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Clinical Trial Details — Status: Suspended

Administrative data

NCT number NCT01962857
Other study ID # FBLS1020
Secondary ID
Status Suspended
Phase N/A
First received October 8, 2013
Last updated June 2, 2016
Start date October 2013
Est. completion date December 2017

Study information

Verified date June 2016
Source University of Glasgow
Contact n/a
Is FDA regulated No
Health authority United Kingdom: Research Ethics Committee
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Suspended
Enrollment 30
Est. completion date December 2017
Est. primary completion date July 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years to 40 Years
Eligibility Inclusion Criteria:

- male

- 18-40 years

- undertaking < 1 hour per week of planned exercise

Exclusion Criteria:

- 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)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science


Intervention

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

Locations

Country Name City State
United Kingdom University of Glasgow Glasgow

Sponsors (1)

Lead Sponsor Collaborator
University of Glasgow

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Other Objectively measured physical activity Time spent sedentary and physically active assessed by accelerometer Change from baseline to week 4 of intervention No
Primary 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) No
Secondary Resting substrate utilization Metabolic rate and fat and carbohydrate oxidation estimated via indirect calorimetry Change from baseline immediately post-intervention (4 weeks after baseline) No
Secondary Endurance exercise performance Time taken to complete 100 x 10m shuttle runs Change from baseline immediately post-intervention (4 weeks after baseline) No
Secondary Sprint exercise performance Time taken to complete 10 x 10m shuttle runs Change from baseline immediately post-intervention (4 weeks after baseline) No
Secondary Body weight Change from baseline immediately post-intervention (4 weeks after baseline) No
Secondary Waist circumference Change from baseline immediately post-intervention (4 weeks after baseline) No
Secondary Percentage body fat Change from baseline immediately post-intervention (4 weeks after baseline) No
Secondary Clustered Cardiometabolic Risk Score Clustered Cardiometabolic Risk Score = -zHDL+zInsulin+zGlucose+zTriglycerides+( zBMI+zWC)/2+(zSBP+zDBP)/2. Change from baseline immediately post-intervention (4 weeks after baseline) No
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