Clinical trial NCT05863143: Intervention on Reducing Risk of Falls Among Community Dwelling Older Adults in Selangor
Official title: Effectiveness of Nutritional and Exercise Intervention on Reducing Risk of Falls Among Community Dwelling Older Adults in Selangor
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fall
Keywords: risk of falls
nutrition
exercise
TUG
intervention
community dwelling older adults
Lead sponsor: Universiti Putra Malaysia
Sponsor class: OTHER
First posted: 2023-05-17
Enrollment: 100
Sex: ALL
Minimum age (years): 60
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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).

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

Primary outcomes:
measure: Mean Changes in Risk of Falls
timeFrame: Assessments will be performed at Baseline (Week 0), mid-intervention (Week 6) and Post-Intervention (Week 12)
measure: Mean Changes in Risk of Falls
timeFrame: Assessments will be performed at Baseline (Week 0), mid-intervention (Week 6) and Post-Intervention (Week 12)
measure: Mean Changes in Risk of Falls
timeFrame: Assessments will be performed at Baseline (Week 0), mid-intervention (Week 6) and Post-Intervention (Week 12)
Secondary outcomes:
measure: Mean Changes in Skeletal Muscle Mass
timeFrame: Assessments will be performed at Baseline (Week 0), mid-intervention (Week 6) and Post-Intervention (Week 12)
measure: Mean Changes in Handgrip Strength
timeFrame: Assessments will be performed at Baseline (Week 0), mid-intervention (Week 6) and Post-Intervention (Week 12)
measure: Mean Changes in Gait Speed
timeFrame: Assessments will be performed at Baseline (Week 0), mid-intervention (Week 6) and Post-Intervention (Week 12)
measure: Mean Changes in Energy Intake
timeFrame: Assessments will be performed at Baseline (Week 0), mid-intervention (Week 6) and Post-Intervention (Week 12)
measure: Mean Changes in Protein Intake
timeFrame: Assessments will be performed at Baseline (Week 0), mid-intervention (Week 6) and Post-Intervention (Week 12)
measure: Mean Changes in Calcium Intake
timeFrame: Assessments will be performed at Baseline (Week 0), mid-intervention (Week 6) and Post-Intervention (Week 12)
measure: Mean Changes in Vitamin D Intake
timeFrame: Assessments will be performed at Baseline (Week 0), mid-intervention (Week 6) and Post-Intervention (Week 12)
measure: Mean Changes in Weight
timeFrame: Assessments will be performed at Baseline (Week 0), mid-intervention (Week 6) and Post-Intervention (Week 12)
measure: Mean Changes in Height
timeFrame: Assessments will be performed at Baseline (Week 0), mid-intervention (Week 6) and Post-Intervention (Week 12)
measure: Mean Changes in calf-circumference
timeFrame: Assessments will be performed at Baseline (Week 0), mid-intervention (Week 6) and Post-Intervention (Week 12)
measure: Mean Changes in Physical Activity Level
timeFrame: Assessments will be performed at Baseline (Week 0), mid-intervention (Week 6) and Post-Intervention (Week 12)
measure: Mean Changes in Nutritional Status
timeFrame: Assessments will be performed at Baseline (Week 0), mid-intervention (Week 6) and Post-Intervention (Week 12)
measure: Mean Changes in Functional Status
timeFrame: Assessments will be performed at Baseline (Week 0), mid-intervention (Week 6) and Post-Intervention (Week 12)
measure: Mean Changes in Quality of Life
timeFrame: Assessments will be performed at Baseline (Week 0), mid-intervention (Week 6) and Post-Intervention (Week 12)
measure: Mean Changes in Knowledge, Attitude and Practice on Falls' risk reduction, nutrition and exercise Questionnaire
timeFrame: Assessments will be performed at Baseline (Week 0) and Post-Intervention (Week 12)
measure: Mean Changes in Sleep Quality
timeFrame: Assessments will be performed at Baseline (Week 0), mid-intervention (Week 6) and Post-Intervention (Week 12)
Other outcomes:
Locations:
city: Serdang
country: Malaysia
facility: Universiti Putra Malaysia
state: Selangor
Study officials:
affiliation: Universiti Putra Malaysia
name: Yoke Mun Chan
role: PRINCIPAL_INVESTIGATOR
References: