NCT02088827

Brief Summary

The rates of sedentary activity are increasing. Studies have shown that time spent on doing sedentary activities is an independent risk factor for cardiovascular disease. Prior studies have shown that interrupting inactivity improved the body's handling of blood glucose and gene expression. The investigators plan to explore this further by examining the effects of interrupting 4 hours of inactivity with 2 minutes of moderate intensity exercise every 20 minutes on the following metabolic parameters: blood pressure, cortisol, C-Reactive Protein, glucose and insulin levels.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 13, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 17, 2014

Completed
10 months until next milestone

Study Start

First participant enrolled

January 1, 2015

Completed
5.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 12, 2020

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2021

Completed
Last Updated

November 2, 2022

Status Verified

October 1, 2022

Enrollment Period

5.4 years

First QC Date

March 13, 2014

Last Update Submit

October 31, 2022

Conditions

Keywords

ExerciseSedentary BehaviourType 2 DiabetesOlder Adults

Outcome Measures

Primary Outcomes (1)

  • Blood Pressure

    every 60 minutes for 4 hours

Secondary Outcomes (3)

  • C Reactive Protein

    every 60 minutes for 4 hours

  • Insulin Levels

    every 60 minutes for 4 hours

  • Blood glucose levels

    every 60 minutes for 4 hours

Study Arms (2)

Activity

OTHER

During a 4 hour Meal Test subjects will cycle for 2 minutes every 20 minutes

Other: Activity

Inactivity

OTHER

During a 4 hour Meal Test study subjects will remain inactive (remain lying on a bed)

Other: Inactivity

Interventions

Subjects will remain inactive (lying on a bed) for 4 hours.

Inactivity

Subjects will spend 4 hours of inactivity (lying on a bed) broken up by 2 minutes of moderate intensity biking (on a stationary bike) every 20 minutes.

Activity

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • years of age or older
  • type 2 diabetes managed with diet or oral hypoglycemic agents

You may not qualify if:

  • using insulin to manage diabetes
  • baseline of pre-session blood glucose reading equal to or greater than 10 mmol/L
  • any medical condition that would limit the ability to perform activity portion of the study
  • people not comfortable exercising on a stationary bicycle
  • subject answers yes to one of more of the questions in the Physical Activity Readiness Questionnaire

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gerontology Research Lab

Vancouver, British Columbia, V5Z 1M9, Canada

Location

MeSH Terms

Conditions

Sedentary BehaviorDiabetes Mellitus, Type 2Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

BehaviorDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Kenneth M Madden, MSc, MD

    University of British Columbia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head, VGH Division of Geriatric Medicine

Study Record Dates

First Submitted

March 13, 2014

First Posted

March 17, 2014

Study Start

January 1, 2015

Primary Completion

May 12, 2020

Study Completion

September 1, 2021

Last Updated

November 2, 2022

Record last verified: 2022-10

Data Sharing

IPD Sharing
Will not share

Locations