NCT03980860

Brief Summary

The purpose of the study is to compare the effectiveness of two exercise programs (High Intensity Interval Training/HIIT and Low Intensity (LIT) Long Duration training) on decreasing fat mass and preserving lean body mass in obese patients. What the investigators are proposing is that HIIT is less effective because it will most likely decrease lean body mass in obese patients, whereas LIT decreases fat mass and conserves lean body tissue.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at below P25 for not_applicable obesity

Timeline
Completed

Started Jun 2019

Shorter than P25 for not_applicable obesity

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 5, 2019

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

June 6, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 10, 2019

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2019

Completed
Last Updated

October 25, 2019

Status Verified

October 1, 2019

Enrollment Period

4 months

First QC Date

June 6, 2019

Last Update Submit

October 24, 2019

Conditions

Outcome Measures

Primary Outcomes (2)

  • Body fat

    Reduction in body fat

    6 weeks

  • Lean body mass

    Retention of lean body mass

    6 weeks

Secondary Outcomes (1)

  • Blood pressure

    6 weeks

Study Arms (3)

HIIT (High Intensity Interval Training)

ACTIVE COMPARATOR

Subjects are undergoing high intensity interval training

Other: Exercise Type

Low intensity training long duration

ACTIVE COMPARATOR

Subjects are undergoing a lower intensity training program for a long duration

Other: Exercise Type

Control

NO INTERVENTION

No exercise program intervention (usual care)

Interventions

The implementation of 2 types of exercise programs to reduce body fat

HIIT (High Intensity Interval Training)Low intensity training long duration

Eligibility Criteria

Age18 Years - 89 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Anyone with a BMI of 25 and above

You may not qualify if:

  • Those that cannot exercise

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rowan SOM Family Medicine

Stratford, New Jersey, 08084, United States

Location

MeSH Terms

Conditions

ObesityHypertension

Interventions

Exercise Therapy

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

RehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy Modalities

Study Officials

  • Adarsh Gupta, DO

    Rowan University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Model Details: This is a case/control study comparing overweight/obese patients of three different groups (control, HIIT, LIT). The goal of a case/control is to show whether exposure to HIIT, two times a week for 6 weeks will decrease lean body mass versus control and LIT. If it turns out that lean body mass does decrease, then HIIT is not an effective exercise modality for overweight/obese patients, and in fact LIT or control may be a better option.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Family Medicine

Study Record Dates

First Submitted

June 6, 2019

First Posted

June 10, 2019

Study Start

June 5, 2019

Primary Completion

October 1, 2019

Study Completion

October 1, 2019

Last Updated

October 25, 2019

Record last verified: 2019-10

Locations