NCT01962857

Brief Summary

A number of studies have shown that short duration, high intensity interval training can improve health-related outcomes, such as insulin sensitivity and cardiorespiratory fitness. However, these often use specialized equipment, such as cycle ergometers, which makes it difficult to roll these interventions out for wide-scale use in the general population. This study aims evaluate the effects of a high intensity shuttle running intervention on insulin sensitivity, fitness and related cardiometabolic risk factors in men who are currently inactive. Participants will be randomized into intervention (4 weeks of shuttle running) and control groups. We hypothesize that the shuttle running programme will result in improved insulin sensitivity, fitness and increased fat oxidation at rest compared with the control group.

Trial Health

33
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Trial recruitment is currently suspended
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
suspended

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

October 1, 2013

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

October 8, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 14, 2013

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2017

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

June 3, 2016

Status Verified

June 1, 2016

Enrollment Period

3.8 years

First QC Date

October 8, 2013

Last Update Submit

June 2, 2016

Conditions

Insulin ResistanceObesityMetabolic Syndrome

Keywords

Physical activityExerciseInsulin resistanceHigh intensity interval trainingFat oxidationFitnessLipidsBlood pressure

Outcome Measures

Primary Outcomes (1)

  • Insulin sensitivity

    Assessed from glucose and insulin concentrations in fasted state and during oral glucose tolerance test.

    Change from baseline immediately post-intervention (4 weeks after baseline)

Secondary Outcomes (7)

  • Resting substrate utilization

    Change from baseline immediately post-intervention (4 weeks after baseline)

  • Endurance exercise performance

    Change from baseline immediately post-intervention (4 weeks after baseline)

  • Sprint exercise performance

    Change from baseline immediately post-intervention (4 weeks after baseline)

  • Body weight

    Change from baseline immediately post-intervention (4 weeks after baseline)

  • Waist circumference

    Change from baseline immediately post-intervention (4 weeks after baseline)

  • +2 more secondary outcomes

Other Outcomes (1)

  • Objectively measured physical activity

    Change from baseline to week 4 of intervention

Study Arms (2)

Exercise

EXPERIMENTAL

4 week supervised high-intensity shuttle running intervention, with 3 sessions per week (12 sessions in total)

Behavioral: Exercise

Control

NO INTERVENTION

No intervention - participants maintain usual lifestyle

Interventions

ExerciseBEHAVIORAL

4-week supervised high intensity shuttle running intervention, 3 sessions per week (12 sessions in total)

Exercise

Eligibility Criteria

Age18 Years - 40 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • male
  • years
  • undertaking \< 1 hour per week of planned exercise

You may not qualify if:

  • BMI \> 35 kg/m2
  • Blood pressure \> 160/90 mm Hg (on anti-hypertensive medication)
  • history of established coronary heart disease
  • family history of early cardiac death (\<40 years)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Glasgow

Glasgow, G12 8QQ, United Kingdom

Location

MeSH Terms

Conditions

Insulin ResistanceObesityMetabolic SyndromeMotor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

HyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesOverweightOvernutritionNutrition DisordersBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Jason Gill, PhD

    University of Glasgow

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Reader in Exercise Metabolism

Study Record Dates

First Submitted

October 8, 2013

First Posted

October 14, 2013

Study Start

October 1, 2013

Primary Completion

July 1, 2017

Study Completion

December 1, 2017

Last Updated

June 3, 2016

Record last verified: 2016-06

Locations

GB(1)