- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT07482995
Auswirkungen von Baduanjin-Übungen auf die Gesundheitsverbesserung bei sitzenden jungen und mittelalten Erwachsenen
Eine multizentrische, randomisierte kontrollierte Studie zur Bewertung der Wirksamkeit und Mechanismen von Baduanjin bei der Verbesserung der Gesundheitsergebnisse bei sitzenden jungen und mittelalten Erwachsenen
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.
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Studientyp
Einschreibung (Geschätzt)
Phase
- Unzutreffend
Kontakte und Standorte
Studienkontakt
- Name: Jingyi Ren, M.D., Chief Physician
- Telefonnummer: 18600195099
- E-Mail: renjingyi@cjfh.org.cn
Studienorte
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Beijing Municipality
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Beijing, Beijing Municipality, China, 100029
- Rekrutierung
- China-Japan Friendship Hospital
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Kontakt:
- Jingyi Ren, Doctor
- Telefonnummer: +86 17367938350
- E-Mail: 1220193509@qq.com
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
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
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Verhütung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Single
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
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Experimental: 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. |
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Sonstiges: 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. |
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Change in Peak Oxygen Uptake (VO₂peak) assessed by Cardiopulmonary Exercise Testing
Zeitfenster: at baseline and Week 13.
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Measured by Cardiopulmonary Exercise Testing (CPET). |
at baseline and Week 13.
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Veränderung der im sitzenden Verhalten verbrachten Zeit, bewertet durch den International Physical Activity Questionnaire (IPAQ)
Zeitfenster: zu Studienbeginn und in Woche 13.
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zu Studienbeginn und in Woche 13.
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Veränderung der durchschnittlichen Kniestreckkraft, bewertet mittels isokinetischer Dynamometrie
Zeitfenster: zu Studienbeginn, Woche 8 und Woche 13.
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zu Studienbeginn, Woche 8 und Woche 13.
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Änderung des Kniesstreckermüdigkeitsindex, bewertet durch isokinetische Dynamometrie
Zeitfenster: zu Studienbeginn, Woche 8 und Woche 13.
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zu Studienbeginn, Woche 8 und Woche 13.
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Änderung der durchschnittlichen Knieflexionsleistung, bewertet durch isokinetische Dynamometrie
Zeitfenster: zu Studienbeginn, Woche 8 und Woche 13
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zu Studienbeginn, Woche 8 und Woche 13
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Veränderung des Knieflexions-Erschöpfungsindex, bewertet durch isokinetische Dynamometrie
Zeitfenster: zu Studienbeginn, Woche 8 und Woche 13
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zu Studienbeginn, Woche 8 und Woche 13
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Änderung der durchschnittlichen Kraft bei Schulterflexion, bewertet durch isokinetische Dynamometrie
Zeitfenster: zu Studienbeginn, Woche 8 und Woche 13
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zu Studienbeginn, Woche 8 und Woche 13
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Änderung des Schulterflexions-Erschöpfungsindex, bewertet durch isokinetische Dynamometrie
Zeitfenster: zu Studienbeginn, Woche 8 und Woche 13
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zu Studienbeginn, Woche 8 und Woche 13
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Änderung der durchschnittlichen Kraft bei der Schulterabduktion, bewertet mittels isokinetischer Dynamometrie
Zeitfenster: zu Beginn, Woche 8 und Woche 13
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zu Beginn, Woche 8 und Woche 13
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Änderung des Schulterabduktionsermüdungsindex bewertet durch isokinetische Dynamometrie
Zeitfenster: zu Studienbeginn, Woche 8 und Woche 13
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zu Studienbeginn, Woche 8 und Woche 13
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Veränderung der durchschnittlichen Kraft bei Ellbogenstreckung, gemessen mit isokinetischer Dynamometrie
Zeitfenster: zu Studienbeginn, Woche 8 und Woche 13
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zu Studienbeginn, Woche 8 und Woche 13
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Veränderung des Ellenbogen-Extensions-Erschöpfungsindex, bewertet durch isokinetische Dynamometrie
Zeitfenster: zu Studienbeginn, Woche 8 und Woche 13
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zu Studienbeginn, Woche 8 und Woche 13
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Änderung der durchschnittlichen Ellenbogenbeugekraft, bewertet durch isokinetische Dynamometrie
Zeitfenster: zu Studienbeginn, Woche 8 und Woche 13
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zu Studienbeginn, Woche 8 und Woche 13
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Veränderung des Ellenbogenbeuge-Ermüdungsindex bewertet durch isokinetische Dynamometrie
Zeitfenster: zum Ausgangswert, Woche 8 und Woche 13
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zum Ausgangswert, Woche 8 und Woche 13
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Veränderung der Muskelmasse bewertet durch Bioelektrische Impedanzanalyse
Zeitfenster: zu Studienbeginn und Woche 13.
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zu Studienbeginn und Woche 13.
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Veränderung des Körperfettanteils bewertet durch Bioelektrische Impedanzanalyse
Zeitfenster: zu Studienbeginn und Woche 13.
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zu Studienbeginn und Woche 13.
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Veränderung der fettfreien Masse bewertet durch Bioelektrische Impedanzanalyse
Zeitfenster: zu Beginn und Woche 13.
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zu Beginn und Woche 13.
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Veränderung der Körpermittelpunkthöhe während Baduanjin-Übungen, bewertet durch 3D-Bewegungserfassung
Zeitfenster: zum Ausgangszeitpunkt und in Woche 13
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zum Ausgangszeitpunkt und in Woche 13
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Änderung der integrierten Elektromyographie (iEMG) während der Baduanjin-Übung bewertet durch Oberflächenelektromyographie
Zeitfenster: zum Ausgangszeitpunkt und in Woche 13
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zum Ausgangszeitpunkt und in Woche 13
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Änderung der Root-Mean-Square (RMS)-Amplitude während der Baduanjin-Übung, bewertet durch Oberflächen-Elektromyographie
Zeitfenster: zu Studienbeginn und Woche 13
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zu Studienbeginn und Woche 13
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Prozentsatz der vorgeschriebenen Baduanjin-Sitzungen abgeschlossen
Zeitfenster: Bis zum Studienabschluss, bis zu Woche 13.
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Bis zum Studienabschluss, bis zu Woche 13.
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Change in Sit-and-Reach Distance
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: at baseline, Week 8, and Week 13
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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
Zeitfenster: at baseline, Week 8, and Week 13
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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
Zeitfenster: at baseline, Week 8, and Week 13
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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
Zeitfenster: at baseline, Week 8, and Week 13
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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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: at baseline, Week 8, and Week 13
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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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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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Mitarbeiter und Ermittler
Sponsor
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- Shoufa 2024-1-4061
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