Home Physiotherapy in Frailty in Patients With Parkinson's Disease

May 6, 2024 updated by: María Cruz Sousa Fraguas, University of Oviedo

Effects of a Home-based Therapeutic Exercise Program on Frailty in Patients With Parkinson's Disease

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

13

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Oviedo, Spain
        • University of Oviedo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention Group
The intervention group will continue with its usual medical-pharmacological treatment, and will also receive a multi-component exercise program and health education guidelines.
Other: Home Physiotherapy Group
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.
Other: Control Group
The control group will be given health education guidelines and will continue with their usual medical-pharmacological treatment.
Other: Control Group
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Frailty: Fried's Frailty Phenotype:
Time Frame: Change in frailty of individuals at baseline up to the 8th and 12th week after interventions.
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.
Change in frailty of individuals at baseline up to the 8th and 12th week after interventions.
Frailty: Clinical Frailty Scale.
Time Frame: Change in frailty of individuals at baseline up to the 8th and 12th week after interventions.
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.
Change in frailty of individuals at baseline up to the 8th and 12th week after interventions.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comorbidities Charlson Index
Time Frame: Baseline - 8 weeks - 3 months
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.
Baseline - 8 weeks - 3 months
Movement Disorder Society Unified Parkinson´s Disease Rating Scale (MDS-UPDRS).
Time Frame: Baseline - 8 weeks - 3 months
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).
Baseline - 8 weeks - 3 months
Cognitive function: Parkinson's Disease Cognitive Rating Scale (PD-CRS).
Time Frame: Baseline - 8 weeks - 3 months
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).
Baseline - 8 weeks - 3 months
Quality of life, PDQ-39
Time Frame: Baseline - 8 weeks - 3 months
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.
Baseline - 8 weeks - 3 months
Short Physical Performance Battery activity level
Time Frame: Baseline - 8 weeks - 3 months
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.
Baseline - 8 weeks - 3 months
Barthel Index
Time Frame: Baseline - 8 weeks - 3 months
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).
Baseline - 8 weeks - 3 months
Lawton Brody Index
Time Frame: Baseline - 8 weeks - 3 months
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.
Baseline - 8 weeks - 3 months
Walking evaluation FAC
Time Frame: Baseline - 8 weeks - 3 months
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).
Baseline - 8 weeks - 3 months
Timed Up and Go (TUG)
Time Frame: Baseline - 8 weeks - 3 months
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.
Baseline - 8 weeks - 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Oviedo

Investigators

  • Principal Investigator: Maria Cruz Sousa Fraguas, University of Oviedo

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 15, 2022

Primary Completion (Actual)

November 2, 2023

Study Completion (Actual)

February 1, 2024

Study Registration Dates

First Submitted

October 30, 2022

First Submitted That Met QC Criteria

November 3, 2022

First Posted (Actual)

November 7, 2022

Study Record Updates

Last Update Posted (Actual)

May 8, 2024

Last Update Submitted That Met QC Criteria

May 6, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022-398 Parkinson´s disease.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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