Parkinson DiseaseINTENSONCT06695286
Impact of Intensive Outpatient Rehabilitation on Non-Motor Patient-Reported Outcomes in Parkinson's Disease (INTENSO)
An observational study of Parkinson Disease, run by Università Politecnica delle Marche at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Multimodal rehabilitation training at high intensity and Multimodal rehabilitation training at low intensity
- How many people
- 48 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jan 2014to 1 Aug 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Italy1 site
Department of Experimental and Clinical Medicine, Politecnica delle Marche University,
Ancona, AN, 60126
About this study
Official title: 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.
- Conditions
- Parkinson Disease
- Being tested
- Multimodal rehabilitation training at high intensity, Multimodal rehabilitation training at low intensity
- Keywords
- Parkinson's Disease, rehabilitation, non-motor symptoms, multimodal, exercise, intensity
- Medical subject headings
- Parkinson Disease, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multimodal rehabilitation training at high intensityOther
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.
Multimodal rehabilitation training at low intensityOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Multimodal rehabilitation training at high intensity; Other: Multimodal rehabilitation training at low intensity |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
Measured: before treatment, immediately after treatment, and six months following the end of the treatment
Secondary outcomes (3)
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)
Measured: 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)
Measured: 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)
Measured: before treatment, immediately after treatment, and six months following the end of the treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2024
- Study start1 Jan 2014
- Primary completion31 Dec 2019
- Study completion1 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Università Politecnica delle Marche
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marianna Capecci, PhD, Università Politecnica delle Marche
- Investigators
- Marianna Capecci, MD, Principal investigator, Università Politecnica delle Marche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06695286
- Sponsor's protocol ID
- ID 101/2024, number 3054
- Acronym
- INTENSO
- Status last verified
- Nov 2024
- First submitted
- 9 Nov 2024
- Last updated
- 19 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Intensive Outpatient Rehabilitation on Non-Motor Patient-Reported Outcomes in Parkinson's Disease: The INTENSO Study
- ClinicalTrials.gov ID
- NCT06695286
- Acronym / sponsor ID
- INTENSO / ID 101/2024, number 3054
- Conditions
- Parkinson Disease
- Keywords
- Parkinson's Disease, rehabilitation, non-motor symptoms, multimodal, exercise, intensity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Università Politecnica delle MarcheUniversity, hospital or other
- Study start
- 1 Jan 2014 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 1 Aug 2024 (actual)
- First posted
- 19 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| People with Parkinson's Disease consecutively referred to the outpatient rehabilitation facility | – | Other: Multimodal rehabilitation training at high intensity, Other: Multimodal rehabilitation training at low intensitySingle 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multimodal rehabilitation training at high intensityIn 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 | People with Parkinson's Disease consecutively referred to the outpatient rehabilitation facility |
| Multimodal rehabilitation training at low intensityIn 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. | Other | People with Parkinson's Disease consecutively referred to the outpatient rehabilitation facility |
Primary outcome
Changes in Non-motor Symptoms
Time frame: before treatment, immediately after treatment, and six months following the end of the treatment
The changes in non-motor symptoms mesaured by the Non Motor Symptoms Scale ( NMSS; score range: 0-360; higher scores mean a worse outcome)
Changes in Non-motor Symptoms
Time frame: before treatment, immediately after treatment, and six months following the end of the treatment
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)
3 secondary outcomes
Changes in Parkinson's Disease related disability
Time frame: before treatment, immediately after treatment, and six months following the end of the treatment
Changes in motor symptoms severity
Time frame: before treatment, immediately after treatment, and six months following the end of the treatment
Changes in the severity of the Freezing of Gait
Time frame: before treatment, immediately after treatment, and six months following the end of the treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2024.
Related trials for Parkinson Disease
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
Enrolling by invitationObservational study
Early Molecular Biomarkers for Differentiating Parkinsonian Syndromes
PARKINSON DISEASE (Disorder), Atypical Parkinsonism
RecruitingPhase 3
A Clinical Study of Sacituzumab Tirumotecan (MK-2870) in Combination With Pembrolizumab (MK-3475) as First-line Maintenance Treatment of Cervical Cancer (MK-2870-036/TroFuse-036/GOG-3123/ENGOT-cx22)
Cervical Cancer
Active, not recruitingPhase 1/2
Clinical Safety and Efficacy of Umbilical Cord Mesenchymal Stromal Cells-derived Exosomes in Patients With Parkinson's Disease
Parkinson Disease (PD)
Active, not recruitingObservational study
Adaptive DBS to Offset STN Dysregulation During Exercise in PD
Parkinson Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marianna Capecci, MD principal investigator
Università Politecnica delle Marche
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Parkinson Disease, run by Università Politecnica delle Marche at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Non-motor Symptoms (time frame: before treatment, immediately after treatment, and six months following the end of the treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2024.