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Home Physiotherapy in Frailty in Patients With Parkinson's Disease or Secondary Parkinsonism

Primary Purpose

Parkinson Disease, Physical Therapy Modalities, Frailty

Status
Active
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Home Physiotherapy Group
Control Group
Sponsored by
University of Oviedo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson Disease focused on measuring Parkinson Disease, Secondary, Home physiotherapy

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Men and women, aged 60 years or older, with a diagnosis of PD or secondary parkinsonism. Having frailty or prefrailty according to the Fried scale (1 or 2 prefrailty criteria, 3 or more frailty criteria). Stage 1-3 of the Hoehn and Yahr scale. 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. Obtaining a score higher 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 4 and 5 of the Hoehn and Yahr scale. Receiving individualized outpatient or home physiotherapy treatment for Parkinson's disease or secondary parkinsonism. Patients unable to speak. Patients in terminal phase. Patient with dementia.

Sites / Locations

  • University of Oviedo

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Intervention Group

Control Group

Arm Description

The intervention group will continue with its usual medical-pharmacological treatment, and will also receive a multi-component exercise program and health education guidelines.

The control group will be given health education guidelines and will continue with their usual medical-pharmacological treatment.

Outcomes

Primary Outcome Measures

Frailty: Fried's Frailty Phenotype:
Fried's Frailty Phenotype proposed in the Cardiovascular Health Study (Fried et al., 2001) 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.
The Clinical Frailty Scale (CFS) was proposed in the Canadian Study of Health and Aging (CSHA) (Rockwood et al., 2005). 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.
Frailty: The Tilburg Frailty Indicator
The Tilburg Frailty Indicator (Gobbens et al., 2010) is a self-reported questionnaire of 15 items addressing physical, psychological and social domains. The total score of the Tilburg scale can range from 0 to 15. Higher scores indicate more frailty.

Secondary Outcome Measures

Comorbidities Charlson Index
It is evaluated according to the Charlson comorbidity index (Charlson et al., 1987). 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.
Movement Disorder Society Unified Parkinson´s Disease Rating Scale (MDS-UPDRS).
This tool allows to study the symptoms and the evolution of the disease (Goetz et al., 2008). 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).
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 (Pagonabarraga J et al., 2008). 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).
Quality of life, PDQ-39
The Spanish version of the questionnaire Parkinson s disease quality of life questionnaire (PDQ39) is used (Martínez Martín P, et al., 1999, Martínez-Martín P et al., 1998). 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.
Short Physical Performance Battery activity level
Physical performance is measured using the Brief Physical Performance Battery (Guralnik et al., 1994). 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.
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). (Mahoney et al. 1965, Granger et al., 1979).
Lawton Brody Index
Functional independence is measured with the Lawton and Brody Questionnaire (Lawton and Brody, 1969, Vergara I et al., 2012). 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.
Walking evaluation FAC
It is measured according to the Holden Ambulation Classification (FAC) (Holden et al., 1984). It consists of 6 response categories, from the value 0 (no gear) to the value 5 (independent gear including up and down stairs).
Timed Up and Go (TUG)
Assesses balance, walking difficulties and decreased strength in lower limbs (Poisadlo D and Richardson S, 1991). 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.
Balance, Berg Scale
The Berg scale is used to evaluate static and dynamic balance. It consists of 14 items, with a score between 0 and 4 points for each item. The 14 tasks of the different items are performed and the performance performed in each task must be rated. The total score is 56 points, where 0 is the minimum (worst outcome) and 56 is the maximum (best outcome).

Full Information

First Posted
October 30, 2022
Last Updated
July 25, 2023
Sponsor
University of Oviedo
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1. Study Identification

Unique Protocol Identification Number
NCT05607862
Brief Title
Home Physiotherapy in Frailty in Patients With Parkinson's Disease or Secondary Parkinsonism
Official Title
Effects of a Home-based Therapeutic Exercise Program on Frailty in Patients With Parkinson's Disease or Secondary Parkinsonism
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
October 15, 2022 (Actual)
Primary Completion Date
November 2, 2023 (Anticipated)
Study Completion Date
February 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Oviedo

