NCT01439022

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

87
On Track

Trial Health Score

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

Enrollment
105

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Sep 2011

Typical duration for phase_2

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

September 1, 2011

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

September 15, 2011

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 22, 2011

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
Last Updated

October 21, 2014

Status Verified

October 1, 2014

Enrollment Period

3 years

First QC Date

September 15, 2011

Last Update Submit

October 20, 2014

Conditions

Keywords

Parkinson's DiseaseExerciseTreatment OutcomePatient Adherence

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

EXPERIMENTAL

6 months 2 x a week aerobic and anaerobic exercise delivered in community facilities by an exercise professional and supported by a physiotherapist.

Behavioral: Exercise Programme

Hand writing programme

ACTIVE COMPARATOR

6 months 2 x a week hand writing practice. Performed in the home supported by a physiotherapist (5 support sessions)

Behavioral: Hand Writing programme

Interventions

6 months 2 x a week aerobic and anaerobic exercise delivered in community facilities by an exercise professional and supported by a physiotherapist

Exercise Programme

6 months 2 x a week hand writing practice. Performed in the home supported by a physiotherapist (5 support sessions)

Hand writing programme

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

Location

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.

  • 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.

  • Collett 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.

Related Links

MeSH Terms

Conditions

Parkinson DiseaseMotor ActivityPatient Compliance

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative DiseasesBehaviorPatient Acceptance of Health CareTreatment Adherence and ComplianceHealth Behavior

Study Officials

  • Helen Dawes, PhD

    Oxford Brookes University

    PRINCIPAL INVESTIGATOR

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

Locations