Supervised Group-based Walking Intervention Among Inactive Older Adults in Saudi Arabia
The Effects of Walking on Frailty, Cognitive Function and Quality of Life Among Inactive Older Adults in Saudi Arabia: A Randomized Control Trial by Comparing Supervised Group-based Intervention and Non-supervised Individual-based Intervention
1 other identifier
interventional
126
0 countries
N/A
Brief Summary
The purpose of the proposed study is to compare the effects of supervised group-based walking and non-supervised individual-based walking interventions on frailty, cognitive function and quality of life among inactive older adults in Saudi Arabia.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jan 2022
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 8, 2021
CompletedFirst Posted
Study publicly available on registry
December 9, 2021
CompletedStudy Start
First participant enrolled
January 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2022
CompletedDecember 9, 2021
November 1, 2021
8 months
November 8, 2021
December 7, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Change from baseline Health-related quality of life at 4 months and at 7 months
The Short Form-36 (SF-36) is a widely used health survey questionnaire, especially for older adults to assess the health-related quality of life (HRQoL). The higher the scores mean a higher level of quality of life.
Time 1: Baseline; TIme 2 after the 16-week intervention; Time 3 12-weeks after the intervention
Change from baseline Frailty level at 4 months and at 7 months
Physical Performance Test (PPT) is one of the tools which is used to assess the level of frailty. For our research we will use 9 item scale that includes 9 standardized tasks such as writing a sentence, simulated eating, turning 360 degrees, putting on and removing a jacket, lifting a book and putting it on a shelf, picking up a penny from the floor, a 50-foot walk test, and climbing stairs (scored as two items) (Reuben and Siu, 1990). The score range of each task is 0-4 and for 9 items it will be 36. A higher score indicates better performance (Villareal et al., 2017).
Time 1: Baseline; TIme 2 after the 16-week intervention; Time 3 12-weeks after the intervention
Change from baseline Cognitive function at 4 months and at 7 months
The Mini-mental state examination (MMSE) is the most commonly used method to measure the level of cognitive impairment, especially in older adults. The score of Mini-mental state examination is calculated on a scale of 0-30 where score 24 or above is usually considered as the normal cognitive status or no cognitive impairment of the individual. The overall scorings are Severe cognitive impairment (0-17), Mild cognitive impairment (18-23) and No cognitive impairment (24-30).
Time 1: Baseline; TIme 2 after the 16-week intervention; Time 3 12-weeks after the intervention
Secondary Outcomes (5)
Change from baseline Health parameters - Body Composition at 4 months and at 7 months
Time 1: Baseline; TIme 2 after the 16-week intervention; Time 3 12-weeks after the intervention
Change from baseline Health parameters - Resting Heart Rate at 4 months and at 7 months
Time 1: Baseline; TIme 2 after the 16-week intervention; Time 3 12-weeks after the intervention
Change from baseline Health parameters - Resting Blood Pressure at 4 months and at 7 months
Time 1: Baseline; TIme 2 after the 16-week intervention; Time 3 12-weeks after the intervention
Change from baseline Physical Activity Enjoyment at 4 months and at 7 months
Time 1: Baseline; TIme 2 after the 16-week intervention; Time 3 12-weeks after the intervention
Change from baseline Walking Performance at 4 months and at 7 months
Time 1: Baseline; TIme 2 after the 16-week intervention; Time 3 12-weeks after the intervention
Study Arms (3)
group-based walking intervention with professional trainer's supervision
EXPERIMENTALParticipants will conduct the intervention in groups under the supervision of a professional fitness trainer.
individual-based walking intervention without professional trainer supervision
ACTIVE COMPARATORParticipants will conduct the intervention individually, without the supervision of a professional fitness trainer
control group
NO INTERVENTIONNo intervention will be given to the control group.
Interventions
Group exercise interventions tended to be systematic and supervised by professionals. The current intervention is proposing to conduct a randomized control trial that is not only examining the nature of walking on older adults' well-being but also involving the elements of group-based and professional supervision intervention, aiming at comparing with the individual-based intervention without professional supervision. Qualified professional fitness trainers (1 male and 1 female separately for male and female groups, respectively) will be involved in the group-based intervention programs in order to provide appropriate guidance and supervision to the participants. Whereas, the non-supervised individual-based intervention will be conducted by a research assistant (males and females) to ensure the attendance and general safety, but without providing professional advice or supervision.
Eligibility Criteria
You may qualify if:
- years old
- capable of walking without assistive device
- healthy and live independently in communities
- being physically inactive
You may not qualify if:
- with cardiovascular or related diseases that prevent from intensive walking
- fail the PAR-Q screening or without physician's advice on readiness of participation in exercise training
- diagnosed with cognitive impairment
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
Wong MYC, Karmakar P, Almarzooqi MA, Rhodes RE, Zhang CQ, Ou KL, Yanping D, Chung PK, Alghamdi NA. The effects of walking on frailty, cognitive function and quality of life among inactive older adults in Saudi Arabia: a study protocol of randomized control trial by comparing supervised group-based intervention and non-supervised individual-based intervention. BMC Geriatr. 2023 Sep 27;23(1):602. doi: 10.1186/s12877-023-04200-w.
PMID: 37759212DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Chung Pak Kwong, Prof
Hong Kong Baptist University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 8, 2021
First Posted
December 9, 2021
Study Start
January 1, 2022
Primary Completion
August 31, 2022
Study Completion
December 31, 2022
Last Updated
December 9, 2021
Record last verified: 2021-11
Data Sharing
- IPD Sharing
- Will not share