Effektene av Baduanjin-trening på helseforbedring blant stillesittende unge og middelaldrende voksne
En multicentrisk, randomisert kontrollert studie for å evaluere effektiviteten og mekanismene til Baduanjin for å forbedre helseutfall hos stillesittende unge og mellomaldrende voksne
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.
Studieoversikt
Status
Status
Forhold
Forhold
Intervensjon / Behandling
Intervensjon / Behandling
Studietype
Studietype
Registrering (Antatt)
Registrering
Fase
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiekontakt
Studiekontakt
- Navn: Jingyi Ren, M.D., Chief Physician
- Telefonnummer: 18600195099
- E-post: renjingyi@cjfh.org.cn
Studiesteder
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Beijing Municipality
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Beijing, Beijing Municipality, Kina, 100029
- Rekruttering
- China-Japan Friendship Hospital
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Ta kontakt med:
- Jingyi Ren, Doctor
- Telefonnummer: +86 17367938350
- E-post: 1220193509@qq.com
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Deltakelseskriterier
Kvalifikasjonskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Forebygging
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Antall våpen
Våpen og intervensjoner
Deltakergruppe / ArmDeltakergruppe / Arm |
Intervensjon / BehandlingIntervensjon / Behandling |
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Eksperimentell: 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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Annen: 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. |
Hva måler studien?
Primære resultatmål
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Change in Peak Oxygen Uptake (VO₂peak) assessed by Cardiopulmonary Exercise Testing
Tidsramme: at baseline and Week 13.
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Measured by Cardiopulmonary Exercise Testing (CPET). |
at baseline and Week 13.
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Sekundære resultatmål
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Endring i tid brukt på stillesittende atferd vurdert ved International Physical Activity Questionnaire (IPAQ)
Tidsramme: ved utgangspunktet og uke 13.
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ved utgangspunktet og uke 13.
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Endring i kneextension gjennomsnittlig kraft vurdert ved isokinetisk dynamometri
Tidsramme: ved baseline, uke 8 og uke 13.
|
ved baseline, uke 8 og uke 13.
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Endring i kneekstensjon tretthetsindeks vurdert ved isokinetisk dynamometri
Tidsramme: ved baseline, uke 8 og uke 13.
|
ved baseline, uke 8 og uke 13.
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Endring i knefleksjons gjennomsnittlig kraft vurdert med isokinetisk dynamometri
Tidsramme: ved baseline, uke 8 og uke 13
|
ved baseline, uke 8 og uke 13
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Endring i Kneleddsfleksjonens Tretthetsindeks vurdert med Isokinetisk Dynamometri
Tidsramme: ved utgangspunktet, uke 8 og uke 13
|
ved utgangspunktet, uke 8 og uke 13
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Endring i gjennomsnittlig kraft i skulderfleksjon vurdert ved isokinetisk dynamometri
Tidsramme: ved baseline, uke 8 og uke 13
|
ved baseline, uke 8 og uke 13
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Endring i Skulderfleksjonsutmatningsindeks vurdert ved isokinetisk dynamometri
Tidsramme: ved baseline, uke 8 og uke 13
|
ved baseline, uke 8 og uke 13
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Endring i gjennomsnittlig kraft ved skulderabduksjon vurdert med isokinetisk dynamometri
Tidsramme: ved baseline, uke 8 og uke 13
|
ved baseline, uke 8 og uke 13
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Endring i skulderabduksjonstretthetsindeks vurdert ved isokinetisk dynamometri
Tidsramme: ved utgangspunktet, uke 8 og uke 13
|
ved utgangspunktet, uke 8 og uke 13
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Endring i albueekstensjons gjennomsnittlig kraft vurdert ved isokinetisk dynamometri
Tidsramme: ved baseline, uke 8 og uke 13
|
ved baseline, uke 8 og uke 13
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Endring i Albueekstensjon Utmattelsesindeks vurdert ved Isokinetisk Dynamometri
Tidsramme: ved baseline, uke 8 og uke 13
|
ved baseline, uke 8 og uke 13
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Endring i gjennomsnittlig kraft i albuefleksjon vurdert ved isokinetisk dynamometri
Tidsramme: ved baseline, uke 8 og uke 13
|
ved baseline, uke 8 og uke 13
|
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Endring i albuefleksjonsutmatningsindeks vurdert ved isokinetisk dynamometri
Tidsramme: ved baseline, uke 8 og uke 13
|
ved baseline, uke 8 og uke 13
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Endring i muskelmasse vurdert ved bioelektrisk impedansanalyse
Tidsramme: ved baseline og uke 13.
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ved baseline og uke 13.
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Endring i kroppsfettprosent målt med bioelektrisk impedansanalyse
Tidsramme: ved baseline og uke 13.
|
ved baseline og uke 13.
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Endring i fettfri masse vurdert ved bioelektrisk impedansanalyse
Tidsramme: ved baseline og uke 13.
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ved baseline og uke 13.
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Endring i massesenterets høyde under Baduanjin-øvelse målt med 3D-bevegelsesfangst
Tidsramme: ved baseline og uke 13
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ved baseline og uke 13
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Endring i integrert elektromyografi (iEMG) under Baduanjin-øvelse vurdert ved overflateelektromyografi
Tidsramme: ved baseline og uke 13
|
ved baseline og uke 13
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Endring i rotmiddelkvadrat (RMS) amplitude under Baduanjin-øvelse vurdert med overflateelektromyografi
Tidsramme: ved baseline og uke 13
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ved baseline og uke 13
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Prosentandel av foreskrevne Baduanjin-økter fullført
Tidsramme: Gjennom studieavslutning, opptil uke 13.
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Gjennom studieavslutning, opptil uke 13.
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Change in Sit-and-Reach Distance
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: at baseline, Week 8, and Week 13
|
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
Tidsramme: at baseline, Week 8, and Week 13
|
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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: at baseline and Week 13
|
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
Tidsramme: 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
Tidsramme: at baseline and Week 13.
|
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
Tidsramme: at baseline and Week 13.
|
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)
Tidsramme: 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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Samarbeidspartnere og etterforskere
Sponsor
Sponsor
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Studiestart
Primær fullføring (Antatt)
Primær fullføring
Studiet fullført (Antatt)
Studiet fullført
Datoer for studieregistrering
Først innsendt
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Først lagt ut
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Sist oppdatering lagt ut
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Sist bekreftet
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