Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| The Cleveland Clinic | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The primary goal of this study is to determine the neuroprotective qualities of long-term, in home, exercise therapy program in human PD patients. It is hypothesized that an exercise intervention might delay the onset of levo-dopa therapy (i.e. evidence for neuroprotection). The first part involves a pilot-study in which the feasibility of the intervention and outcome measures will be tested.
Neuroprotective therapy (i.e. therapy that slows the disease process) is an unmet medical need in Parkinson's disease (PD). Animal studies have shown that 'intensive' exercise improves motor function and may have neuroprotective properties. The promising animal results have not been translated to patients with PD so far. This is a two-cluster randomised control trial in which twenty patients (10 at each site) will undergo a 6-month exercise intervention on a stationary virtual reality bike and twenty patients (10 at each site)will serve as controls.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Exercise | Experimental | Twente patients will perform Aerobic exercise 3 times a week for at least 30 min |
|
| Control | No Intervention | Fifteen patients will be listed as a control group and will be instructed to continue their previous level of activity throughout the study |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exercise | Behavioral | six-months long exercise intervention on a stationary virtual reality bike, 3-5 times a week, each session lasting 30-45 minutes at a target heart rate (60-85% heart rate reserve). |
| Measure | Description | Time Frame |
|---|---|---|
| Trails A and B task | this test requires subjects to connect numbers on a screen from 1 to 25 (part A) and to connect numbers to letters. This neuropsychological test has already been proven to be sensitive to frontal lobe damage (e.g. Boll 1981) and has been recognised as an outcome for executive function in PD21. This test is performed using an online system called i-COMET that allows subject to complete the task weekly at home. Subjects have to login at the i-COMET website (https://i-comet.com) with a username and password that is provided to them by the research team. | every month for 6-7 months |
| Measure | Description | Time Frame |
|---|---|---|
| UPDRS | baseline and after 6 months follow-up (FU) | |
| Cognitive tests | MMSE and SCOPA-org | baseline and after 6 months FU |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Unclear diagnosis with Red Flags
Advanced problems in cognitive functioning: Mini Mental State Examination (MMSE)19 score < 24
Serious co-morbidity: neurological or orthopedic disorder that severely affects movement; known by specialist or medical practitioner
Pulmonary diseases; known by specialist or medical practitioner
Stroke
High risk of cardiovascular complications:
Use of ß-blockers
Not able to complete American (for Cleveland site) or Dutch questionnaires (for the Nijmegen site)
Daily institutionalized care
Contra-indications for fMRI:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Bas Bloem, MD PhD | Radboud University Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cleveland clinic | Cleveland | Ohio | 44195 | United States | ||
| UMC St Radboud |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38588457 | Derived | Ernst M, Folkerts AK, Gollan R, Lieker E, Caro-Valenzuela J, Adams A, Cryns N, Monsef I, Dresen A, Roheger M, Eggers C, Skoetz N, Kalbe E. Physical exercise for people with Parkinson's disease: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2024 Apr 8;4(4):CD013856. doi: 10.1002/14651858.CD013856.pub3. | |
| 36602886 |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D015444 | Exercise |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Kinetics tests |
Timed Up and Go Test (iTUG) and a postural sway test, , as an objective measure for balance and mobility Finger tap test as a measure for bradykinesia and a pegboard test as a measure for complex motor function |
| baseline and after 6 months FU |
| questionaires | The PDQ-39 is a PD specific questionnaire including 39 items concerning quality of life. Other non-motor features such as mood and sleep are respectively measured using the HADS and SCOPA-Sleep. | baseline and after 6 months FU |
| maximal exercise test | to determine training load and subject fitness | baseline and after 6 months FU |
| feasibility parameters | Compliance based on the number of completed exercise sessions and the amount of time that patients exercised at their target heart rate. | after 6 months (termination of intervention) |
| neuroplasticity |
| baseline and after 6 months FU |
| Nijmegen |
| 6500HB |
| Netherlands |
| Ernst M, Folkerts AK, Gollan R, Lieker E, Caro-Valenzuela J, Adams A, Cryns N, Monsef I, Dresen A, Roheger M, Eggers C, Skoetz N, Kalbe E. Physical exercise for people with Parkinson's disease: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2023 Jan 5;1(1):CD013856. doi: 10.1002/14651858.CD013856.pub2. |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |