NCT02616809

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for phase_3 diabetes

Timeline
Completed

Started Jul 2014

Shorter than P25 for phase_3 diabetes

Status
completed

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

Study Start

First participant enrolled

July 1, 2014

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2015

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

November 24, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 30, 2015

Completed
Last Updated

November 30, 2015

Status Verified

November 1, 2015

Enrollment Period

9 months

First QC Date

November 24, 2015

Last Update Submit

November 27, 2015

Conditions

Outcome Measures

Primary Outcomes (2)

  • Evidence of change in blood pressure following changes in posture and increasing energy expenditure

    single-day intervention

  • Evidence of change in blood glucose following changes in posture and increasing energy expenditure

    single-day intervention

Study Arms (4)

Sitting

EXPERIMENTAL

Participants will sit continuously for 8 hours in a simulated office environment

Other: Maintaining posture and energy expenditure

slow cycling

EXPERIMENTAL

Participants will cycle at regular hourly intervals during an 8-hr simulated office environment

Other: Increasing energy expenditure

standing

EXPERIMENTAL

Participants will change posture (from sitting to standing) during hourly intervals for an 8-hr period in a simulated office environment

Other: Changing posture

slow walking

EXPERIMENTAL

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

Other: Increasing energy expenditure and changing posture

Interventions

Participants will sit continuously for 8-hrs during a simulated office environment

Sitting

Participants will cycle slowly while seated in prescribed hourly intervals. This condition will increase energy expenditure while keeping a sitting posture

slow cycling

Participants will transition from sitting to standing in prescribed hourly intervals. This condition will change posture (sit to stand) while maintaining low energy expenditure

standing

Participants will transition from sitting to a walking workstation in prescribed hourly intervals. This condition will both increase energy expenditure and change posture.

slow walking

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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)

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Diabetes MellitusHypertension

Interventions

Energy Metabolism

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Metabolism

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

November 24, 2015

First Posted

November 30, 2015

Study Start

July 1, 2014

Primary Completion

April 1, 2015

Study Completion

April 1, 2015

Last Updated

November 30, 2015

Record last verified: 2015-11