- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT03978975
Water Exercise and Health (WATHEALTH) (WATHEALTH)
Effect of Water Temperature on Energy Response During Aquatic Cycling in Women: Impact of Weight Status
Studieoversigt
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Forventet)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
-
-
-
Clermont-Ferrand, Frankrig, 63000
- Rekruttering
- CHU clermont-ferrand
-
Kontakt:
- Lise Laclautre
- E-mail: drci@chu-clermontferrand.fr
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Randomiseret
- Interventionel model: Crossover opgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Aktiv komparator: normal weight women
20 women with a body mass index ranging between 18,5 and 24,9 kg.m2
|
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:
|
|
Eksperimentel: overweight women
20 women with a body mass index ranging between 25 and 29,9 kg.m2
|
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:
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Food intake during buffet meal 30 minutes after the end of experimental session
Tidsramme: Day 7
|
total energy intake at the post session lunch will be calculated by measuring food intake
|
Day 7
|
|
Food intake during buffet meal 30 minutes after the end of experimental session
Tidsramme: Day 14
|
total energy intake at the post session lunch will be calculated by measuring food intake
|
Day 14
|
|
Food intake during buffet meal 30 minutes after the end of experimental session
Tidsramme: Day 21
|
total energy intake at the post session lunch will be calculated by measuring food intake
|
Day 21
|
|
Food intake during buffet meal 30 minutes after the end of experimental session
Tidsramme: Day 28
|
total energy intake at the post session lunch will be calculated by measuring food intake
|
Day 28
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Appetite, hunger and satiety
Tidsramme: Day 7
|
using a visual analog scale from 0 millimeter (no sensation) to 100mm (highest sensation)
|
Day 7
|
|
Appetite, hunger and satiety
Tidsramme: Day 14
|
using a visual analog scale from 0 millimeter (no sensation) to 100mm (highest sensation)
|
Day 14
|
|
Appetite, hunger and satiety
Tidsramme: Day 21
|
using a visual analog scale from 0 millimeter (no sensation) to 100mm (highest sensation)
|
Day 21
|
|
Appetite, hunger and satiety
Tidsramme: Day 28
|
using a visual analog scale from 0 millimeter (no sensation) to 100mm (highest sensation)
|
Day 28
|
|
Energy expenditure
Tidsramme: Day 7
|
with a gas analyser energy expenditure will be measured in kcal
|
Day 7
|
|
Energy expenditure
Tidsramme: Day 14
|
with a gas analyser energy expenditure will be measured in kcal
|
Day 14
|
|
Energy expenditure
Tidsramme: Day 21
|
with a gas analyser energy expenditure will be measured in kcal
|
Day 21
|
|
Energy expenditure
Tidsramme: Day 28
|
with a gas analyser energy expenditure will be measured in kcal
|
Day 28
|
|
Perceived exertion
Tidsramme: Day 7
|
using Borg scale perceived exertion will be evaluated between 6 (very light) and 20 (extremely difficult)
|
Day 7
|
|
Perceived exertion
Tidsramme: Day 14
|
using Borg scale perceived exertion will be evaluated between 6 (very light) and 20 (extremely difficult)
|
Day 14
|
|
Perceived exertion
Tidsramme: Day 21
|
using Borg scale perceived exertion will be evaluated between 6 (very light) and 20 (extremely difficult)
|
Day 21
|
|
Perceived exertion
Tidsramme: Day 28
|
using Borg scale perceived exertion will be evaluated between 6 (very light) and 20 (extremely difficult)
|
Day 28
|
Samarbejdspartnere og efterforskere
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Forventet)
Studieafslutning (Forventet)
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
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- RBHP 2018 DUCLOS 4 (Wathealth)
- 2019-A00353-54 (Anden identifikator: ANSM)
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .