Bioindicators Associated With Sarcopenia Before and After Intensive Lifestyle Intervention

NCT ID: NCT06128577

Last Updated: 2023-11-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 99 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-01
• Study Completion Date: 2022-08-02

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Sarcopenia group

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.

Group Type: EXPERIMENTAL

3-month intensive intervention

Intervention Type: 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.

Normal control group

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

3-month intensive intervention

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.

Intervention Type: COMBINATION_PRODUCT

Other Intervention Names

Sarcopenia group

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.

• Minimum Eligible Age: 65 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Suzhou Municipal Hospital

OTHER

Sponsor Role: collaborator

Lijun Yang

OTHER

Sponsor Role: lead

Responsible Party

Lijun Yang

Physician in Charge

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Lijun j Yang, Master

Role: STUDY_DIRECTOR

Suzhou Municipal Hospital

Locations

Suzhou Municipal Hospital

Suzhou, Jiangsu, China

Countries

China

References

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.

Reference Type: DERIVED

PMID: 39227842 (View on PubMed)

Other Identifiers

LCZX201911

Identifier Type: -

Identifier Source: org_study_id