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

NCT06695286 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 48

Last updated 2024-11-19

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Università Politecnica delle Marche

    lead OTHER

Principal Investigators

  • Marianna Capecci, MD · Università Politecnica delle Marche

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-01-01
Primary Completion
2019-12-31
Completion
2024-08-01

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06695286 on ClinicalTrials.gov