Phase II randomised controlled trial of a 6-month self-managed community exercise programme for people with Parkinson's disease.
BACKGROUND
Evidence for longer term exercise delivery for people with Parkinson's disease (PwP) is deficient.


OBJECTIVE
Evaluate safety and adherence to a minimally supported community exercise intervention and estimate effect sizes (ES).


METHODS
2-arm parallel phase II randomised controlled trial with blind assessment. PwP able to walk ≥100 m and with no contraindication to exercise were recruited from the Thames valley, UK, and randomised (1:1) to intervention (exercise) or control (handwriting) groups, via a concealed computer-generated list. Groups received a 6-month, twice weekly programme. Exercise was undertaken in community facilities (30 min aerobic and 30 min resistance) and handwriting at home, both were delivered through workbooks with monthly support visits. Primary outcome was a 2 min walk, with motor symptoms (Movement Disorder Society Unified Parkinson's Disease Rating Scale, MDS-UPDRS III), fitness, health and well-being measured.


RESULTS
Between December 2011 and August 2013, n=53 (n=54 analysed) were allocated to exercise and n=52 (n=51 analysed) to handwriting. N=37 adhered to the exercise, most attending ≥1 session/week. Aerobic exercise was performed in 99% of attended sessions and resistance in 95%. Attrition and adverse events (AEs) were similar between groups, no serious AEs (n=2 exercise, n=3 handwriting) were related, exercise group-related AEs (n=2) did not discontinue intervention. Largest effects were for motor symptoms (2 min walk ES=0.20 (95% CI -0.44 to 0.45) and MDS-UPDRS III ES=-0.30 (95% CI 0.07 to 0.54)) in favour of exercise over the 12-month follow-up period. Some small effects were observed in fitness and well-being measures (ES>0.1).


CONCLUSIONS
PwP exercised safely and the possible long-term benefits observed support a substantive evaluation of this community programme.


BACKGROUND
NCT01439022.
Movement Science Group, OxINAHR, Oxford Brookes University, Oxford, UK.
Johnny
J
Collett
Movement Science Group, OxINAHR, Oxford Brookes University, Oxford, UK.|Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.
Marloes
M
Franssen
Movement Science Group, OxINAHR, Oxford Brookes University, Oxford, UK.
Andy
A
Meaney
Movement Science Group, OxINAHR, Oxford Brookes University, Oxford, UK.|Oxford Centre for Enablement, Oxford University Hospitals, Oxford, UK.
Derick
D
Wade
Movement Science Group, OxINAHR, Oxford Brookes University, Oxford, UK.|Department of Mechanical Engineering and Mathematical Sciences, Oxford Brookes University, Oxford, UK.
Hooshang
H
Izadi
Movement Science Group, OxINAHR, Oxford Brookes University, Oxford, UK.
Martin
M
Tims
Movement Science Group, OxINAHR, Oxford Brookes University, Oxford, UK.|Department of Infectious Disease, Churchill Hospital, Oxford University Hospitals, Oxford, UK.
Charlotte
C
Winward
Department of Neurology, Royal Berkshire Hospital, Reading, UK.
Marko
M
Bogdanovic
Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.
Andrew
A
Farmer
Movement Science Group, OxINAHR, Oxford Brookes University, Oxford, UK.|Department of Clinical Neurology, University of Oxford, Oxford, UK.
Helen
H
Dawes
D000368:Aged; D015444:Exercise / Q000502:physiology*; D005260:Female; D006801:Humans; D008297:Male; D053580:Muscle Strength / Q000502:physiology; D010300:Parkinson Disease / Q000628:therapy*; D011788:Quality of Life; D012648:Self Care / Q000379:methods*; D006113:United Kingdom