The Effect of Nutrition and Exercise Program on the Health of Community-dwelling Older Adults

Healthy Aging Clinical Trial

Official title:

Evaluation of the Effect of Nutrition and Exercise Program Intervention on the Health of Community-dwelling Older Adults

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06100198
• Other study ID #: TCHIRB-11206012-E
• Status: Recruiting
• Phase: N/A
• Start date: October 25, 2023
• Est. completion date: June 30, 2025

Study information

• Verified date: November 2023
• Source: Taipei City Hospital
• Contact: Hui-Ping Chang, Doctor
• Phone: +886-2-25553000
• Email: A0239[@]tpech.gov.tw
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to design a nutrition and exercise course for the elderly adults in the community, and to evaluate the effectiveness of this course intervention on the nutritional knowledge, nutritional status, sarcopenia, and health status of the elderly in the community. This study adopted convenience sampling and targeted 108 community elders over 65 years old in Taipei City. All participants receive 3 nutrition and exercise courses. Each course was separated by one week. Measurements and collections were conducted one week before and one week after the course. BMI (body mass index), muscle mass, calf circumference, grip strength, Mini Nutritional Assessment Form Short Form (MNA-SF), SARC-F scale, Taiwan Short Form 36 Health Scale (SF-36) and nutrition knowledge and attitude and behavioral questionnaires will be collected to evaluate the effectiveness of the course.

Description:

The elderly population in Taiwan, aged over 65, has exceeded 14%, officially marking the country's transition into an aging society. This demographic shift has brought forth numerous health-related challenges among the elderly, including malnutrition, sarcopenia, and frailty, thereby increasing the risk of falls, cognitive dysfunction, and morbidity rates. This also results in rising disability and mortality rates, ultimately driving up healthcare costs. The primary aim of this study is to develop a nutrition and exercise program for elderly individuals within the community. This program will be carried out in collaboration with a team of nutrition and exercise professionals. Furthermore, the study seeks to assess the effectiveness of this intervention on the nutritional awareness, nutritional status, sarcopenia, and overall health of elderly community members. The study employed convenience sampling and included 108 community elders aged over 65 from Taipei City, all of whom were sourced from the community congregated meal stations. Each participant received three nutrition and exercise courses, with each course separated by a week. Measurements for body weight, BMI (body mass index), muscle mass, calf circumference, grip strength, Mini Nutritional Assessment Form Short Form (MNA-SF), SARC-F scale, Taiwan Short Form 36 Health Scale (SF-36), as well as pre- and post-course knowledge, attitude, and behavior assessments were conducted one week before and after the program. After collecting the questionnaire data, SPSS version 22 (IBM Corp., Armonk, NY, USA) was used for data storage and statistical analysis. A p-value less than 0.05 was considered statistically significant. Descriptive statistical analysis methods, including mean, standard deviation, and percentages, were employed to provide a basic overview of the participant group. To understand differences and correlations between variables, the study utilized Chi-square and Paired Sample T-test methods. Through this project, the investigators aim to evaluate the impact of the nutrition and exercise course intervention for elderly individuals in Taipei City. This endeavor will empower participants to incorporate nutrition and exercise strategies into daily lives, ultimately fostering better health outcomes for the elderly adults.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 108
• Est. completion date: June 30, 2025
• Est. primary completion date: June 30, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years and older

Eligibility

Inclusion Criteria:

1. Citizens aged 65 and above, residing in communities in Taipei City.

2. Clear consciousness and the ability to communicate in Mandarin and Taiwanese.

3. Capability to move freely.

Exclusion Criteria:

1. Individuals with cognitive impairment who are unable to cooperate with the measurements.

2. Those unable to walk.

3. Individuals with obvious edema of the lower limbs.

4. Those with hand disabilities (such as fractures, arthritis, or stroke) preventing the measurement of grip strength.

Related Conditions & MeSH terms

• Healthy Aging
• Knowledge, Attitudes, Practice

Intervention

Other:
• nutrition and exercise program
Nutrition courses include understanding malnutrition and sarcopenia; understanding the six major food categories and their requirements; and understanding protein-rich food sources. Exercise courses include understanding exercise types, flexibility exercises, and muscle strength training exercises.

Locations

Country	Name	City	State
Taiwan	Huanyu International Culture and Education Foundation Guting Branch	Taipei City

Sponsors (1)

Lead Sponsor	Collaborator
Taipei City Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Body Mass Index	Body Mass Index (BMI) is a person's weight in kilograms divided by the square of height in meters.	One week before the first class, one week after the third class, and 6 months after the course intervention.
Primary	Calf circumference	The widest part of the calf was measured with a non-elastic tape applied flat on the skin and parallel to the floor.	One week before the first class, one week after the third class, and 6 months after the course intervention.
Primary	Hand grip strength	Grip strength is measured using a hand-held dynamometer (TTM-YD, Tsutsumi Industries, Tokyo, Japan).	One week before the first class, one week after the third class, and 6 months after the course intervention.
Primary	Muscle mass	Muscle mass is measured using a Inbody H20B Smart Full Body Composition Analyzer Scale.	One week before the first class, one week after the third class, and 6 months after the course intervention.
Primary	Nutritional status	Nutritional status was assessed using the Mini Nutritional Assessment Form Short Form (MNA-SF), a six-item instrument with scores ranging from 0 to 14 points. A total score of MNA-SF <8, 8-11, and >11 indicates malnutrition, risk of malnutrition, and no malnutrition, respectively.	One week before the first class, one week after the third class, and 6 months after the course intervention.
Primary	The risk of sarcopenia	Strength, assistance with walking, rising from a chair, climbing stairs, and falls (SARC-F) questionnaire scores. The SARC-F scores range from 0 (best) to 10 (worst). Patients with a total score =4 were considered to be at risk of sarcopenia.	One week before the first class, one week after the third class, and 6 months after the course intervention.
Primary	Taiwan Short 36 Health Scale (SF-36)	The SF-36 is a self-rated scale consisting of 36 items that assess health-related quality of life (HRQoL) in eight health dimensions. This questionnaire consists of 36 questions, focusing on the following two norm-based composite scales: physical component scale (PCS) and mental component scale (MCS). The PCS includes four subscales: physical functioning (PF), role functioning due to limitations in physical problems (RP), bodily pain (BP), and general health (GH). The MCS also includes four subscales: vitality (VT), social functioning (SF), role limitations due to emotional problems (RE), and mental health (MH). The subscales are reported as scores that range from 0 to 100. Higher scores indicate more favourable levels of function.	One week before the first class, one week after the third class, and 6 months after the course intervention.
Primary	Nutritional knowledge, attitudes, and behaviors	Using a self-administered questionnaire to study the relationships among dietary knowledge, attitudes, and behaviors. The scores range from 0 to 20, 0 to 12, 0 to 9 for nutritional knowledge, attitudes, and behaviors respectively. Higher scores mean a better outcome.	One week before the first class, one week after the third class, and 6 months after the course intervention.