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
The aim of this protocol is to evaluate the effects of a home-based therapeutic exercise program applied in patients with PD or secondary parkinsonism to reverse frailty. The design of this study is experimental, prospective, randomized and double blind. The study population 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. 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. Frailty is a reversible condition, especially during the early stages, so early detection is important. Previous studies have been carried out with the application of exercise programs to reverse frailty in older adults, obtaining good results at a physical level. General objective: - Evaluate the effects of a therapeutic home exercise program applied in patients with PD or secondary parkinsonism to reverse frailty. Specific objectives: Evaluate the effects of a home therapeutic exercise program on motor and non-motor symptoms, as well as on quality of life, balance and gait. Identify the characteristics of the patients who obtain the greatest improvement. Evaluate the effects of a home therapeutic exercise program after a period of time of three months after the intervention. Study design: experimental, prospective, randomized and double-blinded. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease, Physical Therapy Modalities, Frailty
Keywords
Parkinson Disease, Secondary, Home physiotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
13 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention Group
Arm Type
Experimental
Arm Description
The intervention group will continue with its usual medical-pharmacological treatment, and will also receive a multi-component exercise program and health education guidelines.
Arm Title
Control Group
Arm Type
Other
Arm Description
The control group will be given health education guidelines and will continue with their usual medical-pharmacological treatment.
Intervention Type
Other
Intervention Name(s)
Home Physiotherapy Group
Intervention Description
The intervention group will receive 2 sessions per week for 8 weeks supervised and assisted by a physiotherapist at the patient's home. Muscle strengthening exercises of the lower and upper limbs, stretching, coordination and balance exercises, gait re-education with the relevant technical aids, a pattern of exercises to be performed daily by the patient and health education guidelines will be carried out.
Intervention Type
Other
Intervention Name(s)
Control Group
Intervention Description
The control group will be given health education guidelines and will continue with their usual medical-pharmacological treatment. All patients included in this study will receive physiotherapy treatment, and those in the control group will be treated once the intervention and the post-intervention assessment have been completed.
Primary Outcome Measure Information:
Title
Frailty: Fried's Frailty Phenotype:
Description
Fried's Frailty Phenotype proposed in the Cardiovascular Health Study (Fried et al., 2001) 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.
Time Frame
Change in frailty of individuals at baseline up to the 8th and 12th week after interventions.
Title
Frailty: Clinical Frailty Scale.
Description
The Clinical Frailty Scale (CFS) was proposed in the Canadian Study of Health and Aging (CSHA) (Rockwood et al., 2005). 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.
Time Frame
Change in frailty of individuals at baseline up to the 8th and 12th week after interventions.
Title
Frailty: The Tilburg Frailty Indicator
Description
The Tilburg Frailty Indicator (Gobbens et al., 2010) is a self-reported questionnaire of 15 items addressing physical, psychological and social domains. The total score of the Tilburg scale can range from 0 to 15. Higher scores indicate more frailty.
Time Frame
Change in frailty of individuals at baseline up to the 8th and 12th week after interventions.
Secondary Outcome Measure Information:
Title
Comorbidities Charlson Index
Description
It is evaluated according to the Charlson comorbidity index (Charlson et al., 1987). 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.
Time Frame
Baseline - 8 weeks - 3 months
Title
Movement Disorder Society Unified Parkinson´s Disease Rating Scale (MDS-UPDRS).
Description
This tool allows to study the symptoms and the evolution of the disease (Goetz et al., 2008). 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).
Time Frame
Baseline - 8 weeks - 3 months
Title
Cognitive function: Parkinson's Disease Cognitive Rating Scale (PD-CRS).
Description
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 (Pagonabarraga J et al., 2008). 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).
Time Frame
Baseline - 8 weeks - 3 months
Title
Quality of life, PDQ-39
Description
The Spanish version of the questionnaire Parkinson s disease quality of life questionnaire (PDQ39) is used (Martínez Martín P, et al., 1999, Martínez-Martín P et al., 1998). 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.
Time Frame
Baseline - 8 weeks - 3 months
Title
Short Physical Performance Battery activity level
Description
Physical performance is measured using the Brief Physical Performance Battery (Guralnik et al., 1994). 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.
Time Frame
Baseline - 8 weeks - 3 months
Title
Barthel Index
Description
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). (Mahoney et al. 1965, Granger et al., 1979).
Time Frame
Baseline - 8 weeks - 3 months
Title
Lawton Brody Index
Description
Functional independence is measured with the Lawton and Brody Questionnaire (Lawton and Brody, 1969, Vergara I et al., 2012). 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.
Time Frame
Baseline - 8 weeks - 3 months
Title
Walking evaluation FAC
Description
It is measured according to the Holden Ambulation Classification (FAC) (Holden et al., 1984). It consists of 6 response categories, from the value 0 (no gear) to the value 5 (independent gear including up and down stairs).
Time Frame
Baseline - 8 weeks - 3 months
Title
Timed Up and Go (TUG)
Description
Assesses balance, walking difficulties and decreased strength in lower limbs (Poisadlo D and Richardson S, 1991). 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.
Time Frame
Baseline - 8 weeks - 3 months
Title
Balance, Berg Scale
Description
The Berg scale is used to evaluate static and dynamic balance. It consists of 14 items, with a score between 0 and 4 points for each item. The 14 tasks of the different items are performed and the performance performed in each task must be rated. The total score is 56 points, where 0 is the minimum (worst outcome) and 56 is the maximum (best outcome).
Time Frame
Baseline - 8 weeks - 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Men and women, aged 60 years or older, with a diagnosis of PD or secondary parkinsonism. Having frailty or prefrailty according to the Fried scale (1 or 2 prefrailty criteria, 3 or more frailty criteria). Stage 1-3 of the Hoehn and Yahr scale. 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. Obtaining a score higher 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 4 and 5 of the Hoehn and Yahr scale. Receiving individualized outpatient or home physiotherapy treatment for Parkinson's disease or secondary parkinsonism. Patients unable to speak. Patients in terminal phase. Patient with dementia.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maria Cruz Sousa Fraguas
Organizational Affiliation
University of Oviedo
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Oviedo
City
Oviedo
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
16129869
Citation
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Results Reference
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PubMed Identifier
20511102
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.
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PubMed Identifier
3558716
Citation
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Citation
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Home Physiotherapy in Frailty in Patients With Parkinson's Disease or Secondary Parkinsonism

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