- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05151575
Supervised Group-based Walking Intervention Among Inactive Older Adults in Saudi Arabia
December 7, 2021 updated by: Hong Kong Baptist University
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
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.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Detailed Description
Objectives
- To compare the difference of effects between supervised group-based walking and non-supervised individual-based walking on the primary outcomes, including frailty, cognitive functions, and health-related quality of life among inactive older adults in Saudi Arabia.
- To compare the difference of effects between supervised group-based walking and non-supervised individual-based walking on the secondary outcomes, including physical activity enjoyment, health parameters consisting of resting heart rate, resting blood pressure, and body composition, as well as walking performance among inactive older adults in Saudi Arabia.
- To formulate guidelines for achieving an effective walking intervention for inactive older adults in Saudi Arabia.
- To recommend the government of Saudi Arabia on guidelines and policies for promoting walking and active ageing among the older adults in the country.
Study Type
Interventional
Enrollment (Anticipated)
126
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Chung Pak Kwong, Prof
- Phone Number: 34117728
- Email: pkchung@hkbu.edu.hk
Study Contact Backup
- Name: Ming Yu Claudia Wong, Miss
- Phone Number: 34116579
- Email: 18481795@life.hkbu.edu.hk
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
60 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 60-70 years old
- capable of walking without assistive device
- healthy and live independently in communities
- being physically inactive
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: group-based walking intervention with professional trainer's supervision
Participants will conduct the intervention in groups under the supervision of a professional fitness trainer.
|
Behavioral: supervised group-based walking and non-supervised individual-based walking 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.
|
Active Comparator: individual-based walking intervention without professional trainer supervision
Participants will conduct the intervention individually, without the supervision of a professional fitness trainer
|
Behavioral: supervised group-based walking and non-supervised individual-based walking 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.
|
No Intervention: control group
No intervention will be given to the control group.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from baseline Health-related quality of life at 4 months and at 7 months
Time Frame: Time 1: Baseline; TIme 2 after the 16-week intervention; Time 3 12-weeks after the intervention
|
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
Time Frame: Time 1: Baseline; TIme 2 after the 16-week intervention; Time 3 12-weeks after the intervention
|
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
Time Frame: Time 1: Baseline; TIme 2 after the 16-week intervention; Time 3 12-weeks after the intervention
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from baseline Health parameters - Body Composition at 4 months and at 7 months
Time Frame: Time 1: Baseline; TIme 2 after the 16-week intervention; Time 3 12-weeks after the intervention
|
The walking effects on participants' health parameters, namely body composition, will be assessed.
The body composition will be assessed by Tanita MC780U (Tanita Corporation, 2020), by which the percent body fat and lean body mass of participants will be recorded.
The body mass index (BMI) using participants' heights and weights (measured by the RA) will also be recorded.
|
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 Frame: Time 1: Baseline; TIme 2 after the 16-week intervention; Time 3 12-weeks after the intervention
|
The walking effects on participants' health parameters, namely resting heart rate, will be assessed.
The wrist-worn Fitbit Charge 3 (Fitbit, Inc., 2020) will be used to record the resting heart rate of participants (also the heart rates during walking for reflecting the exercise intensity of the participants as well as the accumulated footsteps and the duration of the completed footsteps during each session of the intervention for performance analyses).
|
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 Frame: Time 1: Baseline; TIme 2 after the 16-week intervention; Time 3 12-weeks after the intervention
|
The walking effects on participants' health parameters, namely resting blood pressure, will be assessed.
The resting blood pressure of the participants will be recorded by Lenus Automatic Blood Pressure Monitor DP65 (MDF Instruments USA, 2020).
|
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 Frame: Time 1: Baseline; TIme 2 after the 16-week intervention; Time 3 12-weeks after the intervention
|
The 8-item Physical Activity Enjoyment Scale (PACES; Chung & Leung, 2019) will be applied to measure the participants' level of enjoyment after engaging in walking intervention programs.
The 8-item Physical Activity Enjoyment Scale is rated by a 7 bipolar rating, with items such as " I enjoy it."
(one extreme) to " I dislike it."(the
other extreme).
In the scale, the negative items (i.e., 1, 4, 5, and 7) requires reverse coding, and the Higher PACES scores the greater levels of physical activity enjoyment demonstrated.
|
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 Frame: Time 1: Baseline; TIme 2 after the 16-week intervention; Time 3 12-weeks after the intervention
|
The time for completing the targeted steps in targeted heart rate zones of each participant in each training session will be recorded for analysis of performance and improvement on walking.
All the data will be recorded by the wrist-worn Fitbit Charge 3 (Fitbit, Inc., 2020) and retrieve from the computer after each training session.
|
Time 1: Baseline; TIme 2 after the 16-week intervention; Time 3 12-weeks after the intervention
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Chung Pak Kwong, Prof, Hong Kong Baptist University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
January 1, 2022
Primary Completion (Anticipated)
August 31, 2022
Study Completion (Anticipated)
December 31, 2022
Study Registration Dates
First Submitted
November 8, 2021
First Submitted That Met QC Criteria
December 7, 2021
First Posted (Actual)
December 9, 2021
Study Record Updates
Last Update Posted (Actual)
December 9, 2021
Last Update Submitted That Met QC Criteria
December 7, 2021
Last Verified
November 1, 2021
More Information
Terms related to this study
Other Study ID Numbers
- 24_PH_in_Sport_Chung
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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