Frailty and Cognitive Function in Parkinson's Disease.

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Relationship Between Frailty and Cognitive Impairment in Patients With Parkinson's Disease or Secondary Parkinsonism.

Conditions
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Parkinson Disease

Intervention / Treatment
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* Other: No intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Parkinson<br>Patients with a diagnosis of PD or secondary parkinsonism belonging to the Health Area V of the Health Service of the Principality of Asturias, Spain. Patient origin: Rehabilitation Service Instituto de Rehabilitación Astur S.A. and Asociación de Parkinson Jovellanos, from Gijón, Asturias, Spain. | Other: No intervention<br>* There was no intervention to be administered, only collection of data through various tests and questionnaires.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frailty: Fried's Frailty Phenotype | 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. | Baseline | 
| Frailty: Clinical Frailty Scale. | 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. | Baseline | 
| Cognitive function: Parkinson's Disease Cognitive Rating Scale (PD-CRS). | 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). | Baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Education level | Maximum level of education attained. Qualitative variable in 5 categories: illiterate (cannot read or write), no education (incomplete primary education), complete primary education, secondary education and university education. | Baseline | 
| Duration of the disease | The number of months since the patient was diagnosed with Parkinson's disease or Parkinsonism will be recorded. | Baseline | 
| Polypharmacy | Number of different drugs normally taken by the patient assessed in 24 hours. The consumption of more than 6 drugs will be considered polymedication. | Baseline | 
| Number of falls | The number of falls suffered in the last year will be collected. | Baseline | 
| Comorbidities | It is evaluated according to the Charlson comorbidity index. This scale consists of 19 items. Absence of comorbidity between 0 and 1 points, low comorbidity 2 points, high comorbidity between 3 and 5 points and severe comorbidity more than 5 points is considered. | Baseline | 
| Hoehn and Yahr scale | This scale indicates the degree of severity of the disease. It is divided into 6 states. Part of State 0 where there are no symptoms of the disease, until State 5 where the patient is totally dependent. | Cross-sectional baseline | 
| Movement Disorder Society Unified Parkinson´s Disease Rating Scale (MDS-UPDRS). | This tool allows to study the symptoms and the evolution of the disease. It is a scale that is subdivided into 4 parts. Part I: non-motor experiences of daily life, comprising 13 items; Part II: motor experiences of daily life, comprising 13 items; Part III: motor exploration, covering 18 items; and Part IV: motor complications, including 6 items. Each question is evaluated from 0 to 4, where 0 is normal and 4 the greater severity, the higher the score the greater involvement (greater impact of PD symptoms). | Baseline | 
| Quality of life. PDQ-39 | The Spanish version of the questionnaire Parkinson s disease quality of life questionnaire (PDQ39) is used. It consists of 39 items with 5 possible answers. 8 dimensions are analyzed: mobility, daily life activities, emotional well-being, stigma, social support, cognitive impairment, communication and body discomfort. The higher the score, the greater the impact on quality of life. | Baseline | 
| Barthel Index | Functional independence is measured using the Barthel index. It has a total score ranging from 0 to 100, where 0 is the minimum (worst outcome) and 100 is the maximum (best outcome). | Baseline | 
| Lawton Brody Index | Functional independence is measured with the Lawton and Brody Questionnaire. Instrumental activities of daily living assesses the ability to use the telephone, shop, use transport, cook, do household chores, take medication and manage finances. It has a total score ranging from 0 to 8, with 0 indicating total dependence and the maximum score indicating total independence. | Baseline | 
| SPPB activity level | Physical performance is measured using the Brief Physical Performance Battery. This measure consists of walking 4 m, a balance test with 3 levels (tandem, semi-tandem and feet together) and sitting and reaching 5 times as fast as possible. Total scores range from 0 to 12, with higher scores denoting higher physical performance. | Baseline | 
| Timed Up and Go (TUG) | Assesses balance, walking difficulties and decreased strength in lower limbs. This test consists of asking the person to get up from a chair with armrests, walk 3 meters, back and sit again, timing the time spent. 10 seconds or less: correct time. Between 10 and 20 seconds: frail marker. Between 20 and 30 seconds risk of falling. More than 30 seconds: high risk of falls. | Baseline | 
| Walking evaluation FAC | It is measured according to the Holden Ambulation Classification (FAC). It consists of 6 response categories, from the value 0 (no gear) to the value 5 (independent gear including up and down stairs). | Baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Parkinson disease, Parkinsonian disorders, Frailty, Cognitive dysfunction, Cognition disorders, Home care services, Home care agencies