Physical ActivityNCT05151575
Supervised Group-based Walking Intervention Among Inactive Older Adults in Saudi Arabia
A study testing supervised group-based walking and non-supervised individual-based walking interventions in people with Physical Activity, run by Hong Kong Baptist University.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Physical Activity
- What is being tested?
- supervised group-based walking and non-supervised individual-based walking interventions
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2022to 31 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 60-70 years old
- capable of walking without assistive device
- healthy and live independently in communities
- being physically inactive
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
Read the 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.
- Conditions
- Physical Activity
- Being tested
- supervised group-based walking and non-supervised individual-based walking interventions
- Keywords
- Ageing, Older Adults, Physical activity, Group-based intervention, Quality of life
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
supervised group-based walking and non-supervised individual-based walking interventionsBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| group-based walking intervention with professional trainer's supervision | Experimental | Participants will conduct the intervention in groups under the supervision of a professional fitness trainer. Receives: Behavioral: supervised group-based walking and non-supervised individual-based walking interventions |
| individual-based walking intervention without professional trainer supervision | Active comparator | Participants will conduct the intervention individually, without the supervision of a professional fitness trainer Receives: Behavioral: supervised group-based walking and non-supervised individual-based walking interventions |
| control group | No intervention | No intervention will be given to the control group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 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).
Measured: 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
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.
Measured: 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
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).
Measured: 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
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).
Measured: 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
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.
Measured: 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
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.
Measured: Time 1: Baseline; TIme 2 after the 16-week intervention; Time 3 12-weeks after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2021
- Study start1 Jan 2022 (estimated)
- Primary completion31 Aug 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Physical ActivityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 126 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hong Kong Baptist University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chung Pak Kwong, Prof, Principal investigator, Hong Kong Baptist University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05151575
- Sponsor's protocol ID
- 24_PH_in_Sport_Chung
- Status last verified
- Nov 2021
- First submitted
- 8 Nov 2021
- Last updated
- 9 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 37759212
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05151575
- Acronym / sponsor ID
- 24_PH_in_Sport_Chung
- Conditions
- Physical Activity
- Keywords
- Ageing, Older Adults, Physical activity, Group-based intervention, Quality of life
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 126 participants (estimated)
- Lead sponsor
- Hong Kong Baptist UniversityUniversity, hospital or other
- Study start
- 1 Jan 2022 (estimated)
- Primary completion
- 31 Aug 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 9 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| group-based walking intervention with professional trainer's supervision | Experimental | Behavioral: supervised group-based walking and non-supervised individual-based walking interventionsParticipants will conduct the intervention in groups under the supervision of a professional fitness trainer. |
| individual-based walking intervention without professional trainer supervision | Active comparator | Behavioral: supervised group-based walking and non-supervised individual-based walking interventionsParticipants will conduct the intervention individually, without the supervision of a professional fitness trainer |
| control group | No intervention | –No intervention will be given to the control group. |
Who may qualify
- Ages
- 60 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 60-70 years old
- capable of walking without assistive device
- healthy and live independently in communities
- being physically inactive
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| supervised group-based walking and non-supervised individual-based walking interventionsGroup 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. | Behavioural | group-based walking intervention with professional trainer's supervision, individual-based walking intervention without professional trainer supervision |
Primary outcome
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.
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).
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).
5 secondary outcomes
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
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
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
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
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2021.
- Derived from this study: PubMed 37759212Wong 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chung Pak Kwong, Prof principal investigator
Hong Kong Baptist University
Questions about this trial
What is this clinical trial studying?
A study testing supervised group-based walking and non-supervised individual-based walking interventions in people with Physical Activity, run by Hong Kong Baptist University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chung Pak Kwong, Prof (34117728, pkchung@hkbu.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05151575, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2021.