SarcopeniaPhase 4NCT06128577
Bioindicators Associated With Sarcopenia Before and After Intensive Lifestyle Intervention
A Phase 4 study testing 3-month intensive intervention in people with Sarcopenia, run by Lijun Yang at 1 site in China.
Trial summary
The goal of this clinical trial is to explore whether the bioindicators of body composition, nutrition-related indicators (lymphocytes, albumin), lipids, and thyroid hormones are associated with sarcopenia and the changes in these indicators after an intensive lifestyle intervention. Read more about this study
- Who is it for?
- Ages 65 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Sarcopenia
- What is being tested?
- 3-month intensive intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 99 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2022to 2 Aug 2022
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 65 to 90 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 1) Resident elderly aged 65-90 years old in the district.
- 2) Voluntary participation in the trial and signing the informed consent form.
Who cannot join
- 1) People with systemic severe diseases, organ failure, malignant tumors, neuromuscular degenerative diseases, or active weight loss.
- 2) People with cognitive impairment, incapacitation, or severe mental illnesses who cannot cooperate with the test.
- 3) People with cardiac pacemakers and artificial joint implantation or others who cannot undergo the BIA test.
- 4) People with severe cardiorespiratory dysfunction and physical disabilities who cannot complete the exercise training.
- 5) Incomplete data, refusal to participate in the survey, body composition analysis, and blood collection.
Trial locations and contacts
1 site in 1 country.
About this study
The goal of this clinical trial is to explore whether the bioindicators of body composition, nutrition-related indicators (lymphocytes, albumin), lipids, and thyroid hormones are associated with sarcopenia and the changes in these indicators after an intensive lifestyle intervention. The main questions it aims to answer are:
- whether the bioindicators such as lymphocytes, albumin, lipids, thyroid hormones, fat mass, fat-free mass, and basal metabolic mass are associated with the development of sarcopenia.
- the changes of these bioindicators that occur in older adults after going through an intensive intervention.
Read more
Participants will receive a 3-month intensive intervention consisting of an intensive nutritional intervention and an individually designed exercise intervention. Nutritional and exercise prescriptions are co-designed through a nutritionist and rehabilitation physician.
Researchers will compare bioindicators in the sarcopenia group before and after intensive lifestyle intervention to determine the association with sarcopenia.
- Conditions
- Sarcopenia
- Being tested
- 3-month intensive intervention
- Keywords
- Sarcopenia, Bioindicators, Intensive lifestyle intervention, Exercise intervention, Nutritional intervention
- Medical subject headings
- Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3-month intensive interventionCombination product
Also called Sarcopenia group
Intensive nutritional interventions were as follows: i）Estimation of ideal body weight according to height, calculation of calories by giving 30-40kcal/kg/day according to BMI stratification, and calculation of daily protein requirement at 1.5g/kg/day, which was finally converted into daily dietary recommendations according to the results of the calculations. ii）Distribution of additional protein supplementation by whey protein, each sachet containing 15g of whey protein.
The resistance training program included 5 min of warm-up, 20 min of muscle strength training, and 5 min of slow walking and was performed three times a week. Resistance training involved a dumbbell and sandbags as weights for the major muscles of the upper and lower limbs. In the study, aerobic training is brisk walking or jogging for 30 minutes/day, five times a week.
| Study group | Role | What they receive |
|---|---|---|
| Sarcopenia group | Experimental | After completing screening, 30 subjects in the sarcopenia group received a 3-month intensive intervention consisting of an intensive nutritional intervention and an individually designed exercise intervention. Nutritional and exercise prescriptions were co-designed through a nutritionist and rehabilitation physician. Receives: Combination Product: 3-month intensive intervention |
| Normal control group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
AMMI(appendicular muscle mass index)
Bioelectrical impedance analysis was used to obtain appendicular muscle mass (AMM) and height. The unit of AMM and height were represented as kilogram and meter respectively. AMMI were calculated as AMM/height^2 (kg/m^2).
