NCT02444377

Brief Summary

Purpose: The purpose of this study would be to evaluate the effects of interval training on cardiovascular health, lipid profile and body composition in overweight and obese men and women. A secondary purpose will be to compare lab based measurements of body composition \[4-compartment model (4C)) with portable equipment \[bioelectrical impedance spectroscopy (BIS) and ultrasound (US)\] Participants: Seventy-six men and women (age 18-55 yrs; BMI 25-45 kg/m2) will be randomly assigned to a high-intensity short interval group (SIT), high-intensity long interval group (HIT) or a control group (CON). Procedures (methods): Participants will be assessed for peak oxygen utilization (VO2peak), blood lipids, glucose and insulin levels. Body composition will also be measured using a 4C model, as measured from dual energy x-ray absorptiometry (DEXA), air displacement plethysmography (BodPod), and BIS, in comparison to US values. Participants assigned to either training group will undergo 3 weeks of interval training, 3 days per week. SIT will complete 10 bouts of a series of 1 min cycling with 1 min rest periods at 90% of the power output obtained during VO2peak;in comparison HIT will complete 5 bouts of the same protocol: 2 min bouts with 1 min recovery at varying intensities of VO2peak (80-100% power output).

Trial Health

100
On Track

Trial Health Score

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

Enrollment
76

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2012

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

Study Start

First participant enrolled

August 1, 2012

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2014

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

May 11, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 14, 2015

Completed
Last Updated

November 30, 2016

Status Verified

May 1, 2015

Enrollment Period

1.7 years

First QC Date

May 11, 2015

Last Update Submit

November 29, 2016

Conditions

Outcome Measures

Primary Outcomes (1)

  • Cardiorespiratory Fitness (VO2peak)

    3 weeks

Secondary Outcomes (2)

  • Body Composition

    3 weeks

  • Blood Lipids

    3 weeks

Study Arms (3)

High-intensity interval -2min

EXPERIMENTAL

5 bouts of 2 min cycling at varying intensities of VO2peak (80-100%) with 1 min recovery.

Behavioral: Interval training

High-intensity interval -1min

EXPERIMENTAL

10 bouts of 1 min cycling at 90% of VO2peak with 1 min rest periods

Behavioral: Interval training

Control

NO INTERVENTION

No exercise

Interventions

High-intensity interval -1minHigh-intensity interval -2min

Eligibility Criteria

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

You may qualify if:

  • written and dated informed consent to participate in the study.
  • willing and able to comply with the protocol.
  • good health as determined by a health and exercise status questionnaire
  • normal electrocardiogram (ECG), and physical.
  • body mass index of 25-45 kg/m 2.
  • has been cleared for participation by a physician (either study or personal).

You may not qualify if:

  • participating in another clinical trial or have received an investigational product within thirty days prior to enrollment.
  • has lost ten or more pounds during the previous three months and maintained the weight loss.
  • significant history or current presence of untreated high blood pressure (BP) \[systolic BP\> 140 mmHg and/or diastolic BP\> 90 mmHg\], thyroid disease, tachyarrhythmia, heart disease, kidney disease, or liver disease. Subject currently suffers from/or has a known history of (or is currently being treated for) clinical depression or an eating disorder(s).
  • has any medical condition or uses any medication, nutritional product, dietary supplement or program, which in the opinion of the investigator, might interfere with the conduct of the study or place the subject at risk.
  • are identified as moderate to high risk individuals by the American College of Sports Medicine will be excluded from the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Obesity, Metabolically Benign

Interventions

High-Intensity Interval Training

Condition Hierarchy (Ancestors)

ObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Physical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 11, 2015

First Posted

May 14, 2015

Study Start

August 1, 2012

Primary Completion

April 1, 2014

Study Completion

April 1, 2014

Last Updated

November 30, 2016

Record last verified: 2015-05