindağ, 06100, Turkey (Türkiye)

Location status: Recruiting

Location contact

EBRU ÇALIK, Professor

CONTACT

[email protected]

+905442850087

About this study

Post-COVID-19 syndrome is characterized by persistent symptoms such as fatigue, reduced exercise tolerance, and impaired respiratory function following acute SARS-CoV-2 infection. Emerging evidence suggests that circadian rhythm disruption may play a role in the pathophysiology of these symptoms by affecting metabolic regulation, hormonal balance, sleep quality, and physical performance.

Circadian rhythm varies between individuals and is commonly classified into chronotypes as morning, intermediate, and evening types. These chronotypes are associated with differences in daily activity patterns, nutritional behaviors, and physiological performance.

The aim of this observational cross-sectional study is to compare respiratory muscle strength, physical activity levels, nutritional habits, sleep quality, fatigue perception, and gastrointestinal symptoms in individuals with post-COVID-19 syndrome according to their chronotype.

Participants aged 18-65 years with a confirmed diagnosis of post-COVID-19 syndrome will be included. Chronotype will be assessed using the Munich Chronotype Questionnaire (MCTQ). Respiratory muscle strength will be evaluated using maximal inspiratory and expiratory pressures (MIP/MEP), and dynamic respiratory parameters will be assessed using a POWERbreathe device. Respiratory muscle endurance will be measured using threshold loading protocols.

Physical activity levels will be assessed using the International Physical Activity Questionnaire (IPAQ), while nutritional intake will be evaluated using 24-hour dietary recall. Sleep quality, fatigue severity, and gastrointestinal symptoms will be assessed using validated questionnaires.

In addition, blood samples will be collected for genetic analysis of the CLOCK gene polymorphism (rs1801260) using PCR-RFLP techniques to provide an objective assessment of circadian rhythm differences.

This study is expected to provide comprehensive insight into the relationship between circadian rhythm and functional, behavioral, and physiological outcomes in post-COVID-19 syndrome, and may contribute to the development of individualized rehabilitation strategies.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosed with Post-COVID-19 Syndrome
  • Aged between 18-65 years
  • Able to read and understand Turkish
  • Voluntary participation
  • Classified as Post-Covid Functional Status Scale (PCFS) grade 2-3
  • Clinically stable condition
  • No uncontrolled comorbidities (e.g., hypertension, diabetes under control)
  • No orthopedic or neurological conditions affecting exercise testing

Exclusion criteria

  • Recent myocardial infarction or pulmonary embolism
  • Severe uncontrolled chronic diseases
  • Neurological or orthopedic conditions limiting mobility
  • Psychiatric or neurological disorders affecting cooperation or test compliance
  • Inability to complete assessments

Treatment and study plan

Primary outcomes

  1. Respiratory Muscle Strength

    Time frame: Time Frame: Day 1

    Maximal inspiratory pressure (MIP), maximal expiratory pressure (MEP) values will be recorded with mouth pressure device.

  2. Dynamic respiratory muscle strength

    Time frame: Time Frame: Day 1

    Respiratory muscle strength index (S index) will be assessed using a portable POWERbreathe K5 device.

  3. Respiratory muscle endurance

    Time frame: Time Frame: Day 1

    Respiratory muscle endurance test at constant threshold load will be used.

Secondary outcomes

  1. Physical Activity Level

    Time frame: Time Frame: Day 1

    Physical activity levels will be assessed using the International Physical Activity Questionnaire Short Form (IPAQ-SF), expressed as MET-min/week.

    The total weekly IPAQ score (MET-min/week) were then used to classify participants into three categories:

    Low PA (individuals who did not meet criteria for moderate or high categories); Moderate PA (≥3 days of vigorous-intensity activity of at least 20 min per day; ≥5 days of moderate-intensity activity and/or walking of at least 30 min per day; or 3-5 or more days of any combination of walking, moderate-intensity or vigorous intensity activities achieving a minimum total PA of at least 600 MET-min/week); high PA (vigorous activity on at least 3 days with a minimum total PA of at least 1500 MET-min/week or 7 days of any combination of walking and moderate or vigorous activities with a minimum total PA of 3000 MET-min/week).

  2. Dietary Intake

    Time frame: Time Frame: Day 1

    Dietary intake will be assessed using 24-hour dietary recall records analyzed for macro and micronutrient intake.

  3. Chronotype Classification

    Time frame: Time Frame: Day 1

    Chronotype will be determined using the Munich Chronotype Questionnaire (MCTQ), categorizing participants into morning-type and evening-type groups.Total MCTQ scores can range from 16 to 86, with the lowest values representing extreme-late chronotypes.

  4. Fatigue Severity

    Time frame: Time Frame: Day 1

    Fatigue will be assessed using the Fatigue Severity Scale (FSS). Total FSS score ranges between 0-7. Total FSS score 4 and more indicates severe fatigue.

  5. Gastrointestinal Symptoms

    Time frame: Time Frame: Day 1

    Gastrointestinal symptoms will be evaluated using the Gastrointestinal Symptom Rating Scale (GSRS).The total GSRS score ranges from 15 to 105, with higher scores indicating more severe gastrointestinal symptoms.

  6. Sleep Quality

    Time frame: Time Frame: Day 1

    Sleep quality will be evaluated using the Pittsburgh Sleep Quality Index (PSQI). Total PSQI score ranges from 0 to 21, with higher scores indicating poorer sleep quality. A total score greater than 5 is widely used as the cutoff, suggesting poor sleep quality.

  7. Classificationof human faeces forms

    Time frame: Time Frame: Day 1

    Classification of human faeces forms will be evaluated using the Bristol Stool Scale.The seven types of stool are recorded by this scale.

    Type 1: Separate hard lumps, like nuts (difficult to pass) Type 2: Sausage-shaped, but lumpy Type 3: Like a sausage but with cracks on its surface Type 4: Like a sausage or snake, smooth and soft (average stool) Type 5: Soft blobs with clear cut edges Type 6: Fluffy pieces with ragged edges, a mushy stool (diarrhea) Type 7: Watery, no solid pieces, entirely liquid (diarrhea)

Study contacts

Contact information is provided by the study sponsor or research team.

Ebru Çalık, Professor

CONTACT

[email protected]

+905442850087

Sponsors and collaborators

Lead sponsor

Hacettepe University

Other

Registry information

Official study title

Comparison of Respiratory Muscle Strength, Physical Activity Level, and Dietary Habits in Individuals With Post-COVID-19 Syndrome Having Different Circadian Rhythms

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Apr 22, 2026
Registry last updated
Apr 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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