Measured: baseline and 3 month
Secondary outcomes (7)
Fat mass
Bioelectrical impedance analysis was used to obtain fat mass. The unit of fat mass was represented as kilogram.
Measured: baseline and 3 month
Fat-free mass
Bioelectrical impedance analysis was used to obtain fat-free mass. The unit of fat-free mass was represented as kilogram.
Measured: baseline and 3 month
Basal metabolic mass
Bioelectrical impedance analysis was used to obtain basal metabolic mass. The unit of basal metabolic mass was represented as kilocalorie.
Measured: baseline and 3 month
Lymphocyte count
Lymphocyte counts were detected using a fully automated hematology analyzer (Mindray BC-6800, Shenzhen, China). The unit of lymphocyte count was represented as 10^9/L.
Measured: baseline and 3 month
Albumin
Albumin was detected using a fully automated biochemistry analyzer (Hitachi 7600, Hitachi, Ltd., Tokyo, Japan). The unit of albumin was represented as g/L.
Measured: baseline and 3 month
Five items of blood lipid (triglycerides (TG), total cholesterol (TC), high-density lipoprotein cholesterol (HDL-C), low-density lipoprotein cholesterol (LDL-C), very low-density lipoprotein cholesterol (VLDL-C))
Five items of blood lipid were detected using a fully automated biochemistry analyzer (Hitachi 7600, Hitachi, Ltd., Tokyo, Japan). The units of the five items of blood lipid were all represented as mmol/L.
Measured: baseline and 3 month
Thyroid hormones (thyroid stimulating hormone (TSH), free thyroxine (FT4), and free triiodothyronine (FT3))
Thyroid hormones were measured by chemiluminescence immunoassay (Abbott I2000, Abbott, Chicago, USA). The units of FT4 and FT3 were represented as pmol/L. The unit of TSH was represented as μIU/mL.
Measured: baseline and 3 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2023
- Study start1 Mar 2022
- Primary completion31 Jul 2022
- Study completion2 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 4
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 99 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lijun Yang
- Sponsor type
- University, hospital or other
- Collaborators
- Suzhou Municipal Hospital
- Responsible party
- Sponsor-investigator, Lijun Yang, Suzhou Municipal Hospital
- Investigators
- Lijun j Yang, Master, Study director, Suzhou Municipal Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06128577
- Sponsor's protocol ID
- LCZX201911
- Status last verified
- Nov 2023
- First submitted
- 7 Nov 2023
- Last updated
- 13 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Yang L, Wang M, Mo L, Yang Y, Cui Y, Wu Y. The relationship between sarcopenia and related bioindicators and changes after intensive lifestyle intervention in elderly East-China populations. BMC Musculoskelet Disord. 2024 Sep 3;25(1):704. doi: 10.1186/s12891-024-07835-x.
PubMed 39227842
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bioindicators Associated With Sarcopenia Before and After Intensive Lifestyle Intervention
- ClinicalTrials.gov ID
- NCT06128577
- Acronym / sponsor ID
- LCZX201911
- Conditions
- Sarcopenia
- Keywords
- Sarcopenia, Bioindicators, Intensive lifestyle intervention, Exercise intervention, Nutritional intervention
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 99 participants (actual)
- Lead sponsor
- Lijun YangUniversity, hospital or other
- Collaborators
- Suzhou Municipal Hospital
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 31 Jul 2022 (actual)
- Study completion
- 2 Aug 2022 (actual)
- First posted
- 13 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to explore whether the bioindicators of body composition, nutrition-related indicators (lymphocytes, albumin), lipids, and thyroid hormones are associated with sarcopenia and the changes in these indicators after an intensive lifestyle intervention. The main questions it aims to answer are:
- whether the bioindicators such as lymphocytes, albumin, lipids, thyroid hormones, fat mass, fat-free mass, and basal metabolic mass are associated with the development of sarcopenia.
- the changes of these bioindicators that occur in older adults after going through an intensive intervention.
Participants will receive a 3-month intensive intervention consisting of an intensive nutritional intervention and an individually designed exercise intervention. Nutritional and exercise prescriptions are co-designed through a nutritionist and rehabilitation physician.
Researchers will compare bioindicators in the sarcopenia group before and after intensive lifestyle intervention to determine the association with sarcopenia.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sarcopenia group | Experimental | Combination Product: 3-month intensive interventionAfter completing screening, 30 subjects in the sarcopenia group received a 3-month intensive intervention consisting of an intensive nutritional intervention and an individually designed exercise intervention. Nutritional and exercise prescriptions were co-designed through a nutritionist and rehabilitation physician. |
| Normal control group | No intervention | – |
Who may qualify
- Ages
- 65 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- 1) Resident elderly aged 65-90 years old in the district.
- 2) Voluntary participation in the trial and signing the informed consent form.
Key exclusion criteria (5 listed)
- 1) People with systemic severe diseases, organ failure, malignant tumors, neuromuscular degenerative diseases, or active weight loss.
- 2) People with cognitive impairment, incapacitation, or severe mental illnesses who cannot cooperate with the test.
- 3) People with cardiac pacemakers and artificial joint implantation or others who cannot undergo the BIA test.
- 4) People with severe cardiorespiratory dysfunction and physical disabilities who cannot complete the exercise training.
- 5) Incomplete data, refusal to participate in the survey, body composition analysis, and blood collection.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 3-month intensive interventionAlso: Sarcopenia groupIntensive nutritional interventions were as follows: i）Estimation of ideal body weight according to height, calculation of calories by giving 30-40kcal/kg/day according to BMI stratification, and calculation of daily protein requirement at 1.5g/kg/day, which was finally converted into daily dietary recommendations according to the results of the calculations. ii）Distribution of additional protein supplementation by whey protein, each sachet containing 15g of whey protein. The resistance training program included 5 min of warm-up, 20 min of muscle strength training, and 5 min of slow walking and was performed three times a week. Resistance training involved a dumbbell and sandbags as weights for the major muscles of the upper and lower limbs. In the study, aerobic training is brisk walking or jogging for 30 minutes/day, five times a week. | Combination product | Sarcopenia group |
Primary outcome
AMMI(appendicular muscle mass index)
Time frame: baseline and 3 month
Bioelectrical impedance analysis was used to obtain appendicular muscle mass (AMM) and height. The unit of AMM and height were represented as kilogram and meter respectively. AMMI were calculated as AMM/height^2 (kg/m^2).
7 secondary outcomes
Fat mass
Time frame: baseline and 3 month
Fat-free mass
Time frame: baseline and 3 month
Basal metabolic mass
Time frame: baseline and 3 month
Lymphocyte count
Time frame: baseline and 3 month
Albumin
Time frame: baseline and 3 month
Five items of blood lipid (triglycerides (TG), total cholesterol (TC), high-density lipoprotein cholesterol (HDL-C), low-density lipoprotein cholesterol (LDL-C), very low-density lipoprotein cholesterol (VLDL-C))
Time frame: baseline and 3 month
Thyroid hormones (thyroid stimulating hormone (TSH), free thyroxine (FT4), and free triiodothyronine (FT3))
Time frame: baseline and 3 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2023.
- Derived from this study: PubMed 39227842Yang L, Wang M, Mo L, Yang Y, Cui Y, Wu Y. The relationship between sarcopenia and related bioindicators and changes after intensive lifestyle intervention in elderly East-China populations. BMC Musculoskelet Disord. 2024 Sep 3;25(1):704. doi: 10.1186/s12891-024-07835-x.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lijun j Yang, Master study director
Suzhou Municipal Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing 3-month intensive intervention in people with Sarcopenia, run by Lijun Yang at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AMMI(appendicular muscle mass index) (time frame: baseline and 3 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06128577, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2023.