Parkinson DiseaseNCT05452655
Intensive Multidisciplinary Rehabilitation and Biomarkers in Parkinson's Disease
A study testing Multidisciplinary Intensive Rehabilitation and Muscle-stretching and active mobilization exercises in people with Parkinson Disease and Biomarkers, run by Fondazione Don Carlo Gnocchi ETS at 1 site in Italy.
Trial summary
Parkinson's disease (PD) is a progressive neurological disorder characterized by motor and non-motor symptoms such as rigidity, bradykinesia, resting tremor, cognitive and autonomic dysfunctions, gait and balance difficulties. Read more about this study
- Who is it for?
- Ages 50 to 85 years
- Conditions the study is for
- Parkinson Disease, Biomarkers, Rehabilitation Outcome
- What is being tested?
- Multidisciplinary Intensive Rehabilitation and Muscle-stretching and active mobilization exercises
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteItaly
- Study dates
- 9 Dec 2020to Dec 2023
- Phase
- Interventional
- 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 50 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- PD diagnosis according to MDS Criteria (MDS clinical diagnostic criteria for Parkinson's disease, Postuma et al., 2015);
- Modified Hoehn\&Yahr (H\&Y): stages from 1.5 to- 3;
- Stable pharmacological treatment in the last 4 weeks.
Who cannot join
- Vascular, familiar and drug- induced forms of parkinsonism, other known or suspected causes of parkinsonism (metabolic, brain tumor etc) or any suggestive features of atypical parkinsonism;
- Significant comorbidities and/or severe systemic diseases that would preclude exercise participation (eg.recent surgery, unstable cardiac dysfunction, anemia, hepatosis, pulmonary disorders, chronic renal failure; auditory, visual and/or vestibular dysfunctions, presence of DBS); previously diagnosed psychiatric diseases.
- Dementia as defined by Montreal Cognitive Assessment (MoCA Test) Correct Score<15.51 (Santangelo et al., 2014);
- Rehabilitation treatment in the previous 4 weeks.
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
IRCCS S. Maria Nascente, Fondazione Don Carlo Gnocchi
Milan, 20148
Mario Meloni, MD; PhD, 0240308304 ext. +39, mmeloni@dongnocchi.it
Francesca Lea Saibene, M.Sc., fsaibene@dongnocchi.it
About this study
Official title: Effects of Intensive Multidisciplinary Rehabilitation and Identification of New Biomarkers in Response to an Integrated Motor-Cognitive and Aerobic Exercises Approaches in People With Parkinson's Disease
Parkinson's disease (PD) is a progressive neurological disorder characterized by motor and non-motor symptoms such as rigidity, bradykinesia, resting tremor, cognitive and autonomic dysfunctions, gait and balance difficulties.
The impairment of gait, balance and cognitive performances is partially responsive to dopaminergic medications. This emphasizes the importance of non-pharmacological interventions for people with PD (pwPD).
Read more
Intensive multidisciplinary motor and cognitive rehabilitation has been proposed as a complementary and effective treatment for managing pwPD.
Several structural and physiological mechanisms have been suggested to underpin exercise-induced neuroplastic changes in PD, such as enhanced synaptic strength and preservation of dopamine neurons. To date, studies on brain changes induced by motor and cognitive exercises in pwPD have been small-scaled and uncontrolled.
Identifying accessible and measurable biomarkers for monitoring the events induced by intensive motor and cognitive rehabilitation program would help in testing the treatment effectiveness and would allow personalization of rehabilitation strategies by predicting patients' responsiveness.
Based on validated clinical assessments of intensive multidisciplinary rehabilitation treatment, the project will test the ability of a new set of biomarkers to evaluate rehabilitative outcomes in a cohort of people with PD.
Read the detailed description
While pharmacological treatment is helpful in the early stages of the disease, increased attention has been given to rehabilitation that may lead to clinical improvements in motor and non-motor impairments.
Recently synthesized evidence suggests that physical exercise may lead to neuroplastic changes at the functional, structural and molecular levels.
Accessible and measurable biomarkers are needed to monitor the disease progression and the neurobiological changes resulting from pharmacological and rehabilitative treatments, also can be a useful and valuable tool to test rehabilitation effectiveness.
The present project will start from the reliable clinical assessment of rehabilitation effectiveness of an intensive multidisciplinary rehabilitation program, to verify the ability of a new panel of measurable biomarkers to assess neurobiological and functional changes in pwPD.
The purpose of this study is to determine the effects of an intensive multidisciplinary, aerobic, motor-cognitive rehabilitation treatment on accessible and measurable molecular biomarkers (primary outcome); balance and gait performance; aerobic capacity; motor and non-motor symptoms; cognitive functions; neuroimaging biomarker (secondary outcomes) in comparison to an active control group receiving a home-based self-treatment program. Thereafter, the investigators aim to relate the effects seen in motor and "non-motor" behavior to changes in biomolecular and neuroimaging markers.
To achieve this purpose, the study is designed as a Randomized Controlled Trial (RCT) and participants will be recruited at Fondazione Don C. Gnocchi-ONLUS, IRCCS S. Maria Nascente. Seventy-two subjects with a diagnosis of PD in accordance of MDS criteria will be randomly allocated to the experimental (EXP) or control group (CTR).
- Conditions
- Parkinson Disease, Biomarkers, Rehabilitation Outcome, Gait Disorders, Neurologic, Parkinsonian Disorders, Basal Ganglia Diseases
- Being tested
- Multidisciplinary Intensive Rehabilitation, Muscle-stretching and active mobilization exercises
- Medical subject headings
- Parkinson Disease, Gait Disorders, Neurologic, Parkinsonian Disorders, Basal Ganglia Diseases, Central Nervous System Diseases, Movement Disorders, Synucleinopathies, Neurodegenerative Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multidisciplinary Intensive RehabilitationBehavioural
The rehabilitation program will last for 6 consecutive weeks and involves the execution of 30 sessions, 5 days a week lasting 160 '/ day each (80' motor; 40 'cognitive and 40' speech therapy rehabilitation) for 3 days a week and 180'/ day (80 'motor; 60' cognitive and 40 'speech therapy rehabilitation) for 2 days a week. The EXP group will receive 18 sessions (3 times a week) of treadmill (20 min), balance exercises and functional reinforcement (20 min). The remaining motor sessions will be defined based on the patient's therapeutic needs.
The cognitive treatment will be proposed both in traditional mode (3 times a week) and through the support of semi-immersive "Virtual Reality Rehabilitation System" (VRRS) (2 times/week). The VRRS treatment is structured in 2 sessions per week (60 min) for 6 consecutive weeks.
The speech therapy program will include clinical and instrumental evaluations and innovative techniques will be used for the treatment (biofeedback with Vitalstim).
Muscle-stretching and active mobilization exercisesBehavioural
The control group subjects will undergo a home-based self-treatment program for 40 '/ day for 6 consecutive weeks consisting of muscle-stretching and active mobilization exercises.
| Study group | Role | What they receive |
|---|---|---|
| Intensive Outpatient Integrated Motor-Cognitive and Aerobic Exercises Rehabilitation Program | Experimental | Intervention of highly challenging motor and cognitive training for 6 consecutive weeks. Receives: Behavioral: Multidisciplinary Intensive Rehabilitation |
| Home-Based Stretching Exercises | Active comparator | Home-based self-treatment program for 40 '/ day for 6 consecutive weeks Receives: Behavioral: Muscle-stretching and active mobilization exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum biomarkers in neuron derived extracellular vesicles (NDEVs)
Oligomeric α-synuclein (α-syn) ng/ml; SNARE complex: Syntaxyn-1(STX-1A) (ng/ml), VAMP-2 (ng/ml) and SNAP-25 (ng/ml); Brain-Derived Neurotrophic Factor (BDNF) (ng/ml), pro-BDNF (ng/ml), Glial cell line-derived Neurotrophic factor (GDNF) (ng/ml) Cerebral dopamine neurotrophic factor (CDNF) (ng/ml)
Measured: 18 weeks
Blood Biomarkers
Pro- [IL-1β (pg/ml), Tumour Necrosis Factor alpha (TNFα) (pg/ml), Interferon gamma (IFN-γ) (pg/ml), IL-6 (pg/ml), IL-18 (pg/ml)], Anti-inflammatory (IL-10) (pg/ml) cytokines.
Measured: 18 weeks
Secondary outcomes (42)
Dynamic Balance
- Timed-Up and -Go Test (TUG); subjects are asked to rise from a standard armchair, walk to a marker 3 m away, turn, walk back, and sit down again. The Time (seconds) is measured.
Measured: 18 weeks
Aerobic capacity and endurance
6 Minute Walk Test (6-MWT). The distance covered over a time of 6 minutes is used as the outcome by which to compare changes in performance capacity.
Measured: 18 weeks
Gait speed
10 Meter Walk Test (10MWT) assess walking speed in meters per second over a distance of 6 meters.
Measured: 18 weeks
Strenght
5-Time Sit-To-Stand (5TSTS) is based on the amount of time (in seconds) a patient is able to transfer from a seated to a standing position and back to sitting five times.
Measured: 18 weeks
Balance
Modified Dynamic Gait Index (mDGI): The mDGI measure balance skills consists of 8 items and results in a total score of 0 to 64.
Measured: 18 weeks
Gait Analysis
Gait analysis will be assessed using a 9-camera SMART-D motion capture system (BTS, Milano, Italy) in order to measure stride length, step width and length, kinematic data and energy recovery.
Measured: 18 weeks
Motor and non-motor symptoms
The Movement Disorders Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part I-IV.
MDS-UPDRS-PART I ''nonmotor experiences of daily living -nM-EDL-" range: 0-52, 0=better outcome, 52=worse outcome; PART-II ''motor experiences of daily living -M-EDL-'' range: 0-52, 0=better outcome, 52=worse outcome; PART-III ''motor examination'' range: 0-132, 0=better outcome, 132=worse outcome; PART IV ''motor complications'' range: 0-24, 0=better outcome, 24=worse outcome.
Measured: 18 weeks
Non-Motor symptoms
Non-Motor Symptoms Scale (NMSS) [range: 0-360, 0=better outcome, 360=worse outcome];
Measured: 18 weeks
Fatigue
Parkinson Fatigue Scale (PFS) [range: 1-5, 1=better outcome, 5=worse outcome];
Measured: 18 weeks
Daytime sleepiness
Epworth Sleepiness Scale (ESS) [range: 0-24, 0=better outcome, 24=worse outcome];
Measured: 18 weeks
Sleep quality
Pittsburgh Sleep Quality Index (PSQI) [range: 0-21, 0=better outcome, 21=worse outcome];
Measured: 18 weeks
Rapid eye movement sleep behavior disorder
REM sleep behavior disorder screening questionnaire (RBDSQ) [range: 0-13, 0=better outcome, 13=worse outcome].
Measured: 18 weeks
Autonomic Symptoms
Italian version of the Composite Autonomic Symptoms Score (COMPASS-31) [weighted score range: 0-100, 0=better outcome, 100=worse outcome];
Measured: 18 weeks
Pain Intensity
Numeric Rating Scale (NRS) [range: 0-10, 0=better outcome, 10=worse outcome];
Measured: 18 weeks
Parkinson's disease-specific health related quality of life
The Parkinson Disease Questionnaire (PDQ-39) [PDQ-39 range: 0%-100%; 0%=better outcome, 100%=worse outcome].
Measured: 18 weeks
Global Cognitive Functioning
Montreal Cognitive Assessment (MoCA Test)[0-30, 0=worse, 30=better outcome] and Mini-Mental Parkinson (MMP)[0-32, 0=worse, 32=better outcome]
Measured: 18 weeks
Verbal short-term and working memory
Forward and Backward Verbal Span [0-9, 0=worse, 9=better outcome]
Measured: 18 weeks
Verbal episodic memory
Immediate and delayed story recall test [0-8, 0=worse, 8=better outcome; Oblivion Index range: 0-8, 0=worse, 8=better outcome]
Measured: 18 weeks
Visuo-constructional ability
Rey's Figure - Copy [0-36, 0=worse, 36=better outcome]
Measured: 18 weeks
Visuo-spatial memory
Rey's Figure - Recall [0-36, 0=worse, 36=better outcome]
Measured: 18 weeks
Frontal lobe functioning
Frontal Assessment Battery (FAB) [0-18, 0=worse, 18=better outcome]
Measured: 18 weeks
Non-verbal reasoning
Raven Coloured Progressive Matrices (CPM-47) [0-36, 0=worse, 36=better outcome]
Measured: 18 weeks
Extradimensional verbal set-shifting
Alternate Verbal Fluency [0-∞, 0=worse, ∞=better outcome;Shifting Index 0-1, 0=worse, 1=better outcome]
Measured: 18 weeks
Extradimensional non-verbal set-shifting
Trail Making Test (TMT) [0-∞, 0=worse, ∞=better outcome]
Measured: 18 weeks
Speed information processing
Symbol Digit Modalities Test (SDMT) (Oral Version) [0-120, 0=worse, 120=better outcome]
Measured: 18 weeks
Cognitive interference inhibition
Stroop Test-Short Version [Error: 0-30, 0=better, 30=worse outcome;Time: range: 0-∞, 0=better, ∞=worse outcome]
Measured: 18 weeks
IdeoMotor praxis
Gesture Imitation Test (IMA-T) [0-72, 0=worse, 72=better outcome]
Measured: 18 weeks
Language production and non-motor processing speed
Verbal fluency test (phonemic and semantic tasks) [0-∞, 0=worse, ∞=better outcome]
Measured: 18 weeks
Depression
Beck Depression Inventory-II (BDI-II) [0-63, 0=better, 63=worse outcome]
Measured: 18 weeks
Anxiety
State-Trait Anxiety Inventory. Forma Y (STAI-Y) [20-80; STAI-Y TRAIT ANXIETY range: 20-80; 20=better, 80=worse outcome]
Measured: 18 weeks
Apathy
Dimensional Apathy Scale (I-DAS) [0-72, 0=better, 72=worse outcome]
Measured: 18 weeks
Anhedonia
Snaith-Hamilton Pleasure Scale (SHAPS) [0-14, 0=better, 14=worse outcome]
Measured: 18 weeks
Impulsivity
Barratt Impulsiveness Scale-11 (BIS-11) [30-120, ;30=better, 120=worse outcome]
Measured: 18 weeks
Alexithymia
Toronto Alexithymia Scale (TAS-20) [20-100, 20=better, 100=worse outcome]
Measured: 18 weeks
Impulsive Control Disorders
Questionnaire for Impulsive-Compulsive Disorders in Parkinson's disease (QUIP-RS-IT) [0-112,; 0=better, 112=worse outcome]
Measured: 18 weeks
Behavioral disturbances
NeuroPsychiatric Inventory Questionnaire (NPI-Q) [SE: 0-36, 0=better, 36=worse outcome; ST= 0-60, 0=better, 60=worse outcome]
Measured: 18 weeks
Functional disability
Modified Barthel Index (MBI) [range: 0-100, 0=worse outcome, 100=better outcome];
Measured: 18 weeks
Daily self-care activities
Activities of Daily Living (ADL) [0-6, 0=worse, 6=better outcome] Instrumental Activities Of Daily Living (IADL) [0-8, 0=worse, 8=better outcome]
Measured: 18 weeks
Caregiver burden
Caregiver Burden Inventory (CBI) [range 0-96, 0=better, 96=worse outcome]
Measured: 18 weeks
Brain functional connectivity
Advanced Magnetic Resonance Imaging (MRI)-3 Tesla protocols, including resting state functional MRI to assess the neural correlates of rehabilitation-induced brain plasticity in pwPD undergoing intensive motor and cognitive rehabilitation.
Measured: 18 weeks
Cerebral blood flow
Advanced MRI-3 Tesla protocols, including arterial spin labeling (ASL) to assess the neural correlates of rehabilitation-induced brain plasticity in pwPD undergoing intensive motor and cognitive rehabilitation.
Measured: 18 weeks
Home-based motor activity monitoring
The acquisitions will be obtained from the actigraphs (mounted one on the right wrist and the other on the left wrist).
Measured: 18 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2022
- Study start9 Dec 2020
- Primary completionSep 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by Fondazione Don Carlo Gnocchi ETSThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study is designed as a Randomized Controlled Trial (RCT). Subjects with a diagnosis of PD in accordance of MDS criteria will be randomly allocated to the experimental (EXP) or control group (CTR). Clinical, kinematic, blood samples and MRI data will be collected before (T0) at the end of treatment (T1) and 3 months after the end of treatment (T2).
