Parkinson DiseaseNCT05388526
Frailty and Cognitive Function in Parkinson's Disease.
An observational study of Parkinson Disease, run by University of Oviedo at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Parkinson Disease
- How many people
- 100 participants
- Where
- 1 siteSpain
- Study dates
- 25 May 2022to 30 Jun 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Men and women diagnosed with PD or secondary parkinsonism
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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.
Read the 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.
- Conditions
- Parkinson Disease
- Being tested
- No intervention
- Keywords
- Parkinson disease, Parkinsonian disorders, Frailty, Cognitive dysfunction, Cognition disorders, Home care services, Home care agencies
- Medical subject headings
- Parkinson Disease, Parkinsonian Disorders, Frailty, Cognitive Dysfunction, Cognition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
There was no intervention to be administered, only collection of data through various tests and questionnaires.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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).
Measured: Baseline
Secondary outcomes (13)
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.
Measured: Baseline
Duration of the disease
The number of months since the patient was diagnosed with Parkinson's disease or Parkinsonism will be recorded.
Measured: 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.
Measured: Baseline
Number of falls
The number of falls suffered in the last year will be collected.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2022
- Study start25 May 2022
- Primary completion31 May 2023
- Study completion30 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oviedo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, María Cruz Sousa Fraguas, University of Oviedo
- Investigators
- MC Sousa-Fraguas, Principal investigator, University of Oviedo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05388526
- Sponsor's protocol ID
- 2022-195 Parkinson´s disease.
- Status last verified
- Jul 2023
- First submitted
- 17 May 2022
- Last updated
- 21 Dec 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 11253156Rockwood 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.
PubMed 16129869Gobbens 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.
PubMed 20511102Pagonabarraga 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.
PubMed 18381647Charlson 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.
PubMed 3558716Hoehn 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.
PubMed 6067254Goetz 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.
PubMed 19025984Guralnik 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.
PubMed 8126356Granger 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.
PubMed 157729Lawton 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.
PubMed 5349366Holden 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.
PubMed 6691052Podsiadlo 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.
PubMed 1991946Sousa-Fraguas MC, Conejo NM, Lastra-Barreira D, Rodriguez-Fuentes G. Feasibility and safety of a home-based physical therapy intervention to reverse frailty in patients with Parkinson's disease: an exploratory pilot randomized clinical trial. Geroscience. 2026 Jun 13. doi: 10.1007/s11357-026-02358-w. Online ahead of print.
PubMed 42287560Sousa-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.
PubMed 39751989
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relationship Between Frailty and Cognitive Impairment in Patients With Parkinson's Disease or Secondary Parkinsonism.
- ClinicalTrials.gov ID
- NCT05388526
- Acronym / sponsor ID
- 2022-195 Parkinson´s disease.
- Conditions
- Parkinson Disease
- Keywords
- Parkinson disease, Parkinsonian disorders, Frailty, Cognitive dysfunction, Cognition disorders, Home care services, Home care agencies
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University of OviedoUniversity, hospital or other
- Study start
- 25 May 2022 (actual)
- Primary completion
- 31 May 2023 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 24 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Parkinson | – | Other: No interventionPatients 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Men and women diagnosed with PD or secondary parkinsonism
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionThere was no intervention to be administered, only collection of data through various tests and questionnaires. | Other | Parkinson |
Primary outcome
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.
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.
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).
13 secondary outcomes
Education level
Time frame: Baseline
Duration of the disease
Time frame: Baseline
Polypharmacy
Time frame: Baseline
Number of falls
Time frame: Baseline
Comorbidities
Time frame: Baseline
Hoehn and Yahr scale
Time frame: Cross-sectional baseline
Movement Disorder Society Unified Parkinson´s Disease Rating Scale (MDS-UPDRS).
Time frame: Baseline
Quality of life. PDQ-39
Time frame: Baseline
Barthel Index
Time frame: Baseline
Lawton Brody Index
Time frame: Baseline
SPPB activity level
Time frame: Baseline
Timed Up and Go (TUG)
Time frame: Baseline
Walking evaluation FAC
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2023.
- Background: PubMed 11253156Fried 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.
- Background: PubMed 16129869Rockwood 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.
- Background: PubMed 20511102Gobbens 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.
- Background: PubMed 18381647Pagonabarraga 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.
- Background: PubMed 3558716Charlson 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.
- Background: PubMed 6067254Hoehn 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.
- Background: PubMed 19025984Goetz 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.
- Background: PubMed 8126356Guralnik 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.
- Background: PubMed 157729Granger 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.
- Background: PubMed 5349366Lawton 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.
- Background: PubMed 6691052Holden 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.
- Background: PubMed 1991946Podsiadlo 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
MC Sousa-Fraguas principal investigator
University of Oviedo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Parkinson Disease, run by University of Oviedo at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frailty: Fried's Frailty Phenotype (time frame: Baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05388526, which also lists 14 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Dec 2023.