- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT01722136
"We Walk": Impact of Exercise Dose on Health Outcomes Among Women Ages 60-75 (WW)
We Walk - Energy Expenditure and Health Outcomes in Older, Sedentary Women.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
The overall goal is to determine whether any energy expenditure compensation in response to 16 weeks of aerobic exercise at a higher-dose is greater compared to a lower-dose intervention in older women, and to begin to investigate underlying physiological mechanisms that influence energy expenditure changes in older women. Changes in all components of energy expenditure, as well as concentrations of plasma leptin and serum free T3, in response to the two different exercise programs (14 and 8 kcal/kg body weight weekly, 60-65% VO2max, 4 days/wk) will be compared in older, non-obese women (60-75 yrs, BMI=18-30 kg/m2).
Specific Aim 1: To determine whether differential changes in total daily energy expenditure and its components occur in older women in response to two exercise programs of different doses. State-of-the-art methods will be used (total daily energy expenditure by doubly labeled water; non-exercise activity thermogenesis using Physical Activity Monitoring System; resting metabolic rate and thermic effect of food via indirect calorimetry).
Primary Hypothesis: Due to a greater decline in NEAT, women will exhibit a smaller increase in total daily energy expenditure in response to the higher-dose, compared to the lower-dose, exercise program, despite greater increases in resting metabolic rate and thermic effect of food.
Specific Aim 2: To explore whether differential changes occur in plasma leptin and serum free triiodo-L-thyronine (free T3) concentrations in older women in response to 16-week aerobic exercise programs of two different doses.
We hypothesize that in response to the higher-dose exercise program, women will exhibit larger decreases in plasma leptin and serum free T3 concentrations, compared to the lower-dose exercise program.
We will also determine whether women exhibit greater improvements in plasma lipids, insulin sensitivity (using homeostasis model assessment, HOMA, score), blood pressure, and aerobic fitness in response to the higher-dose, compared to the lower-dose, exercise program.
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
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South Carolina
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Columbia, South Carolina, Forente stater, 29201
- Public Health Research Center University of South Carolina
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- BMI 18-30
- Sedentary (exercising less than 20 minutes no more than 3 times per week)
- Non-smoking
- Weight stable (+/- 5%) over past 3 months
Exclusion Criteria:
- Self-reported cardiovascular disease
- Additional self-reported medical conditions
- Medications known to affect metabolism
- Excess caffeine use
- Self-reported contradictions according to ACSM
- Unwillingness to provide informed consent
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Støttende omsorg
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Eksperimentell: Low Dosage
Exercise dose of 8kcal/kg/week
|
Exercise dose of 8kcal/kg/week
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Eksperimentell: High Dosage
Exercise dose 14kcal/kg/week
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Exercise dose of 14kcal/kg/week
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
Change from baseline total daily energy expenditure and its components (resting metabolic rate, thermic effect of food, non-exercise activity thermogenesis)in 4 months
Tidsramme: Baseline (pre-intervention); 4 months (post-intervention)
|
Baseline (pre-intervention); 4 months (post-intervention)
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
Change from baseline plasma leptin and serum free triiodo-L-thyronine (free T3) concentrations in 4 months
Tidsramme: Baseline (pre-intervention); 4 month (post-intervention)
|
Baseline (pre-intervention); 4 month (post-intervention)
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Xuewen Wang, PhD, MEd, BM, University of South Carolina
Publikasjoner og nyttige lenker
Hjelpsomme linker
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Andre studie-ID-numre
- Pro00016306
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