NCT03162978

Brief Summary

The purpose of this study is to research the effects of exercising at high intensities for short periods of time on exercise tolerance and motivation.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
66

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2017

Typical duration 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

May 19, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 22, 2017

Completed
6 months until next milestone

Study Start

First participant enrolled

November 29, 2017

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 21, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 21, 2019

Completed
Last Updated

April 11, 2025

Status Verified

April 1, 2025

Enrollment Period

1.9 years

First QC Date

May 19, 2017

Last Update Submit

April 8, 2025

Conditions

Keywords

Exercisebehavior economics

Outcome Measures

Primary Outcomes (2)

  • Change in relative reinforcing value (RRV) of physical activity

    RRV of physical activity will be assessed by evaluating the number of responses (mouse button presses) a subject is willing to complete to gain access to physical activity or a sedentary alternative.

    Week 0, Week 6, Week 10

  • Changes in preference for intense physical activity and tolerance for exercise discomfort

    Changes in preference for intense physical activity and tolerance for exercise discomfort will be assessed by self-report questionnaire responses to the Preference for and Tolerance of the Intensity of Exercise Questionnaire (PRETIE-Q). The PRETIE-Q measures preference for high intensity vs. low intensity exercise and ability to persist or tolerate the discomfort associationed with intense exercise. The PRETIE-Q consists of two subscales: Preference for Exercise Intensity and Tolerance of Exercise Intensity. Each subscale has 8 items rated on a 5 point response scale (range 8 - 40). Higher scores indicate greater preference for intense exercise and/or greater tolerance for exercise discomfort. Total scale scores are not used. Scale averages will be used.

    Week 0, Week 6, Week 10

Secondary Outcomes (15)

  • Change in minutes of physical activity, as assessed by activity tracker

    Week 0, Week 6, Week 10

  • Changes in quadriceps and hamstring (thigh muscle) strength assessed separately on each leg

    Week 0, Week 6, Week 10

  • Changes in aerobic fitness, as assessed using the Standardized Exponential Exercise Protocol (STEEP)

    Week 0, Week 6, Week 10

  • Changes in anaerobic power, as during a Wingate anaerobic power exercise test

    Week 0, Week 6, Week 10

  • Changes in fat mass as assessed by dual energy x-ray absorptiometry (DXA) scans

    Week 0, Week 6, Week 10

  • +10 more secondary outcomes

Study Arms (2)

HIIT + POE

EXPERIMENTAL

High-intensity interval training (HIIT) plus positive outcome expectations (POE) from participating in the exercise program.

Other: HIIT + POE

HIIT only

EXPERIMENTAL

High-intensity interval training (HIIT) only.

Other: HIIT only

Interventions

Subjects will participate in high-intensity interval training (HIIT) with an additional treatment component to increase positive outcome expectations (POE) of exercise.

HIIT + POE

Subjects will participate in high-intensity interval training (HIIT) only.

HIIT only

Eligibility Criteria

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

You may qualify if:

  • Body Mass Index of 25-35 kg/m2
  • Sedentary (not regularly engaging in exercise more than once per week)
  • Weight stable (have not lost or gained over 10 pounds of body weight in the past 3 months)

You may not qualify if:

  • Taking any medications that affect energy expenditure or treat high blood pressure
  • Tobacco use
  • Pregnant or breastfeeding or plan to become pregnant in the next 3 months
  • Have any medical conditions that prevent subject from safely exercising (e.g., orthopedic injuries, cardiovascular, liver, endocrine, or pulmonary diseases)
  • Resting systolic blood pressure ≥ 140 mmHg
  • Resting diastolic blood pressure ≥ 90 mmHg
  • Non-fasting plasma glucose of ≥ 200 mg/dl

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

USDA Grand Forks Human Nutrition Research Center

Grand Forks, North Dakota, 58203, United States

Location

Related Links

MeSH Terms

Conditions

OverweightObesityMotor Activity

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Study Officials

  • James N Roemmich, PhD

    USDA Grand Forks Human Nutrition Research Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 19, 2017

First Posted

May 22, 2017

Study Start

November 29, 2017

Primary Completion

October 21, 2019

Study Completion

October 21, 2019

Last Updated

April 11, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Locations