- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT03435315
Treadmill Exercise in Metabolic Syndrome
20 mai 2022 mis à jour par: Gloria Y. Yeh, Beth Israel Deaconess Medical Center
The main purpose of this study is to better understand the effects of two types of treadmill exercise programs that include education and/or techniques that may be helpful for exercise among individuals with, or at risk for, metabolic syndrome.
Aperçu de l'étude
Statut
Résilié
Les conditions
Intervention / Traitement
Type d'étude
Interventionnel
Inscription (Réel)
12
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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Massachusetts
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Boston, Massachusetts, États-Unis, 02215
- BIDMC
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-
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
18 ans à 65 ans (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
La description
Inclusion Criteria:
- Referred by healthcare provider and given medical clearance for moderate-intensity exercise
Metabolic syndrome, defined as meeting three or more of the following criteria:
- Obesity or overweight defined as BMI > 25
- Impaired glycemia (fasting blood sugar of ≥ 100 [5.6 mmol/L] or glycated hemoglobin [A1C] of ≥ 5.7)
- Increased blood pressure (130/85 mmHg or higher) or if you take medicine for high blood pressure
- Increased fasting levels of triglycerides (≥ 150 or 1.7 mmol/L) or decreased fasting high-density lipoprotein (HDL) cholesterol (less than 40 mg/dL or 1 mmol/L for men or 50 mg/dL or 1.3 mmol/L for women) or if you take any medicines for dyslipidemia
- Between the ages of 18-65
- No regular physical activity (≥ 3 or more days per week) for the past 3 months
Exclusion Criteria:
- Contraindications for treadmill exercise determined by their physician (e.g., cardiopulmonary limitations or diagnoses) or other inability to do treadmill exercise (e.g., musculoskeletal restrictions or severe balance impairment)
- Confirmed diagnosis of coronary artery disease
- Confirmed diagnosis of diabetes
- Currently taking a beta blocker or calcium channel blocker medication
- Uncontrolled and untreated hypertension, defined as a resting blood pressure of 150/90
- Confirmed diagnosis of chronic obstructive pulmonary disease or other severe lung dysfunction that may interfere with exercise (e.g., severe asthma)
- Self-reported psychotic disorder
- Current practice of mindfulness mediation or mindful movement (e.g., yoga or tai chi), defined as regular daily practice or >2 classes or self-guided sessions per week in the past three months.
- Non-English speaking
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Autre
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
---|---|
Comparateur actif: Exercice sur tapis roulant
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12-session, 6-week traditional treadmill exercise program
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Expérimental: Treadmill exercise with behavioral techniques
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12-session, 6-week treadmill exercise program utilizing behavioral techniques while walking
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Recruitment Feasibility
Délai: Through study completion, an average of 1 year
|
% willing to be randomized
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Through study completion, an average of 1 year
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Protocol Adherence
Délai: Through study completion, an average of 1 year
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% sessions attended
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Through study completion, an average of 1 year
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Cardiopulmonary Dynamics
Délai: Weeks 1 and 6
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CardioPulmonary Exercise Testing (standard metabolic cart)
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Weeks 1 and 6
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Fatigue
Délai: Week 0, week 3, post-intervention (after 6 week intervention)
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Fatigue Severity Scale-7; total score range: 7-49, higher scores = greater fatigue severity
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Week 0, week 3, post-intervention (after 6 week intervention)
|
Global Health
Délai: Week 0, week 3, post-intervention (after 6 week intervention)
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PROMIS Global Health-10; Global physical health total score range: 4-20, higher scores = better global physical health
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Week 0, week 3, post-intervention (after 6 week intervention)
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Psychological Symptoms
Délai: Week 0, week 3, post-intervention (after 6 week intervention)
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Depression Anxiety and Stress Scale-21; Depression total score range: 0-21, higher scores = greater depressive symptoms
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Week 0, week 3, post-intervention (after 6 week intervention)
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Affect
Délai: Week 0, week 3, post-intervention (after 6 week intervention)
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Positive and Negative Affect Schedule; 2 subscales; each with score range 10-50, higher = greater positive or negative affect
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Week 0, week 3, post-intervention (after 6 week intervention)
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Anxiety Sensitivity
