- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica 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
Panoramica dello studio
Stato
Condizioni
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Stimato)
Contatti e Sedi
Contatto studio
- Nome: Gamze Koyutürk, Asst Prof
- Numero di telefono: +905065798671
- Email: gamzealtinkaynak@gmail.com
Backup dei contatti dello studio
- Nome: Mehmet Burak Uyaroğlu, Asst Prof
- Numero di telefono: 5396545352
- Email: m.uyaroglu1@gmail.com
Luoghi di studio
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Istanbul, Turchia (Türkiye)
- Reclutamento
- İstanbul Topkapı University
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Contatto:
- Gamze Koyutürk, Asst. Prof
- Numero di telefono: 5065798671
- Email: gamzekoyuturk@topkapi.edu.tr
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Metodo di campionamento
Popolazione di studio
Healthy volunteers aged 18-45 years who meet the study eligibility criteria and agree to participate voluntarily.
Descrizione
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.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Modelli osservazionali: COHORT
- Prospettive temporali: PROSPECTIVE
Coorti e interventi
Gruppo / Coorte |
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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 |
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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Heart Rate Recovery After the 6-Minute Walk Test
Lasso di tempo: 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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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Oxygen Saturation (SpO₂) During Post-Exercise Recovery
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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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Collaboratori e investigatori
Sponsor
Investigatori
- Investigatore principale: Gamze Koyutürk, Asst Prof, Topkapı University
- Direttore dello studio: Mehmet B Uyaroğlu, Asst Prof, Fenerbahce University
- Cattedra di studio: Beyza Erdoğmuş, Dr
- Cattedra di studio: Hüsna Güzel, MsC, Fenerbahce University
Studiare le date dei record
Studia le date principali
Inizio studio (Stimato)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Altri numeri di identificazione dello studio
- TopkapıUniver
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Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .