SarcopeniaNCT07871240
Yijinjing Exercise for Musculoskeletal Health in Adults With Sarcopenia
A study testing Modified Yijinjing Exercise, Progressive Resistance Training and Dietary Counseling and Health Education in people with Sarcopenia, run by Beijing Hospital of Traditional Chinese Medicine at 6 sites in China.
Trial summary
Sarcopenia is a condition involving loss of muscle mass and strength that can make walking and other daily activities more difficult. This study will compare a modified seven-form Yijinjing exercise program with resistance training in 240 adults aged 50 years or older with sarcopenia at six hospitals in Beijing. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Sarcopenia
- What is being tested?
- Modified Yijinjing Exercise, Progressive Resistance Training and Dietary Counseling and Health Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 6 sitesChina
- Study dates
- Jan 2027to Mar 2029
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 50 years or older, of either sex.
- Confirmed sarcopenia with both low muscle mass and low handgrip strength according to the protocol. For ages 50-64: ASMI <7.6 kg/m² in men or <5.7 kg/m² in women, and grip strength <34 kg in men or <20 kg in women. For ages 65 or older: ASMI <7.0 kg/m² in men or <5.7 kg/m² in women, and grip strength <28 kg in men or <18 kg in women. ASMI is appendicular skeletal muscle mass measured by multifrequency bioelectrical impedance analysis divided by height squared.
- Clinically stable, with no acute illness, infection, major surgery or hospitalization within the preceding 4 weeks.
- Physician assessment confirms ability to tolerate moderate-intensity exercise and safely undertake Yijinjing and resistance training.
- Adequate cognitive function to cooperate with training, assessments and follow-up.
- Voluntary written informed consent.
Who cannot join
- Severe cardiopulmonary disease, including unstable angina, myocardial infarction within the preceding 3 months, severe heart failure or severe ventilatory impairment.
- Severe hepatic, renal or endocrine disease, including cirrhosis, renal failure, uncontrolled diabetes or severe thyroid dysfunction.
- Parkinson disease, residual deficits after stroke, severe joint deformity or persistent back or leg pain preventing completion of the prescribed exercise.
- Severe cognitive decline, Alzheimer disease, uncontrolled psychiatric illness or severe depression preventing adequate cooperation.
- Active malignancy or cachexia, or current anticancer treatment.
- Participation in another sarcopenia intervention trial within the preceding 3 months.
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- Long-term use of glucocorticoids, anabolic hormones or other medicines affecting muscle metabolism.
- Unstable nutritional status, including weight fluctuation greater than 5% within the preceding month or dependence on parenteral nutrition.
- Severe osteoporosis with T-score <= -3.5 or fracture within the preceding 6 months creating a high exercise risk.
- Other exercise safety concerns or inability to complete study procedures as determined by the investigator.
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
China6 sites
Beijing Friendship Hospital, Capital Medical University
Beijing, Beijing Municipality
Beijing Hospital of Traditional Chinese Medicine, Capital Medical University
Beijing, Beijing Municipality
Beijing Jishuitan Hospital, Capital Medical University
Beijing, Beijing Municipality
Beijing Luhe Hospital, Capital Medical University
Beijing, Beijing Municipality
China-Japan Friendship Hospital
Beijing, Beijing Municipality
Xuanwu Hospital, Capital Medical University
Beijing, Beijing Municipality
About this study
Official title: A Multicenter Study of the Effects of Yijinjing Exercise on Musculoskeletal Health in Patients With Sarcopenia
Sarcopenia is a condition involving loss of muscle mass and strength that can make walking and other daily activities more difficult. This study will compare a modified seven-form Yijinjing exercise program with resistance training in 240 adults aged 50 years or older with sarcopenia at six hospitals in Beijing. Yijinjing is a traditional Chinese exercise that combines movements, breathing and focused attention.
For the first 6 months, participants will be randomly assigned to Yijinjing or resistance training. Exercise is scheduled at least three times per week, with one supervised group session and two remotely supervised home sessions. Both groups will receive the same dietary counseling and health education. The main question is whether Yijinjing improves physical performance at 6 months by an amount that is not meaningfully worse than resistance training. Physical performance will be measured using the Short Physical Performance Battery, which includes balance, walking and repeated chair stands.
