Clinical trial NCT05607862: Home Physiotherapy in Frailty in Patients With Parkinson's Disease
Official title: Effects of a Home-based Therapeutic Exercise Program on Frailty in Patients With Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson Disease
Physical Therapy Modalities
Frailty
Keywords: Home physiotherapy
Lead sponsor: University of Oviedo
Sponsor class: OTHER
First posted: 2022-11-07
Enrollment: 13
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The aim of this protocol is to evaluate the effects of a home-based therapeutic exercise program applied in patients with PD to reverse frailty. The design of this study is experimental, prospective, randomized and single blind. The study population that will be part of this study will be men and women with a diagnosis of PD 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 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 single-blinded.

Study population: The subjects that will be part of this study will be men and women with a diagnosis of PD belonging to the Health Area V of the Health Service of the Principality of Asturias, Spain.

Eligibility criteria: Inclusion Criteria:

* Men and women, aged 60 years or older, with a diagnosis of PD
* 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.
* Obtaining a score higher than 24 points in the Mini Mental State Examination (MMSE).
* Signing the informed consent form.

Exclusion Criteria:

* Parkinsonisms secondary, 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.

Primary outcomes:
measure: Frailty: Fried's Frailty Phenotype:
timeFrame: Change in frailty of individuals at baseline up to the 8th and 12th week after interventions.
measure: Frailty: Clinical Frailty Scale.
timeFrame: Change in frailty of individuals at baseline up to the 8th and 12th week after interventions.
Secondary outcomes:
measure: Comorbidities Charlson Index
timeFrame: Baseline - 8 weeks - 3 months
measure: Movement Disorder Society Unified Parkinson´s Disease Rating Scale (MDS-UPDRS).
timeFrame: Baseline - 8 weeks - 3 months
measure: Cognitive function: Parkinson's Disease Cognitive Rating Scale (PD-CRS).
timeFrame: Baseline - 8 weeks - 3 months
measure: Quality of life, PDQ-39
timeFrame: Baseline - 8 weeks - 3 months
measure: Short Physical Performance Battery activity level
timeFrame: Baseline - 8 weeks - 3 months
measure: Barthel Index
timeFrame: Baseline - 8 weeks - 3 months
measure: Lawton Brody Index
timeFrame: Baseline - 8 weeks - 3 months
measure: Walking evaluation FAC
timeFrame: Baseline - 8 weeks - 3 months
measure: Timed Up and Go (TUG)
timeFrame: Baseline - 8 weeks - 3 months
Other outcomes:
Locations:
city: Oviedo
country: Spain
facility: University of Oviedo
Study officials:
affiliation: University of Oviedo
name: Maria Cruz Sousa Fraguas
role: PRINCIPAL_INVESTIGATOR
References:
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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.
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