ClinicalTrials.Veeva

Menu

Frailty and Cognitive Function in Parkinson's Disease.

U

University of Oviedo

Status

Completed

Conditions

Parkinson Disease

Treatments

Other: No intervention

Study type

Observational

Funder types

Other

Identifiers

NCT05388526
2022-195 Parkinson´s disease.

Details and patient eligibility

About

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.

Full 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.

Enrollment

100 patients

Sex

All

Volunteers

No Healthy Volunteers

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.

Trial design

100 participants in 1 patient group

Parkinson
Description:
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.
Treatment:
Other: No intervention

Trial contacts and locations

1

Loading...

Central trial contact

MC Sousa-Fraguas

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2026 Veeva Systems