座りがちな若年・中年成人における健康改善への八段錦運動の効果
運動不足の若年・中年成人における健康アウトカム改善への八段錦の有効性とメカニズムを評価するための多施設共同無作為化比較試験
The goal of this clinical trial is to learn if a 12-week Baduanjin exercise program can improve health in sedentary young and middle-aged adults. The main questions it aims to answer are:
- Does the Baduanjin program improve participants' cardiorespiratory fitness (measured as peak oxygen uptake)?
- Does it improve their body composition, muscle strength, balance, and flexibility?
- Does it reduce their daily sitting time?
Researchers will compare the Baduanjin training group to a health education control group to see if Baduanjin is more effective in improving these health outcomes.
Participants will:
- Be randomly assigned to one of the two groups.
- If in the Baduanjin group, attend supervised group sessions and practice at home for 12 weeks.
- Complete a series of assessments at the beginning, middle, and end of the study, including fitness tests, body measurements, and questionnaires.
調査の概要
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Jingyi Ren, M.D., Chief Physician
- 電話番号：18600195099
- メール：renjingyi@cjfh.org.cn
研究場所
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Beijing Municipality
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Beijing、Beijing Municipality、中国、100029
- 募集
- China-Japan Friendship Hospital
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コンタクト：
- Jingyi Ren, Doctor
- 電話番号：+86 17367938350
- メール：1220193509@qq.com
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- Adults aged 18 to 59 years
- Sedentary and physically inactive, defined as: (a) self-reported sitting time ≥ 8 hours per day, AND (b) not meeting the World Health Organization (WHO) recommended level of physical activity ( engaging in < 150 minutes of moderate-to-vigorous intensity physical activity per week, assessed by the International Physical Activity Questionnaire [IPAQ])
- In good general health as self-reported, and free from any known diseases
- Willing and able to provide written informed consent
Exclusion Criteria:
- Contraindications to cardiopulmonary exercise testing
- Currently participating in, or planning to participate within the next 3 months, in any other structured exercise or behavioral intervention program
- Pregnancy, lactation, or planning to become pregnant during the study period
- Inability to understand or comply with the study procedures
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：防止
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：Baduanjin Training Group
Participants in this group will receive a 12-week Baduanjin exercise program. The program consists of supervised group sessions combined with home-based practice, with a frequency of 5 sessions per week. Each session lasts 60 minutes, including warm-up, standardized Baduanjin practice, and cool-down. The Baduanjin exercises follow a standardized protocol. |
A 12-week, standardized Baduanjin exercise program. Participants will complete 5 sessions per week, each lasting 60 minutes (including warm-up, Baduanjin practice, and cool-down). The program includes both supervised group sessions and guided home practice. |
|
他の：Health Education Control Group
Participants in this group will receive general health education, which includes recommendations on physical activity types and duration (e.g., following the WHO guidelines). However, they will not be enrolled in any structured, supervised exercise program. They will be instructed to maintain their usual lifestyle throughout the study period. |
Participants will receive general health education (including recommendations on physical activity types and duration), but will not be enrolled in any structured or supervised exercise program. They will be instructed to maintain their usual lifestyle. |
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Change in Peak Oxygen Uptake (VO₂peak) assessed by Cardiopulmonary Exercise Testing
時間枠：at baseline and Week 13.
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Measured by Cardiopulmonary Exercise Testing (CPET). |
at baseline and Week 13.
