- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07584551
Calisthenics-Based Intervention in Adolescents: Effects on Strength, Body Composition, Eating Habits, and Self-Concept (CALI-TEENS)
School-Based Calisthenics Intervention for Promoting Physical Activity in Adolescents
This study evaluates the effectiveness of a school-based calisthenics intervention in promoting physical activity and improving health-related outcomes in adolescents. Physical inactivity during adolescence is a growing public health concern associated with increased risks of obesity, poor physical fitness, and reduced psychological well-being. Schools provide an optimal environment to implement structured interventions that encourage lifelong healthy habits.
Calisthenics is a form of exercise that uses bodyweight movements to improve strength, flexibility, and coordination. It is cost-effective, accessible, and does not require specialized equipment, making it particularly suitable for school settings. The present study integrates a structured calisthenics program into regular physical education classes.
A total of 100 students aged 13 to 16 years will be randomly assigned to either an experimental group, which will participate in the calisthenics program, or a control group, which will follow the standard physical education curriculum. The intervention will last 12 weeks, with three sessions per week.
Primary and secondary outcomes will be assessed at baseline and after the intervention. These include physical fitness (muscle strength), body composition, dietary habits, and self-concept. Strength will be measured using a handgrip dynamometer, body composition through anthropometric assessment, dietary habits through a validated questionnaire, and self-concept using the Self-Concept Form-5 (AF5).
Findings from this study will provide evidence regarding the feasibility and effectiveness of implementing calisthenics in school settings as a strategy to improve both physical and psychological health in adolescents.
연구 개요
상세 설명
Study Design This is a randomized, parallel-group, controlled trial designed to assess the effects of a school-based calisthenics intervention on physical fitness, body composition, dietary habits, and self-concept in adolescents. Participants will be randomly assigned in a 1:1 ratio to an experimental group or a control group.
Study Setting The study will be conducted at a public secondary school in Turmequé, Boyacá, Colombia, involving ninth-grade students.
Participants A total of 120 adolescents aged between 13 and 16 years will be recruited. Eligibility will be determined based on predefined inclusion and exclusion criteria. Written informed consent from parents or legal guardians and assent from participants will be obtained prior to enrollment.
Randomization and Allocation Participants will be assigned to study groups using a computer-generated randomization sequence. Allocation will be conducted by an independent individual not directly involved in the study procedures to minimize selection bias. Due to the nature of the intervention, participant blinding is not feasible.
Intervention The experimental group will participate in a structured calisthenics program integrated into physical education classes over a 12-week period. The program consists of three weekly sessions of approximately 60 minutes each.
Each session will include the following components:
- Warm-up phase (mobility and dynamic stretching)
- Main exercise phase, including six bodyweight exercises targeting upper body, lower body, or full-body strength
- Cool-down phase with static stretching and relaxation exercises
The intervention follows a progressive overload model:
Exercise duration will increase over time (from 60 to 90 seconds per exercise) Rest intervals between sets will decrease progressively (from 40 to 15 seconds) Effort intensity will be monitored using the Borg Rating of Perceived Exertion scale
Sessions will be conducted in school facilities, including outdoor spaces and sports courts, under the supervision of a qualified instructor to ensure safety and proper execution.
Control Group Participants in the control group will continue with their standard physical education curriculum, which includes activities such as volleyball and handball, according to the institutional academic plan.
Outcome Measures Assessments will be conducted at baseline (week 0) and post-intervention (week 13).
Primary Outcomes
- Muscle strength: measured using a digital handgrip dynamometer
Secondary Outcomes
- Body composition: assessed through anthropometric measurements and skinfold thickness to estimate body fat percentage and body mass index
- Dietary habits: evaluated using a validated food frequency questionnaire
- Self-concept: assessed using the Self-Concept Form-5 (AF5), which measures multiple dimensions including physical self-perception
Sample Size Calculation The sample size was calculated to detect a meaningful difference in strength outcomes between groups, assuming a standard deviation of 15 units, with 90% power and a 5% significance level. A minimum of 60 participants per group is required.
