Effects of a Multicomponent Exercise Program on Frailty, Cognitive Function, and Sleep Quality in Older Adults: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- Frailty total mean score
研究概览
简要总结
This study was aimed to examine the effects of participation in a 12-week multicomponent exercise program on frailty, cognitive function, and sleep quality among older adults.
The primary research questions of this study are as follows:
- Is a multicomponent exercise program effective in reducing frailty levels in older adults?
- Is a multicomponent exercise program effective in improving cognitive functions (memory, attention, and executive functions) in older adults?
- Is a multicomponent exercise program effective in improving sleep quality in older adults? The study hypothesizes that participation in a multicomponent exercise program will lead to a reduction in frailty levels, improvement in cognitive functions, and enhancement of sleep quality among older adults.
Researchers were compared the multicomponent exercise program to a control group (no intervention) to see if the multicomponent exercise program works on frailty, cognitive function, and sleep quality among older adults.
Intervention group participants were:
- attended the multicomponent exercise program, 12-week period, with sessions held twice weekly, each lasting 45-60 minutes, in groups of 6-8 participants at a municipally affiliated healthy living center under nurse supervision.
详细描述
The study was conducted with elderly individuals aged 65 and over enrolled in a municipal wellness centre meeting the inclusion-exclusion criteria. A total of 110 elderly individuals were included in the study. These individuals were randomly assigned to two groups: intervention and control groups. Pre-test data were collected November 2025 in a quiet room at the wellness centre by outcome assessors from both the intervention and control groups using the "Personal Information Form", "Edmonton Frail Scale (EFS)", "Mini Mental State Examination (MMSE)" and "Pittsburgh Sleep Quality Index (PSQI)" on a self-report basis. The Multicomponent Exercise Program was administered to the intervention group for 12 weeks, twice a week, in groups of 6-8 people, in sessions lasting 45-60 minutes each, under nurse supervision. At the end of the Multicomponent Exercise Program, both the intervention and control groups were administered the "Edmonton Frail Scale (EFS)", "Mini Mental State Examination (MMSE)" and "Pittsburgh Sleep Quality Index (PSQI)" as a post-test between January and February 2026. The control group received no intervention during the 12-week program; individuals continued with their daily living activities.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
盲法说明
Due to the nature of the exercise intervention, participants and intervention providers could not be blinded to group allocation. However, outcome assessors and data analysts were blinded to group assignments to minimize assessment and analysis bias.
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age 65 years or older, absence of severe physical disability,
- •no medical contraindications to exercise,
- •a Mini-Mental State Examination (MMSE) score ≥24 indicating no significant cognitive impairment,
- •provision of written informed consent.
排除标准
- •the presence of severe cardiovascular disease,
- •diagnosed cognitive impairment (MMSE <24),
- •any condition that could prevent participation in physical exercise.
研究组 & 干预措施
Intervention
The intervention group was a group of 55 people consisting of older adults who followed the 12-week Multicomponent Exercise Program.
干预措施: The Multicomponent Exercise Program (Behavioral)
Control Group
The control group consisted of 55 older adults who attended receive any exercise intervention and were instructed to continue their routine daily activities for 12 weeks without any intervention.
结局指标
主要结局
Frailty total mean score
时间窗: From enrollment to the end of the multicomponent exercise program at 12 weeks
Frailty was assessed using the Edmonton Frail Scale (EFS), a multidimensional instrument comprising nine domains that evaluate frailty in older adults. Total scores range from 0 to 17, with higher scores indicating increased frailty.
Cognitive function total mean score
时间窗: From enrollment to the end of the multicomponent exercise program at 12 weeks
Cognitive function was measured using the Mini-Mental State Examination (MMSE), which evaluates orientation, registration, attention and calculation, recall, and language skills. Scores range from 0 to 30, with higher scores reflecting better cognitive performance
Sleep quality total mean score
时间窗: From enrollment to the end of the multicomponent exercise program at 12 weeks.
Sleep quality was assessed using the Pittsburgh Sleep Quality Index (PSQI), which consists of seven components evaluating sleep quality over the past month. Higher total scores indicate poorer sleep quality
次要结局
未报告次要终点
研究者
Neslihan Lok
Prof.Dr
Selcuk University