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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国際身体活動質問票（IPAQ）により評価される座位行動に費やす時間の変化
時間枠：ベースライン時および第13週時。
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ベースライン時および第13週時。
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等速性ダイナモメトリーによる膝伸展平均パワーの変化
時間枠：ベースライン時、第8週、第13週。
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ベースライン時、第8週、第13週。
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等速性ダイナモメトリーによって評価される膝伸展疲労指数の変化
時間枠：ベースライン時、第8週、および第13週に。
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ベースライン時、第8週、および第13週に。
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アイソキネティック・ダイナモメトリーにより評価された膝屈曲平均パワーの変化
時間枠：ベースライン時、8週目、および13週目
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ベースライン時、8週目、および13週目
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等速性ダイナモメトリーにより評価される膝屈曲疲労指数の変化
時間枠：ベースライン時、第8週、および第13週に
|
ベースライン時、第8週、および第13週に
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アイソキネティックダイナモメトリーで評価された肩屈曲平均パワーの変化
時間枠：ベースライン時、第8週、および第13週
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ベースライン時、第8週、および第13週
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アイソキネティックダイナモメトリーによる肩関節屈曲疲労指数の変化
時間枠：ベースライン時、第8週、および第13週
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ベースライン時、第8週、および第13週
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等速性ダイナモメトリーによる肩関節外転平均パワーの変化
時間枠：ベースライン時、第8週、および第13週
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ベースライン時、第8週、および第13週
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等速性ダイナモメトリーによる評価での肩関節外転疲労指数の変化
時間枠：ベースライン時、第8週、および第13週
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ベースライン時、第8週、および第13週
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等速性筋力測定による肘伸展平均パワーの変化
時間枠：ベースライン時、第8週、および第13週
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ベースライン時、第8週、および第13週
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アイソキネティックダイナモメトリーによる肘伸展疲労指数の変化
時間枠：ベースライン時、第8週、第13週
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ベースライン時、第8週、第13週
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等速性ダイナモメトリーにより評価された肘関節屈曲平均パワーの変化
時間枠：ベースライン時、8週目、13週目
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ベースライン時、8週目、13週目
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等速性ダイナモメトリーによる肘屈曲疲労指数の変化
時間枠：ベースライン時、第8週、および第13週
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ベースライン時、第8週、および第13週
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バイオ電気インピーダンス分析により評価される筋肉量の変化
時間枠：ベースライン時および13週目に。
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ベースライン時および13週目に。
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バイオ電気インピーダンス分析による体脂肪率の変化
時間枠：ベースライン時および第13週時。
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ベースライン時および第13週時。
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バイオ電気インピーダンス分析による除脂肪体重の変化
時間枠：ベースライン時および13週目時
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ベースライン時および13週目時
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3Dモーションキャプチャによる八段錦運動中の重心高変化の評価
時間枠：ベースライン時および第13週
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ベースライン時および第13週
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表面筋電図で評価された八段錦運動中の統合筋電図（iEMG）の変化
時間枠：ベースライン時および第13週
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ベースライン時および第13週
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表面筋電図による八段錦運動中のRoot Mean Square (RMS) Amplitudeの変化
時間枠：ベースライン時および第13週時
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ベースライン時および第13週時
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処方された八段錦セッションの完了率
時間枠：研究完了まで、最大13週間まで。
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研究完了まで、最大13週間まで。
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Change in Sit-and-Reach Distance
時間枠：at baseline, Week 8, and Week 13.
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Assessed by the standard sit-and-reach test. |
at baseline, Week 8, and Week 13.
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Change in Active Range of Motion of the Shoulder, Hip, Knee, and Ankle joints assessed by Goniometry
時間枠：at baseline, Week 8, and Week 13.
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Measured using a goniometer |
at baseline, Week 8, and Week 13.
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Scores on the Exercise Benefits/Barriers Scale (EBBS)
時間枠：at baseline and Week 13
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The scale consists of two subscales: the Exercise Benefits Subscale (29 items) and the Exercise Barriers Subscale (14 items). The total score ranges from 43 to 172, with a higher score indicating a more positive perception towards exercise. |
at baseline and Week 13
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Change in Knee Extension Peak Torque assessed by Isokinetic Dynamometry
時間枠：at baseline, Week 8, and Week 13.
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Maximum torque generated during knee extension |
at baseline, Week 8, and Week 13.
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Change in Knee Extension Total Work assessed by Isokinetic Dynamometry
時間枠：at baseline, Week 8, and Week 13.
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Total work performed during repeated maximal knee extension contractions. |
at baseline, Week 8, and Week 13.
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Change in Knee Flexion Peak Torque assessed by Isokinetic Dynamometry
時間枠：at baseline, Week 8, and Week 13
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Maximum torque generated during Knee Flexion measured at a preset angular velocity |
at baseline, Week 8, and Week 13
|
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Change in Knee Flexion Total Work assessed by Isokinetic Dynamometry
時間枠：at baseline, Week 8, and Week 13
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Total work performed during repeated maximal Knee Flexion contractions |
at baseline, Week 8, and Week 13
|
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Change in Shoulder Flexion Peak Torque assessed by Isokinetic Dynamometry
時間枠：at baseline, Week 8, and Week 13
|
Maximum torque generated during Shoulder Flexion, measured at a preset angular velocity. |
at baseline, Week 8, and Week 13
|
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Change in Shoulder Flexion Total Work assessed by Isokinetic Dynamometry
時間枠：at baseline, Week 8, and Week 13
|
Total work performed during repeated maximal Shoulder Flexion contractions |
at baseline, Week 8, and Week 13
|
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Change in Shoulder Abduction Peak Torque assessed by Isokinetic Dynamometry
時間枠：at baseline, Week 8, and Week 13
|
Maximum torque generated during Shoulder Abduction , measured at a preset angular velocity |
at baseline, Week 8, and Week 13
|
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Change in Shoulder Abduction Total Work assessed by Isokinetic Dynamometry
時間枠：at baseline, Week 8, and Week 13
|
Total work performed during repeated maximal Shoulder Abduction contractions |
at baseline, Week 8, and Week 13
|
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Change in Elbow Extension Peak Torque assessed by Isokinetic Dynamometry
時間枠：at baseline, Week 8, and Week 13
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Maximum torque generated during Elbow Extension, measured at a preset angular velocity |
at baseline, Week 8, and Week 13
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Change in Elbow Extension Total Work assessed by Isokinetic Dynamometry
時間枠：at baseline, Week 8, and Week 13
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Total work performed during repeated maximal Elbow Extension contractions |
at baseline, Week 8, and Week 13
|
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Change in Elbow Flexion Peak Torque assessed by Isokinetic Dynamometry
時間枠：at baseline, Week 8, and Week 13
|
Maximum torque generated during Elbow Flexion, measured at a preset angular velocity |
at baseline, Week 8, and Week 13
|
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Change in Elbow Flexion Total Work assessed by Isokinetic Dynamometry
時間枠：at baseline, Week 8, and Week 13
|
Total work performed during repeated maximal Elbow Flexion contractions |
at baseline, Week 8, and Week 13
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Change in Rhythmic Weight Shift (RWS) Score assessed by Computerized Dynamic Posturography
時間枠：at baseline, Week 8, and Week 13.
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Measured using a computerized dynamic posturography system. |
at baseline, Week 8, and Week 13.
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Change in Modified Clinical Test of Sensory Interaction on Balance (mCTSIB) Score assessed by Computerized Dynamic Posturography
時間枠：at baseline, Week 8, and Week 13.
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Measured using a computerized dynamic posturography system. |
at baseline, Week 8, and Week 13.
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Change in Sensory Organization Test (SOT) Composite Score assessed by Computerized Dynamic Posturography
時間枠：at baseline, Week 8, and Week 13.
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Measured using a computerized dynamic posturography system. |
at baseline, Week 8, and Week 13.
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Change in Motor Control Test (MCT) Latency assessed by Computerized Dynamic Posturography
時間枠：at baseline, Week 8, and Week 13.
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Measured using a computerized dynamic posturography system. |
at baseline, Week 8, and Week 13.
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Change in Limits of Stability (LOS) Score assessed by Computerized Dynamic Posturography
時間枠：at baseline, Week 8, and Week 13.
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Measured using a computerized dynamic posturography system. |
at baseline, Week 8, and Week 13.
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Change in Waist-to-Hip Ratio
時間枠：at baseline and Week 13.
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Ratio of waist circumference to hip circumference |
at baseline and Week 13.
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Change in Center of Mass Sway Amplitude during Baduanjin Exercise assessed by 3D Motion Capture
時間枠：at baseline and Week 13
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Magnitude of anteroposterior and mediolateral displacement of the body's center of mass during static postures of Baduanjin, analyzed using a markerless 3D motion capture system |
at baseline and Week 13
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Change in Joint Range of Motion during Baduanjin Exercise assessed by 3D Motion Capture
時間枠：at baseline and Week 13
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Angular displacement of primary joints during the performance of Baduanjin movements, analyzed using a markerless 3D motion capture system. |
at baseline and Week 13
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Change in Glycemic Control Biomarkers
時間枠：at baseline and Week 13.
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Fasting venous blood samples will be analyzed for indicators of glucose metabolism, such as glycated hemoglobin (HbA1c) and fasting insulin. |
at baseline and Week 13.
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Change in Lipid Profile
時間枠：at baseline and Week 13.
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Fasting venous blood samples will be analyzed for indicators of lipid metabolism, including total cholesterol (TC), triglycerides (TG), low-density lipoprotein cholesterol (LDL-C), and high-density lipoprotein cholesterol (HDL-C). |
at baseline and Week 13.
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Change in Inflammatory and Neurotrophic Biomarkers
時間枠：at baseline and Week 13.
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Fasting venous blood samples will be analyzed for inflammatory markers (e.g., high-sensitivity C-reactive protein [hs-CRP], interleukin-6 [IL-6], tumor necrosis factor-alpha [TNF-α]) and brain-derived neurotrophic factor (BDNF). |
at baseline and Week 13.
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Baduanjin Movement Quality Score assessed by Blinded Expert Review (100-point scale)
時間枠：at Week 13
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Score assessed by blinded experts using a standardized 100-point scoring rubric. Scores range from 0 to 100, with a higher score indicating better movement quality. |
at Week 13
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協力者と研究者
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。