NCT03479177

Brief Summary

The purpose of this study is to examine the effect of a home-based high intensity interval training intervention on exercise among low active adults (defined as engaging in exercise 90 minutes or less per week). Participants will be randomly assigned to a HIIT-based intervention or a wait-list control each lasting 12 weeks (participants in the wait-list control condition will have the option of receiving the HIIT intervention following the 12 weeks).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable cardiovascular-diseases

Timeline
Completed

Started Jul 2018

Shorter than P25 for not_applicable cardiovascular-diseases

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

January 29, 2018

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 27, 2018

Completed
3 months until next milestone

Study Start

First participant enrolled

July 1, 2018

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2019

Completed
Last Updated

October 9, 2019

Status Verified

October 1, 2019

Enrollment Period

1.2 years

First QC Date

January 29, 2018

Last Update Submit

October 8, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • Exercise minutes per week

    Exercise minutes per week as assessed by an accelerometer for one week at baseline and 12 weeks. Higher reported minutes per week indicates a higher level of physical activity.

    Change from Baseline to 12 weeks

Secondary Outcomes (5)

  • Biometrics

    Change from Baseline to 12 weeks

  • Social Support for Exercise Questionnaire

    Change from Baseline to 12 weeks

  • Physical Activity Self-efficacy Questionnaire

    Change from Baseline to 12 weeks

  • Physical Activity Enjoyment Scale (PACES)

    Change from Baseline to 12 weeks

  • Outcome Expectancies Questionnaire

    Change from Baseline to 12 weeks

Study Arms (2)

High Intensity Interval Training

EXPERIMENTAL

The exercise group will participate in a home and telephone-based program consisting of a 12-week high intensity interval training workout (HIIT). The home-based exercise sessions will be prescribed by the program exercise counselor, with a goal to exercise three times per week. The program will be tailored to meet specific fitness and strength needs of the participant. The participant will receive weekly telephone calls during the first month and bi-weekly calls during months 2 and 3. At 12 weeks, participants in both the exercise and wait-list control group will complete online questionnaires. The ActiGraph will be returned to the University of Minnesota research staff via a pre-paid postage envelope.

Behavioral: High Intensity Interval Training

Wait-List Control Group

NO INTERVENTION

Participants in the wait-list control condition will have the option of receiving the exercise intervention program after completion of the final assessment.

Interventions

The exercise sessions will be based on exercises the participant can confidentially engage in (regular push-ups vs. knee push-ups vs. wall push-ups). The goal will be to engage in three exercise sessions per week. The participants will receive weekly telephone calls during the first month and bi-weekly calls during months 2 and 3. The exercise counselor will also engage in dialogue that will motivate the participant to exercise.

High Intensity Interval Training

Eligibility Criteria

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

You may qualify if:

  • and older
  • Exercising for 90 minutes or less each week
  • Access to the Internet

You may not qualify if:

  • A history of coronary heart disease (history of myocardial infarction, symptoms of angina)
  • Orthopedic problems that would limit physical activity participation
  • Diabetes
  • Stroke
  • Osteoarthritis
  • Any other medical condition that may make physical activity unsafe or unwise.
  • Current or planned pregnancy
  • Psychosis or current suicidal ideation
  • Psychiatric hospitalization within the last six months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Minnesota- Twin Cities

Minneapolis, Minnesota, 55455, United States

Location

Related Publications (1)

  • Lewis BA, Schuver K, Dunsiger S. Evaluating the feasibility and efficacy of a home-based combined high intensity interval and moderate intensity training program for increasing physical activity among low-active adults: A randomized pilot trial. PLoS One. 2023 Feb 21;18(2):e0281985. doi: 10.1371/journal.pone.0281985. eCollection 2023.

MeSH Terms

Conditions

Cardiovascular Diseases

Interventions

High-Intensity Interval Training

Intervention Hierarchy (Ancestors)

Physical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Beth Lewis, PhD

    University of Minnesota

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 29, 2018

First Posted

March 27, 2018

Study Start

July 1, 2018

Primary Completion

September 1, 2019

Study Completion

September 1, 2019

Last Updated

October 9, 2019

Record last verified: 2019-10

Data Sharing

IPD Sharing
Will not share

IPD will not be shared with other researchers.

Locations