Bioindicators Associated With Sarcopenia Before and After Intensive Lifestyle Intervention

NCT06128577 | Completed Phase 4

• 1 other identifier: LCZX201911
• Study Type: interventional
• Target: 99
• Locations: 1 country
• Sites: 1

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.

Conditions

Sarcopenia

Keywords

Sarcopenia; Bioindicators; Intensive lifestyle intervention; Exercise intervention; Nutritional intervention

Outcome Measures

Primary Outcomes (1)

• 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).

  baseline and 3 month

Secondary Outcomes (7)

• Fat mass

  baseline and 3 month

• Fat-free mass

  baseline and 3 month

• Basal metabolic mass

  baseline and 3 month

• Lymphocyte count

  baseline and 3 month

• Albumin

  baseline and 3 month

Study Arms (2)

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.

Combination Product: 3-month intensive intervention

Normal control group

NO INTERVENTION

Interventions

3-month intensive intervention COMBINATION_PRODUCT

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.

Also known as: Sarcopenia group

Sarcopenia group

Eligibility Criteria

• Age: 65 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• \) People with systemic severe diseases, organ failure, malignant tumors, neuromuscular degenerative diseases, or active weight loss.
• \) People with cognitive impairment, incapacitation, or severe mental illnesses who cannot cooperate with the test.
• \) People with cardiac pacemakers and artificial joint implantation or others who cannot undergo the BIA test.
• \) People with severe cardiorespiratory dysfunction and physical disabilities who cannot complete the exercise training.
• \) Incomplete data, refusal to participate in the survey, body composition analysis, and blood collection.

Sponsors & Collaborators

• Lijun Yang: lead
• Suzhou Municipal Hospital: collaborator

Study Sites (1)

Suzhou Municipal Hospital

Suzhou, Jiangsu, 215000, China

Location

Related Publications (1)

• 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.

  PMID: 39227842 DERIVED

MeSH Terms

Conditions

Sarcopenia

Condition Hierarchy (Ancestors)

Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Study Officials

• Lijun j Yang, Master

  Suzhou Municipal Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Physician in Charge

Study Record Dates

• First Submitted: November 7, 2023
• First Posted: November 13, 2023
• Study Start: March 1, 2022
• Primary Completion: July 31, 2022
• Study Completion: August 2, 2022
• Last Updated: November 13, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)