Effects of Standing and Light-intensity Activity on Ambulatory Blood Pressure and Blood Glucose

Hypertension Clinical Trial

Official title:

Effects of Standing and Light-intensity Activity on Ambulatory Blood Pressure and Blood Glucose

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02616809
• Other study ID #: 1306009298
• Status: Completed
• Phase: Phase 3
• First received: November 24, 2015
• Last updated: November 27, 2015
• Start date: July 2014
• Est. completion date: April 2015

Study information

• Verified date: November 2015
• Source: Arizona State University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: April 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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 Design

Allocation: Non-Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Diabetes
• Hypertension
• Sleep

Intervention

Other:
• Maintaining posture and energy expenditure
Participants will sit continuously for 8-hrs during a simulated office environment
• Increasing energy expenditure
Participants will cycle slowly while seated in prescribed hourly intervals. This condition will increase energy expenditure while keeping a sitting posture
• Changing posture
Participants will transition from sitting to standing in prescribed hourly intervals. This condition will change posture (sit to stand) while maintaining low energy expenditure
• Increasing energy expenditure and changing posture
Participants will transition from sitting to a walking workstation in prescribed hourly intervals. This condition will both increase energy expenditure and change posture.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Arizona State University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evidence of change in blood pressure following changes in posture and increasing energy expenditure		single-day intervention	No
Primary	Evidence of change in blood glucose following changes in posture and increasing energy expenditure		single-day intervention	No