Impact of Intensive Outpatient Rehabilitation on Non-Motor Patient-Reported Outcomes in Parkinson's Disease (INTENSO)

NCT06695286 | Completed

• 1 other identifier: ID 101/2024, number 3054
• Study Type: observational
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

This historical cohort study aims to evaluate the impact of different intensity rehabilitation protocols on the short and medium-term severity of non-motor symptoms in patients with Parkinson's Disease. One of the principal strengths of this study is that it is a real-life study, so it has a high external validity necessary to test the clinical effectiveness of these two types of training, which could have significant practical implications for rehabilitation in Parkinson's disease.

Conditions

Parkinson Disease

Keywords

Parkinson's Disease; rehabilitation; non-motor symptoms; multimodal; exercise; intensity

Outcome Measures

Primary Outcomes (2)

• Changes in Non-motor Symptoms

  The changes in non-motor symptoms mesaured by the Non Motor Symptoms Scale ( NMSS; score range: 0-360; higher scores mean a worse outcome)

  before treatment, immediately after treatment, and six months following the end of the treatment

• Changes in Non-motor Symptoms

  The changes in non-motor symptoms mesaured by the Unified Parkinson's Disease Rating Scale part I ( UPDRS part I; score range 0-52; higher scores mean a worse outcome)

  before treatment, immediately after treatment, and six months following the end of the treatment

Secondary Outcomes (3)

• Changes in Parkinson's Disease related disability

  before treatment, immediately after treatment, and six months following the end of the treatment

• Changes in motor symptoms severity

  before treatment, immediately after treatment, and six months following the end of the treatment

• Changes in the severity of the Freezing of Gait

  before treatment, immediately after treatment, and six months following the end of the treatment

Study Arms (1)

People with Parkinson's Disease consecutively referred to the outpatient rehabilitation facility

Single center historical cohort study of people with PD consecutively referred to the outpatient rehabilitation facility of a Center for Diagnosis and Treatment of Movement Disorders, based in a university hospital in Italy.

Other: Multimodal rehabilitation training at high intensity; Other: Multimodal rehabilitation training at low intensity

Interventions

Multimodal rehabilitation training at high intensity OTHER

In High Intensive Training patients received 1800 minutes of training globally. In our practice, a single outpatient session varies from 60 to 90 minutes, the number of sessions per cycle from 10 to 20, and the frequency from 2 days a week to 5 days a week. Irrespective of total course intensity, each session comprises at least 15 minutes of aerobic training (over ground or treadmill) and 10 minutes of flexibility and strengthening exercise. No less than 10 minutes of balance training, 10 minutes of overground training in dual tasks, and 15 minutes of occupational therapy are additionally delivered. The duration of the single training components in each session may increase according to the patients' functioning profiles, requesting a more intensive practice of gait, balance or trunk alignment or a focused training of arm dexterity or basic ADL.

People with Parkinson's Disease consecutively referred to the outpatient rehabilitation facility

Multimodal rehabilitation training at low intensity OTHER

In Low Intensive Training patients received less than 900 minutes of training globally. In our practice, a single outpatient session varies from 60 to 90 minutes, the number of sessions per cycle from 10 to 20, and the frequency from 2 days a week to 5 days a week. Irrespective of total course intensity, each session comprises at least 15 minutes of aerobic training (over ground or treadmill) and 10 minutes of flexibility and strengthening exercise. No less than 10 minutes of balance training, 10 minutes of overground training in dual tasks, and 15 minutes of occupational therapy are additionally delivered. The duration of the single training components in each session may increase according to the patients' functioning profiles, requesting a more intensive practice of gait, balance or trunk alignment or a focused training of arm dexterity or basic ADL.

People with Parkinson's Disease consecutively referred to the outpatient rehabilitation facility

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population is characterized by people with Parkinson's Disease consecutively referred to the outpatient rehabilitation facility of a Center for Diagnosis and Treatment of Movement Disorders, based in a university hospital in Italy.

You may qualify if:

• adults diagnosed with Idiopathic PD, Hoehn \& Yahr stage ≥ 1 \< 5, consecutive referral to the rehabilitation facility between 1 January 2014 and 31 December 2019 to receive outpatient physiotherapy treatment for the management of motor disability, specifically targeting gait, balance, or posture disorders;
• completion of the course of rehabilitation treatment;
• availability of Non-Motor Symptom Scale and Unified Parkinson's Disease Rating Scale, recorded before and after treatment and 6 plus or minus 1 months later

You may not qualify if:

• diagnosis of any primary or secondary parkinsonism rather than PD
• symptom onset since less than three years
• any concomitant neurological disease (e.g. polyneuropathy, stroke, etc)
• any other chronically disabling disease (e.g. severe heart, liver or kidney failure, cancer, psychiatric disorders, limb amputation, severe musculoskeletal or neuropathic pain)
• changes in antiparkinsonian drug therapy during the whole study period
• exposure to a course of physiotherapy during the 6 months preceding the study

Sponsors & Collaborators

• Università Politecnica delle Marche: lead

Study Sites (1)

Department of Experimental and Clinical Medicine, Politecnica delle Marche University,

Ancona, AN, 60126, Italy

Location

MeSH Terms

Conditions

Parkinson Disease; Motor Activity

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Behavior

Study Officials

• Marianna Capecci, MD

  Università Politecnica delle Marche

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 9, 2024
• First Posted: November 19, 2024
• Study Start: January 1, 2014
• Primary Completion: December 31, 2019
• Study Completion: August 1, 2024
• Last Updated: November 19, 2024

Record last verified: 2024-11

Locations

IT (1)