- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT01259661
Physical Activity and Metabolic Risk Factors in Postmenopausal Women
Hormonal changes associated with menopause, chronological aging, and lifestyle, especially physical inactivity, may increase the risk of metabolic syndrome in postmenopausal women. Women exhibiting "the metabolic syndrome" have multiple coronary artery disease risk factors, including insulin resistance, hyperlipidemia, and hypertension. This study will be conducted to test the hypotheses: (1) physical activity and physical fitness levels may have effects on individual risk factors of the metabolic syndrome in postmenopausal women; (2) endurance exercise training may have a favorable effect on components of the metabolic risk variables in these women.
In this study, the associations among physical activity (including daily energy expenditure and energy expenditure from moderate to vigorous activity), cardiopulmonary fitness level, and metabolic risk profile of the women will be assessed. The investigators will perform a randomized trial to compare the effects of moderate-intensity aerobic exercise training regimens on metabolic risk factors. Postmenopausal women who exhibit at least one risk factor for metabolic syndrome will be randomized in the exercise group or control groups. Metabolic risk factors (e.g., body mass index, waist-to-hip ratio, glucose, insulin, blood pressure, lipid profile and adiponectin level) will be measured at baseline, and 12 weeks of the study. Differences from baseline to follow-up will be calculated and compared across groups.
Results of this study may help health care providers providing advice to postmenopausal women for life style changes to reduce risk of insulin resistance, coronary heart disease, and diabetes.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Anticipé)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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Taipei, Taïwan
- Recrutement
- Taipei Medical University WanFang Hospital
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Contact:
- Jen-Chen Tsai
- Numéro de téléphone: 6308 886-2-27361661
- E-mail: jenchent@tmu.edu.tw
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- have one or more metabolic risk variables as defined by the ATP III (2001)
- age between 35 and 64 years
- absence of known heart disease
- resting BP: 130 < SBP < 160 and 85 < DBP < 100
- currently physical inactive (< 30 min of physical activity per week)
Exclusion Criteria:
- None of the participants has a diagnosis of type 2 diabetes, physical illness or disabilities that will limit daily physical activities.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
---|---|
Expérimental: Groupe expérimental
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In our longitudinal intervention study, all eligible subjects will undergo a physical examination by a physician to rule out obvious secondary causes of hypertension and contraindications to exercise.
Randomization will be performed by random member generation.
The exercise participants will attend three sessions per week at the facility during the study period.
Training intensity is initially set at heart rate equivalent to 60% and progress to 80% of each subject's maximal heart rate reserve for 30 min/day with a frequency of 3 days/wk.
Facility-based exercise sessions will consist of treadmill walking.
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Comparateur actif: Groupe de contrôle
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In our longitudinal intervention study, all eligible subjects will undergo a physical examination by a physician to rule out obvious secondary causes of hypertension and contraindications to exercise.
Randomization will be performed by random member generation.
The exercise participants will attend three sessions per week at the facility during the study period.
Training intensity is initially set at heart rate equivalent to 60% and progress to 80% of each subject's maximal heart rate reserve for 30 min/day with a frequency of 3 days/wk.
Facility-based exercise sessions will consist of treadmill walking.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
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Postmenopausal women's daily energy expenditure
Délai: 12 week
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12 week
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Collaborateurs et enquêteurs
Les enquêteurs
- Chercheur principal: Jen-Chen Tsai, Taipei Medical University
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Anticipé)
Achèvement de l'étude (Anticipé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Autres numéros d'identification d'étude
- 99070
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