Relationship Between Frailty and Cognitive Impairment in Patients With Parkinson's Disease or Secondary Parkinsonism.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Frailty: Fried's Frailty Phenotype
研究概览
简要总结
Introduction: Parkinson's disease (PD) is the association of tremor, rigidity, akinesia-bradykinesia and loss of postural reflexes. Non-motor symptoms such as cognitive impairment may also develop. Cognitive impairment can be highly variable in its progression, symptoms and severity and can begin from the onset of the disease to the most advanced stages. Frailty is a syndrome characterized by a decrease in physiological reserve that results in an individual's increased vulnerability, which can lead to a variety of adverse factors when exposed to stressors. PD and frailty are highly prevalent in older people and are associated with increased morbidity and mortality. The presence of frailty in patients with PD is poorly studied, as is the association between cognitive impairment and frailty in this patient profile.
Objective: Evaluate the relationship between frailty and cognitive impairment in patients with PD or secondary parkinsonism.
Study design: observational, descriptive, correlative and cross-sectional.
Study population: The subjects that will be part of this study will be men and women with a diagnosis of PD or secondary parkinsonism belonging to the Health Area V of the Health Service of the Principality of Asturias, Spain.
详细描述
Introduction
Parkinson's disease (PD) is the association of tremor, rigidity, akinesia-bradykinesia and loss of postural reflexes. Non-motor symptoms such as cognitive impairment may also develop. Cognitive impairment in PD can be very varied in its progression, symptoms and severity, and can begin from the onset of the disease to the most advanced stages. At the same time, it may be one of the most prevalent non-motor symptoms in PD, with mild cognitive impairment being present in 20% to 30% of patients. Frailty is a syndrome characterized by a decrease in physiological reserve that results in an individual's increased vulnerability, which can lead to a variety of adverse factors when exposed to stressors. There are three prominent theoretical frameworks for the study of frailty, the physical model developed by Fried et al., the deficit accumulation model by Rockwood et al. and the biopsychosocial model by Gobbens et al. PD and frailty are highly prevalent in older people and are associated with increased morbidity and mortality. The presence of frailty in patients with PD is poorly studied, as is the association between cognitive impairment and frailty in this patient profile.
Objective
Evaluate the relationship between frailty and cognitive impairment in patients with PD or secondary parkinsonism.
Study design: observational, descriptive, correlational and cross-sectional.
Study population: The subjects that will be part of this study will be men and women with a diagnosis of PD or secondary parkinsonism belonging to the Health Area V of the Health Service of the Principality of Asturias, Spain.
Data collection: Data will be collected by means of a structured, face-to-face interview at the patient's home or at the Jovellanos Parkinson's Association facilities. These assessments will be carried out, whenever possible, in the presence of a family member or the patient's primary caregiver. The collection of information, the assessment of the patients and the completion of the questionnaires will be carried out by two physiotherapists who are experts in home care following the same guidelines and applying exactly the same criteria.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Cross Sectional
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women, without age limit, with a diagnosis of PD or secondary parkinsonism.
- •Patients belonging to Health Area V of the Health Service of the Principality of Asturias, Spain.
- •Patients who have been referred to the Home Rehabilitation Service of the Instituto de Rehabilitación Astur S.A. and/or who belong to the Jovellanos de Gijón Parkinson's Association of Gijón.
- •Obtaining a score of more than 24 points in the Mini Mental State Examination (MMSE).
- •Signing the informed consent form.
排除标准
- •Parkinsonisms plus or atypical (progressive supranuclear palsy, multiple system atrophy, corticobasal degeneration, Lewy body disease).
- •Acute disease causing clinical instability.
- •Stage 5 of the Hoehn and Yahr scale.
- •Patients unable to speak.
- •Terminally ill patients.
- •Patient with dementia.
结局指标
主要结局
Frailty: Fried's Frailty Phenotype
时间窗: Baseline
Fried's Frailty Phenotype proposed in the Cardiovascular Health Study consists of 5 criteria: unintentional weight loss, exhaustion, low physical activity, reduced grip strength, and reduced gait speed. It has a total score ranging from 0 to 5. A frail person is who scores 3 to 5; prefrail when scores 1 to 2, and robust when scores 0.
Cognitive function: Parkinson's Disease Cognitive Rating Scale (PD-CRS).
时间窗: Baseline
Parkinson's Disease Cognitive Rating Scale (PD-CRS): It is a scale designed to detect the entire spectrum of cognitive dysfunction that occurs in the course of PD. It consists of nine cognitive tasks distributed in two sub-scores, with a maximum score of 134 points: fronto-subcortical (fixation verbal memory 12 points, maintained attention 10 points, working memory 10 points, drawing a clock 10 points, deferred verbal memory 12 points, alternating verbal fluence 20 points, action verbal fluence 30 points) and posterior cortical (denomination by confrontation 20 points and copy of a clock 10 points).
Frailty: Clinical Frailty Scale.
时间窗: Baseline
The Clinical Frailty Scale (CFS) was proposed in the Canadian Study of Health and Aging. It is a hierarchical scale of 9 levels ranging from 1, the best state of health, to 9, the worst situation: fit, well, well managed, vulnerable, mildly frail, moderately frail, severely frail, very severely frail, terminally ill.
次要结局
- Education level(Baseline)
- Duration of the disease(Baseline)
- Comorbidities(Baseline)
- Polypharmacy(Baseline)
- Number of falls(Baseline)
- SPPB activity level(Baseline)
- Hoehn and Yahr scale(Cross-sectional baseline)
- Movement Disorder Society Unified Parkinson´s Disease Rating Scale (MDS-UPDRS).(Baseline)
- Quality of life. PDQ-39(Baseline)
- Barthel Index(Baseline)
- Lawton Brody Index(Baseline)
- Timed Up and Go (TUG)(Baseline)
- Walking evaluation FAC(Baseline)
研究者
María Cruz Sousa Fraguas
Principal Investigator. Physiotherapist.
University of Oviedo