Intervention on Reducing Risk of Falls Among Community Dwelling Older Adults in Selangor

NCT ID: NCT05863143

Last Updated: 2024-02-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-23
• Study Completion Date: 2023-10-30

Brief 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.

Detailed 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).

Conditions

Fall

Study Design

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

Study Groups

Intervention Group

Subjects in the intervention group are required to involve in 12 sessions of nutrition education program and prescribed exercise program during the 12 weeks intervention period. Generally, respondents in the intervention group will received the developed educational materials and exercise diary as guide during this period.

Group Type: EXPERIMENTAL

Nutritional and Exercise

Intervention Type: BEHAVIORAL

Provide Nutritional Education Program and Falls Module Exercise (FME) to the intervention group

Control Group

Subjects required to continue with usual lifestyle (eating habits and exercise pattern) for 12 weeks. Tips on healthy eating and active living, which are suitable for them will be provided.

When the study is completed (after 12 weeks), they will receive the same intervention activities as the intervention group.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Nutritional and Exercise

Provide Nutritional Education Program and Falls Module Exercise (FME) to the intervention group

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Men or women aged 60 years old to 80 years old in Malaysia
• Able to ambulate without personal assistance
• Able to read and write

Exclusion Criteria

• Self-reported chronic diseases (severely poorly control diabetics and hyperlipidemia, heart-related disease, Chronic obstructive pulmonary disease, osteoarthritis, osteoporosis, stroke, cancer, asthma, renal dysfunction, terminally ill that may limit participations in physical activity)
• Any sustained fracture or undergoing surgery (hip, vertebrata) in past six months
• Bedridden
• Sensory impairment (visual & hearing) that will interfere with communication
• Anyone who participated in similar program before

• Minimum Eligible Age: 60 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Universiti Putra Malaysia

OTHER

Sponsor Role: lead

Responsible Party

Chan Yoke Mun

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yoke Mun Chan

Role: PRINCIPAL_INVESTIGATOR

Universiti Putra Malaysia

Locations

Universiti Putra Malaysia

Serdang, Selangor, Malaysia

Countries

Malaysia

Other Identifiers

UPM11062022

Identifier Type: -

Identifier Source: org_study_id