Design of the Park-in-Shape study: A phase II double blind randomized controlled trial evaluating the effects of exercise on motor and non-motor symptoms in Parkinson's disease

BMC Neurology

Volumn 15, Issue 1, 2015, Pages

  van der Kolk, Nicolien M ^a   Overeem, Sebastiaan ^a   de Vries, Nienke M ^a   Kessels, Roy P C ^a   Donders, Rogier ^a   Brouwer, Marc ^a   Berg, Daniela ^b   Post, Bart ^a   Bloem, Bas R ^a  

^a RADBOUD UNIVERSITY MEDICAL CENTER   (Netherlands)

^b UNIVERSITY OF TÜBINGEN   (Germany)

Author keywords

Exergaming; Parkinson disease; Physical activity; RCT

Indexed keywords

LEVODOPA;

AEROBIC EXERCISE; ARTICLE; COMMUNITY; CONTROLLED STUDY; DOUBLE BLIND PROCEDURE; FITNESS; HUMAN; LEISURE; MAJOR CLINICAL STUDY; PARKINSON DISEASE; PHASE 2 CLINICAL TRIAL; PHYSICAL ACTIVITY; QUALITY OF LIFE; RANDOMIZED CONTROLLED TRIAL; SEDENTARY LIFESTYLE; STRETCHING EXERCISE; UNIFIED PARKINSON DISEASE RATING SCALE; ADULT; AGED; CLINICAL TRIAL; EXERCISE; FEMALE; KINESIOTHERAPY; MALE; METHODOLOGY; MIDDLE AGED; MOTOR PERFORMANCE; PATIENT COMPLIANCE; PROCEDURES; SOCIAL SUPPORT; TREATMENT OUTCOME;

ADULT; AGED; DOUBLE-BLIND METHOD; EXERCISE; EXERCISE THERAPY; FEMALE; HUMANS; MALE; MIDDLE AGED; MOTOR SKILLS; PARKINSON DISEASE; PATIENT COMPLIANCE; PHYSICAL FITNESS; QUALITY OF LIFE; RESEARCH DESIGN; SOCIAL SUPPORT; TREATMENT OUTCOME;

EID: 84929300530     PISSN: None     EISSN: 14712377     Source Type: Journal    
DOI: 10.1186/s12883-015-0312-6     Document Type: Article

References (64)

