Frailty and Cognitive Function in Parkinson's Disease.

December 15, 2023 updated by: María Cruz Sousa Fraguas, University of Oviedo

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Observational

Enrollment (Actual)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Asturias
      • Gijon, Asturias, Spain
        • Home patients

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Men and women diagnosed with PD or secondary parkinsonism

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Parkinson

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
There was no intervention to be administered, only collection of data through various tests and questionnaires.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Education level
Time Frame: Baseline
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
Time Frame: Baseline
The number of months since the patient was diagnosed with Parkinson's disease or Parkinsonism will be recorded.
Baseline
Polypharmacy
Time Frame: Baseline
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
Time Frame: Baseline
The number of falls suffered in the last year will be collected.
Baseline
Comorbidities
Time Frame: Baseline
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
Time Frame: Cross-sectional baseline
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).
Time Frame: Baseline
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
Time Frame: Baseline
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
Time Frame: Baseline
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
Time Frame: Baseline
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
Time Frame: Baseline
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)
Time Frame: Baseline
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
Time Frame: Baseline
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Oviedo

Investigators

  • Principal Investigator: MC Sousa-Fraguas, University of Oviedo

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 25, 2022

Primary Completion (Actual)

May 31, 2023

Study Completion (Actual)

June 30, 2023

Study Registration Dates

First Submitted

May 17, 2022

First Submitted That Met QC Criteria

May 19, 2022

First Posted (Actual)

May 24, 2022

Study Record Updates

Last Update Posted (Estimated)

December 21, 2023

Last Update Submitted That Met QC Criteria

December 15, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022-195 Parkinson´s disease.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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