Bioindicators Associated With Sarcopenia Before and After Intensive Lifestyle Intervention

Phase 4

Completed

• Conditions: Sarcopenia
• Interventions: Combination Product: 3-month intensive intervention

• Registration Number: NCT06128577
• Lead Sponsor: Lijun Yang

Brief 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. 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-03-01
• Primary Completion: 2022-07-31
• Study Completion: 2022-08-02
• Status Verified: 2023-11
• Study First Submitted: 2023-11-07
• Study First Submitted QC: 2023-11-10
• Last Update Submitted: 2023-11-10
• Study First Posted: 2023-11-13
• Last Update Posted: 2023-11-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 99

Inclusion Criteria

• 1. Resident elderly aged 65-90 years old in the district.
• 2. Voluntary participation in the trial and signing the informed consent form.

Exclusion Criteria

• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sarcopenia group	3-month intensive intervention	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.

Primary Outcome Measures

Name	Time	Method
AMMI(appendicular muscle mass index)	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).

Secondary Outcome Measures

Name	Time	Method
Lymphocyte count	baseline and 3 month	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.
Basal metabolic mass	baseline and 3 month	Bioelectrical impedance analysis was used to obtain basal metabolic mass. The unit of basal metabolic mass was represented as kilocalorie.
Fat-free mass	baseline and 3 month	Bioelectrical impedance analysis was used to obtain fat-free mass. The unit of fat-free mass was represented as kilogram.
Albumin	baseline and 3 month	Albumin was detected using a fully automated biochemistry analyzer (Hitachi 7600, Hitachi, Ltd., Tokyo, Japan). The unit of albumin was represented as g/L.
Thyroid hormones (thyroid stimulating hormone (TSH), free thyroxine (FT4), and free triiodothyronine (FT3))	baseline and 3 month	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.
Fat mass	baseline and 3 month	Bioelectrical impedance analysis was used to obtain fat mass. The unit of fat mass was represented as kilogram.
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))	baseline and 3 month	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.

Trial Locations

Locations (1)

Suzhou Municipal Hospital; 🇨🇳 Suzhou, Jiangsu, China