After the 6-month assessment, participants in the resistance training group will switch to standard-duration Yijinjing. Eligible participants originally assigned to Yijinjing will be randomly assigned again to standard-duration or longer-duration Yijinjing for another 6 months. Participants who are not eligible for this second random assignment may continue standard-duration Yijinjing when clinically appropriate. Assessments at baseline, 6 months and 12 months will examine muscle mass and strength, physical function, quality of life and other health measures. Exercise-related adverse events will be monitored throughout the 12-month intervention.
Read the detailed description
This multicenter, assessor-blinded study will enroll 240 adults aged 50 years or older with sarcopenia. The two lead centers are Beijing Hospital of Traditional Chinese Medicine, Capital Medical University, and Beijing Jishuitan Hospital, Capital Medical University. Participating centers are Xuanwu Hospital, Capital Medical University; Beijing Friendship Hospital, Capital Medical University; China-Japan Friendship Hospital; and Beijing Luhe Hospital, Capital Medical University. The study is jointly led by principal investigators Yuchao Liu and Wei Tian.
The study uses a two-stage randomized design. During months 0-6, participants are randomized in a 1:1 ratio to modified seven-form Yijinjing or progressive resistance training. The first-stage objective is to evaluate whether Yijinjing is noninferior to resistance training for change in the Short Physical Performance Battery (SPPB) total score from baseline to 6 months. SPPB scores range from 0 to 12, with higher scores indicating better performance. The prespecified noninferiority margin is 0.5 points: noninferiority is concluded if the lower bound of the 95% confidence interval for the between-group difference in change (Yijinjing minus resistance training) exceeds -0.5 points.
Stage 1 Yijinjing sessions last approximately 40-45 minutes, including warm-up and cool-down, three times weekly. Resistance training is performed at least three times weekly for approximately 40 minutes per session and includes five functional exercises for major muscle groups. Weekly delivery consists of one supervised group session and two remotely supervised home sessions. Exercise technique and intensity are adjusted for tolerance and safety.
After the 6-month assessment, all participants originally assigned to resistance training switch to standard-duration Yijinjing for months 7-12. Eligible participants originally assigned to Yijinjing undergo a second 1:1 randomization to standard-duration Yijinjing (40 minutes per session) or extended-duration Yijinjing (progressively increased to 50-60 minutes, with a maximum of 65 minutes including warm-up and cool-down). Both schedules involve three sessions weekly. Original Yijinjing participants who do not meet the prespecified criteria for the second randomization continue standard-duration training if clinically appropriate; they are distinguished from re-randomized participants in analyses. Thus, the three registered treatment pathways arise from the two-stage design rather than an initial three-group randomization. The second stage explores the effects of session duration and longer-term intervention.
All participants receive standardized dietary counseling and health education. Dietary advice targets protein intake of 1.2-1.5 g/kg per day through ordinary food, using the lower of ideal or actual body weight. The study does not supply protein supplements. Health education is delivered weekly during the first three weeks, with identical content and contact time across groups.
Assessments are scheduled at baseline, 6 months and 12 months. In addition to the primary 6-month SPPB endpoint, outcomes include muscle mass index, handgrip strength, walking and chair-stand performance, 12-month SPPB change, quality of life, frailty, cognition, depression and anxiety. Bone mineral density measurements are collected at the two lead centers. Circulating biomarkers are assessed for exploratory mechanistic analyses. Adverse events are monitored throughout the 12-month intervention. Outcome assessors, data managers and primary statistical analysts are blinded to allocation; participants and exercise instructors cannot be blinded.
Enrollment is anticipated to begin in January 2027. Primary outcome collection is expected to finish in September 2028, and 12-month follow-up is expected to finish in March 2029.
