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临床试验/NCT06710691
NCT06710691已完成不适用

A Randomized Factorial Feasibility Study of High-Resistance Circuit Training and Strength Training Intervention in Untrained Adolescents: A Mixed Methods Approach

University of Utah2 个研究点 分布在 1 个国家目标入组 7 人开始时间: 2023年9月20日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
7
试验地点
2
主要终点
Recruitment process

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Other
盲法
None

入排标准

年龄范围
14 Years 至 19 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • 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).

结局指标

主要结局

Recruitment process

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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.

次要结局

  • 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)
  • Body Mass Index(Through study completion, an average of 4 weeks)
  • Aerobic Fitness(Through study completion, an average of 4 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mitch Wyatt

PhD Student

University of Utah

研究点 (2)

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