Feasibility StudiesNCT06710691
Feasibility Study of Resistance Training Intervention in Untrained Adolescents
A study testing Physical activity intervention using traditional strength training protocols and Physical activity intervention using high-resistance circuit training. in people with Feasibility Studies, run by University of Utah at 1 site in United States.
Trial summary
Adolescents may have limited time to engage in physical activity during the school day prompting investigations of before and after-school times along with time efficient programming. High-resistance circuit training has been used as a time effective protocol, however adolescents have yet to be studied. Read more about this study
- Who is it for?
- Ages 14 to 19 yearsHealthy volunteers can take part
- Conditions the study is for
- Feasibility Studies
- What is being tested?
- Physical activity intervention using traditional strength training protocols and Physical activity intervention using high-resistance circuit training.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Sep 2023to 24 Jan 2024
- 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 14 to 19 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Untrained
- Male and female
- Student at site
- Available to workout before or after-school
Who cannot join
- Recent injuries or medical conditions that may influence high-intensity performance
- Currently enrolled in another training program including resistance, cardiovascular, or sports-based program
- Uninsured participants
- Drastically altering diet
- Use of performance-enhancing substances (i.e., creatine, pre-workout, post-workout supplements).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Factorial Feasibility Study of High-Resistance Circuit Training and Strength Training Intervention in Untrained Adolescents: A Mixed Methods Approach
Adolescents may have limited time to engage in physical activity during the school day prompting investigations of before and after-school times along with time efficient programming. High-resistance circuit training has been used as a time effective protocol, however adolescents have yet to be studied. The primary aim was to assess feasibility (recruitment, sample size, consent rate, retention rate, fidelity, attendance, adverse events, and participant experience) of a high-resistance circuit training or strength training intervention, conducted before or after-school. The second aim was to explore changes in body composition, strength, and aerobic fitness.
Researchers compared feasibility outcomes as well as participant experience between time frames and treatment group.
- Conditions
- Feasibility Studies
- Being tested
- Physical activity intervention using traditional strength training protocols, Physical activity intervention using high-resistance circuit training.
- Keywords
- High-Resistance Circuit Training, Strength Training, Resistance Training, Feasibility, Mixed-Methods, Before-School, After-School
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical activity intervention using traditional strength training protocolsOther
Also called ST
Strength training participants performed the 6 reps of the first exercise at the prescribed RPE and then rested for 1 minute. Participants then completed another set of their first exercise with the required rest until the prescribed sets were completed. Participants performed the second and third exercises in the same fashion. Once the first block was completed, participants rested 5 min, then completed the second block. Six exercises were completed.
Physical activity intervention using high-resistance circuit training.Other
An adapted version of Alcaraz's high-resistance circuit training (HRC) was utilized in the intervention. Exercises and intensities used by strength training was the same for HRC except HRC participants performed the first three exercises as a circuit with 35 seconds rest between exercises, then completed the second block of exercises in the same fashion.
| Study group | Role | What they receive |
|---|---|---|
| Before-school high-resistance circuit training group | Experimental | Participants conducted circuit-based training before school at submaximal intensities (6, 7 and 8 RPE) with limited rest between exercises. Receives: Other: Physical activity intervention using high-resistance circuit training. |
| Before-school strength training group | Active comparator | Participants conducted strength training before school at submaximal intensities (6, 7 and 8 RPE) with 1 min rest between exercises. Receives: Other: Physical activity intervention using traditional strength training protocols |
| After-school high-resistance circuit training group | Experimental | Participants conducted circuit-based training after school at submaximal intensities (6, 7 and 8 RPE) with limited rest between exercises. Receives: Other: Physical activity intervention using high-resistance circuit training. |
| After-school strength training group | Active comparator | Participants conducted strength training after school at submaximal intensities (6, 7 and 8 RPE) with 1 min rest between exercises. Receives: Other: Physical activity intervention using traditional strength training protocols |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment process
The recruitment process refers to the protocols used to find, select, and enroll participants into a study. The recruitment process for this study was represented by reporting the total number of unique QR code scans from posted flyers and tabling events, the number of completed interest forms, the number of eligible participants and the number of consented participants. A recruitment period of 3 weeks was given for the before and after-school trials.
Measured: Three weeks.
Sample Size
Sample size was used as another key feasibility marker and refers to the total number of individuals used in the intervention.
Measured: From enrollment through 4 weeks of treatment.
Consent Rate
Consent rate is often referred to as the percentage of participants enrolled divided by the number of eligible participants. For this study, consent rate was calculated by taking the total number of participants that consented and were randomized divided by the number of eligible students.
