- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT07753291
The Effects of the Yi Jin Jing on the Muscles and Bones of Adults
Studieöversikt
Status
Betingelser
Intervention / Behandling
Studietyp
Inskrivning (Beräknad)
Fas
- Inte tillämpbar
Kontakter och platser
Studiekontakt
- Namn: jin he hejin
- Telefonnummer: +8617600765734
- E-post: 17600765734@163.com
Studieorter
-
-
-
Beijing, Kina
- Rekrytering
- No. 23, Ganju Road, Dongcheng District, Beijing
-
Kontakt:
- Jin He
- Telefonnummer: 17600765734
- E-post: 17600765734@163.com
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Beskrivning
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
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Förebyggande
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: The effects of Yi Jin Jing on the muscles and bones of adults
Yijinjing exercise
|
Yijinjing
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Appendicular Skeletal Muscle Index
Tidsram: Day 180 ± 10 days
|
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.
|
Day 180 ± 10 days
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Handgrip strength
Tidsram: 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
|
|
Nutrition intake form(MNA)
Tidsram: 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
|
|
Fried
Tidsram: 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.
|
Day 180 ± 10 days
|
|
FRAIL
Tidsram: Day 180 ± 10 days
|
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
|
|
SPPB
Tidsram: 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
|
|
Muscle mass measured by ultrasound
Tidsram: Day 180 ± 10 days
|
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
|
Samarbetspartners och utredare
Studieavstämningsdatum
Studera stora datum
Studiestart (Beräknad)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Andra studie-ID-nummer
- 2025BL02-161-02
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