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OpenTrials
Completed

NCT Number: NCT06128577

Bioindicators Associated With Sarcopenia Before and After Intensive Lifestyle Intervention

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.

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Key information

Conditions

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

Age range

65 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Suzhou Municipal Hospital

Suzhou, Jiangsu, 215000, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: Sarcopenia group

Primary outcomes

  1. 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).

Secondary outcomes

  1. Fat mass

    Time frame: baseline and 3 month

    Bioelectrical impedance analysis was used to obtain fat mass. The unit of fat mass was represented as kilogram.

  2. Fat-free mass

    Time frame: baseline and 3 month

    Bioelectrical impedance analysis was used to obtain fat-free mass. The unit of fat-free mass was represented as kilogram.

  3. Basal metabolic mass

    Time frame: baseline and 3 month

    Bioelectrical impedance analysis was used to obtain basal metabolic mass. The unit of basal metabolic mass was represented as kilocalorie.

  4. Lymphocyte count

    Time frame: 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.

  5. Albumin

    Time frame: 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.

  6. 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

    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.

  7. Thyroid hormones (thyroid stimulating hormone (TSH), free thyroxine (FT4), and free triiodothyronine (FT3))

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Lijun Yang

Other

Collaborators

  • Suzhou Municipal Hospital

Registry information

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Nov 13, 2023
Registry last updated
Nov 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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