Measured: From a 3 week recruitment period to enrollment.
Retention Rate
Retention rate is defined as the percentage of the total number of randomized participants assessed for primary outcomes and used in the primary outcome analysis. For the purpose of this study, researchers were interested in retention for both primary and secondary outcomes meaning researchers tracked retention from pre-intervention fitness testing, through treatments, and post-intervention fitness testing sessions. The follow up interview was not included in calculating the retention rate. Only participants that withdrew from the study or were not included in the primary and secondary outcome analysis influenced the retention rate. Thus, retention was calculated as the percentage of participants that completed pre and post-intervention fitness assessments and intervention treatment divided by the number of participants randomized into treatment groups.
Measured: From enrollment through 4 weeks of treatment.
Fidelity
For this study, fidelity was assessed at the instructor and participant level. Instructor fidelity was measured as a percentage by totaling the provided sessions divided by the total number of planned sessions. An acceptable percentage was set at 80% due to conflicts with events such as holiday breaks or parent teacher conferences. To assess participant fidelity, the primary researcher and participants recorded session durations, completed sets and intensity along with activity and diet audits at weeks 2, and 4 of the intervention. The activity and diet audit included a modified Copper Institute Fitnessgram and Activitygram questionnaire.
Measured: From enrollment through 4 weeks of treatment.
Average Attendance
Participant attendance was observed by the researcher and measured as attended sessions divided by total sessions offered.
Measured: From enrollment through 4 weeks of treatment.
Adverse Events
Adverse events were recorded during the intervention by the participants on workout documents and by observations from the primary researcher.
Measured: From enrollment through 4 weeks of treatment.
Participant Experience
Participant experience was assessed by utilizing the validated short form 4 item Physical Activity Enjoyment Scale (PACES-S) survey for adolescents [48]. Participants answered 4 items including: "I enjoyed it; I find it pleasurable; It is very pleasant; and It feels good" by responding with the five-point Likert scale ranging from 1= "strongly disagree" to 5 = "strongly agree". To further investigators' depth of understanding, participant experience was also assessed by a follow up interview concluding the intervention.
Measured: From enrollment through 4 weeks of treatment in addition to a 1 month follow up interview.
Secondary outcomes (6)
Body Mass Index
In a separate private room, one participant at a time weighed themselves on a certified scale. Participants used the handheld Omron model HBF-306 to enter their weight, age, sex and activity level. Resulting body mass index (kg/m^2) was recorded.
Measured: Through study completion, an average of 4 weeks
Body Fat Percentage
In a separate private room, one participant at a time weighed themselves on a certified scale. Participants used the handheld Omron model HBF-306 to enter their weight, age, sex and activity level. Resulting body fat percentage data was recorded.
Measured: Through study completion, an average of 4 weeks
Isometric lower body pull
Isometric lower body pull. Using the Baseline 12-0400 Back-Leg-Chest dynamometer participants stood up-right and feet hip width apart on the dynamometer platform with the chain adjusted so the handle was at the intra-articular space of the knee joint. Participants were instructed to grip the handle evenly at the center then produce a maximal 5 sec pull keeping the back from bending and arms straight. Participants were allowed to rest 30 sec between attempts. Participants had one practice attempt for familiarization purposes and then the best score of the three following attempts were recorded.
Measured: Through study completion, an average of 4 weeks
90° push-up
Participants were paired; participant 1 performed the test while participant 2 recorded the number of push-ups. Participants performed the assessment in accordance with the Cooper Institute's procedures. Participant 1 assumed a prone plank position with hands slightly outside of shoulders, fingers stretched out and legs straight with a slight gap. While performing push-ups, the participants' back maintained a straight line from head to ankles. Participants started by lowering their body until the upper arms became parallel to the ground. The participant then extended their arms straight pushing their body up. This movement was performed every three seconds by metronome and repeated until failure. Participants were allowed one form correction and two form corrections resulted in test termination. Form corrections included participants stopping to rest, a failure to maintain a straight back, achieving proper depth or fully extending the arms.
Measured: Through study completion, an average of 4 weeks
Modified Pull-up
Participants performed the modified pull-up test in accordance with Cooper Institute's procedure. Participants placed a barbell in a squat rack so that the barbell was one to two inches away from participant's reach while supine on the ground. A band was then placed seven to eight inches below the barbell. Participants started the assessment by overhand gripping the barbell and creating a straight line from head to heels so that only the heels were in ground contact. Participants then pulled their body toward the barbell until the chin was above the band. This movement was performed every three seconds by metronome and repeated until failure. Participants were allowed one form of correction and two form corrections would result in test termination. Form corrections included participants stopping to rest, failure to maintain a straight line, achieve proper depth and fully extending the arms.