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondazione Don Carlo Gnocchi ETS
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mario Meloni, MD;PhD, Principal investigator, IRCCS S. Maria Nascente, Fondazione Don Carlo Gnocchi ONLUS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05452655
- Sponsor's protocol ID
- 11_16/04/2020
- Status last verified
- May 2022
- First submitted
- 30 May 2022
- Last updated
- 11 Jul 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Agostini S, Meloni M, Mancuso R, Nuzzi R, Ferraro G, Salvatore A, Arcuri P, Castagna A, Navarro J, Saibene FL, Clerici M. Intensive multidisciplinary rehabilitation modulates serum alpha-synuclein and miRNA expression in Parkinson's disease: preliminary results of a randomized study. Front Cell Neurosci. 2026 May 28;20:1760593. doi: 10.3389/fncel.2026.1760593. eCollection 2026.
PubMed 42290958Saibene FL, Agliardi C, Salvatore A, Arcuri P, Castagna A, Gobbo S, Merlo F, Bowman T, Anastasi D, Pagliari C, Farina E, Alberoni M, Calabrese E, La Rosa F, Arienti C, Saresella M, Guerini FR, Cattaneo D, Baglio F, Clerici M, Navarro J, Meloni M. Investigating the effects of a daily multidisciplinary intensive outpatient rehabilitation program on innovative biomarkers in people with Parkinson's disease: Study protocol for a phase III randomized controlled clinical trial. PLoS One. 2024 Oct 23;19(10):e0309405. doi: 10.1371/journal.pone.0309405. eCollection 2024.
PubMed 39441873
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Intensive Multidisciplinary Rehabilitation and Identification of New Biomarkers in Response to an Integrated Motor-Cognitive and Aerobic Exercises Approaches in People With Parkinson's Disease
- ClinicalTrials.gov ID
- NCT05452655
- Acronym / sponsor ID
- 11_16/04/2020
- Conditions
- Parkinson Disease, Biomarkers, Rehabilitation Outcome, Gait Disorders, Neurologic, Parkinsonian Disorders, Basal Ganglia Diseases
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Fondazione Don Carlo Gnocchi ETSUniversity, hospital or other
- Study start
- 9 Dec 2020 (actual)
- Primary completion
- Sep 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 11 Jul 2022 (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.
Parkinson's disease (PD) is a progressive neurological disorder characterized by motor and non-motor symptoms such as rigidity, bradykinesia, resting tremor, cognitive and autonomic dysfunctions, gait and balance difficulties.
The impairment of gait, balance and cognitive performances is partially responsive to dopaminergic medications. This emphasizes the importance of non-pharmacological interventions for people with PD (pwPD).
Intensive multidisciplinary motor and cognitive rehabilitation has been proposed as a complementary and effective treatment for managing pwPD.
Several structural and physiological mechanisms have been suggested to underpin exercise-induced neuroplastic changes in PD, such as enhanced synaptic strength and preservation of dopamine neurons. To date, studies on brain changes induced by motor and cognitive exercises in pwPD have been small-scaled and uncontrolled.
Identifying accessible and measurable biomarkers for monitoring the events induced by intensive motor and cognitive rehabilitation program would help in testing the treatment effectiveness and would allow personalization of rehabilitation strategies by predicting patients' responsiveness.
Based on validated clinical assessments of intensive multidisciplinary rehabilitation treatment, the project will test the ability of a new set of biomarkers to evaluate rehabilitative outcomes in a cohort of people with PD.
Detailed description
While pharmacological treatment is helpful in the early stages of the disease, increased attention has been given to rehabilitation that may lead to clinical improvements in motor and non-motor impairments.
Recently synthesized evidence suggests that physical exercise may lead to neuroplastic changes at the functional, structural and molecular levels.
Accessible and measurable biomarkers are needed to monitor the disease progression and the neurobiological changes resulting from pharmacological and rehabilitative treatments, also can be a useful and valuable tool to test rehabilitation effectiveness.
The present project will start from the reliable clinical assessment of rehabilitation effectiveness of an intensive multidisciplinary rehabilitation program, to verify the ability of a new panel of measurable biomarkers to assess neurobiological and functional changes in pwPD.
The purpose of this study is to determine the effects of an intensive multidisciplinary, aerobic, motor-cognitive rehabilitation treatment on accessible and measurable molecular biomarkers (primary outcome); balance and gait performance; aerobic capacity; motor and non-motor symptoms; cognitive functions; neuroimaging biomarker (secondary outcomes) in comparison to an active control group receiving a home-based self-treatment program. Thereafter, the investigators aim to relate the effects seen in motor and "non-motor" behavior to changes in biomolecular and neuroimaging markers.
To achieve this purpose, the study is designed as a Randomized Controlled Trial (RCT) and participants will be recruited at Fondazione Don C. Gnocchi-ONLUS, IRCCS S. Maria Nascente. Seventy-two subjects with a diagnosis of PD in accordance of MDS criteria will be randomly allocated to the experimental (EXP) or control group (CTR).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This study is designed as a Randomized Controlled Trial (RCT). Subjects with a diagnosis of PD in accordance of MDS criteria will be randomly allocated to the experimental (EXP) or control group (CTR). Clinical, kinematic, blood samples and MRI data will be collected before (T0) at the end of treatment (T1) and 3 months after the end of treatment (T2).
| Arm | Type | Receives |
|---|---|---|
| Intensive Outpatient Integrated Motor-Cognitive and Aerobic Exercises Rehabilitation Program | Experimental | Behavioral: Multidisciplinary Intensive RehabilitationIntervention of highly challenging motor and cognitive training for 6 consecutive weeks. |
| Home-Based Stretching Exercises | Active comparator | Behavioral: Muscle-stretching and active mobilization exercisesHome-based self-treatment program for 40 '/ day for 6 consecutive weeks |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- PD diagnosis according to MDS Criteria (MDS clinical diagnostic criteria for Parkinson's disease, Postuma et al., 2015);
- Modified Hoehn\&Yahr (H\&Y): stages from 1.5 to- 3;
- Stable pharmacological treatment in the last 4 weeks.
Key exclusion criteria (4 listed)
- Vascular, familiar and drug- induced forms of parkinsonism, other known or suspected causes of parkinsonism (metabolic, brain tumor etc) or any suggestive features of atypical parkinsonism;
- Significant comorbidities and/or severe systemic diseases that would preclude exercise participation (eg.recent surgery, unstable cardiac dysfunction, anemia, hepatosis, pulmonary disorders, chronic renal failure; auditory, visual and/or vestibular dysfunctions, presence of DBS); previously diagnosed psychiatric diseases.
- Dementia as defined by Montreal Cognitive Assessment (MoCA Test) Correct Score<15.51 (Santangelo et al., 2014);
- Rehabilitation treatment in the previous 4 weeks.
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 |
|---|---|---|
| Multidisciplinary Intensive RehabilitationThe rehabilitation program will last for 6 consecutive weeks and involves the execution of 30 sessions, 5 days a week lasting 160 '/ day each (80' motor; 40 'cognitive and 40' speech therapy rehabilitation) for 3 days a week and 180'/ day (80 'motor; 60' cognitive and 40 'speech therapy rehabilitation) for 2 days a week. The EXP group will receive 18 sessions (3 times a week) of treadmill (20 min), balance exercises and functional reinforcement (20 min). The remaining motor sessions will be defined based on the patient's therapeutic needs. The cognitive treatment will be proposed both in traditional mode (3 times a week) and through the support of semi-immersive "Virtual Reality Rehabilitation System" (VRRS) (2 times/week). The VRRS treatment is structured in 2 sessions per week (60 min) for 6 consecutive weeks. The speech therapy program will include clinical and instrumental evaluations and innovative techniques will be used for the treatment (biofeedback with Vitalstim). | Behavioural | Intensive Outpatient Integrated Motor-Cognitive and Aerobic Exercises Rehabilitation Program |
| Muscle-stretching and active mobilization exercisesThe control group subjects will undergo a home-based self-treatment program for 40 '/ day for 6 consecutive weeks consisting of muscle-stretching and active mobilization exercises. | Behavioural | Home-Based Stretching Exercises |
Primary outcome
Serum biomarkers in neuron derived extracellular vesicles (NDEVs)
Time frame: 18 weeks
Oligomeric α-synuclein (α-syn) ng/ml; SNARE complex: Syntaxyn-1(STX-1A) (ng/ml), VAMP-2 (ng/ml) and SNAP-25 (ng/ml); Brain-Derived Neurotrophic Factor (BDNF) (ng/ml), pro-BDNF (ng/ml), Glial cell line-derived Neurotrophic factor (GDNF) (ng/ml) Cerebral dopamine neurotrophic factor (CDNF) (ng/ml)
Blood Biomarkers
Time frame: 18 weeks
Pro- [IL-1β (pg/ml), Tumour Necrosis Factor alpha (TNFα) (pg/ml), Interferon gamma (IFN-γ) (pg/ml), IL-6 (pg/ml), IL-18 (pg/ml)], Anti-inflammatory (IL-10) (pg/ml) cytokines.
