Effekter af Baduanjin-træning på forbedring af sundheden hos stillesiddende unge og midaldrende voksne
Et multicenter, randomiseret kontrolleret forsøg for at evaluere effektiviteten og mekanismerne af Baduanjin til at forbedre sundhedsresultater hos stillesiddende unge og midaldrende 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.
Studieoversigt
Status
Status
Betingelser
Betingelser
Intervention / Behandling
Intervention / Behandling
Undersøgelsestype
Undersøgelsestype
Tilmelding (Anslået)
Tilmelding
Fase
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiekontakt
Studiekontakt
- Navn: Jingyi Ren, M.D., Chief Physician
- Telefonnummer: 18600195099
- E-mail: 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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Kontakt:
- Jingyi Ren, Doctor
- Telefonnummer: +86 17367938350
- E-mail: 1220193509@qq.com
-
-
Deltagelseskriterier
Berettigelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
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 undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Antal våben
Våben og indgreb
Deltagergruppe / ArmDeltagergruppe / Arm |
Intervention / BehandlingIntervention / Behandling |
|---|---|
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Eksperimentel: 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. |
|
Andet: 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. |
Hvad måler undersøgelsen?
Primære resultatmål
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
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 |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Ændring i tid brugt på stillesiddende adfærd vurderet ved International Physical Activity Questionnaire (IPAQ)
Tidsramme: ved baseline og uge 13.
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ved baseline og uge 13.
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Ændring i knæekstensions gennemsnitlige effekt vurderet ved isokinetisk dynamometri
Tidsramme: ved baseline, uge 8 og uge 13.
|
ved baseline, uge 8 og uge 13.
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Ændring i knæekstensionsudmattelsesindeks vurderet ved isokinetisk dynamometri
Tidsramme: ved baseline, uge 8 og uge 13.
|
ved baseline, uge 8 og uge 13.
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Ændring i gennemsnitlig knæfleksionskraft vurderet ved isokinetisk dynamometri
Tidsramme: ved baseline, uge 8 og uge 13
|
ved baseline, uge 8 og uge 13
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Ændring i knæfleksion træthedsindeks vurderet ved isokinetisk dynamometri
Tidsramme: ved baseline, uge 8 og uge 13
|
ved baseline, uge 8 og uge 13
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Ændring i gennemsnitlig kraft ved skulderfleksion vurderet ved isokinetisk dynamometri
Tidsramme: ved baseline, uge 8 og uge 13
|
ved baseline, uge 8 og uge 13
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Ændring i Skulderfleksion Træthedsindeks vurderet ved Isokinetisk Dynamometri
Tidsramme: ved baseline, uge 8 og uge 13
|
ved baseline, uge 8 og uge 13
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Ændring i gennemsnitlig kraft ved skulderabduktion vurderet ved isokinetisk dynamometri
Tidsramme: ved baseline, uge 8 og uge 13
|
ved baseline, uge 8 og uge 13
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Ændring i Skulderabduktions Træthedsindeks vurderet ved Isokinetisk Dynamometri
Tidsramme: ved baseline, uge 8 og uge 13
|
ved baseline, uge 8 og uge 13
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Ændring i gennemsnitlig strækkekraft i albuen vurderet ved isokinetisk dynamometri
Tidsramme: ved baseline, uge 8 og uge 13
|
ved baseline, uge 8 og uge 13
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Ændring i Albueledsextensions Træthedsindeks vurderet ved Isokinetisk Dynamometri
Tidsramme: ved baseline, uge 8 og uge 13
|
ved baseline, uge 8 og uge 13
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Ændring i gennemsnitlig kraft ved albuebøjning vurderet ved isokinetisk dynamometri
Tidsramme: ved baseline, uge 8 og uge 13
|
ved baseline, uge 8 og uge 13
|
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Ændring i albuefleksionstræthedsindeks vurderet ved isokinetisk dynamometri
Tidsramme: ved baseline, uge 8 og uge 13
|
ved baseline, uge 8 og uge 13
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Ændring i muskelmasse vurderet ved bioelektrisk impedansanalyse
Tidsramme: ved baseline og uge 13.
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ved baseline og uge 13.
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Ændring i kropsfedtprocent vurderet ved bioelektrisk impedansanalyse
Tidsramme: ved baseline og uge 13.
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ved baseline og uge 13.
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Ændring i fedtfri masse vurderet ved bioelektrisk impedansanalyse
Tidsramme: ved baseline og uge 13.
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ved baseline og uge 13.
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Ændring i tyngdepunktets højde under Baduanjin-øvelse vurderet med 3D-bevægelsesregistrering
Tidsramme: ved baseline og uge 13
|
ved baseline og uge 13
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Ændring i integreret elektromyografi (iEMG) under Baduanjin-øvelser vurderet ved overfladeelektromyografi
Tidsramme: ved baseline og uge 13
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ved baseline og uge 13
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Ændring i Root Mean Square (RMS) amplitude under Baduanjin-øvelse vurderet ved overfladeelektromyografi
Tidsramme: ved baseline og uge 13
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ved baseline og uge 13
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Procentdel af forordnede Baduanjin-sessioner fuldført
Tidsramme: Gennem studiefærdiggørelse, op til uge 13.
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Gennem studiefærdiggørelse, op til uge 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
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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
Tidsramme: 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
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
|
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.
|
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
|
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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Samarbejdspartnere og efterforskere
Sponsor
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Studiestart
Primær færdiggørelse (Anslået)
Primær færdiggørelse
Studieafslutning (Anslået)
Studieafslutning
Datoer for studieregistrering
Først indsendt
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Først opslået
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering sendt
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Sidst verificeret
Mere information
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Andre undersøgelses-id-numre
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