Clinical trial NCT06128577: Bioindicators Associated With Sarcopenia Before and After Intensive Lifestyle Intervention
Official title: Bioindicators Associated With Sarcopenia Before and After Intensive Lifestyle Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Sarcopenia
Keywords: Sarcopenia
Bioindicators
Intensive lifestyle intervention
Exercise intervention
Nutritional intervention
Lead sponsor: Suzhou Municipal Hospital
Sponsor class: OTHER
Collaborators: name: Suzhou Municipal Hospital
First posted: 2023-11-13
Enrollment: 99
Sex: ALL
Minimum age (years): 65
Maximum age (years): 90
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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.

Primary outcomes:
measure: AMMI(appendicular muscle mass index)
timeFrame: baseline and 3 month
Secondary outcomes:
measure: Fat mass
timeFrame: baseline and 3 month
measure: Fat-free mass
timeFrame: baseline and 3 month
measure: Basal metabolic mass
timeFrame: baseline and 3 month
measure: Lymphocyte count
timeFrame: baseline and 3 month
measure: Albumin
timeFrame: baseline and 3 month
measure: 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))
timeFrame: baseline and 3 month
measure: Thyroid hormones (thyroid stimulating hormone (TSH), free thyroxine (FT4), and free triiodothyronine (FT3))
timeFrame: baseline and 3 month
Other outcomes:
Locations:
city: Suzhou
country: China
facility: Suzhou Municipal Hospital
state: Jiangsu
Study officials:
affiliation: Suzhou Municipal Hospital
name: Lijun j Yang, Master
role: STUDY_DIRECTOR
References: