Frailty and Cognitive Function in Parkinson's Disease.

NCT05388526 | Completed

• 1 other identifier: 2022-195 Parkinson´s disease.
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Parkinson Disease

Keywords

Parkinson disease; Parkinsonian disorders; Frailty; Cognitive dysfunction; Cognition disorders; Home care services; Home care agencies

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (13)

• Education level

  Baseline

• Duration of the disease

  Baseline

• Polypharmacy

  Baseline

• Number of falls

  Baseline

• Comorbidities

  Baseline

Study Arms (1)

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

Interventions

No intervention OTHER

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

Parkinson

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Men and women diagnosed with PD or secondary parkinsonism

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Oviedo: lead

Study Sites (1)

Home patients

Gijón, Principality of Asturias, Spain

Location

Related Publications (13)

• 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.

  PMID: 11253156 BACKGROUND

• 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.

  PMID: 16129869 BACKGROUND

• 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.

  PMID: 20511102 BACKGROUND

• 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.

  PMID: 18381647 BACKGROUND

• 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.

  PMID: 3558716 BACKGROUND

• 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.

  PMID: 6067254 BACKGROUND

• 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.

  PMID: 19025984 BACKGROUND

• 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.

  PMID: 8126356 BACKGROUND

• 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.

  PMID: 157729 BACKGROUND

• 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.

  PMID: 5349366 BACKGROUND

• 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.

  PMID: 6691052 BACKGROUND

• 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.

  PMID: 1991946 BACKGROUND

• Sousa-Fraguas MC, Rodriguez-Fuentes G, Lastra-Barreira D, Conejo NM. Associations between frailty and cognitive impairment in Parkinson s disease: a cross-sectional study. Aging Clin Exp Res. 2025 Jan 3;37(1):19. doi: 10.1007/s40520-024-02922-4.

  PMID: 39751989 DERIVED

MeSH Terms

Conditions

Parkinson Disease; Parkinsonian Disorders; Frailty; Cognitive Dysfunction; Cognition Disorders

Condition Hierarchy (Ancestors)

Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Study Officials

• MC Sousa-Fraguas

  University of Oviedo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator. Physiotherapist.

Study Record Dates

• First Submitted: May 17, 2022
• First Posted: May 24, 2022
• Study Start: May 25, 2022
• Primary Completion: May 31, 2023
• Study Completion: June 30, 2023
• Last Updated: December 21, 2023

Record last verified: 2023-07

Locations

ES (1)