- Conditions
- Sarcopenia
- Being tested
- Modified Yijinjing Exercise, Progressive Resistance Training, Dietary Counseling and Health Education
- Medical subject headings
- Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Modified Yijinjing ExerciseBehavioural
Modified seven-form traditional Chinese exercise adapted for adults with sarcopenia, combining movement, breathing and attention. Three sessions weekly: one supervised group session and two remotely supervised home sessions. Stage 1 sessions last 40-45 minutes including warm-up and cool-down; stage 2 standard-duration sessions last 40 minutes and extended-duration sessions progressively increase to 50-60 minutes, maximum 65 minutes. Target Borg RPE is 11-13 on the 6-20 scale. Duration and movement intensity are adjusted for tolerance and safety.
Progressive Resistance TrainingBehavioural
Six months of progressive resistance training at least three times weekly, approximately 40 minutes per session: 5 minutes of warm-up, 30 minutes of exercise and 5 minutes of cool-down. Five functional exercises target major muscle groups: wall squats, wall push-ups, forward lunges, reverse arm flexion/extension and supported heel raises. Each exercise is performed for two sets of 6-8 repetitions, with 1 minute of rest between sets. One session is supervised in person and two are remotely supervised at home each week. Exercise intensity and technique are adjusted for tolerance and safety. Participants switch to standard-duration modified Yijinjing after the 6-month assessment.
Dietary Counseling and Health EducationBehavioural
Provided to all treatment pathways. Dietary advice targets total daily protein intake of 1.2-1.5 g/kg through ordinary food, using the lower of ideal or actual body weight. The study does not supply protein supplements. Three-day food diaries, including two weekdays and one non-working day, are reviewed at baseline, 6 months and 12 months with individualized advice. Standardized health education is delivered weekly for the first three weeks, approximately 30 minutes plus 5-10 minutes of questions per session, covering sarcopenia, nutrition, exercise safety and health management. Content and contact time are identical across groups.
| Study group | Role | What they receive |
|---|---|---|
| Yijinjing Followed by Standard-Duration Yijinjing | Experimental | Months 0-6: modified seven-form Yijinjing three times weekly, 40-45 minutes per session. Months 7-12: standard-duration Yijinjing, 40 minutes per session, three times weekly. This pathway includes eligible original Yijinjing participants assigned to standard duration by the second randomization, and participants who are not eligible for the second randomization and continue standard duration if clinically appropriate; these subgroups are distinguished in analyses. Weekly delivery consists of one supervised group session and two remotely supervised home sessions. Dietary counseling and health education are provided. Receives: Behavioral: Modified Yijinjing Exercise; Behavioral: Dietary Counseling and Health Education |
| Yijinjing Followed by Extended-Duration Yijinjing | Experimental | Months 0-6: modified seven-form Yijinjing three times weekly, 40-45 minutes per session. After completing the 6-month assessment and meeting the prespecified eligibility criteria, participants assigned to extended duration by the second 1:1 randomization receive modified Yijinjing three times weekly for months 7-12. Session duration increases progressively to 50-60 minutes according to exercise tolerance, with a maximum of 65 minutes including warm-up and cool-down. Weekly delivery consists of one supervised group session and two remotely supervised home sessions. Dietary counseling and health education are provided. Receives: Behavioral: Modified Yijinjing Exercise; Behavioral: Dietary Counseling and Health Education |
| Resistance Training Followed by Standard-Duration Yijinjing | Active comparator | Months 0-6: progressive resistance training at least three times weekly, approximately 40 minutes per session, including warm-up and cool-down. Five exercises are performed for two sets of 6-8 repetitions with 1 minute of rest between sets. Months 7-12: all participants switch to modified seven-form Yijinjing, 40 minutes per session, three times weekly, following technique instruction and a safety assessment. Weekly delivery consists of one supervised group session and two remotely supervised home sessions. Dietary counseling and health education are provided. Receives: Behavioral: Modified Yijinjing Exercise; Behavioral: Progressive Resistance Training; Behavioral: Dietary Counseling and Health Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Short Physical Performance Battery Total Score at 6 Months
The Short Physical Performance Battery (SPPB) assesses standing balance, 4-meter walking performance and five repeated chair stands. Total scores range from 0 to 12; higher scores indicate better physical performance. The primary endpoint is the 6-month total score minus the baseline total score. Noninferiority is concluded if the lower bound of the 95% confidence interval for the difference in change (Yijinjing minus resistance training) exceeds -0.5 points.
