Effectiveness of Technology for Metabolic Diseases Combined Sarcopenia

Metabolic Disease Clinical Trial

Official title:

The Effectiveness of Technology Combined Self-health Management and Home Care Model Improved the Metabolic Diseases, Sarcopenia, and Serum Inflammation and Metabolic Markers Among Middle-aged and Elderly Individuals in the Community

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05476536
• Other study ID #: MOST-110-2314-B-255-007-
• Status: Recruiting
• Phase: N/A
• Start date: February 15, 2023
• Est. completion date: July 31, 2023

Study information

• Verified date: February 2023
• Source: Chang Gung University of Science and Technology
• Contact: Shu-Hung Chang, Ph.D
• Phone: 886-2118999
• Email: shchang[@]mail.cgust.edu.tw
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The lifestyle program intervention program focusing on healthy dietary habit and exercise effectively prevents metabolic syndrome, sarcopenia or frailty. Thus, the purpose of this study was to assess the efficacy of intervention program on metabolic syndrome subjects in Taiwan.

Description:

The study is a 2-parallel groups' randomized controlled trial. Participants with metabolic syndrome (three or more risk factors - triglycerides (TG) >150 mg/dL, systolic blood pressure (SBP) ≥130 mm Hg, diastolic blood pressure (DBP) ≥85 mm Hg, or fasting blood glucose≥100 mg/dL; high-density lipoprotein cholesterol<50 mg/dL, or waist circumference ≥80 cm) are enrolled. The four community units are randomized to receive a lifestyle intervention (intervention arm) or an education leaflet (control arm). The parameters are obtained from physical examination and biochemical assessments by well-trained case manager at baseline and 4th months. All participants complete a structured questionnaire, including basic information, SOF, physical performance, physical activity, and food-frequency.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: July 31, 2023
• Est. primary completion date: July 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 90 Years

Eligibility

Inclusion Criteria:

• older adult with age = 40 years

• community-dwelling

• no hearing and visual acuity difficulties

Exclusion Criteria:

• Unconscious

• Cognitive impairment or dementia

Related Conditions & MeSH terms

• Metabolic Disease
• Metabolic Diseases
• Sarcopenia

Intervention

Behavioral:
• self-management skills and healthy technology APP
self-management skills and healthy technology APP

Locations

Country	Name	City	State
Taiwan	Taoyuan	Taoyuan

Sponsors (3)

Lead Sponsor	Collaborator
Chang Gung University of Science and Technology	Chang Gung Memorial Hospital, Ministry of Science and Technology, Taiwan

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Physical activity	used International Physical Activity Questionnaire (IPAQ)	4 month follow up
Other	dietary behaviors	intake rate of whole grains, vegetables, fruits, proteins, dairy products, and nuts.	4 month follow up
Primary	metabolic syndrome	changes in triglycerides, high-density lipoprotein cholesterol, systolic blood pressure, diastolic blood pressure, fasting blood glucose, waist circumference	4 month follow up
Primary	body weight	weight in kilograms	4 month follow up
Primary	BMI	weight and height will be combined to report BMI in kg/m^2	4 month follow up
Primary	Frailty	measurement used study of osteoporotic fracture index (SOF).	4 month follow up
Secondary	short physical performance battery	sit-to-stand, standing balance, and gait-speed	4 month follow up
Secondary	upper limb muscle strength	hand-grip strength	4 month follow up
Secondary	static balance ability	single-leg standing with the eyes open	4 month follow up
Secondary	physical agility and dynamic balance ability	Timed-Up and Go and Functional Reach Test	4 month follow up