NCT06710691

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
7

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2023

Shorter than P25 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 20, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 18, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 24, 2024

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

November 20, 2024

Completed
9 days until next milestone

First Posted

Study publicly available on registry

November 29, 2024

Completed
Last Updated

November 29, 2024

Status Verified

November 1, 2024

Enrollment Period

3 months

First QC Date

November 20, 2024

Last Update Submit

November 26, 2024

Conditions

Keywords

High-Resistance Circuit TrainingStrength TrainingResistance TrainingFeasibilityMixed-MethodsBefore-SchoolAfter-School

Outcome Measures

Primary Outcomes (8)

  • 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.

    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.

    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.

    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.

    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.

    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.

    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.

    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.

    From enrollment through 4 weeks of treatment in addition to a 1 month follow up interview.

Secondary Outcomes (6)

  • Body Mass Index

    Through study completion, an average of 4 weeks

  • Body Fat Percentage

    Through study completion, an average of 4 weeks

  • Isometric lower body pull

    Through study completion, an average of 4 weeks

  • 90° push-up

    Through study completion, an average of 4 weeks

  • Modified Pull-up

    Through study completion, an average of 4 weeks

  • +1 more secondary outcomes

Study Arms (4)

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.

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.

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.

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.

Other: Physical activity intervention using traditional strength training protocols

Interventions

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.

Also known as: ST
After-school strength training groupBefore-school strength training group

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.

After-school high-resistance circuit training groupBefore-school high-resistance circuit training group

Eligibility Criteria

Age14 Years - 19 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Untrained
  • Male and female
  • Student at site
  • Available to workout before or after-school

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Murray High School

Murray, Utah, 84107, United States

Location

Study Officials

  • Timothy Brusseau Jr.

    University of Utah

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
FACTORIAL
Model Details: The study also used an explanatory sequential design.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD Student

Study Record Dates

First Submitted

November 20, 2024

First Posted

November 29, 2024

Study Start

September 20, 2023

Primary Completion

December 18, 2023

Study Completion

January 24, 2024

Last Updated

November 29, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share

In the consent process, participants and guardians were informed that their data will not be used in future studies.

Locations