NCT01741584

Brief Summary

The aim of the study is to investigate whether exercise improves cognitive and motor functions in Parkinson's disease. To test this hypothesis, the researchers study general brain functions in subjects with PD during a 6-months exercise program.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2010

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

December 3, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 5, 2012

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
Last Updated

March 16, 2016

Status Verified

March 1, 2016

Enrollment Period

3.8 years

First QC Date

December 3, 2012

Last Update Submit

March 15, 2016

Conditions

Parkinson's Disease

Outcome Measures

Primary Outcomes (1)

  • UPDRS motor score

    Prior to intervention and after 6 months of intervention

Secondary Outcomes (3)

  • Functional/Structural brain changes

    Prior to intervention and after 6 months of intervention

  • Plasma biomarkers

    Prior to intervention and after 6 months of intervention

  • Cognitive Function based on neuropsychological test-performance

    Prior to intervention and after 6 months of intervention

Study Arms (2)

stationary bike exercise

EXPERIMENTAL

6 months of exercise (60% of anaerobic threshold)

Behavioral: stationary bike exercise

aerobic

PLACEBO COMPARATOR

6 months of exercise \<30% anaerobic threshold

Behavioral: aerobic

Interventions

stationary bike exerciseBEHAVIORAL
stationary bike exercise
aerobicBEHAVIORAL
aerobic

Eligibility Criteria

Age35 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • UPDRS \<15
  • L-DOPA responsive
  • \<5 yrs since diagnosis

You may not qualify if:

  • severe other diseases
  • MMSE \< 26
  • treatment with psychiatric medication

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Neurology, Charité Universitätsmedizin Berlin

Berlin, State of Berlin, 10117, Germany

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Study Officials

  • Agnes Flöel, MD

    Charite University, Berlin, Germany

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr. med. Agnes Floeel

Study Record Dates

First Submitted

December 3, 2012

First Posted

December 5, 2012

Study Start

December 1, 2010

Primary Completion

September 1, 2014

Last Updated

March 16, 2016

Record last verified: 2016-03

Locations

DE(1)