- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07738809
Effects of Exercise Intervention on Sleep Quality and Emotional Problems in College Students With Depressive Symptoms
Effects of Exercise Intervention on Sleep Quality, Emotional Problems, and Neuroelectrophysiological Mechanisms in College Students With Depressive Symptoms
연구 개요
상세 설명
Depressive symptoms are highly prevalent among college students and are frequently accompanied by poor sleep quality, emotional disturbances, impaired executive function, and altered brain activity. Although physical exercise has been recognized as an effective non-pharmacological intervention for improving mental health, the neurophysiological mechanisms underlying these benefits remain unclear.
This study adopts an exploratory randomized controlled design consisting of two consecutive phases. In Phase I, participants will complete a single session of low-to-moderate intensity exercise to investigate immediate changes in emotional state, executive function, resting-state EEG, brain functional connectivity, and event-related potentials (ERP). In Phase II, the same participants will continue to participate in an 8-week exercise intervention to examine the effects of regular exercise on sleep quality, depressive symptoms, emotional problems, executive function, and neurophysiological characteristics.
Behavioral assessments, standardized psychological questionnaires, resting-state EEG, brain functional connectivity analysis, and ERP recordings will be performed before and after intervention. The study will also investigate whether the immediate response to acute exercise is associated with subsequent improvements following long-term exercise intervention, providing evidence for individualized exercise prescriptions and neurophysiological mechanisms of exercise in college students with depressive symptoms.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Yongguo Zhu, Professor
- 전화번호: +86 13811265116
- 이메일: zhuyongguo@cupes.edu.cn
연구 장소
-
-
Shanghai Municipality
-
Shanghai, Shanghai Municipality, 중국
- Shanghai University of Sport
-
연락하다:
- Yongguo Zhu, Professor
- 전화번호: +86 13811265116
- 이메일: zhuyongguo@cupes.edu.cn
-
-
참여기준
자격 기준
공부할 수 있는 나이
- 성인
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
• Aged 18-23 years.
- Right-handed.
- Non-physical education major.
- No history of psychiatric disorders and no current or previous use of psychotropic medications, hypnotics, or other medications affecting the central nervous system.
- No history of traumatic brain injury or chronic physical diseases.
- No contraindications to physical exercise.
- Participants with a Beck Depression Inventory-II (BDI-II) score >13 will be classified as having depressive symptoms, whereas participants with a BDI-II score ≤13 will be classified as having no depressive symptoms.
Exclusion Criteria:
Vigorous physical exercise, alcohol consumption, caffeine intake, or other stimulating behaviors within 24 hours before testing.
- Withdrawal from the study before completion of EEG recording or behavioral task assessments.
- Participants will be excluded from the final analysis if they fail to complete the required questionnaires or if the collected data do not meet predefined quality control criteria.
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 |
|---|---|
|
실험적: Archery Exercise Group
Participants assigned to this group will first complete one supervised session of low-to-moderate intensity archery exercise and will subsequently participate in an 8-week regular archery exercise program.
The acute exercise session consists of a 5-minute warm-up, 20 minutes of archery exercise, and a 5-minute cool-down.
The 8-week intervention will be conducted three times per week, with at least 48 hours between sessions.
Exercise intensity will be maintained at 50%-75% of age-predicted maximum heart rate and monitored using heart rate and ratings of perceived exertion.
Psychological questionnaires, behavioral tasks, resting-state EEG, and task-related ERP assessments will be completed before and after the acute session and before and after the 8-week intervention.
|
Participants perform a standardized archery exercise program consisting of an acute exercise session followed by an 8-week supervised training program.
The acute session includes a 5-minute warm-up, 20 minutes of archery exercise, and a 5-minute cool-down.
The long-term intervention is conducted three times per week for 8 weeks at moderate exercise intensity.
|
|
활성 비교기: Control Group
Participants assigned to this group will complete an equal-duration seated rest or non-exercise control activity during the acute experiment.
During the subsequent 8-week period, participants will maintain their usual lifestyle and attend the laboratory three times per week at the same scheduled times as the exercise group to complete 30 minutes of seated rest or another non-exercise control activity.
Psychological questionnaires, behavioral tasks, resting-state EEG, and task-related ERP assessments will be completed at the same assessment time points as those in the archery exercise group.
|
Participants continue their usual daily activities without participating in the archery exercise intervention.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Depressive symptoms measured by the Beck Depression Inventory-II (BDI-II)
기간: Baseline, immediately after the acute exercise session, and after completion of the 8-week intervention.
|
Depressive symptoms will be assessed using the Beck Depression Inventory-II (BDI-II).
Changes in depressive symptom severity following acute and long-term archery exercise interventions will be evaluated.
|
Baseline, immediately after the acute exercise session, and after completion of the 8-week intervention.
|
|
Sleep quality measured by the Pittsburgh Sleep Quality Index (PSQI)
기간: Baseline, immediately after the acute exercise session, and after completion of the 8-week intervention.
|
Sleep quality will be assessed using the Pittsburgh Sleep Quality Index (PSQI).
Changes in sleep quality after acute and long-term archery exercise interventions will be evaluated.
|
Baseline, immediately after the acute exercise session, and after completion of the 8-week intervention.
|
|
Resting-state EEG functional connectivity
기간: Baseline, immediately after the acute exercise session, and after completion of the 8-week intervention.
|
Resting-state EEG functional connectivity will be analyzed using phase synchronization metrics to evaluate neural changes associated with archery exercise interventions.
|
Baseline, immediately after the acute exercise session, and after completion of the 8-week intervention.
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Yongguo Zhu, Professor, Capital University of Physical Education and Sports
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
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
기타 연구 ID 번호
- 2026A137
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .