Development and Effectiveness of the Occupational Activities Module on the Quality of Life of Older Persons

NCT07251855 | Completed DMC

• 1 other identifier: JEP-2022-677
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study was to find out whether the Occupational Activities Module (Modul Aktiviti Cara Kerja - MACK) could help older adults stay more active and healthier. The study examined whether participation in the programme using MACK improved how well older adults carried out their daily activities, how strong and fit they felt, and how good their overall quality of life was. Two groups of older adults took part. One group joined the MACK programme for 14 weeks, while the other group continued with their normal daily routines. Their ability to perform daily activities, physical fitness, and quality of life were measured at the beginning, middle, and end of the study to identify any changes or improvements.

Conditions

Ageing and Geriatric Health

Keywords

Cluster Randomized Trials

Outcome Measures

Primary Outcomes (4)

• Modified Barthel Index

  The Modified Barthel Index (MBI) is a tool to assess functional ability in performing basic activities of daily living (ADL). It evaluates 10 essential activities, including transfers from bed to chair, mobility through walking or wheelchair use, stair climbing, toileting, bladder and bowel control, bathing, dressing, grooming, and feeding. Each activity is scored on a scale from 0 to 10, with the total score ranging from 0 to 100. A total score of 100 indicates full independence, 91-99 reflects minimal assistance, 61-91 indicates moderate assistance, 21-60 reflects substantial assistance, and 0-21 indicates complete dependence in daily functioning. The MBI has demonstrated high internal consistency, with a Cronbach's alpha coefficient of 0.92, confirming its reliability as a measure of functional independence among individuals.

  Screening of inclusion criteria, Baseline (Before MACK programme), Mid of intervention (Week 8 or after 7 weeks of MACK programme), Post intervention (Week 15 or after 14 weeks of MACK programme

• Lawton Instrumental Activities of Daily Living Scale (Lawton IADL)

  The Lawton Instrumental Activities of Daily Living Scale (Lawton IADL) is used to assess functional ability in performing instrumental activities of daily living, which are more complex than basic daily activities. The instrument evaluates eight domains: ability to use the telephone, shopping, food preparation, housekeeping, laundry, transportation, medication management, and handling finances. Each domain is scored according to the individual's level of independence, with a total score ranging from 0 to 8. A score of 0 indicates low function with dependence on others, while a score of 8 reflects high function and independence. The scale is simple to administer, can be self-reported, and typically takes 10-15 minutes to complete. It has good inter-item reliability (α = 0.85) and demonstrated validity through significant correlations with other functional status measures.

  Baseline (Before MACK programme), Mid of intervention (Week 8 or after 7 weeks of MACK programme), Post intervention (Week 15 or after 14 weeks of MACK programme

• Bruininks Motor Ability Test (BMAT)

  The Bruininks Motor Ability Test (BMAT) is a standardized assessment used to measure fine and gross motor skills in adults aged 40 years and above. These motor abilities are closely related to physical functioning and the capacity to perform daily activities. The test evaluates performance through subtests and composite structures focusing on fine and gross motor aspects such as balance, mobility, strength, coordination, and object manipulation. BMAT comprises comprehensive, stand-alone subtests with established validity, reliability, and sensitivity. Its psychometric properties include test-retest reliability ranging from 0.77 to 0.94, inter-rater reliability between 0.95 and 0.99, and internal consistency values from 0.60 to 0.92. The subtests include fine motor integration, manual dexterity, coordination, balance and mobility, and strength and flexibility.

