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

Impact of Intensive Outpatient Rehabilitation on Non-Motor Patient-Reported Outcomes in Parkinson's Disease: The INTENSO Study

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.

Study Overview

• Status: Completed
• Conditions: Parkinson Disease
• Intervention / Treatment: Other: Multimodal rehabilitation training at high intensity; Other: Multimodal rehabilitation training at low intensity

• Study Type: Observational
• Enrollment (Actual): 48

Contacts and Locations

Study Locations

• Italy
  • AN
    • Ancona, AN, Italy, 60126
      • Department of Experimental and Clinical Medicine, Politecnica delle Marche University,

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in Parkinson's Disease related disability	The Parkinson's Disease related disability measured by the the Unified Parkinson's Disease Rating Scale part II (UPDRS Part II; score range 0-52; higher scores mean a worse outcome)	before treatment, immediately after treatment, and six months following the end of the treatment
Changes in motor symptoms severity	Changes in motor symptoms severity measured by the Unified Parkinson's Disease Rating Scale part III (UPDRS Part III; score range 0-128; higher scores mean a worse outcome)	before treatment, immediately after treatment, and six months following the end of the treatment
Changes in the severity of the Freezing of Gait	The changes in Severity of the Freezing of Gait mesaured by the Freezing of Gait Questionnaire (FOGQ; score range 0-24; higher scores mean a worse outcome)	before treatment, immediately after treatment, and six months following the end of the treatment

Collaborators and Investigators

• Sponsor: Università Politecnica delle Marche
• Investigators: Principal Investigator: Marianna Capecci, MD, Università Politecnica delle Marche

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2014
• Primary Completion (Actual): December 31, 2019
• Study Completion (Actual): August 1, 2024

Study Registration Dates

• First Submitted: November 9, 2024
• First Submitted That Met QC Criteria: November 16, 2024
• First Posted (Estimated): November 19, 2024

Study Record Updates

• Last Update Posted (Estimated): November 19, 2024
• Last Update Submitted That Met QC Criteria: November 16, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: exercise; rehabilitation; Parkinson's Disease; intensity; non-motor symptoms; multimodal
• Additional Relevant MeSH Terms: Synucleinopathies; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurodegenerative Diseases; Movement Disorders; Parkinsonian Disorders; Basal Ganglia Diseases; Parkinson Disease
• Other Study ID Numbers: ID 101/2024, number 3054

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No