Body CompositionNCT04751240
Effect of Interval and Resistance Exercise on Physiological and Psychological Parameters.
A study testing SIT and resistance training in people with Body Composition, run by Auburn University at 1 site in United States.
Trial summary
The purpose of this study is to examine the physiological and psychological effects of a sprint interval and resistance training intervention on females. Read more about this study
- Who is it for?
- Ages 25 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Body Composition
- What is being tested?
- SIT and resistance training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Jan 2019to 31 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 55 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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+)
Who cannot join
- Females who are below age 25 or over age 55, who are currently exercising and have existing conditions that would exclude them from exercise.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to examine the physiological and psychological effects of a sprint interval and resistance training intervention on females.
Read the 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.
- Conditions
- Body Composition
- Being tested
- SIT and resistance training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SIT and resistance trainingBehavioural
Participants complete 30 sessions of sprints and resistance training. Outcomes are assessed acutely and at 6 months.
| Study group | Role | What they receive |
|---|---|---|
| SIT and Resistance | Experimental | Participants will complete 10 weeks of a SIT and resistance training paradigm. Receives: Behavioral: SIT and resistance training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fat mass post
Changes in Fat mass in Kg assessed by idexa
Measured: Change in fat mass at 13 weeks
Fat mass retention
Changes in Fat mass in Kg assessed by idexa
Measured: Change in fat mass at 6 months
Lean mass post
Changes in Lean mass in Kg assessed by idexa
Measured: Change in lean mass at 13 weeks
Lean mass retention
Changes in Lean mass in Kg assessed by idexa
Measured: Change in lean mass at 6 months
Visceral Fat post
Changes in Visceral Fat in Kg assessed by idexa
Measured: Change in visceral fat at 13 weeks
Visceral Fat retention
Changes in Visceral Fat in Kg assessed by idexa
Measured: Change in visceral fat at 13 weeks
Participate perception of the program post
Interviews to assess participants perception of the program
Measured: 13 weeks
Participate perception of the program retention
Interviews to assess participants perception of the program
Measured: 6 months
Secondary outcomes (8)
Strength - bench press
Changes in bench press measured in Kg
Measured: Change in bench press at 13 weeks
Strength - back squat
Changes in back squat measured in Kg
Measured: Change in back squat at 13 weeks
Blood glucose post
Changes in fasting blood glucose
Measured: Changes in fasting blood glucose at 13 weeks
Blood glucose retention
Changes in fasting blood glucose
Measured: Changes in fasting blood glucose at 6 months
Cholesterol post
Changes in Cholesterol
Measured: Changes in Cholesterol at 13 weeks
Cholesterol retention
Changes in Cholesterol
Measured: Changes in Cholesterol at 6 months
Triglycerides post
Changes in Triglycerides
Measured: Changes in Triglycerides at13 weeks
Triglycerides retention
Changes in Triglycerides
Measured: Changes in Triglycerides at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2021
- Study start20 Jan 2019
- Primary completion31 Dec 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Body CompositionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All subjects will participate in an exercise intervention consisting of sprint interval training and resistance training.
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Auburn University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Danielle D Wadsworth, Auburn University
- Investigators
- Danielle Wadsworth, PhD, Principal investigator, Auburn University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04751240
- Sponsor's protocol ID
- 18-323
- Status last verified
- Feb 2021
- First submitted
- 7 Feb 2021
- Last updated
- 12 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No IPD will be shard with other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Interval and Resistance Exercise on Physiological and Psychological Parameters.
- ClinicalTrials.gov ID
- NCT04751240
- Acronym / sponsor ID
- 18-323
- Conditions
- Body Composition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Auburn UniversityUniversity, hospital or other
- Study start
- 20 Jan 2019 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 12 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to examine the physiological and psychological effects of a sprint interval and resistance training intervention on females.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All subjects will participate in an exercise intervention consisting of sprint interval training and resistance training.
| Arm | Type | Receives |
|---|---|---|
| SIT and Resistance | Experimental | Behavioral: SIT and resistance trainingParticipants will complete 10 weeks of a SIT and resistance training paradigm. |
Who may qualify
- Ages
- 25 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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+)
Key exclusion criteria (1 listed)
- Females who are below age 25 or over age 55, who are currently exercising and have existing conditions that would exclude them from exercise.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SIT and resistance trainingParticipants complete 30 sessions of sprints and resistance training. Outcomes are assessed acutely and at 6 months. | Behavioural | SIT and Resistance |
Primary outcome
Fat mass post
Time frame: Change in fat mass at 13 weeks
Changes in Fat mass in Kg assessed by idexa
Fat mass retention
Time frame: Change in fat mass at 6 months
Changes in Fat mass in Kg assessed by idexa
Lean mass post
Time frame: Change in lean mass at 13 weeks
Changes in Lean mass in Kg assessed by idexa
Lean mass retention
Time frame: Change in lean mass at 6 months
Changes in Lean mass in Kg assessed by idexa
Visceral Fat post
Time frame: Change in visceral fat at 13 weeks
Changes in Visceral Fat in Kg assessed by idexa
Visceral Fat retention
Time frame: Change in visceral fat at 13 weeks
Changes in Visceral Fat in Kg assessed by idexa
Participate perception of the program post
Time frame: 13 weeks
Interviews to assess participants perception of the program
Participate perception of the program retention
Time frame: 6 months
Interviews to assess participants perception of the program
8 secondary outcomes
Strength - bench press
Time frame: Change in bench press at 13 weeks
Strength - back squat
Time frame: Change in back squat at 13 weeks
Blood glucose post
Time frame: Changes in fasting blood glucose at 13 weeks
Blood glucose retention
Time frame: Changes in fasting blood glucose at 6 months
Cholesterol post
Time frame: Changes in Cholesterol at 13 weeks
Cholesterol retention
Time frame: Changes in Cholesterol at 6 months
Triglycerides post
Time frame: Changes in Triglycerides at13 weeks
Triglycerides retention
Time frame: Changes in Triglycerides at 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2021.
- Individual participant dataSharing planned: No. No IPD will be shard with other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Danielle Wadsworth, PhD principal investigator
Auburn University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SIT and resistance training in people with Body Composition, run by Auburn University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fat mass post (time frame: Change in fat mass at 13 weeks). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2021.