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Research paper
Phase II randomised controlled trial of a 6-month self-managed community exercise programme for people with Parkinson's disease
  1. Johnny Collett1,
  2. Marloes Franssen1,2,
  3. Andy Meaney1,
  4. Derick Wade1,3,
  5. Hooshang Izadi1,4,
  6. Martin Tims1,
  7. Charlotte Winward1,5,
  8. Marko Bogdanovic6,
  9. Andrew Farmer2,
  10. Helen Dawes1,7
  1. 1Movement Science Group, OxINAHR, Oxford Brookes University, Oxford, UK
  2. 2Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK
  3. 3Oxford Centre for Enablement, Oxford University Hospitals, Oxford, UK
  4. 4Department of Mechanical Engineering and Mathematical Sciences, Oxford Brookes University, Oxford, UK
  5. 5Department of Infectious Disease, Churchill Hospital, Oxford University Hospitals, Oxford, UK
  6. 6Department of Neurology, Royal Berkshire Hospital, Reading, UK
  7. 7Department of Clinical Neurology, University of Oxford, Oxford, UK
  1. Correspondence to Dr Johnny Collett, Faculty of Health and Life Sciences, Oxford Brookes University Gipsy Lane, Headington, Oxford OX3 0BP, UK; Jcollett{at}brookes.ac.uk

Abstract

Background Evidence for longer term exercise delivery for people with Parkinson's disease (PwP) is deficient.

Aim 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.

Trial registration number NCT01439022.

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Footnotes

  • Contributors All authors were involved with the management of the research and drafting or critically revising the manuscript for important intellectual content. JC, DW, HI, MT, AM, CW, MB, AF and HD were involved in the conception and design of the work. JC, MF, AM and HD were involved in acquisition of data. HI, JC, MF, HD, DW and MB were involved in analysis and interpretation of data.

  • Funding This study was funded by the National Institute for Health Research (NIHR), research for patient benefit programme (PB-PG-0110-20250). HD is supported by the Elizabeth Casson Trust; AF is a NIHR Senior Investigator. HD and AF receive support from the NIHR Oxford Biomedical Research Centre.

  • Competing interests None declared.

  • Ethics approval NRES Committee South Central—Southampton A: 11/SC/0267.

  • Provenance and peer review Not commissioned; externally peer reviewed.

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