Exercise Interventions in Parkinson's Disease
Longer-term Exercise Interventions in People With Parkinson's Disease
1 other identifier
interventional
105
1 country
1
Brief Summary
This study sets out to determine the effect of exercise performed over a longer period of time (6 months), delivered using community facilities, on motor and non motor symptoms, health and well being in people with Parkinson's Disease.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Sep 2011
Typical duration for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2011
CompletedFirst Submitted
Initial submission to the registry
September 15, 2011
CompletedFirst Posted
Study publicly available on registry
September 22, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2014
CompletedOctober 21, 2014
October 1, 2014
3 years
September 15, 2011
October 20, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Change in Two minute walk from baseline at 3 months
Distance covered in 2 minutes by walking at self selected speed
baseline and 3 months
Change in Two minute walk from 3 months at 6 months
Distance covered in 2 minutes by walking at self selected speed
3 months and 6 months
Change in Two minute walk from 6 months at 12 months
Distance covered in 2 minutes by walking at self selected speed
6 months and 12 months
Secondary Outcomes (48)
Change in Time Up and Go (TUG) from baseline at 3 months
baseline and 3 months
Change in Nine hole peg test from baseline at 3 months
baseline and 3 months
Change in SF-36 from baseline at 3 months
baseline and 3 months
Change in EQ-5D from baseline at 3 months
Baseline and 3 months
Change in Prescribed medication from baseline at 3 months
baseline and 3 months
- +43 more secondary outcomes
Study Arms (2)
Exercise Programme
EXPERIMENTAL6 months 2 x a week aerobic and anaerobic exercise delivered in community facilities by an exercise professional and supported by a physiotherapist.
Hand writing programme
ACTIVE COMPARATOR6 months 2 x a week hand writing practice. Performed in the home supported by a physiotherapist (5 support sessions)
Interventions
6 months 2 x a week aerobic and anaerobic exercise delivered in community facilities by an exercise professional and supported by a physiotherapist
6 months 2 x a week hand writing practice. Performed in the home supported by a physiotherapist (5 support sessions)
Eligibility Criteria
You may qualify if:
- Parkinson's disease diagnosed by neurological examination; idiopathic PD defined by the UK Parkinson's Disease Society Brain Bank Criteria
- Able to walk ≥ 100m
- maintained a stable medical regime for 12 weeks prior to initiation of the study, and anticipated to maintain a stable regime for the course of study (as determined by the referring clinician).
You may not qualify if:
- Dementia
- History of additional prior neurological condition
- Severe depression or psychosis or a mental state that would preclude consistent active involvement with the study over its duration
- Cardiac precautions that would prevent the subject from completing the exercise program or the full battery of outcome measures
- Any known contraindication to exercise
- Reduced cognition of any cause \[Minimental state examination \[(MMSE) \< 23\]
- An orthopaedic condition that independently limits walking;
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Oxford Brookes University
Oxford, Oxfordshire, OX3 0SB, United Kingdom
Related Publications (3)
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: 38588457DERIVEDErnst 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: 36602886DERIVEDCollett J, Franssen M, Meaney A, Wade D, Izadi H, Tims M, Winward C, Bogdanovic M, Farmer A, Dawes H. Phase II randomised controlled trial of a 6-month self-managed community exercise programme for people with Parkinson's disease. J Neurol Neurosurg Psychiatry. 2017 Mar;88(3):204-211. doi: 10.1136/jnnp-2016-314508. Epub 2016 Nov 11.
PMID: 27837101DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Helen Dawes, PhD
Oxford Brookes University
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Research Fellow
Study Record Dates
First Submitted
September 15, 2011
First Posted
September 22, 2011
Study Start
September 1, 2011
Primary Completion
September 1, 2014
Study Completion
September 1, 2014
Last Updated
October 21, 2014
Record last verified: 2014-10