The ParkCycle Study: Aerobic Exercise in PD

NCT01562496 | Completed

• 1 other identifier: NL38116.091.11
• Study Type: interventional
• Target: 35
• Locations: 2 countries
• Sites: 2

Brief Summary

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.

Conditions

Parkinson's Disease

Keywords

Parkinson's disease; Neuroprotective; Intensive exercise

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (7)

• UPDRS

  baseline and after 6 months follow-up (FU)

• Cognitive tests

  baseline and after 6 months FU

• Kinetics tests

  baseline and after 6 months FU

• questionaires

  baseline and after 6 months FU

• maximal exercise test

  baseline and after 6 months FU

Study Arms (2)

Exercise

EXPERIMENTAL

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

Behavioral: Exercise

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

Interventions

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).

Exercise

Eligibility Criteria

• Age: 30 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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:

Sponsors & Collaborators

• Radboud University Medical Center: lead
• The Cleveland Clinic: collaborator

Study Sites (2)

Cleveland clinic

Cleveland, Ohio, 44195, United States

Location

UMC St Radboud

Nijmegen, 6500HB, Netherlands

Location

Related Publications (2)

• 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.

  PMID: 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. 2023 Jan 5;1(1):CD013856. doi: 10.1002/14651858.CD013856.pub2.

  PMID: 36602886 DERIVED

MeSH Terms

Conditions

Parkinson Disease

Interventions

Exercise

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Bas Bloem, MD PhD

  Radboud University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 19, 2012
• First Posted: March 23, 2012
• Study Start: January 1, 2012
• Primary Completion: October 1, 2014
• Study Completion: October 1, 2014
• Last Updated: November 13, 2014

Record last verified: 2014-11

Locations

US (1); NL (1)