Measured: Baseline and 6 months
Secondary outcomes (24)
Appendicular Skeletal Muscle Mass Index
Appendicular skeletal muscle mass measured by multifrequency bioelectrical impedance analysis divided by height squared, expressed in kg/m².
Measured: Baseline, 6 months and 12 months
Handgrip Strength
Maximum dominant-hand grip strength from two dynamometer measurements, expressed in kg.
Measured: Baseline, 6 months and 12 months
Usual Walking Performance Over 6 Meters
Time required to walk 6 meters at usual pace, averaged over two trials.
Measured: Baseline, 6 months and 12 months
Five-Repetition Chair Stand Performance
Performance on five repeated chair stands as a measure of lower-limb function.
Measured: Baseline, 6 months and 12 months
Change From Baseline in SPPB Total Score at 12 Months
The 12-month Short Physical Performance Battery total score minus baseline score. Scores range from 0 to 12, with higher scores indicating better physical performance.
Measured: Baseline and 12 months
SF-36 Health-Related Quality of Life
The SF-36 assesses eight domains: physical functioning, role limitations due to physical health, bodily pain, general health, vitality, social functioning, role limitations due to emotional health and mental health. Higher scores indicate better health-related quality of life.
Measured: Baseline, 6 months and 12 months
Fried Frailty Phenotype
Frailty is assessed using the Fried Frailty Phenotype, which includes five criteria: unintentional weight loss, slow walking speed, low handgrip strength, low physical activity, and exhaustion. Each criterion is scored as 0 (absent) or 1 (present), yielding a total score ranging from 0 to 5. Higher scores indicate greater frailty and a worse outcome. A score of 0 indicates non-frailty, 1-2 indicates pre-frailty, and 3-5 indicates frailty.
Measured: Baseline, 6 months and 12 months.
Montreal Cognitive Assessment
Cognitive function is assessed using the Montreal Cognitive Assessment. The total score ranges from 0 to 30. Higher scores indicate better cognitive function and a better outcome. When applicable, the education adjustment is applied according to the instrument's scoring instructions, with the adjusted total score capped at 30.
Measured: Baseline, 6 months and 12 months
Hamilton Depression Rating Scale
Depressive symptom severity is assessed using the 24-item Hamilton Depression Rating Scale. The total score is the sum of 24 item scores and ranges from 0 to 76. Higher scores indicate more severe depressive symptoms and a worse outcome.
Measured: Baseline, 6 months and 12 months
Hamilton Anxiety Rating Scale
Anxiety symptom severity is assessed using the 14-item Hamilton Anxiety Rating Scale. Each item is rated from 0 to 4, yielding a total score ranging from 0 to 56. Higher scores indicate more severe anxiety symptoms and a worse outcome.
Measured: Baseline, 6 months and 12 months
Adverse Event Incidence
Adverse events including falls, muscle strains and joint injuries are recorded throughout the intervention, including timing, severity, management and relationship to the intervention.
Measured: Throughout the 12-month intervention
Lumbar Spine Bone Mineral Density
DXA measurement of lumbar spine L1-L4 bone mineral density, collected only for participants enrolled at the two lead institutions.
Measured: Baseline, 6 months and 12 months
Femoral Neck Bone Mineral Density
DXA measurement of femoral neck bone mineral density, collected only for participants enrolled at the two lead institutions.
Measured: Baseline, 6 months and 12 months
Total Hip Bone Mineral Density
DXA measurement of total hip bone mineral density, collected only for participants enrolled at the two lead institutions.
Measured: Baseline, 6 months and 12 months
Irisin
Circulating Irisin measured from morning fasting blood samples for exploratory mechanistic analysis. Sampling is performed at 07:00-09:00 after an 8-12-hour fast, at least 48 hours after the last exercise session and after 20 minutes of seated rest.
