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

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

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON35233

Enrollment

Registered

2011-12-27

Start date

2012-01-01

Completion date

Unknown

Last updated

2024-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Parkinson Disease

Interventions

Twenty patients (10 patients each site) will undergo an exercise intervention. The exercise intervention means cycling on a stationary home trainer within a virtual environment, 3-5 times a week, ea

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

Exclusion criteria: 1. Unclear diagnosis with Red Flags 2. Mini Mental State Examination (MMSE) score

Design outcomes

Primary

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

Secondary

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

Measure

Time frame

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

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)