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Clinical Trial Summary

Falls is a major concern in geriatrics due to its high prevalence and various adverse health complications among elderly population. Risk of falls can be reduced by improving nutritional status and increase the level of physical activity. Besides, knowledge regarding risk of falls, nutrition and exercise are important in reducing the risks of falls. Therefore, this study aims to develop, implement and evaluate the effectiveness of a nutritional education and exercise intervention among community dwelling older adults in Selangor.


Clinical Trial Description

General Objective: To develop, implement and evaluate the effectiveness of nutrition education and exercise intervention on risk of fall among older person in Selangor. Specific Objectives: - To determine the risk of falls among the older adults. - To determine the dietary intake, anthropometric parameters (body mass index, mid upper arm circumference, calf circumference, body fat percentage and skeletal muscle mass), nutritional status, level of physical activity, functional status, perceived quality of life, risk of sarcopenia, level of knowledge, attitude and practice (KAP) towards falls' risk reduction, nutrition and exercise among the older adults. - To identify the factors determining risk of falls among older adults. - To evaluate the implementation process of the nutrition education and exercise intervention program (attendance and feedback of the program). - To determine the mean differences in risk of falls, dietary intake, anthropometric parameters, nutritional status, physical activity, functional status, perceived quality of life, risk of sarcopenia and knowledge, attitude and practice (KAP) towards falls' risks reduction, nutrition and exercise between intervention and control groups before and after intervention. The proposed study location is in Selangor. This is a randomized wait-list controlled trial for 3 months (12 weeks) among community dwelling older adults in Selangor. A two-stage sampling design will be applied. Firstly, a random sampling will be applied to select two districts from Selangor. This is followed by a purposive sampling to recruit eligible subjects according to inclusion criteria. Subjects will be recruited from free living older adults residing in Selangor through various community settings including including affiliations of National Council of Senior Citizens Organisations Malaysia (NACSCOM), University of Third Age (U3A) and Alzheimer's Disease Foundation Malaysia (ADFM). Subjects will be allocated randomly into 2 groups: Group 1: Intervention group (nutrition education + exercise intervention) Group 2: Control group (no intervention) which total of 100 eligible subjects will be recruited, with 50 subjects are needed in respective groups. This study will use a set of questionnaires to obtain information on personal information, anthropometry data, nutritional status, level of physical activity, functional status, sleep quality, quality of life, risk of falls, risk of sarcopenia and KAP on falls' risk reduction, nutrition and exercise based on appropriate instruments. Assessments will be performed at baseline (week 0), mid-way (week 6) and post-intervention (after week 12). ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05863143
Study type Interventional
Source Universiti Putra Malaysia
Contact
Status Completed
Phase N/A
Start date October 23, 2022
Completion date October 30, 2023

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