Délai: Week 0, week 3, post-intervention (after 6 week intervention)
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Anxiety Sensitivity Index-3; Total score range: 0-72, higher scores = higher levels of anxiety sensitivity
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Week 0, week 3, post-intervention (after 6 week intervention)
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Distress Tolerance
Délai: Week 0, week 3, post-intervention (after 6 week intervention)
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Distress Tolerance Scale; total score range: 15-75, higher scores = higher levels of distress tolerance
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Week 0, week 3, post-intervention (after 6 week intervention)
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Discomfort Intolerance
Délai: Week 0, week 3, post-intervention (after 6 week intervention)
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Discomfort Intolerance Scale-Revised; total score range: 0-126, higher scores = higher levels of discomfort intolerance
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Week 0, week 3, post-intervention (after 6 week intervention)
|
Physical Activity Acceptance
Délai: Week 0, week 3, post-intervention (after 6 week intervention)
|
Physical Activity Acceptance Questionnaire; total score range: 10-70, higher scores = greater physical activity acceptance
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Week 0, week 3, post-intervention (after 6 week intervention)
|
Exercise Self-Efficacy
Délai: Week 0, week 3, post-intervention (after 6 week intervention)
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Multidimensional Self-Efficacy Scale; total score range: 0-90, higher scores = higher levels of exercise self-efficacy
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Week 0, week 3, post-intervention (after 6 week intervention)
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Exercise Motivation
Délai: Week 0, week 3, post-intervention (after 6 week intervention)
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Behavioral Regulation towards Exercise Questionnaire-2; 5 subscales, each with score range: 0-16, higher scores = higher levels of regulation
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Week 0, week 3, post-intervention (after 6 week intervention)
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Exercise Barriers
Délai: Week 0, week 3, post-intervention (after 6 week intervention)
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Exercise Benefits and Barriers Scale; 2 subscales; Exercise benefits subscale score range: 29-116, higher scores = higher perceived benefit from exercise; Exercise barriers subscale score range: 14-56, higher scores = higher perceived barriers to exercise
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Week 0, week 3, post-intervention (after 6 week intervention)
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Physical Activity
Délai: Week 0, week 3, post-intervention (after 6 week intervention)
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Godin Leisure Time Exercise Questionnaire; open-ended responses, higher scores = greater activity time
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Week 0, week 3, post-intervention (after 6 week intervention)
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Trait Mindfulness
Délai: Week 0, week 3, post-intervention (after 6 week intervention)
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Five Facet Mindfulness Questionnaire; 5 subscales; Observe subscale score range: 8-40, higher scores = greater observing skills; Describe subscale score range: 8-40, higher scores = greater describing skills; Acting with Awareness subscale score range: 8-40, higher scores = greater awareness skills; Nonjudgment subscale score range: 8-40, higher scores = greater nonjudgment skills; Nonreactivity subscale score range: 7-35, higher scores = greater nonreactivity skills
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Week 0, week 3, post-intervention (after 6 week intervention)
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State Mindfulness
Délai: Weeks 1, 3, 6
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State Mindfulness Scale for Physical Activity; 2 subscales, each with score range: 0-24, higher scores = higher levels of mindfulness
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Weeks 1, 3, 6
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Interoceptive Awareness
Délai: Week 0, week 3, post-intervention (after 6 week intervention)
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Multidimensional Assessment of Interoceptive Awareness; 8 subscales, each with score ranges: 0-5, higher scores = better
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Week 0, week 3, post-intervention (after 6 week intervention)
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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
9 janvier 2019
Achèvement primaire (Réel)
7 juillet 2021
Achèvement de l'étude (Réel)
20 octobre 2021
Dates d'inscription aux études
Première soumission
23 janvier 2018
Première soumission répondant aux critères de contrôle qualité
9 février 2018
Première publication (Réel)
19 février 2018
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
26 mai 2022
Dernière mise à jour soumise répondant aux critères de contrôle qualité
20 mai 2022
Dernière vérification
1 mai 2022
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 2018P000014
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
NON
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
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