Home Physiotherapy in Frailty in Patients With Parkinson's Disease

University of Oviedo

Status: Completed

Conditions: Parkinson Disease; Frailty; Physical Therapy Modalities

Treatments: Other: Control Group; Other: Home Physiotherapy Group

Study type: Interventional

Funder types: Other

Identifiers

NCT05607862

2022-398 Parkinson´s disease.

Details and patient eligibility

About

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.

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. 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.

Enrollment: 13 patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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13 participants in 2 patient groups

Intervention Group

Experimental group

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.

Treatment:

Other: Home Physiotherapy Group

Control Group

Other group

Description:

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

Treatment:

Other: Control Group