Treadmill Exercise in Metabolic Syndrome
Descripción general del estudio
Estado
Estado
Condiciones
Condiciones
Intervención / Tratamiento
Intervención / Tratamiento
Tipo de estudio
Tipo de estudio
Inscripción (Actual)
Inscripción
Fase
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Massachusetts
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Boston, Massachusetts, Estados Unidos, 02215
- BIDMC
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Criterios de participación
Criterio de elegibilidad
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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 de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Otro
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Número de brazos
Armas e Intervenciones
Grupo de participantes/brazoGrupo de participantes/brazo |
Intervención / TratamientoIntervención / Tratamiento |
|---|---|
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Comparador activo: Ejercicio en caminadora
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12-session, 6-week traditional treadmill exercise program
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Experimental: 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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¿Qué mide el estudio?
Medidas de resultado primarias
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Recruitment Feasibility
Periodo de tiempo: Through study completion, an average of 1 year
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% willing to be randomized
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Through study completion, an average of 1 year
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Protocol Adherence
Periodo de tiempo: 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
|
Medidas de resultado secundarias
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Cardiopulmonary Dynamics
Periodo de tiempo: 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
Periodo de tiempo: 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)
|
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Global Health
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: Week 0, week 3, post-intervention (after 6 week intervention)
|
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
Periodo de tiempo: 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)
|
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Physical Activity Acceptance
Periodo de tiempo: Week 0, week 3, post-intervention (after 6 week intervention)
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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)
|
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Exercise Self-Efficacy
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: Week 0, week 3, post-intervention (after 6 week intervention)
|
Multidimensional Assessment of Interoceptive Awareness; 8 subscales, each with score ranges: 0-5, higher scores = better
|
Week 0, week 3, post-intervention (after 6 week intervention)
|
Colaboradores e Investigadores
Patrocinador
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Inicio del estudio
Finalización primaria (Actual)
Finalización primaria
Finalización del estudio (Actual)
Finalización del estudio
Fechas de registro del estudio
Enviado por primera vez
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Publicado por primera vez
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización publicada
Última actualización enviada que cumplió con los criterios de control de calidad
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
Otros números de identificación del estudio
- 2018P000014
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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