Measured: Baseline, 6 months and 12 months
Brain-Derived Neurotrophic Factor (BDNF)
Circulating Brain-Derived Neurotrophic Factor (BDNF) measured from morning fasting blood samples for exploratory mechanistic analysis. Sampling is performed at 07:00-09:00 after an 8-12-hour fast, at least 48 hours after the last exercise session and after 20 minutes of seated rest.
Measured: Baseline, 6 months and 12 months
Myostatin
Circulating Myostatin measured from morning fasting blood samples for exploratory mechanistic analysis. Sampling is performed at 07:00-09:00 after an 8-12-hour fast, at least 48 hours after the last exercise session and after 20 minutes of seated rest.
Measured: Baseline, 6 months and 12 months
Follistatin
Circulating Follistatin measured from morning fasting blood samples for exploratory mechanistic analysis. Sampling is performed at 07:00-09:00 after an 8-12-hour fast, at least 48 hours after the last exercise session and after 20 minutes of seated rest.
Measured: Baseline, 6 months and 12 months
Follistatin-to-Myostatin Ratio
Ratio calculated from measured follistatin and myostatin concentrations as an exploratory mechanistic endpoint.
Measured: Baseline, 6 months and 12 months
Insulin-Like Growth Factor 1 (IGF-1)
Circulating Insulin-Like Growth Factor 1 (IGF-1) measured from morning fasting blood samples for exploratory mechanistic analysis. Sampling is performed at 07:00-09:00 after an 8-12-hour fast, at least 48 hours after the last exercise session and after 20 minutes of seated rest.
Measured: Baseline, 6 months and 12 months
Insulin-Like Growth Factor Binding Protein 3 (IGFBP-3)
Circulating Insulin-Like Growth Factor Binding Protein 3 (IGFBP-3) measured from morning fasting blood samples for exploratory mechanistic analysis. Sampling is performed at 07:00-09:00 after an 8-12-hour fast, at least 48 hours after the last exercise session and after 20 minutes of seated rest.
Measured: Baseline, 6 months and 12 months
Basal Growth Hormone
Circulating Basal Growth Hormone measured from morning fasting blood samples for exploratory mechanistic analysis. Sampling is performed at 07:00-09:00 after an 8-12-hour fast, at least 48 hours after the last exercise session and after 20 minutes of seated rest. Single basal growth hormone measurements are used only as an auxiliary indicator because secretion is pulsatile.
Measured: Baseline, 6 months and 12 months
Adrenocorticotropic Hormone (ACTH)
Circulating Adrenocorticotropic Hormone (ACTH) measured from morning fasting blood samples for exploratory mechanistic analysis. Sampling is performed at 07:00-09:00 after an 8-12-hour fast, at least 48 hours after the last exercise session and after 20 minutes of seated rest.
Measured: Baseline, 6 months and 12 months
Cortisol
Circulating Cortisol measured from morning fasting blood samples for exploratory mechanistic analysis. Sampling is performed at 07:00-09:00 after an 8-12-hour fast, at least 48 hours after the last exercise session and after 20 minutes of seated rest.
Measured: Baseline, 6 months and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2026
- Study startJan 2027 (estimated)
- Primary completionSep 2028 (estimated)
- Study completionMar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SarcopeniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- Two-stage randomized design. During months 0-6, participants are randomized 1:1 to modified Yijinjing or resistance training. At 6 months, the resistance group switches to standard-duration Yijinjing. Eligible original Yijinjing participants undergo a second 1:1 randomization to standard-duration or extended-duration Yijinjing; those ineligible for the second randomization continue standard-duration training if clinically appropriate. Three treatment pathways result: Yijinjing to standard-duration Yijinjing, Yijinjing to extended-duration Yijinjing, and resistance training to standard-duration Yijinjing.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Hospital of Traditional Chinese Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yuchao Liu, Beijing Hospital of Traditional Chinese Medicine
- Investigators
- Yuchao Liu, Principal investigator, Beijing Hospital of Traditional Chinese MedicineWei Tian, Principal investigator, Beijing Jishuitan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07871240
- Sponsor's protocol ID
- 2026BL02-122-02
- Status last verified
- Oct 2026
- First submitted
- 7 Oct 2026
- Last updated
- 21 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No