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

NCT05863143 | Completed

• 1 other identifier: UPM11062022
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Fall

Keywords

risk of falls; nutrition; exercise; TUG; intervention; community dwelling older adults

Outcome Measures

Primary Outcomes (3)

• Mean Changes in Risk of Falls

  Risk of falls of the respondents will be determined using Timed Up and Go (TUG) test, Five Times Sit to Stand Test (5XSST) and 30 Second Sit to Stand Test (30CST). For the Timed Up and Go (TUG) test, respondents will be timed while they rise from an arm- chair, walk at a comfortable and safe pace to a line on the floor three meters away (10 feet), turn and walk back to the chair and sit down again. The respondents will walk through the test once before being timed to become familiar with the test.

  Assessments will be performed at Baseline (Week 0), mid-intervention (Week 6) and Post-Intervention (Week 12)

• Mean Changes in Risk of Falls

  Besides assessing risk of falls using Timed Up and Go (TUG) test, risk of falls of the respondents will be determined using Five Times Sit to Stand Test (5XSST) and 30 Second Sit to Stand Test (30CST). Five Times Sit to Stand Test is performed to determine time taken for respondent to shift five times from a seated to a standing posture.

  Assessments will be performed at Baseline (Week 0), mid-intervention (Week 6) and Post-Intervention (Week 12)

• Mean Changes in Risk of Falls

  Besides assessing risk of falls using Timed Up and Go (TUG) test and Five Times Sit to Stand Test, risk of falls of the respondents will be determined using 30 Second Sit to Stand Test (30CST). For 30 Second Sit to Stand Test, respondents are required to sit straight on a chair with arms are crossed at the wrists and held in front of the chest. The respondents are encouraged to complete as many full stands as possible within 30 seconds.

  Assessments will be performed at Baseline (Week 0), mid-intervention (Week 6) and Post-Intervention (Week 12)

Secondary Outcomes (16)

• Mean Changes in Skeletal Muscle Mass

  Assessments will be performed at Baseline (Week 0), mid-intervention (Week 6) and Post-Intervention (Week 12)

• Mean Changes in Handgrip Strength

  Assessments will be performed at Baseline (Week 0), mid-intervention (Week 6) and Post-Intervention (Week 12)

• Mean Changes in Gait Speed

  Assessments will be performed at Baseline (Week 0), mid-intervention (Week 6) and Post-Intervention (Week 12)

• Mean Changes in Energy Intake

  Assessments will be performed at Baseline (Week 0), mid-intervention (Week 6) and Post-Intervention (Week 12)

• Mean Changes in Protein Intake

  Assessments will be performed at Baseline (Week 0), mid-intervention (Week 6) and Post-Intervention (Week 12)

Study Arms (2)

Intervention Group

EXPERIMENTAL

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.

Behavioral: Nutritional and Exercise

Control Group

NO INTERVENTION

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.

Interventions

Nutritional and Exercise BEHAVIORAL

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

Intervention Group

Eligibility Criteria

• Age: 60 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universiti Putra Malaysia: lead

Study Sites (1)

Universiti Putra Malaysia

Serdang, Selangor, 43400, Malaysia

Location

MeSH Terms

Conditions

Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Yoke Mun Chan

  Universiti Putra Malaysia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 21, 2022
• First Posted: May 17, 2023
• Study Start: October 23, 2022
• Primary Completion: October 30, 2023
• Study Completion: October 30, 2023
• Last Updated: February 1, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

MY (1)