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The ParkCycle Study: Aerobic Exercise in PD

NCT ID: NCT01562496

Last Updated: 2014-11-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-31

Study Completion Date

2014-10-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Parkinson's Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Exercise

Twente patients will perform Aerobic exercise 3 times a week for at least 30 min

Group Type EXPERIMENTAL

Exercise

Intervention Type 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).

Control

Fifteen patients will be listed as a control group and will be instructed to continue their previous level of activity throughout the study

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Exercise

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).

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

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

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:

* Hypertension (systole \>150 and diastole \> 100)
* Diabetes Mellitus; known by specialist or medical practitioner
* Cardiac valve defect (especially aortic valve stenosis); known by specialist or medical practitioner
* Cardiac rhythm disorder; known by specialist or medical practitioner
* Heart failure; known by specialist or medical practitioner
* 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:

* Pregnancy
* Metallic implants or electronic devices
* Previous seizure
* Claustrophobia
* Not able to keep the head still for longer period, i.e. due to severe head tremor
Minimum Eligible Age

30 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Cleveland Clinic

OTHER

Sponsor Role collaborator

Radboud University Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bas Bloem, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Radboud University Medical Center

Locations

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Cleveland clinic

Cleveland, Ohio, United States

Site Status

UMC St Radboud

Nijmegen, , Netherlands

Site Status

Countries

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United States Netherlands

References

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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.

Reference Type DERIVED
PMID: 38588457 (View on PubMed)

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.

Reference Type DERIVED
PMID: 36602886 (View on PubMed)

Other Identifiers

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NL38116.091.11

Identifier Type: -

Identifier Source: org_study_id