N/A
N=100
The Cyclical Lower-extremity Exercise for Parkinson's Trial
Parkinson's Disease
Bottom Line
View on ClinicalTrials.gov: NCT01636297 ↗Enrolled (actual)
100
Serious AEs
0.0%
Results posted
Sep 2018
Primary outcome: Primary: MDS-UPDRS Motor III Score — -4.8; -4.9; 1.8 change in MDS- UPDRS III score
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Forced exercise (Behavioral); Voluntary exercise (Behavioral)
- Age
- Adult, Older Adult · 30+ yrs
- Sex
- All
- Sponsor
- The Cleveland Clinic
- Primary completion
- Dec 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY MDS-UPDRS Motor III Score |
-4.8; -4.9; 1.8 | — |
| PRIMARY Trail Making Test |
-3.26; -2.91; -3.8 | — |
| PRIMARY Number of Participants With Increased Motor Cortex and Thalamus Connectivity |
4; 2; 0 | — |
Summary
The purpose of this study is to gain a better understanding of how exercise training affects motor/hand function and brain function in those diagnosed with Parkinson's disease. The investigators want to study if exercise will improve hand function and improve the level of brain activity.
Eligibility Criteria
Inclusion Criteria
- Able to provide informed consent.
- Clinical diagnosis of idiopathic PD. The diagnosis of PD will be based on the presence of at least two of the cardinal signs of this disorder (akine¬sia/bradykinesia, rest tremor, rigidity, gait and postural instability) with at least one of the signs being rest tremor or akinesia/bradykinesia.
- Hoehn and Yahr stage II-III when off PD medication.
- UPDRS motor score between 6-45 out of a maximum of 108 when off PD medication.
- Stable anti-parkinsonian medication for one month prior to study enrollment or consistent in desire to stay off anti-parkinson medication.
- Age between 30 and 75 years.
Exclusion Criteria
- Clinically significant medical disease that would increase the risk of exercise-related complications (e.g. cardiac or pulmonary disease, diabetes mellitus, hypertension, stroke).
- Dementia as evidenced by a score less than 116 on the Mattis Dementia Rating Scale.
- Other medical or musculoskeletal contraindications to exercise.
- Undergone any surgical procedure for treatment of PD, DBS, pallidotomy or thalamotomy
Data sourced from ClinicalTrials.gov (NCT01636297). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.