- ICH GCP
- Registre américain des essais cliniques
- Essai clinique 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
Aperçu de l'étude
Statut
Les conditions
Description détaillée
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.
Type d'étude
Inscription (Estimé)
Contacts et emplacements
Coordonnées de l'étude
- Nom: Gamze Koyutürk, Asst Prof
- Numéro de téléphone: +905065798671
- E-mail: gamzealtinkaynak@gmail.com
Sauvegarde des contacts de l'étude
- Nom: Mehmet Burak Uyaroğlu, Asst Prof
- Numéro de téléphone: 5396545352
- E-mail: m.uyaroglu1@gmail.com
Lieux d'étude
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Istanbul, Turquie (Türkiye)
- Recrutement
- İstanbul Topkapı University
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Contact:
- Gamze Koyutürk, Asst. Prof
- Numéro de téléphone: 5065798671
- E-mail: gamzekoyuturk@topkapi.edu.tr
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
Healthy volunteers aged 18-45 years who meet the study eligibility criteria and agree to participate voluntarily.
La 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.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Modèles d'observation: COHORT
- Perspectives temporelles: PROSPECTIVE
Cohortes et interventions
Groupe / Cohorte |
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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 |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Heart Rate Recovery After the 6-Minute Walk Test
Délai: 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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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Oxygen Saturation (SpO₂) During Post-Exercise Recovery
Délai: 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
Délai: 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
Délai: 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
Délai: 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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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Gamze Koyutürk, Asst Prof, Topkapı University
- Directeur d'études: Mehmet B Uyaroğlu, Asst Prof, Fenerbahce University
- Chaise d'étude: Beyza Erdoğmuş, Dr
- Chaise d'étude: Hüsna Güzel, MsC, Fenerbahce University
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Autres numéros d'identification d'étude
- TopkapıUniver
Informations sur les médicaments et les dispositifs, documents d'étude
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