Treadmill Exercise in Metabolic Syndrome
Studieöversikt
Status
Status
Betingelser
Betingelser
Intervention / Behandling
Intervention / Behandling
Studietyp
Studietyp
Inskrivning (Faktisk)
Inskrivning
Fas
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
Massachusetts
-
Boston, Massachusetts, Förenta staterna, 02215
- BIDMC
-
-
Deltagandekriterier
Urvalskriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Övrig
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Enda
Antal vapen
Vapen och interventioner
Deltagargrupp / ArmDeltagargrupp / Arm |
Intervention / BehandlingIntervention / Behandling |
|---|---|
|
Aktiv komparator: Löpband träning
|
12-session, 6-week traditional treadmill exercise program
|
|
Experimentell: Treadmill exercise with behavioral techniques
|
12-session, 6-week treadmill exercise program utilizing behavioral techniques while walking
|
Vad mäter studien?
Primära resultatmått
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Recruitment Feasibility
Tidsram: Through study completion, an average of 1 year
|
% willing to be randomized
|
Through study completion, an average of 1 year
|
|
Protocol Adherence
Tidsram: Through study completion, an average of 1 year
|
% sessions attended
|
Through study completion, an average of 1 year
|
Sekundära resultatmått
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Cardiopulmonary Dynamics
Tidsram: Weeks 1 and 6
|
CardioPulmonary Exercise Testing (standard metabolic cart)
|
Weeks 1 and 6
|
|
Fatigue
Tidsram: Week 0, week 3, post-intervention (after 6 week intervention)
|
Fatigue Severity Scale-7; total score range: 7-49, higher scores = greater fatigue severity
|
Week 0, week 3, post-intervention (after 6 week intervention)
|
|
Global Health
Tidsram: Week 0, week 3, post-intervention (after 6 week intervention)
|
PROMIS Global Health-10; Global physical health total score range: 4-20, higher scores = better global physical health
|
Week 0, week 3, post-intervention (after 6 week intervention)
|
|
Psychological Symptoms
Tidsram: Week 0, week 3, post-intervention (after 6 week intervention)
|
Depression Anxiety and Stress Scale-21; Depression total score range: 0-21, higher scores = greater depressive symptoms
|
Week 0, week 3, post-intervention (after 6 week intervention)
|
|
Affect
Tidsram: Week 0, week 3, post-intervention (after 6 week intervention)
|
Positive and Negative Affect Schedule; 2 subscales; each with score range 10-50, higher = greater positive or negative affect
|
Week 0, week 3, post-intervention (after 6 week intervention)
|
|
Anxiety Sensitivity
Tidsram: Week 0, week 3, post-intervention (after 6 week intervention)
|
Anxiety Sensitivity Index-3; Total score range: 0-72, higher scores = higher levels of anxiety sensitivity
|
Week 0, week 3, post-intervention (after 6 week intervention)
|
|
Distress Tolerance
Tidsram: 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
|
Week 0, week 3, post-intervention (after 6 week intervention)
|
|
Discomfort Intolerance
Tidsram: Week 0, week 3, post-intervention (after 6 week intervention)
|
Discomfort Intolerance Scale-Revised; total score range: 0-126, higher scores = higher levels of discomfort intolerance
|
Week 0, week 3, post-intervention (after 6 week intervention)
|
|
Physical Activity Acceptance
Tidsram: 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
|
Week 0, week 3, post-intervention (after 6 week intervention)
|
|
Exercise Self-Efficacy
Tidsram: 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
|
Week 0, week 3, post-intervention (after 6 week intervention)
|
|
Exercise Motivation
Tidsram: Week 0, week 3, post-intervention (after 6 week intervention)
|
Behavioral Regulation towards Exercise Questionnaire-2; 5 subscales, each with score range: 0-16, higher scores = higher levels of regulation
|
Week 0, week 3, post-intervention (after 6 week intervention)
|
|
Exercise Barriers
Tidsram: Week 0, week 3, post-intervention (after 6 week intervention)
|
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
|
Week 0, week 3, post-intervention (after 6 week intervention)
|
|
Physical Activity
Tidsram: Week 0, week 3, post-intervention (after 6 week intervention)
|
Godin Leisure Time Exercise Questionnaire; open-ended responses, higher scores = greater activity time
|
Week 0, week 3, post-intervention (after 6 week intervention)
|
|
Trait Mindfulness
Tidsram: Week 0, week 3, post-intervention (after 6 week intervention)
|
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
|
Week 0, week 3, post-intervention (after 6 week intervention)
|
|
State Mindfulness
Tidsram: Weeks 1, 3, 6
|
State Mindfulness Scale for Physical Activity; 2 subscales, each with score range: 0-24, higher scores = higher levels of mindfulness
|
Weeks 1, 3, 6
|
|
Interoceptive Awareness
Tidsram: 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)
|
Samarbetspartners och utredare
Sponsor
Sponsor
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Studiestart
Primärt slutförande (Faktisk)
Primärt slutförande
Avslutad studie (Faktisk)
Avslutad studie
Studieregistreringsdatum
Först inskickad
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Första postat
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste uppdatering publicerad
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
Andra studie-ID-nummer
- 2018P000014
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