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
试验速览
- 阶段
- 不适用
- 入组人数
- 126
- 主要终点
- Change from baseline Frailty level at 4 months and at 7 months
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 60 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •60-70 years old
- •capable of walking without assistive device
- •healthy and live independently in communities
- •being physically inactive
排除标准
- •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
结局指标
主要结局
Change from baseline Frailty level at 4 months and at 7 months
时间窗: 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 Health-related quality of life at 4 months and at 7 months
时间窗: 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 Cognitive function at 4 months and at 7 months
时间窗: 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).
次要结局
- 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)
- 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)