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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

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
      • 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:

  1. Referred by healthcare provider and given medical clearance for moderate-intensity exercise
  2. 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
  3. Between the ages of 18-65
  4. No regular physical activity (≥ 3 or more days per week) for the past 3 months

Exclusion Criteria:

  1. 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)
  2. Confirmed diagnosis of coronary artery disease
  3. Confirmed diagnosis of diabetes
  4. Currently taking a beta blocker or calcium channel blocker medication
  5. Uncontrolled and untreated hypertension, defined as a resting blood pressure of 150/90
  6. Confirmed diagnosis of chronic obstructive pulmonary disease or other severe lung dysfunction that may interfere with exercise (e.g., severe asthma)
  7. Self-reported psychotic disorder
  8. 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.
  9. 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
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

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

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Prenumerera