The ParkCycle study: A feasibility study to investigate the effects of intensive exercise on cognitive function and adaptive plasticity in Parkinson's disease

Phase 2

Completed

Conditions: Parkinson Disease
10028037

Registration Number: NL-OMON35233

Lead Sponsor: niversitair Medisch Centrum Sint Radboud

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 20

Inclusion Criteria

1. Diagnosis of idiopathic Parkinson*s disease according to the Queen Square Brain Bank criteria
2. Hoehn & Yahr disease stages I-II
3. Age between 30 and 75 years
4. Untreated with anti-parkinsonian medication or receiving medication, for less than two years, medication-responsive without fluctuations.
5. Having insufficient physical activity according to the ACSM guideline for adults, 50-64 years old with a chronic condition

Exclusion Criteria

1. Unclear diagnosis with Red Flags
2. Mini Mental State Examination (MMSE) score < 24
3. Serious co-morbidity: neurological or orthopedic disorder that severely affects movement
4. Pulmonary diseases
5. High risk of cardiovascular complications (specified in protocol)
6. Use of ß-blokkers
7. Not being able to complete questionnaires
8. Daily institutionalized care
9. Pregnancy
10. Metallic implants
11. Previous seizure
12. Claustrophobia
13. Not being able to keep the head still for longer period

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>De primary parameter for the large Phase III Trial will be chosen on base of<br /><br>the results of this pilot study. Candidate primary endpoints will be:<br /><br>- Cognitive function (Trails A and B task).<br /><br>- Resting state fMRI: Volumetric brain changes<br /><br>Resting state brain perfusion</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Furthermore we will use endpoints, which will serve as surrogate endpoints for<br /><br>disease progression:<br /><br>- Cognitive functioning (SCOPA-cog)<br /><br>- Motor function (UPDRS-III)<br /><br>- Depression scale (HADS)<br /><br>- Effect of Parkinson on daily life (PDQ-39)<br /><br>- Parkinson Disability (SPDDS<br /><br>- Sleeping problems (SCOPA-sleep)<br /><br>- Falling (ABC-16-scale)<br /><br>- VO2max<br /><br>- 6 Minute Walking test<br /><br>- Instrumental Timed Up and Go Test (iTUG)<br /><br>- Postural Sway Test<br /><br>- Finger Tapping Test<br /><br>- Pegboard Test<br /><br><br /><br>Parameters are measured before the intervention and after the intervention</p><br>