- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT03978975
Water Exercise and Health (WATHEALTH) (WATHEALTH)
Effect of Water Temperature on Energy Response During Aquatic Cycling in Women: Impact of Weight Status
Panoramica dello studio
Descrizione dettagliata
After inclusion visit, all subject will be submitted to DXA to obtain body composition data. Then subjects will be submitted to four experimental session in a semi-randomized order. For all those session, subjects will take a standardized breakfast (570kcal) three hours before experimental session.
Control session (CON): subject will stand sited without any activity during 40 min.
Subjects will be submitted to three aquatic cycling exercise session:
- session 27°C :aquatic cycling at 27°C without water jet during 40 min
- session 27°C+ water jets : aquatic cycling at 27 °C with water jets during 40 min
- session 18°C : aquatic cycling at 187°C without water jet during 40 min Every exercise session will be set at 70% of theorical maximal heart rate During each session, oxygen consumption and carbon dioxide production will be analysed with gas analysis system. Appetite and hunger sensation will be measured with a specific scale at different time point of each day of experimental session. Thirty minutes after the end of each experimental session subjects will have a buffet meal for lunch time.
Tipo di studio
Iscrizione (Anticipato)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
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Clermont-Ferrand, Francia, 63000
- Reclutamento
- CHU clermont-ferrand
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Contatto:
- Lise Laclautre
- Email: drci@chu-clermontferrand.fr
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
- Women aged between 20 and 40 years
- BMI under 25kg.m2 for normal weight women and between 25 and 29,9 kg.m2 for overweight women
- Daily breakfast
- Subject which approved informed consent
- Subject with French medical affiliation
Exclusion Criteria:
- Specific medical treatment
- Aquaphobia
- Subject under specific diet regimen or weight loss program
- Subject with cardio-vascular disease
- Surgical intervention less than 3 months
- Subject refusing informed and written consent
- Subject without French medical affiliation
- subject refusing inscription to the national voluntary list
- subject being in an exclusion period
- subject smoking or drinking alcohol frequently
- subject with intense physical activity
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Prevenzione
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione incrociata
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Comparatore attivo: normal weight women
20 women with a body mass index ranging between 18,5 and 24,9 kg.m2
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For all those session, subjects will take a standardized breakfast (570kcal) three hours before experimental session. Control session (CON): subject will stand sited without any activity during 40 min. Subjects will be submitted to three aquatic cycling exercise session:
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Sperimentale: overweight women
20 women with a body mass index ranging between 25 and 29,9 kg.m2
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For all those session, subjects will take a standardized breakfast (570kcal) three hours before experimental session. Control session (CON): subject will stand sited without any activity during 40 min. Subjects will be submitted to three aquatic cycling exercise session:
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Food intake during buffet meal 30 minutes after the end of experimental session
Lasso di tempo: Day 7
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total energy intake at the post session lunch will be calculated by measuring food intake
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Day 7
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Food intake during buffet meal 30 minutes after the end of experimental session
Lasso di tempo: Day 14
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total energy intake at the post session lunch will be calculated by measuring food intake
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Day 14
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Food intake during buffet meal 30 minutes after the end of experimental session
Lasso di tempo: Day 21
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total energy intake at the post session lunch will be calculated by measuring food intake
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Day 21
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Food intake during buffet meal 30 minutes after the end of experimental session
Lasso di tempo: Day 28
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total energy intake at the post session lunch will be calculated by measuring food intake
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Day 28
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Appetite, hunger and satiety
Lasso di tempo: Day 7
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using a visual analog scale from 0 millimeter (no sensation) to 100mm (highest sensation)
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Day 7
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Appetite, hunger and satiety
Lasso di tempo: Day 14
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using a visual analog scale from 0 millimeter (no sensation) to 100mm (highest sensation)
|
Day 14
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Appetite, hunger and satiety
Lasso di tempo: Day 21
|
using a visual analog scale from 0 millimeter (no sensation) to 100mm (highest sensation)
|
Day 21
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Appetite, hunger and satiety
Lasso di tempo: Day 28
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using a visual analog scale from 0 millimeter (no sensation) to 100mm (highest sensation)
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Day 28
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Energy expenditure
Lasso di tempo: Day 7
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with a gas analyser energy expenditure will be measured in kcal
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Day 7
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Energy expenditure
Lasso di tempo: Day 14
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with a gas analyser energy expenditure will be measured in kcal
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Day 14
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Energy expenditure
Lasso di tempo: Day 21
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with a gas analyser energy expenditure will be measured in kcal
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Day 21
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Energy expenditure
Lasso di tempo: Day 28
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with a gas analyser energy expenditure will be measured in kcal
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Day 28
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Perceived exertion
Lasso di tempo: Day 7
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using Borg scale perceived exertion will be evaluated between 6 (very light) and 20 (extremely difficult)
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Day 7
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Perceived exertion
Lasso di tempo: Day 14
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using Borg scale perceived exertion will be evaluated between 6 (very light) and 20 (extremely difficult)
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Day 14
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Perceived exertion
Lasso di tempo: Day 21
|
using Borg scale perceived exertion will be evaluated between 6 (very light) and 20 (extremely difficult)
|
Day 21
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Perceived exertion
Lasso di tempo: Day 28
|
using Borg scale perceived exertion will be evaluated between 6 (very light) and 20 (extremely difficult)
|
Day 28
|
Collaboratori e investigatori
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Anticipato)
Completamento dello studio (Anticipato)
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
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- RBHP 2018 DUCLOS 4 (Wathealth)
- 2019-A00353-54 (Altro identificatore: ANSM)
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
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 .