Effects of Physical Exercise Programs, Cognitive Stimulation, and Their Combination on Mobility, Cognitive Function, and Psychosocial Well-Being in Institutionalized Older Adults
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 140
- 主要终点
- Change from Baseline in Functional Mobility Measured by the Timed Up and Go (TUG) Test at 12 Weeks
研究概览
简要总结
The goal of this clinical trial is to learn if physical exercise, cognitive stimulation, or a combination of both can improve mobility, cognitive function, and psychosocial well-being in institutionalized older adults aged 65 and older. The main questions it aims to answer are:
- Does physical exercise improve strength, flexibility, balance, and mobility?
- Does cognitive stimulation improve executive function and mental state?
- Does combining both interventions provide greater benefits than either intervention alone?
Researchers will compare the physical exercise group, the cognitive stimulation group, and the combined group to a control group that receives no active intervention to see which approach leads to the most improvement.
Participants will:
- Take part in either physical exercise, cognitive stimulation, or both, 3 times per week for 12 weeks
- Complete assessments before the intervention, after 12 weeks, and again after 6 months
- Answer questionnaires and perform physical and cognitive tests to measure changes in health and well-being
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •Individuals of both sexes.
- •Age 65 years or older.
- •Institutionalized for more than three months.
- •Provide informed consent and agree to participate.
排除标准
- •Lack of cooperation or cognitive capacity to participate.
- •Diagnosis of dementia or Alzheimer's disease.
- •Presence of acute medical conditions.
- •Physical or cognitive impairments that prevent completion of study procedures.
研究组 & 干预措施
Physical Exercise Group
Participants will engage in moderate-intensity physical exercise sessions 3 times per week for 12 weeks (150 minutes per week), including balance, strength, and functional mobility exercises led by physiotherapists.
干预措施: Physical Exercise Program (Behavioral)
Cognitive Stimulation Group
Participants will attend 3 weekly sessions for 12 weeks, involving activities such as memory games, problem-solving tasks, orientation exercises, and attention training, led by a psychologist and a social educator.
干预措施: Cognitive Stimulation Program (Behavioral)
Combined Intervention Group
Participants will receive both the physical exercise and cognitive stimulation programs simultaneously, with the same weekly frequency and duration as the individual interventions.
干预措施: Combined Physical Exercise and Cognitive Stimulation (Behavioral)
Control Group
Participants will continue their usual routines without structured physical or cognitive interventions. They will receive standard care provided by the institution.
结局指标
主要结局
Change from Baseline in Functional Mobility Measured by the Timed Up and Go (TUG) Test at 12 Weeks
时间窗: From baseline to the end of the intervention at 12 weeks.
Functional mobility will be assessed using the Timed Up and Go (TUG) test. The participant is timed while rising from a chair, walking 3 meters, turning, returning, and sitting. Score: Time in seconds (lower values indicate better mobility).
Change from Baseline in Executive Function Assessed by the Stroop Test at 12 Weeks
时间窗: From baseline to the end of the intervention at 12 weeks.
Executive function will be assessed using the Stroop Color and Word Test, which evaluates attention, inhibition, and cognitive flexibility. Score: Time (seconds) and error count; lower values indicate better performance.
Change from Baseline in Quality of Life Measured by EQ-5D at 12 Weeks
时间窗: From baseline to the end of the intervention at 12 weeks.
The EQ-5D assesses five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Score Range: -0.594 to 1. Higher scores indicate better quality of life.
次要结局
- Change in Balance Performance Measured by the Tinetti Performance Oriented Mobility Assessment (POMA) at 12 Weeks(From baseline to the end of the intervention at 12 weeks.)
- Change in Lower Body Strength Measured by the 30-Second Chair Stand Test at 12 Weeks(From baseline to the end of the intervention at 12 weeks.)
- Change in Upper Body Strength Measured by the Arm Curl Test at 12 Weeks(From baseline to 12 weeks post-intervention.)
- Change in Grip Strength Measured by Hand Dynamometer at 12 Weeks(From baseline to 12 weeks post-intervention.)
- Change in Sleep Quality Measured by the Pittsburgh Sleep Quality Index (PSQI) at 12 Weeks(From baseline to the end of the intervention at 12 weeks.)
- Change in Depressive Symptoms Measured by the Geriatric Depression Scale (GDS) at 12 Weeks(From baseline to the end of the intervention at 12 weeks.)
- Change in Life Satisfaction Measured by the Satisfaction With Life Scale (SWLS) at 12 Weeks(From baseline to the end of the intervention at 12 weeks.)
- Change in Functional Mobility Measured by the Timed Up and Go (TUG) Test at 6-Month Follow-Up(From the end of the intervention to 6 months follow-up.)
- Change in Executive Function Measured by the Stroop Test at 6-Month Follow-Up(From baseline to the end of the intervention at 12 weeks.)
- Change in Quality of Life Measured by the EQ-5D at 6-Month Follow-Up(From end of intervention to 6 months post-intervention.)
研究者
Nuno Adriano Sousa Carvalho
Doctoral Program Student
University of Salamanca