  Baseline (Before MACK programme), Mid of intervention (Week 8 or after 7 weeks of MACK programme), Post intervention (Week 15 or after 14 weeks of MACK programme

• Older People's Quality of Life Questionnaire - Short Version (OPQOL-Brief)

  The Older People's Quality of Life Questionnaire Short Version (OPQOL-Brief) is used to assess the quality of life among older adults. Adapted from the original OPQOL with 35 items, the OPQOL-Brief contains 13 items and has been validated in studies conducted in Britain and Italy. It has shown high reliability and validity when compared with other established instruments such as the World Health Organization Quality-of-Life Scale (WHOQOL) and the CASP-19 (Control, Autonomy, Self-Realization, and Pleasure) questionnaire. The internal consistency of the OPQOL-Brief is strong, with a Cronbach's alpha coefficient of 0.856, comparable to that of the original OPQOL. Each item is scored on a five-point Likert scale ranging from 1 (strongly agree) to 5 (strongly disagree), with responses reverse-coded for scoring purposes (e.g., 1 = 5, 2 = 4). The maximum possible score is 65, which indicates the highest quality of life, while lower scores reflect poorer quality of life.

  Baseline (Before MACK programme), Mid of intervention (Week 8 or after 7 weeks of MACK programme), Post intervention (Week 15 or after 14 weeks of MACK programme

Other Outcomes (1)

• Mini Mental State Examination (MMSE)

  Screening of inclusion criteria

Study Arms (2)

Intervention group

EXPERIMENTAL

The intervention arm received the MACK program, a structured activity-based intervention for older adults delivered over 14 weeks, twice weekly (9:00 a.m.-3:00 p.m.). Sessions were held at PAWE.

Behavioral: Occupational Activities

Control group

NO INTERVENTION

The control group not receiving any intervention. The group continued with PAWE's usual activities that has been established prior to the study.

Interventions

Occupational Activities BEHAVIORAL

The intervention consists of the MACK programme, a structured 14-week activity-based program designed for older adults, delivered twice weekly at PAWE. Unlike general recreational or social programs, MACK provides a standardized framework that combines four domains of engagement such as exercise, sports and games, recreational activities, and social participation. Activities include light to moderate physical exercises, culturally relevant games such as congkak, snakes and ladders, creative tasks like batik painting, and structured group interactions. Participants are encouraged to start with light activities and gradually progress in difficulty, with safety measures explained and monitored throughout. Supervisors trained in the MACK module schedule and oversaw activities using a 14-week template to ensure consistency across centers. This distinguishes the intervention from usual PAWE activities, which are unstructured and not guided by a standardized module.

Intervention group

Eligibility Criteria

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

You may qualify if:

• Aged 60 years and above.
• Registered member of PAWE.
• Able to understand and communicate in Malay language.
• Not involved in the feasibility study.

You may not qualify if:

• Diagnosed with degenerative diseases (e.g., Alzheimer's, Parkinson's, Hungtinton's, multiple sclerosis).
• Untreateable vision or hearing impairment.
• Moderate to full dependence in basic daily activities (MBI score ≤ 60).
• Moderate to severe cognitive impairment (MMSE score ≤ 20).

Sponsors & Collaborators

• National University of Malaysia: lead
• Department of Social Welfare, Ministry of Women, Family and Community Development, Malaysia: collaborator

Study Sites (1)

Pusat Aktiviti Warga Emas in Klang Valley, Bahagian Warga Emas, Jabatan Kebajikan Masyarakat, Malaysia

Putrajaya, 62100, Malaysia

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This study employed a quantitative design using a Cluster Randomized Trial (CRT). This design was chosen because the study involved community centres, the Centre for Older Persons (Pusat Aktiviti Warga Emas, PAWE), making CRT suitable for evaluating new interventions delivered at the organizational or community level. It also helps to prevent contamination between groups, since participants within the same PAWE could otherwise be exposed to both intervention and control activities. The study adopted a modified Stepped Wedge approach in the CRT design (SW-CRT). In this modification, only the intervention group implemented the MACK programme in stages, while control group continued usual activities without intervention throughout the study period. This design was considered appropriate because the intervention was expected to be beneficial but could not be delivered to all clusters at the same time due to limitation to the number of assessors and logistics.

Study Record Dates

• First Submitted: September 29, 2025
• First Posted: November 26, 2025
• Study Start: May 20, 2024
• Primary Completion: August 28, 2024
• Study Completion: December 20, 2024
• Last Updated: November 26, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

MY (1)