Study Stopped
Original PI changed institutions and COVID
Effects of Brisk Walking and Regular Intensity Exercise Interventions on Glycemic Control
1 other identifier
interventional
N/A
1 country
2
Brief Summary
Physical activity is shown to positively reduce the risk of developing both cardiovascular disease and type 2 diabetes. Current guidelines recommend 30-60 minutes of moderate intensity cardiorespiratory exercise five days per week. However, studies report that \<40% of young adults 18-24 years achieve the recommended weekly physical activity guidelines, and close to 40% of young adults are overweight or obese. Traditional aerobic exercise and high intensity exercise have been shown to improve glycemic control in young and middle-aged sedentary adults, however, long term implementation of such exercise regimens are difficult. Recent evidence suggests that short bouts (15 minutes) of moderate intensity walking following a meal, significantly improves glycemic control in older adults with impaired glucose control. Due to the low burden of walking on participants, moderate intensity post-meal walking might be a better alternative exercise intervention to improve overall health in a sedentary population. Therefore, the purpose of this pilot proposal is to determine if 15 minutes of post-meal walking is an effective intervention to improve glycemic control in sedentary young adults at risk for developing MetS. Additionally, the study will investigate whether ambulatory blood pressure profiles in obese young adults are disrupted.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Sep 2017
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 28, 2017
CompletedFirst Posted
Study publicly available on registry
July 24, 2017
CompletedStudy Start
First participant enrolled
September 7, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 8, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
November 8, 2024
CompletedNovember 12, 2024
November 1, 2024
7.2 years
June 28, 2017
November 8, 2024
Conditions
Outcome Measures
Primary Outcomes (2)
Determine whether ambulatory blood glucose control responses are improved following 28 days of exercise training (Post Training).
Examine blood glucose (mg/dL) responses during two oral glucose tolerance test (70g glucose drink). The first test will be measured at baseline (Base) and the second test will be measured following 28 days of exercise training. These two tests (Base vs Post Training) will be separated by an average of 32 days.
An average of 32 days will separate these two measurements.
Determine whether serum insulin (IU/mL) responses are improved following 28 days of exercise training (Post Training).
Examine serum insulin (IU/mL) responses during two oral glucose tolerance tests (70g glucose drink). The first test will be measured at baseline (Base) and the second test will be measured following 28 days of exercise training. These two tests (Base vs Post Training) will be separated by an average of 32 days.
An average of 32 days will separate these two measurements.
Secondary Outcomes (1)
Determine whether ambulatory blood pressure profiles are different following an average of 28 day exercise intervention compared to sedentary healthy controls.
An average of 28 days will separate these two measurements.
Study Arms (3)
Post-Meal Walking Group
EXPERIMENTALFollowing a 30-minute digestion period, the Post-Meal Walking Group will be instructed to walk following breakfast, lunch, and dinner at least 4 times per week (180 minutes of moderate intensity exercise/week). Participants will walk at a brisk pace for 15 minutes, as demonstrated in a previous study. A Garmin VivoFit activity monitor will measure their physical activity across the four-week intervention. The Garmin VivoFit activity monitor must be returned during the "Follow-up Study Visit".
Traditional Exercise Group
EXPERIMENTALThe Traditional Exercise Group will perform aerobic and light resistance training exercise over the 4-week intervention. A group of trained Exercise and Sports Physiology students will conduct the aerobic exercise and light resistance training program three times per week (180 minutes of moderate to high intensity exercise/week). Garmin VivoFit activity monitors will measure their physical activity across the four-week intervention. The Garmin VivoFit activity monitor must be returned during the "Follow-up Study Visit".
Case Control Group
NO INTERVENTIONThe participant will be instructed to maintain their current diet and levels of physical activity for four weeks. Participants in this group will wear an ambulatory blood pressure monitor at baseline and at follow-up. Any change in diet and physical activity level might significantly affect the study results. The Control Group will maintain their current lifestyle for four weeks. Garmin VivoFit activity monitors will measure their physical activity throughout the 4-week intervention. The Garmin VivoFit activity monitor must be returned during the "Follow-up Study Visit".
Interventions
The use of exercise to improve glycemic responses in young adults who are at risk for Metabolic Syndrome.
Eligibility Criteria
You may qualify if:
- Body mass index ≥ 30
- Currently not physically active
- Free of any signs and symptoms of cardiovascular disease, diabetes, chronic kidney disease, and cancer.
You may not qualify if:
- Planning to become pregnant
- Any known signs and symptoms of cardiovascular disease, diabetes, chronic kidney disease, and cancer.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Draper & Maynard
Plymouth, New Hampshire, 03264, United States
Plymouth State University
Plymouth, New Hampshire, 03264, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 28, 2017
First Posted
July 24, 2017
Study Start
September 7, 2017
Primary Completion
November 8, 2024
Study Completion
November 8, 2024
Last Updated
November 12, 2024
Record last verified: 2024-11
Data Sharing
- IPD Sharing
- Will not share