Treadmill Exercise in Metabolic Syndrome
Studieoversigt
Status
Status
Betingelser
Betingelser
Intervention / Behandling
Intervention / Behandling
Undersøgelsestype
Undersøgelsestype
Tilmelding (Faktiske)
Tilmelding
Fase
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
-
-
Massachusetts
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Boston, Massachusetts, Forenede Stater, 02215
- BIDMC
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-
Deltagelseskriterier
Berettigelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Andet
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Antal våben
Våben og indgreb
Deltagergruppe / ArmDeltagergruppe / Arm |
Intervention / BehandlingIntervention / Behandling |
|---|---|
|
Aktiv komparator: Løbebåndsøvelse
|
12-session, 6-week traditional treadmill exercise program
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Eksperimentel: 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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Hvad måler undersøgelsen?
Primære resultatmål
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Recruitment Feasibility
Tidsramme: Through study completion, an average of 1 year
|
% willing to be randomized
|
Through study completion, an average of 1 year
|
|
Protocol Adherence
Tidsramme: Through study completion, an average of 1 year
|
% sessions attended
|
Through study completion, an average of 1 year
|
Sekundære resultatmål
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Cardiopulmonary Dynamics
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
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Week 0, week 3, post-intervention (after 6 week intervention)
|
|
Distress Tolerance
Tidsramme: 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)
|
|
Discomfort Intolerance
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
|
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Exercise Barriers
Tidsramme: 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
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Week 0, week 3, post-intervention (after 6 week intervention)
|
|
Physical Activity
Tidsramme: Week 0, week 3, post-intervention (after 6 week intervention)
|
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)
|
|
Trait Mindfulness
Tidsramme: 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
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Week 0, week 3, post-intervention (after 6 week intervention)
|
|
State Mindfulness
Tidsramme: 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
Tidsramme: 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)
|
Samarbejdspartnere og efterforskere
Sponsor
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Studiestart
Primær færdiggørelse (Faktiske)
Primær færdiggørelse
Studieafslutning (Faktiske)
Studieafslutning
Datoer for studieregistrering
Først indsendt
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Først opslået
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering sendt
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
Andre undersøgelses-id-numre
- 2018P000014
Plan for individuelle deltagerdata (IPD)
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