- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07753291
The Effects of the Yi Jin Jing on the Muscles and Bones of Adults
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiekontakt
- Navn: jin he hejin
- Telefonnummer: +8617600765734
- E-mail: 17600765734@163.com
Studiesteder
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Beijing, Kina
- Rekruttering
- No. 23, Ganju Road, Dongcheng District, Beijing
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Kontakt:
- Jin He
- Telefonnummer: 17600765734
- E-mail: 17600765734@163.com
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Beskrivelse
Inclusion Criteria:
- Age 18-90 years inclusive;
- Generally healthy, no acute or chronic diseases affecting major organ functions;
- No cognitive impairment, able to understand and comply with study procedures;
- Willing and able to provide written informed consent;
- No pregnancy or lactation (for females);
- No recent (within 3 months) major surgery, hospitalization, or significant weight change (>5% body weight).
Exclusion Criteria:
- Presence of acute or unstable chronic diseases (e.g., uncontrolled hypertension, diabetes, heart failure, or malignancy);
- Severe cognitive impairment, psychiatric disorders, or inability to follow study instructions;
- Recent (≤3 months) major surgery, trauma, or hospitalization;
- Pregnancy, lactation, or childbearing potential without reliable contraception;
- Body mass index (BMI) <16 or >40 kg/m²;
- Current use of medications affecting muscle or nutritional metabolism (e.g., corticosteroids, anabolic steroids);
- Participation in another interventional trial within 30 days.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: The effects of Yi Jin Jing on the muscles and bones of adults
Yijinjing exercise
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Yijinjing
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Appendicular Skeletal Muscle Index
Tidsramme: Day 180 ± 10 days
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Appendicular Skeletal Muscle Index (ASMI) = appendicular lean mass (kg) / height² (m²).
It reflects muscle mass, used for sarcopenia diagnosis.
Lower values indicate muscle loss, linked to aging, malnutrition, or disease.
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Day 180 ± 10 days
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Handgrip strength
Tidsramme: Day 180 ± 10 days
|
Handgrip strength (HGS) = maximum force (kg) measured by a dynamometer.
It reflects overall muscle function, predicts disability, morbidity, and mortality.
Low HGS indicates sarcopenia, frailty, or poor nutritional status.
|
Day 180 ± 10 days
|
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Nutrition intake form(MNA)
Tidsramme: Day 180 ± 10 days
|
Mini Nutritional Assessment - Short Form (MNA-SF) consists of 6 items:
Each item scores 0-3 points. A total score ≤11 indicates a risk of malnutrition. It is commonly used for nutritional screening in elderly populations. |
Day 180 ± 10 days
|
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Fried
Tidsramme: Day 180 ± 10 days
|
Fried Frailty Phenotype = a 5-item scale assessing unintentional weight loss, exhaustion, low grip strength, slow walking speed, and low physical activity.
item ≥3 = frail; 1-2 = prefrail; 0 = robust.
Predicts falls, disability, and mortality.
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Day 180 ± 10 days
|
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FRAIL
Tidsramme: Day 180 ± 10 days
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FRAIL Scale = a 5-item questionnaire: Fatigue, Resistance (climb stairs), Ambulation (walk), Illness (≥5 chronic conditions), and Loss of weight (≥5%).
Score 0 = robust, 1-2 = prefrail, 3-5 = frail.
Quick screening for frailty in community settings.
|
Day 180 ± 10 days
|
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SPPB
Tidsramme: Day 180 ± 10 days
|
Short Physical Performance Battery (SPPB) = a 3-component test: standing balance (0-4), 4-meter gait speed (0-4), and 5-repetition chair stand (0-4).
Total score 0-12; ≤8 indicates poor physical function, predicts disability, falls, and mortality in older adults.
|
Day 180 ± 10 days
|
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Muscle mass measured by ultrasound
Tidsramme: Day 180 ± 10 days
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Ultrasound-based measurements of peripheral skeletal muscles offer a practical, non-invasive, and radiation-free approach for assessing muscle mass in clinical and research settings. In accordance with previously established cut-off values, the following parameters are employed to identify a tendency toward reduced muscle mass:
These ultrasonographic parameters are intended for initial screening and may assist in the early identification of individuals at risk for sarcopenia, particularly when access to dual-energy X-ray abs |
Day 180 ± 10 days
|
Samarbejdspartnere og efterforskere
Datoer for undersøgelser
Studer store datoer
Studiestart (Anslået)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- 2025BL02-161-02
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
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