Body and Brain: Effects of a Multicomponent Exercise Intervention on Physical and Cognitive Function of Older Adults With Dementia
试验速览
- 阶段
- 不适用
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- Change from Baseline on Short Physical Performance Battery (SPBB)
研究概览
简要总结
Dementia is a leading cause of death and disability that was declared as one of the greatest health and social care challenges of the 21st century. Regular physical activity and exercise have been proposed as a non-pharmacological strategy in disease prevention and management. Multicomponent Training (MT) combines aerobic, strength, balance, and postural exercises and might be an effective training to improve both functional capacity and cognitive function in individuals with dementia (IwD). Nevertheless, data on the effects of MT in IwD are still limited and the extent to which IwD can retain improvements after an exercise intervention still needs to be elucidated. The aim of "Body & Brain" study is to investigate the effects of a 6-month MT intervention and 3-month detraining on the physical and cognitive function of IwD. Additionally, we aim to explore the impact of this intervention on psychosocial factors and physiologic markers related to dementia.
详细描述
Although exercise interventions for IwD seem to be feasible and well tolerated, resulting in positive effects on ADL functionality for people at mild-to-moderate stages [1, 2], the therapeutic role of physical activity, particularly exercise, after dementia diagnosis still needs further evidence [3-5], - especially when considering community-based contexts and caregivers as participants on exercise sessions [6]. It also matters to highlight that the dose-dependent relationship remains unclear [1, 7, 8]. Therefore, research is needed to identify the triad: stage/type of dementia, FITT variables (frequency, intensity, type, and time) of exercise intervention, and target outcome [7, 9]. Regarding exercise modality, Multicomponent Training (MT) [10] - combining aerobics, strength and balance exercises - seems to be effective at improving functional and cognitive performances in older adults with neurodegenerative disorders, particularly dementia [11-13]. Exercise programs previously developed by our group confirmed that a 6-month MT intervention can positively impact the physical and cognitive function of institutionalized older adults with AD [14, 15] and can be beneficial in physical fitness and ADL functionality performance among community-dwelling patients [9, 16]. However, the extent to which IwD can retain these improvements after the cessation of MT intervention still need to be elucidated [17] in order to understand how detraining affects functionality and cognition following the cessation of MT stimulus.
This study is a quasi-experimental controlled trial using a parallel-group design. The study sample consists of community-dwelling individuals aged ≥ 60 years who are clinically diagnosed with dementia or major neurocognitive disorder. Participants will be either allocated into the intervention group or the control group. The intervention group will participate in MT biweekly exercise sessions, whereas the control group will receive monthly sessions regarding physical activity and health-related topics for 6 months. The main outcomes will be physical function as measured by the Short Physical Performance Battery (SPPB) and cognitive function evaluated using the Alzheimer Disease Assessment Scale - Cognitive (ADAS-Cog) at baseline, after 6-months and 3-months after the end of intervention. Secondary outcomes will be body composition, physical fitness, daily functionality, quality of life, neuropsychiatric symptoms and caregiver's burden. Cardiovascular, inflammatory and neurotrophic blood-based biomarkers, and arterial stiffness will also be evaluated in subsamples.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Individuals aged ≥ 60 years capable of walking autonomously without an assistive device or human assistance;
- •Individuals diagnosed with dementia or major neurocognitive disorder using accepted diagnostic criteria such as that established by the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV-TR or DSM-5), ICD-10, or the NINCDS-ADRDA; by a physician for at least for 6-months.
排除标准
- •Individuals diagnosed with certain disorders or conditions in which exercise is contraindicated such as unstable or ongoing cardiovascular and/or respiratory disorder;
- •Hospitalized individuals and/or recovering from surgery or rehabilitation;
- •Individuals presenting an advanced stage of dementia (e.g., scored 3-points in CDR or ≤ 10 points on MMSE) that could affect physical performance in the exercise training sessions or testing procedures.
研究组 & 干预措施
Experimental Group
Training protocol will be held for 6 months, twice per week/ 60 min per sessions.
干预措施: Exercise (Other)
Control Group
Participants in the control group will receive monthly sessions regarding physical activity and health related topics as a complement to standard care. No specific exercise intervention will be conducted for this group.
结局指标
主要结局
Change from Baseline on Short Physical Performance Battery (SPBB)
时间窗: Assessment at baseline, immediately after 6 months of intervention, and at 3 months follow-up for experimental and control groups
The Short Physical Performance Battery (SPPB) is a standardised assessment tool of lower limb function, testing 3 dimensions: standing balance, walking speed, and chair stands. Each component is scored between 0-4, total score from 0 (poor performance) to 12 (best performance).
Change from Baseline on Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog)
时间窗: Assessment at baseline, immediately after 6 months of intervention, and at 3 months follow-up for experimental and control groups
To evaluate cognitive function with a total scoring ranging between 0 - 68. A score of 68 represents the most severe impairment and 0 represents the least impairment.
次要结局
- Change from Baseline on Back Scratch Test(Assessment at baseline, immediately after 6 months of intervention, and at 3 months follow-up for experimental and control groups)
- Change from Baseline on Sit and reach Test(Assessment at baseline, immediately after 6 months of intervention, and at 3 months follow-up for experimental and control groups)
- Change from Baseline on Modified Bruce Treadmill Test(Assessment at baseline, immediately after 6 months of intervention, and at 3 months follow-up for experimental and control groups)
- Change from Baseline on 8-Foot Up and Go Test(Assessment at baseline, immediately after 6 months of intervention, and at 3 months follow-up for experimental and control groups)
- Change from Baseline on Lawton & Brody (IADL)(Assessment at baseline, immediately after 6 months of intervention, and at 3 months follow-up for experimental and control groups)
- Change from Baseline on Circulating levels of Interleukin-6 (IL-6),Interleukin-8 (IL-8), Interleukin-10 (IL-10)(Assessment at baseline, immediately after 6 months of intervention, and at 3 months follow-up for experimental and control groups)
- Change from Baseline on One Leg Balance Test(Assessment at baseline, immediately after 6 months of intervention, and at 3 months follow-up for experimental and control groups)
- Change from Baseline on Handgrip test(Assessment at baseline, immediately after 6 months of intervention, and at 3 months follow-up for experimental and control groups)
- Change from Baseline on Appendicular Skeletal Muscle Mass Index (ASMI)(Assessment at baseline, immediately after 6 months of intervention, and at 3 months follow-up for experimental and control groups)
- Change from Baseline on Barthel Index (BI)(Assessment at baseline, immediately after 6 months of intervention, and at 3 months follow-up for experimental and control groups)
- Change from Baseline on Trail-making test (TMT)(Assessment at baseline, immediately after 6 months of intervention, and at 3 months follow-up for experimental and control groups)
- Change from Baseline on Quality of Life in Alzheimer's Disease scale (QoL-AD)(Assessment at baseline, immediately after 6 months of intervention, and at 3 months follow-up for experimental and control groups)
- Change from Baseline on Caregiver subjective burden (CarerQol-7D)(Assessment at baseline, immediately after 6 months of intervention, and at 3 months follow-up for experimental and control groups)
- Change from Baseline on Blood triglycerides (TG), total cholesterol (TC), Low-density lipoprotein cholesterol (LDL-C) and high-density lipoprotein cholesterol (HDL-C)(Assessment at baseline, immediately after 6 months of intervention, and at 3 months follow-up for experimental and control groups)
- Change from Baseline on Circulating levels of C-Reactive Protein (CRP) and Tumor Necrosis Factor (TNF-alfa)(Assessment at baseline, immediately after 6 months of intervention, and at 3 months follow-up for experimental and control groups)
- Change from Baseline on 30-second Arm Curl Test(Assessment at baseline, immediately after 6 months of intervention, and at 3 months follow-up for experimental and control groups)
- Change from Baseline on Body mass, fat-free mass, fat mass(Assessment at baseline, immediately after 6 months of intervention, and at 3 months follow-up for experimental and control groups)
- Change from Baseline on 30-second Chair-stand Test(Assessment at baseline, immediately after 6 months of intervention, and at 3 months follow-up for experimental and control groups)
- Change from Baseline on 2-minute Step Test(Assessment at baseline, immediately after 6 months of intervention, and at 3 months follow-up for experimental and control groups)
- Caregiver subjective well-being (CarerQol-VAS)(Assessment at baseline, immediately after 6 months of intervention, and at 3 months follow-up for experimental and control groups)
- Change from Baseline on Circulating levels of Glycated Hemoglobin (HbA1c)(Assessment at baseline, immediately after 6 months of intervention, and at 3 months follow-up for experimental and control groups)
- Change from Baseline on Mini-Mental State Examination (MMSE)(Assessment at baseline, immediately after 6 months of intervention, and at 3 months follow-up for experimental and control groups)
- Change from Baseline on Neuropsychiatric inventory (NPI)(Assessment at baseline, immediately after 6 months of intervention, and at 3 months follow-up for experimental and control groups)
- Change from Baseline on Circulating levels of free brain-derived neurotrophic factor (BDNF),Vascular Endothelial Growth Factor (VEGF), intercellular adhesion molecule 1 (sICAM-1), vascular cell adhesion molecule-1 (sVCAM-1), metalloproteinase-9 (MMP-9)(Assessment at baseline, immediately after 6 months of intervention, and at 3 months follow-up for experimental and control groups)
- Change from Baseline on Systolic and Diastolic Blood Pressure(Assessment at baseline, immediately after 6 months of intervention, and at 3 months follow-up for experimental and control groups)
- Change from Baseline on Arterial stiffness(Assessment at baseline, immediately after 6 months of intervention, and at 3 months follow-up for experimental and control groups)
- Change from Baseline on Circulating levels of Insulin-like growth factor-1 (IGF-1)(Assessment at baseline, immediately after 6 months of intervention, and at 3 months follow-up for experimental and control groups)