Measured: Through study completion, an average of 4 weeks
Aerobic Fitness
To assess cardiovascular fitness, the Progressive Aerobic Cardiovascular Endurance Run (PACER) assessment was used. Prior to the start of assessment, the primary investigator measured and marked a designated 20-meter distance in the gymnasium for testing. Participants were briefed on the assessment guidelines and participated in one practice opportunity prior to the official assessment. Once familiarized, participants ran the 20-meter distance in accordance to PACER cadences from the Cooper Institute for as long as possible. The test was terminated when the participant voluntarily stopped due to fatigue or when two laps were missed. The primary researcher recorded total number of successful levels. Once completed, the primary researcher computed predicted peak VO2 by using VO2peak = 0.353(Laps) - 1.121(Age) + 45.619.
Measured: Through study completion, an average of 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2024
- Study start20 Sep 2023
- Primary completion18 Dec 2023
- Study completion24 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Feasibility StudiesStudies of the same condition, open and under way.
- More trials run by University of UtahThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- The study also used an explanatory sequential design.
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mitch Wyatt, University of Utah
- Investigators
- Timothy Brusseau Jr., Study chair, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06710691
- Sponsor's protocol ID
- IRB_00166762
- Status last verified
- Nov 2024
- First submitted
- 20 Nov 2024
- Last updated
- 29 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: In the consent process, participants and guardians were informed that their data will not be used in future studies.
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Factorial Feasibility Study of High-Resistance Circuit Training and Strength Training Intervention in Untrained Adolescents: A Mixed Methods Approach
- ClinicalTrials.gov ID
- NCT06710691
- Acronym / sponsor ID
- IRB_00166762
- Conditions
- Feasibility Studies
- Keywords
- High-Resistance Circuit Training, Strength Training, Resistance Training, Feasibility, Mixed-Methods, Before-School, After-School
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Study start
- 20 Sep 2023 (actual)
- Primary completion
- 18 Dec 2023 (actual)
- Study completion
- 24 Jan 2024 (actual)
- First posted
- 29 Nov 2024 (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.
Adolescents may have limited time to engage in physical activity during the school day prompting investigations of before and after-school times along with time efficient programming. High-resistance circuit training has been used as a time effective protocol, however adolescents have yet to be studied. The primary aim was to assess feasibility (recruitment, sample size, consent rate, retention rate, fidelity, attendance, adverse events, and participant experience) of a high-resistance circuit training or strength training intervention, conducted before or after-school. The second aim was to explore changes in body composition, strength, and aerobic fitness.
Researchers compared feasibility outcomes as well as participant experience between time frames and treatment group.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- The study also used an explanatory sequential design.
| Arm | Type | Receives |
|---|---|---|
| Before-school high-resistance circuit training group | Experimental | Other: Physical activity intervention using high-resistance circuit training.Participants conducted circuit-based training before school at submaximal intensities (6, 7 and 8 RPE) with limited rest between exercises. |
| Before-school strength training group | Active comparator | Other: Physical activity intervention using traditional strength training protocolsParticipants conducted strength training before school at submaximal intensities (6, 7 and 8 RPE) with 1 min rest between exercises. |
| After-school high-resistance circuit training group | Experimental | Other: Physical activity intervention using high-resistance circuit training.Participants conducted circuit-based training after school at submaximal intensities (6, 7 and 8 RPE) with limited rest between exercises. |
| After-school strength training group | Active comparator | Other: Physical activity intervention using traditional strength training protocolsParticipants conducted strength training after school at submaximal intensities (6, 7 and 8 RPE) with 1 min rest between exercises. |
Who may qualify
- Ages
- 14 to 19 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Untrained
- Male and female
- Student at site
- Available to workout before or after-school
Key exclusion criteria (5 listed)
- Recent injuries or medical conditions that may influence high-intensity performance
- Currently enrolled in another training program including resistance, cardiovascular, or sports-based program
- Uninsured participants
- Drastically altering diet
- Use of performance-enhancing substances (i.e., creatine, pre-workout, post-workout supplements).
