- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT03435315
Treadmill Exercise in Metabolic Syndrome
20 maj 2022 uppdaterad av: 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.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Studietyp
Interventionell
Inskrivning (Faktisk)
12
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
Massachusetts
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Boston, Massachusetts, Förenta staterna, 02215
- BIDMC
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år till 65 år (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Övrig
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / 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
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
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
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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
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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
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Weeks 1, 3, 6
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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
Det är här du hittar personer och organisationer som är involverade i denna studie.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
9 januari 2019
Primärt slutförande (Faktisk)
7 juli 2021
Avslutad studie (Faktisk)
20 oktober 2021
Studieregistreringsdatum
Först inskickad
23 januari 2018
Först inskickad som uppfyllde QC-kriterierna
9 februari 2018
Första postat (Faktisk)
19 februari 2018
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
26 maj 2022
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
20 maj 2022
Senast verifierad
1 maj 2022
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 2018P000014
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
NEJ
Läkemedels- och apparatinformation, studiedokument
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Nej
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Nej
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