- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04751240
Effect of Interval and Resistance Exercise on Physiological and Psychological Parameters.
February 10, 2021 updated by: Danielle D Wadsworth, Auburn University
The purpose of this study is to examine the physiological and psychological effects of a sprint interval and resistance training intervention on females.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Females aged 20-65 will attend 10 weeks of exercise training consisting of sprint interval training and resistance training for 30 sessions.
We will examine changes in body composition, blood panel (fasting glucose, cholesterol, triglycerides), strength (bench press and back squat), aerobic capacity and psychological parameters (hardiness, affect, enjoyment, perception and self-regulation).
The effects will be measured acutely after the program and 6-months after the cessation of the program.
Study Type
Interventional
Enrollment (Actual)
42
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Alabama
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Auburn, Alabama, United States, 36830
- School of Kinesiology
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
25 years to 55 years (ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- This population consists of: females, aged 25-55, who are: sedentary (not reporting a regular schedule of exercise over the last 3 months), and able to start an exercise program (assessed by the PARQ+)
Exclusion Criteria:
- Females who are below age 25 or over age 55, who are currently exercising and have existing conditions that would exclude them from exercise.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: SIT and Resistance
Participants will complete 10 weeks of a SIT and resistance training paradigm.
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Participants complete 30 sessions of sprints and resistance training.
Outcomes are assessed acutely and at 6 months.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Fat mass post
Time Frame: Change in fat mass at 13 weeks
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Changes in Fat mass in Kg assessed by idexa
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Change in fat mass at 13 weeks
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Fat mass retention
Time Frame: Change in fat mass at 6 months
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Changes in Fat mass in Kg assessed by idexa
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Change in fat mass at 6 months
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Lean mass post
Time Frame: Change in lean mass at 13 weeks
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Changes in Lean mass in Kg assessed by idexa
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Change in lean mass at 13 weeks
|
Lean mass retention
Time Frame: Change in lean mass at 6 months
|
Changes in Lean mass in Kg assessed by idexa
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Change in lean mass at 6 months
|
Visceral Fat post
Time Frame: Change in visceral fat at 13 weeks
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Changes in Visceral Fat in Kg assessed by idexa
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Change in visceral fat at 13 weeks
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Visceral Fat retention
Time Frame: Change in visceral fat at 13 weeks
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Changes in Visceral Fat in Kg assessed by idexa
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Change in visceral fat at 13 weeks
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Participate perception of the program post
Time Frame: 13 weeks
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Interviews to assess participants perception of the program
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13 weeks
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Participate perception of the program retention
Time Frame: 6 months
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Interviews to assess participants perception of the program
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6 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Strength - bench press
Time Frame: Change in bench press at 13 weeks
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Changes in bench press measured in Kg
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Change in bench press at 13 weeks
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Strength - back squat
Time Frame: Change in back squat at 13 weeks
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Changes in back squat measured in Kg
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Change in back squat at 13 weeks
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Blood glucose post
Time Frame: Changes in fasting blood glucose at 13 weeks
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Changes in fasting blood glucose
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Changes in fasting blood glucose at 13 weeks
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Blood glucose retention
Time Frame: Changes in fasting blood glucose at 6 months
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Changes in fasting blood glucose
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Changes in fasting blood glucose at 6 months
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Cholesterol post
Time Frame: Changes in Cholesterol at 13 weeks
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Changes in Cholesterol
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Changes in Cholesterol at 13 weeks
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Cholesterol retention
Time Frame: Changes in Cholesterol at 6 months
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Changes in Cholesterol
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Changes in Cholesterol at 6 months
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Triglycerides post
Time Frame: Changes in Triglycerides at13 weeks
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Changes in Triglycerides
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Changes in Triglycerides at13 weeks
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Triglycerides retention
Time Frame: Changes in Triglycerides at 6 months
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Changes in Triglycerides
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Changes in Triglycerides at 6 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Danielle Wadsworth, PhD, Auburn University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
January 20, 2019
Primary Completion (ACTUAL)
December 31, 2020
Study Completion (ACTUAL)
December 31, 2020
Study Registration Dates
First Submitted
February 7, 2021
First Submitted That Met QC Criteria
February 10, 2021
First Posted (ACTUAL)
February 12, 2021
Study Record Updates
Last Update Posted (ACTUAL)
February 12, 2021
Last Update Submitted That Met QC Criteria
February 10, 2021
Last Verified
February 1, 2021
More Information
Terms related to this study
Other Study ID Numbers
- 18-323
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
No IPD will be shard with other researchers.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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