- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07833956
Circadian Rhythm and Cardiovascular Recovery After Submaximal Exercise
Relationship Between Cardiovascular Recovery After a Submaximal Exercise Test and Circadian Rhythm: A 6-Minute Walk Test-Based Study
This cross-sectional, observational, and analytical study aims to investigate the relationship between morningness-eveningness characteristics and cardiovascular recovery after a submaximal exercise test in healthy individuals aged 18-45 years. Circadian preference will be assessed using the Morningness-Eveningness Questionnaire, sleep quality will be assessed using the Pittsburgh Sleep Quality Index, and cardiovascular recovery will be evaluated following the 6-Minute Walk Test
Study Overview
Status
Conditions
Detailed Description
The study will include healthy volunteers aged 18-45 years. After written informed consent is obtained, participants will complete a sociodemographic information form, the Morningness-Eveningness Questionnaire, and the Pittsburgh Sleep Quality Index. Resting heart rate, oxygen saturation, and Borg dyspnea/fatigue scores will then be recorded, followed by the 6-Minute Walk Test. Physiological measurements will be repeated immediately after the test and at the 1st, 3rd, and 5th minutes of recovery.
The planned sample size is at least 124 participants. This was calculated using G*Power 3.1.9.7 based on a medium effect size (r=0.30), a significance level of 5% (α=0.05), and 90% statistical power, with an additional 10% allowance for possible data loss or missing data. Data will be analyzed using descriptive statistics, normality analyses, appropriate parametric or non-parametric comparison tests, correlation analyses, and multivariable regression analyses, with statistical significance set at p<0.05.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Gamze Koyutürk, Asst Prof
- Phone Number: +905065798671
- Email: gamzealtinkaynak@gmail.com
Study Contact Backup
- Name: Mehmet Burak Uyaroğlu, Asst Prof
- Phone Number: 5396545352
- Email: m.uyaroglu1@gmail.com
Study Locations
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Istanbul, Turkey (Türkiye)
- Recruiting
- İstanbul Topkapı University
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Contact:
- Gamze Koyutürk, Asst. Prof
- Phone Number: 5065798671
- Email: gamzekoyuturk@topkapi.edu.tr
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Healthy volunteers aged 18-45 years who meet the study eligibility criteria and agree to participate voluntarily.
Description
Inclusion Criteria:
- Aged 18-45 years.
- Being healthy.
- Voluntarily agreeing to participate in the study.
Exclusion Criteria:
- Presence of cardiovascular, pulmonary, neurological, or orthopedic disease.
- Having a health problem that prevents exercise.
- Use of medication that may affect exercise tolerance.
- Pregnancy.
Study Plan
How is the study designed?
Design Details
- Observational Models: COHORT
- Time Perspectives: PROSPECTIVE
Cohorts and Interventions
Group / Cohort |
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Single Group
Healthy volunteers aged 18-45 years. Participants will complete a sociodemographic information form, the Morningness-Eveningness Questionnaire, and the Pittsburgh Sleep Quality Index. Resting heart rate, oxygen saturation, and Borg dyspnea/fatigue scores will be recorded, followed by the 6-Minute Walk Test. Physiological measurements will also be obtained immediately after the test and at the 1st, 3rd, and 5th minutes of recovery. No intervention will be administered |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Heart Rate Recovery After the 6-Minute Walk Test
Time Frame: Baseline and up to 5 minutes post-exercise
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Heart rate will be recorded at rest, immediately after the 6-Minute Walk Test, and at the 1st, 3rd, and 5th minutes of the recovery period to evaluate cardiovascular recovery following submaximal exercise. |
Baseline and up to 5 minutes post-exercise
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Oxygen Saturation (SpO₂) During Post-Exercise Recovery
Time Frame: Up to 5 minutes after the 6-Minute Walk Test
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Oxygen saturation will be recorded at rest, immediately after the 6-Minute Walk Test, and at the 1st, 3rd, and 5th minutes of recovery. |
Up to 5 minutes after the 6-Minute Walk Test
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Borg Dyspnea/Fatigue Score During Post-Exercise Recovery
Time Frame: Baseline and up to 5 minutes post-exercise
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Dyspnea and fatigue will be assessed using the Borg Dyspnea/Fatigue Scale at rest, immediately after the 6-Minute Walk Test, and at the 1st, 3rd, and 5th minutes of recovery. |
Baseline and up to 5 minutes post-exercise
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Morningness-Eveningness Characteristics
Time Frame: Baseline
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The Morningness-Eveningness Questionnaire assesses individuals' preference for the timing of sleep and daily activities. Scores range from 16 to 86, with higher scores indicating a stronger morning preference and lower scores indicating a stronger evening preference, rather than better or worse outcomes. |
Baseline
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Sleep Quality
Time Frame: Baseline
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Sleep quality will be assessed using the Pittsburgh Sleep Quality Index (PSQI), which evaluates sleep quality and disturbances over the past month. The global score ranges from 0 to 21, with higher scores indicating poorer sleep quality. |
Baseline
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Gamze Koyutürk, Asst Prof, Topkapı University
- Study Director: Mehmet B Uyaroğlu, Asst Prof, Fenerbahce University
- Study Chair: Beyza Erdoğmuş, Dr
- Study Chair: Hüsna Güzel, MsC, Fenerbahce University
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- TopkapıUniver
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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