- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06100198
The Effect of Nutrition and Exercise Program on the Health of Community-dwelling Older Adults
Evaluation of the Effect of Nutrition and Exercise Program Intervention on the Health of Community-dwelling Older Adults
Study Overview
Status
Intervention / Treatment
Detailed 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, we 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 their daily lives, ultimately fostering better health outcomes for the elderly.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Hui-Ping Chang, Doctor
- Phone Number: 2770 +886-2-25553000
- Email: A0239@tpech.gov.tw
Study Contact Backup
- Name: Ying-Chun Chen, Bachelor
- Phone Number: 2778 +886-2-25553000
- Email: T1130@tpech.gov.tw
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- The conditions for accepting cases include: (1) citizens over 65 years old living in communities in Taipei City, (2) clear consciousness, able to communicate in Mandarin and Taiwanese, and capable of action.
Exclusion Criteria:
- Exclusion criteria include: those with cognitive impairment who are unable to cooperate with the measurement, those who are unable to walk, those with obvious edema of the lower limbs, and those with hand disabilities (such as fractures, arthritis or stroke) who cannot measure grip strength.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intervention group
A one-group pretest-posttest design was adopted.
Participants participated in 3 nutrition and exercise courses, each lasting 2 hours (including 1 hour nutrition course and 1 hour exercise course) with an interval of 1 week between each course.
All subjects underwent anthropometric measurements and completed questionnaires one week before the start of the course and one week after the end of the course.
A repeat assessment was conducted 6 months after the course intervention.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Body Mass Index
Time Frame: One week before the first class, one week after the third class, and 6 months after the course intervention.
|
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.
|
Calf circumference
Time Frame: One week before the first class, one week after the third class, and 6 months after the course intervention.
|
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.
|
Hand grip strength
Time Frame: One week before the first class, one week after the third class, and 6 months after the course intervention.
|
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.
|
Muscle mass
Time Frame: One week before the first class, one week after the third class, and 6 months after the course intervention.
|
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.
|
Nutritional status
Time Frame: One week before the first class, one week after the third class, and 6 months after the course intervention.
|
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.
|
One week before the first class, one week after the third class, and 6 months after the course intervention.
|
Sarcopenia Risk Assessment Scale
Time Frame: One week before the first class, one week after the third class, and 6 months after the course intervention.
|
Strength, assistance with walking, rising from a chair, climbing stairs, and falls (SARC-F) questionnaire.
|
One week before the first class, one week after the third class, and 6 months after the course intervention.
|
Taiwan Short 36 Health Scale (SF-36)
Time Frame: One week before the first class, one week after the third class, and 6 months after the course intervention.
|
The SF-36 is a self-rated scale consisting of 36 items that assess HRQoL in eight health dimensions.
|
One week before the first class, one week after the third class, and 6 months after the course intervention.
|
Nutritional knowledge, attitudes, and behaviors
Time Frame: One week before the first class, one week after the third class, and 6 months after the course intervention.
|
Using a self-administered questionnaire to study the relationships among dietary knowledge, attitudes, and behaviors.
|
One week before the first class, one week after the third class, and 6 months after the course intervention.
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Hui-Ping Chang, Doctor, Taipei City Hospital
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- TCHIRB-11206012-E
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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