NCT05151575

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

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
126

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2022

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 8, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

December 9, 2021

Completed
23 days until next milestone

Study Start

First participant enrolled

January 1, 2022

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2022

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

December 9, 2021

Status Verified

November 1, 2021

Enrollment Period

8 months

First QC Date

November 8, 2021

Last Update Submit

December 7, 2021

Conditions

Keywords

AgeingOlder AdultsPhysical activityGroup-based interventionQuality of life

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

EXPERIMENTAL

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

individual-based walking intervention without professional trainer supervision

ACTIVE COMPARATOR

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

control group

NO INTERVENTION

No 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.

group-based walking intervention with professional trainer's supervisionindividual-based walking intervention without professional trainer supervision

Eligibility Criteria

Age60 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

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.

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Chung Pak Kwong, Prof

    Hong Kong Baptist University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Chung Pak Kwong, Prof

CONTACT

Ming Yu Claudia Wong, Miss

CONTACT

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