Frailty and Cognitive Function in Parkinson's Disease.

Parkinson Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05388526
• Other study ID #: 2022-195 Parkinson´s disease.
• Status: Completed
• Start date: May 25, 2022
• Est. completion date: June 30, 2023

Study information

• Verified date: July 2023
• Source: University of Oviedo
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: June 30, 2023
• Est. primary completion date: May 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Frailty
• Parkinson Disease

Intervention

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

Locations

Country	Name	City	State
Spain	Home patients	Gijon	Asturias

Sponsors (1)

Lead Sponsor	Collaborator
University of Oviedo

Country where clinical trial is conducted

Spain, 

References & Publications (12)

Charlson ME, Pompei P, Ales KL, MacKenzie CR. A new method of classifying prognostic comorbidity in longitudinal studies: development and validation. J Chronic Dis. 1987;40(5):373-83. doi: 10.1016/0021-9681(87)90171-8. — View Citation

Fried LP, Tangen CM, Walston J, Newman AB, Hirsch C, Gottdiener J, Seeman T, Tracy R, Kop WJ, Burke G, McBurnie MA; Cardiovascular Health Study Collaborative Research Group. Frailty in older adults: evidence for a phenotype. J Gerontol A Biol Sci Med Sci. 2001 Mar;56(3):M146-56. doi: 10.1093/gerona/56.3.m146. — View Citation

Gobbens RJ, van Assen MA, Luijkx KG, Wijnen-Sponselee MT, Schols JM. The Tilburg Frailty Indicator: psychometric properties. J Am Med Dir Assoc. 2010 Jun;11(5):344-55. doi: 10.1016/j.jamda.2009.11.003. Epub 2010 May 8. — View Citation

Goetz CG, Tilley BC, Shaftman SR, Stebbins GT, Fahn S, Martinez-Martin P, Poewe W, Sampaio C, Stern MB, Dodel R, Dubois B, Holloway R, Jankovic J, Kulisevsky J, Lang AE, Lees A, Leurgans S, LeWitt PA, Nyenhuis D, Olanow CW, Rascol O, Schrag A, Teresi JA, van Hilten JJ, LaPelle N; Movement Disorder Society UPDRS Revision Task Force. Movement Disorder Society-sponsored revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS): scale presentation and clinimetric testing results. Mov Disord. 2008 Nov 15;23(15):2129-70. doi: 10.1002/mds.22340. — View Citation

Granger CV, Albrecht GL, Hamilton BB. Outcome of comprehensive medical rehabilitation: measurement by PULSES profile and the Barthel Index. Arch Phys Med Rehabil. 1979 Apr;60(4):145-54. — View Citation

Guralnik JM, Simonsick EM, Ferrucci L, Glynn RJ, Berkman LF, Blazer DG, Scherr PA, Wallace RB. A short physical performance battery assessing lower extremity function: association with self-reported disability and prediction of mortality and nursing home admission. J Gerontol. 1994 Mar;49(2):M85-94. doi: 10.1093/geronj/49.2.m85. — View Citation

Hoehn MM, Yahr MD. Parkinsonism: onset, progression and mortality. Neurology. 1967 May;17(5):427-42. doi: 10.1212/wnl.17.5.427. No abstract available. — View Citation

Holden MK, Gill KM, Magliozzi MR, Nathan J, Piehl-Baker L. Clinical gait assessment in the neurologically impaired. Reliability and meaningfulness. Phys Ther. 1984 Jan;64(1):35-40. doi: 10.1093/ptj/64.1.35. — View Citation

Lawton MP, Brody EM. Assessment of older people: self-maintaining and instrumental activities of daily living. Gerontologist. 1969 Autumn;9(3):179-86. No abstract available. — View Citation

Pagonabarraga J, Kulisevsky J, Llebaria G, Garcia-Sanchez C, Pascual-Sedano B, Gironell A. Parkinson's disease-cognitive rating scale: a new cognitive scale specific for Parkinson's disease. Mov Disord. 2008 May 15;23(7):998-1005. doi: 10.1002/mds.22007. — View Citation

Podsiadlo D, Richardson S. The timed "Up & Go": a test of basic functional mobility for frail elderly persons. J Am Geriatr Soc. 1991 Feb;39(2):142-8. doi: 10.1111/j.1532-5415.1991.tb01616.x. — View Citation

Rockwood K, Song X, MacKnight C, Bergman H, Hogan DB, McDowell I, Mitnitski A. A global clinical measure of fitness and frailty in elderly people. CMAJ. 2005 Aug 30;173(5):489-95. doi: 10.1503/cmaj.050051. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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
Secondary	Duration of the disease	The number of months since the patient was diagnosed with Parkinson's disease or Parkinsonism will be recorded.	Baseline
Secondary	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
Secondary	Number of falls	The number of falls suffered in the last year will be collected.	Baseline
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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