- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg 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
Studieoversigt
Status
Betingelser
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Anslået)
Kontakter og lokationer
Studiekontakt
- Navn: Gamze Koyutürk, Asst Prof
- Telefonnummer: +905065798671
- E-mail: gamzealtinkaynak@gmail.com
Undersøgelse Kontakt Backup
- Navn: Mehmet Burak Uyaroğlu, Asst Prof
- Telefonnummer: 5396545352
- E-mail: m.uyaroglu1@gmail.com
Studiesteder
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Istanbul, Tyrkiet (Türkiye)
- Rekruttering
- İstanbul Topkapı University
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Kontakt:
- Gamze Koyutürk, Asst. Prof
- Telefonnummer: 5065798671
- E-mail: gamzekoyuturk@topkapi.edu.tr
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Healthy volunteers aged 18-45 years who meet the study eligibility criteria and agree to participate voluntarily.
Beskrivelse
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.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Observationsmodeller: COHORT
- Tidsperspektiver: PROSPECTIVE
Kohorter og interventioner
Gruppe / kohorte |
|---|
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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 |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Heart Rate Recovery After the 6-Minute Walk Test
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Oxygen Saturation (SpO₂) During Post-Exercise Recovery
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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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Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Gamze Koyutürk, Asst Prof, Topkapı University
- Studieleder: Mehmet B Uyaroğlu, Asst Prof, Fenerbahce University
- Studiestol: Beyza Erdoğmuş, Dr
- Studiestol: Hüsna Güzel, MsC, Fenerbahce University
Datoer for undersøgelser
Studer store datoer
Studiestart (Anslået)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- TopkapıUniver
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