Treadmill Exercise in Metabolic Syndrome
Panoramica dello studio
Stato
Stato
Condizioni
Condizioni
Intervento / Trattamento
Intervento / Trattamento
Tipo di studio
Tipo di studio
Iscrizione (Effettivo)
Iscrizione
Fase
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
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Massachusetts
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Boston, Massachusetts, Stati Uniti, 02215
- BIDMC
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Criteri di partecipazione
Criteri di ammissibilità
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Altro
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Separare
Numero di armi
Armi e interventi
Gruppo di partecipanti / ArmGruppo di partecipanti / Arm |
Intervento / TrattamentoIntervento / Trattamento |
|---|---|
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Comparatore attivo: Esercizio su tapis roulant
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12-session, 6-week traditional treadmill exercise program
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Sperimentale: 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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Cosa sta misurando lo studio?
Misure di risultato primarie
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Recruitment Feasibility
Lasso di tempo: 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
Lasso di tempo: Through study completion, an average of 1 year
|
% sessions attended
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Through study completion, an average of 1 year
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Misure di risultato secondarie
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Cardiopulmonary Dynamics
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
|
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Exercise Self-Efficacy
Lasso di tempo: Week 0, week 3, post-intervention (after 6 week intervention)
|
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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
|
Collaboratori e investigatori
Sponsor
Sponsor
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Studia le date principali
Inizio studio (Effettivo)
Inizio studio
Completamento primario (Effettivo)
Completamento primario
Completamento dello studio (Effettivo)
Completamento dello studio
Date di iscrizione allo studio
Primo inviato
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Primo Inserito
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento pubblicato
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
Altri numeri di identificazione dello studio
- 2018P000014
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