- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02616809
Effects of Standing and Light-intensity Activity on Ambulatory Blood Pressure and Blood Glucose
November 27, 2015 updated by: Noe Crespo, Arizona State University
This study aims to test the short-term effects of intermittent standing, slow cycling and slow walking, compared to sitting, on continuous blood glucose and ambulatory blood pressure among pre-hypertensive and pre-diabetic adults.
Study Overview
Status
Completed
Conditions
Detailed Description
This study will enroll 10 adults who will each complete four experimental conditions in random order.
Each of the four experimental conditions are as follows: 1) sit continuously for 8 hours in a simulated office environment, 2) break-up sitting time with standing based on set hourly intervals, 3) break-up sitting time with slow-walking on a treadmill desk based on set hourly intervals, 4) increase energy expenditure by slow cycling based on set hourly intervals.
Participants will completed each condition one week apart and dietary intake will be standardized by giving participants the same meals during each intervention condition.
Study measures will include: anthropometrics (height and weight), blood pressure, fasting glucose, 24-continuous glucose monitoring, full-day ambulatory blood pressure monitoring, cognitive testing (cognitive performance), energy expenditure, physical activity via accelerometer, sleep via accelerometer, and heart rate.
Study Type
Interventional
Enrollment (Actual)
10
Phase
- Phase 3
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 55 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- pre-hypertensive (systolic blood pressure 120-139 mmHg, or diastolic blood pressure 80-89 mmHg)
- impaired fasting glucose (5.6-6.9 mmil/L)
- not meeting the physical activity guidelines for adults (>=150 min/wk of moderate-to-vigorous physical activity)
Exclusion Criteria:
- smoking, pregnancy, known coronary heart disease, orthopedic limitations for performing physical activity, taking medications to control high blood pressure or high blood glucose, special dietary requirements, and being advised by a doctor to avoid prolonged periods of sitting.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Non-Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Sitting
Participants will sit continuously for 8 hours in a simulated office environment
|
Participants will sit continuously for 8-hrs during a simulated office environment
|
|
Experimental: slow cycling
Participants will cycle at regular hourly intervals during an 8-hr simulated office environment
|
Participants will cycle slowly while seated in prescribed hourly intervals.
This condition will increase energy expenditure while keeping a sitting posture
|
|
Experimental: standing
Participants will change posture (from sitting to standing) during hourly intervals for an 8-hr period in a simulated office environment
|
Participants will transition from sitting to standing in prescribed hourly intervals.
This condition will change posture (sit to stand) while maintaining low energy expenditure
|
|
Experimental: slow walking
Participants will transition from sitting to slow walking on a treadmill desk at regular hourly intervals during an 8-hr period in a simulated office environment
|
Participants will transition from sitting to a walking workstation in prescribed hourly intervals.
This condition will both increase energy expenditure and change posture.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Evidence of change in blood pressure following changes in posture and increasing energy expenditure
Time Frame: single-day intervention
|
single-day intervention
|
|
Evidence of change in blood glucose following changes in posture and increasing energy expenditure
Time Frame: single-day intervention
|
single-day intervention
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2014
Primary Completion (Actual)
April 1, 2015
Study Completion (Actual)
April 1, 2015
Study Registration Dates
First Submitted
November 24, 2015
First Submitted That Met QC Criteria
November 27, 2015
First Posted (Estimate)
November 30, 2015
Study Record Updates
Last Update Posted (Estimate)
November 30, 2015
Last Update Submitted That Met QC Criteria
November 27, 2015
Last Verified
November 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1306009298
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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