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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06695286
Acronym
INTENSO
Enrollment
48
Registered
2024-11-19
Start date
2014-01-01
Completion date
2024-08-01
Last updated
2024-11-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Parkinson Disease

Keywords

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

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.

Interventions

OTHERMultimodal 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.

OTHERMultimodal 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.

Sponsors

Università Politecnica delle Marche
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Changes in Non-motor Symptomsbefore treatment, immediately after treatment, and six months following the end of the treatmentThe changes in non-motor symptoms mesaured by the Non Motor Symptoms Scale ( NMSS; score range: 0-360; higher scores mean a worse outcome)

Secondary

MeasureTime frameDescription
Changes in Parkinson's Disease related disabilitybefore treatment, immediately after treatment, and six months following the end of the treatmentThe 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)
Changes in motor symptoms severitybefore treatment, immediately after treatment, and six months following the end of the treatmentChanges 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)
Changes in the severity of the Freezing of Gaitbefore treatment, immediately after treatment, and six months following the end of the treatmentThe 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)

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026