- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg 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.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret 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.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
-
-
South Carolina
-
Columbia, South Carolina, Forenede Stater, 29201
- Public Health Research Center University of South Carolina
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
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 undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Støttende pleje
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: Low Dosage
Exercise dose of 8kcal/kg/week
|
Exercise dose of 8kcal/kg/week
|
Eksperimentel: High Dosage
Exercise dose 14kcal/kg/week
|
Exercise dose of 14kcal/kg/week
|
Hvad måler undersøgelsen?
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)
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Xuewen Wang, PhD, MEd, BM, University of South Carolina
Publikationer og nyttige links
Hjælpsomme links
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- Pro00016306
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 .
Kliniske forsøg med Low Dosage
-
University of MichiganNational Institute on Drug Abuse (NIDA); Brown University; Pennington Biomedical... og andre samarbejdspartnereRekruttering
-
University Hospital, Basel, SwitzerlandRekrutteringFedme | GlucoseintoleranceSchweiz
-
Medical University of WarsawNutricia FoundationUkendt
-
Karolinska InstitutetAleris Gastromottagningen CityIkke rekrutterer endnu
-
University Hospital, RouenUkendt
-
Dalhousie UniversityGrand Challenges CanadaAfsluttet
-
Universidade do PortoNOVA Medical School | Faculdade de Ciências Médicas, Universidade Nova... og andre samarbejdspartnereAktiv, ikke rekrutterende
-
University of Nove de JulhoFundação de Amparo à Pesquisa do Estado de São PauloAfsluttetMuskel; Træthed, hjerte | Gendannelse af skeletmusklerBrasilien
-
University of Alabama at BirminghamIkke rekrutterer endnuType 2 diabetes | Fysisk handicap
-
National Center for Complementary and Integrative...AfsluttetFibromyalgiForenede Stater