Metabolic SyndromeNCT03435315
Treadmill Exercise in Metabolic Syndrome
A study testing Treadmill Exercise- behavioral approach and Treadmill Exercise- traditional approach in people with Metabolic Syndrome, run by Beth Israel Deaconess Medical Center at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Metabolic Syndrome
- What is being tested?
- Treadmill Exercise- behavioral approach and Treadmill Exercise- traditional approach
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Jan 2019to 20 Oct 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Metabolic Syndrome
- Being tested
- Treadmill Exercise- behavioral approach, Treadmill Exercise- traditional approach
- Medical subject headings
- Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treadmill Exercise- behavioral approachOther
12-session, 6-week treadmill exercise program utilizing behavioral techniques while walking
Treadmill Exercise- traditional approachOther
12-session, 6-week traditional treadmill exercise program
| Study group | Role | What they receive |
|---|---|---|
| Treadmill exercise | Active comparator | Not described Receives: Other: Treadmill Exercise- traditional approach |
| Treadmill exercise with behavioral techniques | Experimental | Not described Receives: Other: Treadmill Exercise- behavioral approach |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment Feasibility
% willing to be randomized
Measured: Through study completion, an average of 1 year
Protocol Adherence
% sessions attended
Measured: Through study completion, an average of 1 year
Secondary outcomes (16)
Cardiopulmonary Dynamics
CardioPulmonary Exercise Testing (standard metabolic cart)
Measured: Weeks 1 and 6
Fatigue
Fatigue Severity Scale-7; total score range: 7-49, higher scores = greater fatigue severity
Measured: Week 0, week 3, post-intervention (after 6 week intervention)
Global Health
PROMIS Global Health-10; Global physical health total score range: 4-20, higher scores = better global physical health
Measured: Week 0, week 3, post-intervention (after 6 week intervention)
Psychological Symptoms
Depression Anxiety and Stress Scale-21; Depression total score range: 0-21, higher scores = greater depressive symptoms
Measured: Week 0, week 3, post-intervention (after 6 week intervention)
Affect
Positive and Negative Affect Schedule; 2 subscales; each with score range 10-50, higher = greater positive or negative affect
Measured: Week 0, week 3, post-intervention (after 6 week intervention)
Anxiety Sensitivity
Anxiety Sensitivity Index-3; Total score range: 0-72, higher scores = higher levels of anxiety sensitivity
Measured: Week 0, week 3, post-intervention (after 6 week intervention)
Distress Tolerance
Distress Tolerance Scale; total score range: 15-75, higher scores = higher levels of distress tolerance
Measured: Week 0, week 3, post-intervention (after 6 week intervention)
Discomfort Intolerance
Discomfort Intolerance Scale-Revised; total score range: 0-126, higher scores = higher levels of discomfort intolerance
Measured: Week 0, week 3, post-intervention (after 6 week intervention)
Physical Activity Acceptance
Physical Activity Acceptance Questionnaire; total score range: 10-70, higher scores = greater physical activity acceptance
Measured: Week 0, week 3, post-intervention (after 6 week intervention)
Exercise Self-Efficacy
Multidimensional Self-Efficacy Scale; total score range: 0-90, higher scores = higher levels of exercise self-efficacy
Measured: Week 0, week 3, post-intervention (after 6 week intervention)
Exercise Motivation
Behavioral Regulation towards Exercise Questionnaire-2; 5 subscales, each with score range: 0-16, higher scores = higher levels of regulation
Measured: Week 0, week 3, post-intervention (after 6 week intervention)
Exercise Barriers
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
Measured: Week 0, week 3, post-intervention (after 6 week intervention)
Physical Activity
Godin Leisure Time Exercise Questionnaire; open-ended responses, higher scores = greater activity time
Measured: Week 0, week 3, post-intervention (after 6 week intervention)
Trait Mindfulness
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
Measured: Week 0, week 3, post-intervention (after 6 week intervention)
State Mindfulness
State Mindfulness Scale for Physical Activity; 2 subscales, each with score range: 0-24, higher scores = higher levels of mindfulness
Measured: Weeks 1, 3, 6
Interoceptive Awareness
Multidimensional Assessment of Interoceptive Awareness; 8 subscales, each with score ranges: 0-5, higher scores = better
Measured: Week 0, week 3, post-intervention (after 6 week intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2018
- Study start9 Jan 2019
- Primary completion7 Jul 2021
- Study completion20 Oct 2021
Why it stopped: Stopped prior to enrolling anticipated sample size due to COVID-19
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic SyndromeStudies of the same condition, open and under way.