Statistical Analysis Descriptive statistics will be calculated for all variables. Normality will be assessed using the Kolmogorov-Smirnov test. A two-way analysis of variance (ANOVA) will be performed to examine the effects of time, group, and their interaction. Bonferroni post hoc tests will be applied where appropriate. Statistical significance will be set at p < 0.05.
Data Management Participant data will be coded to ensure confidentiality. Only authorized research personnel will have access to the dataset. Data will be stored securely and managed in accordance with data protection regulations.
Ethical Considerations The study will be conducted in accordance with the principles of the Declaration of Helsinki and applicable national and international regulations. The study involves minimal risk, as it consists of supervised physical activity within a school setting. Participants will be informed that their participation is voluntary and that they may withdraw at any time without consequences.
Expected Impact This study aims to provide evidence on the effectiveness of calisthenics as a low-cost, accessible intervention to promote physical activity and improve health outcomes in adolescents. The results may contribute to the development of innovative physical education strategies and inform public health policies targeting youth populations.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Departamento de Boyacá
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Turmequé, Departamento de Boyacá, 콜롬비아, 153060
- Institución Educativa Técnica Industrial de Turmequé-Boyacá
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참여기준
자격 기준
공부할 수 있는 나이
- 어린이
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- Enrollment in the ninth grade at the Institución Educativa Técnica Industrial de Turmequé, Boyacá.
- Age between 13 and 16 years.
- Agreement to random group assignment.
Exclusion Criteria:
- Presence of medical conditions or disorders that could contraindicate physical exercise, including but not limited to cardiac arrhythmias, heart murmurs, coronary artery disease, or hypertension, as diagnosed by a physician at the start of the calisthenics program.
- Presence of psychiatric disorders, such as severe anxiety attacks or depression, diagnosed by a qualified healthcare professional at the beginning of the calisthenics program.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: Calisthenics
Calisthenics 12 week, 3 times per week, exercise program
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12 week exercise program, with a frequency of 3 times per week and a duration of 1 hour per session
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활성 비교기: Control
School exercise programm
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Physical activity following School Education Program
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Hand grip strenght
기간: From enrollment to the end of the intervention at 12 weeks
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Handgrip strength is assessed using a handheld dynamometer to evaluate muscular strength.
Participants are instructed to squeeze the device with maximal effort, usually with the dominant hand, for a few seconds.
The highest value from repeated trials is recorded in kilograms or newtons
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From enrollment to the end of the intervention at 12 weeks
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Percentage of body fat
기간: From enrollment to the end of treatment at 12 weeks
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Skinfold anthropometric measurements will be determined to estimate body fat.
The thickness of subcutaneous fat at the biceps, triceps, subscapular and suprailiac sites using standarized calipers will be performed.
These values will be applied to equations to calculate body density and, from it, body fat percentage.
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From enrollment to the end of treatment at 12 weeks
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Dietary habits
기간: From enrollment to the end of treatment at 12 weeks
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Self-report of habitual food frequency consumption using a standardized and validated questionnaire.
Briefly, it consists of a 33-item questionnaire including foods commonly consumed by the selected study group.
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From enrollment to the end of treatment at 12 weeks
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Self-concept
기간: From enrollment to the end to the treatment at 12 weeks
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Reported by each volunteer using the AF5 Self-Concept Questionnaire, a validated instrument that assesses self-concept across five dimensions (academic/work, social, emotional, family, and physical) using a Likert-type scale, where higher scores indicate a more positive self-perception in each domain.
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From enrollment to the end to the treatment at 12 weeks
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공동 작업자 및 조사자
수사관
- 연구 책임자: Jose CE Serrano, PhD, Universitat de Lleida
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- CALI-TEENS
- Universitat de Lleida (레지스트리 식별자: Escola de Doctorat)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
IPD 공유 기간
IPD 공유 액세스 기준
IPD 공유 지원 정보 유형
- 연구_프로토콜
- 수액
- CSR
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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