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 |
|---|---|---|
| Physical activity intervention using traditional strength training protocolsAlso: STStrength training participants performed the 6 reps of the first exercise at the prescribed RPE and then rested for 1 minute. Participants then completed another set of their first exercise with the required rest until the prescribed sets were completed. Participants performed the second and third exercises in the same fashion. Once the first block was completed, participants rested 5 min, then completed the second block. Six exercises were completed. | Other | After-school strength training group, Before-school strength training group |
| Physical activity intervention using high-resistance circuit training.An adapted version of Alcaraz's high-resistance circuit training (HRC) was utilized in the intervention. Exercises and intensities used by strength training was the same for HRC except HRC participants performed the first three exercises as a circuit with 35 seconds rest between exercises, then completed the second block of exercises in the same fashion. | Other | After-school high-resistance circuit training group, Before-school high-resistance circuit training group |
Primary outcome
Recruitment process
Time frame: Three weeks.
The recruitment process refers to the protocols used to find, select, and enroll participants into a study. The recruitment process for this study was represented by reporting the total number of unique QR code scans from posted flyers and tabling events, the number of completed interest forms, the number of eligible participants and the number of consented participants. A recruitment period of 3 weeks was given for the before and after-school trials.
Sample Size
Time frame: From enrollment through 4 weeks of treatment.
Sample size was used as another key feasibility marker and refers to the total number of individuals used in the intervention.
Consent Rate
Time frame: From a 3 week recruitment period to enrollment.
Consent rate is often referred to as the percentage of participants enrolled divided by the number of eligible participants. For this study, consent rate was calculated by taking the total number of participants that consented and were randomized divided by the number of eligible students.
Retention Rate
Time frame: From enrollment through 4 weeks of treatment.
Retention rate is defined as the percentage of the total number of randomized participants assessed for primary outcomes and used in the primary outcome analysis. For the purpose of this study, researchers were interested in retention for both primary and secondary outcomes meaning researchers tracked retention from pre-intervention fitness testing, through treatments, and post-intervention fitness testing sessions. The follow up interview was not included in calculating the retention rate. Only participants that withdrew from the study or were not included in the primary and secondary outcome analysis influenced the retention rate. Thus, retention was calculated as the percentage of participants that completed pre and post-intervention fitness assessments and intervention treatment divided by the number of participants randomized into treatment groups.
Fidelity
Time frame: From enrollment through 4 weeks of treatment.
For this study, fidelity was assessed at the instructor and participant level. Instructor fidelity was measured as a percentage by totaling the provided sessions divided by the total number of planned sessions. An acceptable percentage was set at 80% due to conflicts with events such as holiday breaks or parent teacher conferences. To assess participant fidelity, the primary researcher and participants recorded session durations, completed sets and intensity along with activity and diet audits at weeks 2, and 4 of the intervention. The activity and diet audit included a modified Copper Institute Fitnessgram and Activitygram questionnaire.
Average Attendance
Time frame: From enrollment through 4 weeks of treatment.
Participant attendance was observed by the researcher and measured as attended sessions divided by total sessions offered.
Adverse Events
Time frame: From enrollment through 4 weeks of treatment.
Adverse events were recorded during the intervention by the participants on workout documents and by observations from the primary researcher.
Participant Experience
Time frame: From enrollment through 4 weeks of treatment in addition to a 1 month follow up interview.
Participant experience was assessed by utilizing the validated short form 4 item Physical Activity Enjoyment Scale (PACES-S) survey for adolescents [48]. Participants answered 4 items including: "I enjoyed it; I find it pleasurable; It is very pleasant; and It feels good" by responding with the five-point Likert scale ranging from 1= "strongly disagree" to 5 = "strongly agree". To further investigators' depth of understanding, participant experience was also assessed by a follow up interview concluding the intervention.
6 secondary outcomes
Body Mass Index
Time frame: Through study completion, an average of 4 weeks
Body Fat Percentage
Time frame: Through study completion, an average of 4 weeks
Isometric lower body pull
Time frame: Through study completion, an average of 4 weeks
90° push-up
Time frame: Through study completion, an average of 4 weeks
Modified Pull-up
Time frame: Through study completion, an average of 4 weeks
Aerobic Fitness
Time frame: Through study completion, an average of 4 weeks
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 29 Nov 2024.
- Individual participant dataSharing planned: No. In the consent process, participants and guardians were informed that their data will not be used in future studies.
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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.
Timothy Brusseau Jr. study chair
University of Utah
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical activity intervention using traditional strength training protocols and Physical activity intervention using high-resistance circuit training. in people with Feasibility Studies, run by University of Utah 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 4 inclusion and 5 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 29 Nov 2024. 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?
Recruitment process (time frame: Three 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 29 Nov 2024.