42 secondary outcomes
Dynamic Balance
Time frame: 18 weeks
Aerobic capacity and endurance
Time frame: 18 weeks
Gait speed
Time frame: 18 weeks
Strenght
Time frame: 18 weeks
Balance
Time frame: 18 weeks
Gait Analysis
Time frame: 18 weeks
Motor and non-motor symptoms
Time frame: 18 weeks
Non-Motor symptoms
Time frame: 18 weeks
Fatigue
Time frame: 18 weeks
Daytime sleepiness
Time frame: 18 weeks
Sleep quality
Time frame: 18 weeks
Rapid eye movement sleep behavior disorder
Time frame: 18 weeks
Autonomic Symptoms
Time frame: 18 weeks
Pain Intensity
Time frame: 18 weeks
Parkinson's disease-specific health related quality of life
Time frame: 18 weeks
Global Cognitive Functioning
Time frame: 18 weeks
Verbal short-term and working memory
Time frame: 18 weeks
Verbal episodic memory
Time frame: 18 weeks
Visuo-constructional ability
Time frame: 18 weeks
Visuo-spatial memory
Time frame: 18 weeks
Frontal lobe functioning
Time frame: 18 weeks
Non-verbal reasoning
Time frame: 18 weeks
Extradimensional verbal set-shifting
Time frame: 18 weeks
Extradimensional non-verbal set-shifting
Time frame: 18 weeks
Speed information processing
Time frame: 18 weeks
Cognitive interference inhibition
Time frame: 18 weeks
IdeoMotor praxis
Time frame: 18 weeks
Language production and non-motor processing speed
Time frame: 18 weeks
Depression
Time frame: 18 weeks
Anxiety
Time frame: 18 weeks
Apathy
Time frame: 18 weeks
Anhedonia
Time frame: 18 weeks
Impulsivity
Time frame: 18 weeks
Alexithymia
Time frame: 18 weeks
Impulsive Control Disorders
Time frame: 18 weeks
Behavioral disturbances
Time frame: 18 weeks
Functional disability
Time frame: 18 weeks
Daily self-care activities
Time frame: 18 weeks
Caregiver burden
Time frame: 18 weeks
Brain functional connectivity
Time frame: 18 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2022.
- Derived from this study: PubMed 42290958Agostini S, Meloni M, Mancuso R, Nuzzi R, Ferraro G, Salvatore A, Arcuri P, Castagna A, Navarro J, Saibene FL, Clerici M. Intensive multidisciplinary rehabilitation modulates serum alpha-synuclein and miRNA expression in Parkinson's disease: preliminary results of a randomized study. Front Cell Neurosci. 2026 May 28;20:1760593. doi: 10.3389/fncel.2026.1760593. eCollection 2026.
- Derived from this study: PubMed 39441873Saibene FL, Agliardi C, Salvatore A, Arcuri P, Castagna A, Gobbo S, Merlo F, Bowman T, Anastasi D, Pagliari C, Farina E, Alberoni M, Calabrese E, La Rosa F, Arienti C, Saresella M, Guerini FR, Cattaneo D, Baglio F, Clerici M, Navarro J, Meloni M. Investigating the effects of a daily multidisciplinary intensive outpatient rehabilitation program on innovative biomarkers in people with Parkinson's disease: Study protocol for a phase III randomized controlled clinical trial. PLoS One. 2024 Oct 23;19(10):e0309405. doi: 10.1371/journal.pone.0309405. eCollection 2024.
- Individual participant dataSharing planned: No
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.
Mario Meloni, MD;PhD principal investigator
IRCCS S. Maria Nascente, Fondazione Don Carlo Gnocchi ONLUS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multidisciplinary Intensive Rehabilitation and Muscle-stretching and active mobilization exercises in people with Parkinson Disease and Biomarkers, run by Fondazione Don Carlo Gnocchi ETS 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 4 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: status not confirmed, as of the sponsor's last update on 11 Jul 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mario Meloni, MD; PhD (0240308304 ext. +39, mmeloni@dongnocchi.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum biomarkers in neuron derived extracellular vesicles (NDEVs) (time frame: 18 weeks). 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?
On the ClinicalTrials.gov record for NCT05452655, which also lists 2 linked publications.
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 11 Jul 2022.