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- Ensaio Clínico 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
Visão geral do estudo
Status
Condições
Descrição detalhada
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 de estudo
Inscrição (Estimado)
Contactos e Locais
Contato de estudo
- Nome: Gamze Koyutürk, Asst Prof
- Número de telefone: +905065798671
- E-mail: gamzealtinkaynak@gmail.com
Estude backup de contato
- Nome: Mehmet Burak Uyaroğlu, Asst Prof
- Número de telefone: 5396545352
- E-mail: m.uyaroglu1@gmail.com
Locais de estudo
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Istanbul, Turquia (Türkiye)
- Recrutamento
- İstanbul Topkapı University
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Contato:
- Gamze Koyutürk, Asst. Prof
- Número de telefone: 5065798671
- E-mail: gamzekoyuturk@topkapi.edu.tr
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Método de amostragem
População do estudo
Healthy volunteers aged 18-45 years who meet the study eligibility criteria and agree to participate voluntarily.
Descrição
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.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Modelos de observação: COHORT
- Perspectivas de Tempo: PROSPECTIVE
Coortes e Intervenções
Grupo / 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 |
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Heart Rate Recovery After the 6-Minute Walk Test
Prazo: 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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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Oxygen Saturation (SpO₂) During Post-Exercise Recovery
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Gamze Koyutürk, Asst Prof, Topkapı University
- Diretor de estudo: Mehmet B Uyaroğlu, Asst Prof, Fenerbahce University
- Cadeira de estudo: Beyza Erdoğmuş, Dr
- Cadeira de estudo: Hüsna Güzel, MsC, Fenerbahce University
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Estimado)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Outros números de identificação do estudo
- TopkapıUniver
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