- More trials run by Beth Israel Deaconess Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beth Israel Deaconess Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gloria Y. Yeh, Beth Israel Deaconess Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03435315
- Sponsor's protocol ID
- 2018P000014
- Status last verified
- May 2022
- First submitted
- 23 Jan 2018
- Last updated
- 26 May 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treadmill Exercise in Metabolic Syndrome
- ClinicalTrials.gov ID
- NCT03435315
- Acronym / sponsor ID
- 2018P000014
- Conditions
- Metabolic Syndrome
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Stopped prior to enrolling anticipated sample size due to COVID-19
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Beth Israel Deaconess Medical CenterUniversity, hospital or other
- Study start
- 9 Jan 2019 (actual)
- Primary completion
- 7 Jul 2021 (actual)
- Study completion
- 20 Oct 2021 (actual)
- First posted
- 19 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treadmill exercise | Active comparator | Other: Treadmill Exercise- traditional approach |
| Treadmill exercise with behavioral techniques | Experimental | Other: Treadmill Exercise- behavioral approach |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Referred by healthcare provider and given medical clearance for moderate-intensity exercise
- Metabolic syndrome, defined as meeting three or more of the following criteria:
- Between the ages of 18-65
- No regular physical activity (≥ 3 or more days per week) for the past 3 months
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Treadmill Exercise- behavioral approach12-session, 6-week treadmill exercise program utilizing behavioral techniques while walking | Other | Treadmill exercise with behavioral techniques |
| Treadmill Exercise- traditional approach12-session, 6-week traditional treadmill exercise program | Other | Treadmill exercise |
Primary outcome
Recruitment Feasibility
Time frame: Through study completion, an average of 1 year
% willing to be randomized
Protocol Adherence
Time frame: Through study completion, an average of 1 year
% sessions attended
16 secondary outcomes
Cardiopulmonary Dynamics
Time frame: Weeks 1 and 6
Fatigue
Time frame: Week 0, week 3, post-intervention (after 6 week intervention)
Global Health
Time frame: Week 0, week 3, post-intervention (after 6 week intervention)
Psychological Symptoms
Time frame: Week 0, week 3, post-intervention (after 6 week intervention)
Affect
Time frame: Week 0, week 3, post-intervention (after 6 week intervention)
Anxiety Sensitivity
Time frame: Week 0, week 3, post-intervention (after 6 week intervention)
Distress Tolerance
Time frame: Week 0, week 3, post-intervention (after 6 week intervention)
Discomfort Intolerance
Time frame: Week 0, week 3, post-intervention (after 6 week intervention)
Physical Activity Acceptance
Time frame: Week 0, week 3, post-intervention (after 6 week intervention)
Exercise Self-Efficacy
Time frame: Week 0, week 3, post-intervention (after 6 week intervention)
Exercise Motivation
Time frame: Week 0, week 3, post-intervention (after 6 week intervention)
Exercise Barriers
Time frame: Week 0, week 3, post-intervention (after 6 week intervention)
Physical Activity
Time frame: Week 0, week 3, post-intervention (after 6 week intervention)
Trait Mindfulness
Time frame: Week 0, week 3, post-intervention (after 6 week intervention)
State Mindfulness
Time frame: Weeks 1, 3, 6
Interoceptive Awareness
Time frame: Week 0, week 3, post-intervention (after 6 week intervention)
Results and safety
The study was stopped early (reason given: Stopped prior to enrolling anticipated sample size due to COVID-19). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Treadmill Exercise- behavioral approach and Treadmill Exercise- traditional approach in people with Metabolic Syndrome, run by Beth Israel Deaconess Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 26 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Stopped prior to enrolling anticipated sample size due to COVID-19). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment Feasibility (time frame: Through study completion, an average of 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 May 2022.