1. Speelman AD, van de Warrenburg BP, van Nimwegen M, Petzinger GM, Munneke M, Bloem BR. How might physical activity benefit patients with Parkinson disease? Nat Rev Neurol. 2011;7(9):528-34.
2. Tomlinson CL, Patel S, Meek C, Clarke CE, Stowe R, Shah L, et al. Physiotherapy versus placebo or no intervention in Parkinson's disease. Cochrane Database Syst Rev. 2012;8:CD002817.
3. van der Kolk NM, King LA. Effects of exercise on mobility in people with Parkinson's disease. Mov Disord Off J Mov Disord Soc. 2013;28(11):1587-96.
4. Fisher BE, Petzinger GM, Nixon K, Hogg E, Bremmer S, Meshul CK, et al. Exercise-induced behavioral recovery and neuroplasticity in the 1-methyl-4-phenyl-1,2,3,6-tetrahydropyridine-lesioned mouse basal ganglia. J Neurosci Res. 2004;77(3):378-90.
5. Mehrholz J, Friis R, Kugler J, Twork S, Storch A, Pohl M. Treadmill training for patients with Parkinson's disease. Cochrane Database Syst Rev. 2010;1:CD007830.
6. Schenkman M, Hall DA, Baron AE, Schwartz RS, Mettler P, Kohrt WM. Exercise for people in early- or mid-stage Parkinson disease: a 16-month randomized controlled trial. Phys Ther. 2012;92(11):1395-410.
7. Shulman LM, Katzel LI, Ivey FM, Sorkin JD, Favors K, Anderson KE, et al. Randomized clinical trial of 3 types of physical exercise for patients with Parkinson disease. JAMA Neurol. 2013;70(2):183-90.
8. Al-Jarrah M, Jamous M, Al Zailaey K, Bweir SO. Endurance exercise training promotes angiogenesis in the brain of chronic/progressive mouse model of Parkinson's Disease. NeuroRehabilitation. 2010;26(4):369-73.
9. Al-Jarrah MD, Jamous M. Effect of endurance exercise training on the expression of GFAP, S100B, and NSE in the striatum of chronic/progressive mouse model of Parkinson's disease. NeuroRehabilitation. 2011;28(4):359-63.
10. Vuckovic MG, Li Q, Fisher B, Nacca A, Leahy RM, Walsh JP, et al. Exercise elevates dopamine D2 receptor in a mouse model of Parkinson's disease: in vivo imaging with [(1) (8) F] fallypride. Mov Disord Off J Mov Disord Soc. 2010;25(16):2777-84.
11. Yoon MC, Shin MS, Kim TS, Kim BK, Ko IG, Sung YH, et al. Treadmill exercise suppresses nigrostriatal dopaminergic neuronal loss in 6-hydroxydopamine-induced Parkinson's rats. Neurosci Lett. 2007;423(1):12-7.
12. Fisher BE, Li Q, Nacca A, Salem GJ, Song J, Yip J, et al. Treadmill exercise elevates striatal dopamine D2 receptor binding potential in patients with early Parkinson's disease. Neuroreport. 2013;24(10):509-14.
13. Fisher BE, Wu AD, Salem GJ, Song J, Lin CH, Yip J, et al. The effect of exercise training in improving motor performance and corticomotor excitability in people with early Parkinson's disease. Arch Phys Med Rehabil. 2008;89(7):1221-9.
14. Goodwin VA, Richards SH, Taylor RS, Taylor AH, Campbell JL. The effectiveness of exercise interventions for people with Parkinson's disease: a systematic review and meta-analysis. Mov Disord Off J Mov Disord Soc. 2008;23(5):631-40.
15. Shu HF, Yang T, Yu SX, Huang HD, Jiang LL, Gu JW, et al. Aerobic exercise for Parkinson's disease: a systematic review and meta-analysis of randomized controlled trials. PLoS One. 2014;9(7):e100503.
16. Nelson ME, Rejeski WJ, Blair SN, Duncan PW, Judge JO, King AC, et al. Physical activity and public health in older adults: recommendation from the American College of Sports Medicine and the American Heart Association. Med Sci Sports Exerc. 2007;39(8):1435-45.
17. Goetz CG, Poewe W, Rascol O, Sampaio C, Stebbins GT, Counsell C, et al. Movement disorder society task force report on the Hoehn and Yahr staging scale: status and recommendations. Mov Disord Off J Mov Disord Soc. 2004;19(9):1020-8.
18. Goetz CG, Tilley BC, Shaftman SR, Stebbins GT, Fahn S, Martinez-Martin P, et al. Movement Disorder Society-sponsored revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS): scale presentation and clinimetric testing results. Mov Disord Off J Mov Disord Soc. 2008;23(15):2129-70.
19. Stowe R, Ives N, Clarke CE, Deane K, Wheatley K, Gray R, et al. Evaluation of the efficacy and safety of adjuvant treatment to levodopa therapy in Parkinson s disease patients with motor complications. Cochrane Database Syst Rev. 2010;7:CD007166.
20. Tomlinson CL, Stowe R, Patel S, Rick C, Gray R, Clarke CE. Systematic review of levodopa dose equivalency reporting in Parkinson's disease. Mov Disord Off J Mov Disord Soc. 2010;25(15):2649-53.
21. Goetz CG, LeWitt PA, Weidenman M. Standardized training tools for the UPDRS activities of daily living scale: newly available teaching program. Mov Disord Off J Mov Disord Soc. 2003;18(12):1455-8.
22. Schrag A, Sampaio C, Counsell N, Poewe W. Minimal clinically important change on the unified Parkinson's disease rating scale. Mov Disord Off J Mov Disord Soc. 2006;21(8):1200-7.
23. Shulman LM, Gruber-Baldini AL, Anderson KE, Fishman PS, Reich SG, Weiner WJ. The clinically important difference on the unified Parkinson's disease rating scale. Arch Neurol. 2010;67(1):64-70.
24. Poewe W. Clinical measures of progression in Parkinson's disease. Mov Disord Off J Mov Disord Soc. 2009;24 Suppl 2:S671-6.
25. Poewe W, Mahlknecht P. The clinical progression of Parkinson's disease. Parkinsonism Relat Disord. 2009;15 Suppl 4:S28-32.
26. Schrag A, Dodel R, Spottke A, Bornschein B, Siebert U, Quinn NP. Rate of clinical progression in Parkinson's disease. A prospective study. Mov Disord Off J Mov Disord Soc. 2007;22(7):938-45.
27. Post B, Merkus MP, de Bie RM, de Haan RJ, Speelman JD. Unified Parkinson's disease rating scale motor examination: are ratings of nurses, residents in neurology, and movement disorders specialists interchangeable? Mov Disord Off J Mov Disord Soc. 2005;20(12):1577-84.
28. King LA, Priest KC, Salarian A, Pierce D, Horak FB. Comparing the mini-BESTest with the berg balance scale to evaluate balance disorders in Parkinson's disease. Parkinson's Dis. 2012;2012:375419.
29. King L, Horak F. On the mini-BESTest: scoring and the reporting of total scores. Phys Ther. 2013;93(4):571-5.
30. Morris S, Morris ME, Iansek R. Reliability of measurements obtained with the Timed "Up & Go" test in people with Parkinson disease. Phys Ther. 2001;81(2):810-8.
31. Keus SHH, Hendriks HJM, Bloem BR, Bredero-Cohen AB, de Goede CJT, van Haaren M, et al. KNGF-richtlijn de ziekte van Parkinson. Nederlands Tijdschrift voor Fysiotherapie. 2004;114(3):Supplement 1-46.
32. Stocchi F, Jenner P, Obeso JA. When do levodopa motor fluctuations first appear in Parkinson's disease? Eur Neurol. 2010;63(5):257-66.
33. Colcombe S, Kramer AF. Fitness effects on the cognitive function of older adults: a meta-analytic study. Psychol Sci. 2003;14(2):125-30.
34. Zadikoff C, Fox SH, Tang-Wai DF, Thomsen T, de Bie RM, Wadia P, et al. A comparison of the mini mental state exam to the Montreal cognitive assessment in identifying cognitive deficits in Parkinson's disease. Mov Disord Off J Mov Disord Soc. 2008;23(2):297-9.
35. Hu MT, Szewczyk-Krolikowski K, Tomlinson P, Nithi K, Rolinski M, Murray C, et al. Predictors of cognitive impairment in an early stage Parkinson's disease cohort. Mov Dis Off J Movement Disorder Soc. 2014;29(3):351-9.
36. Williams-Gray CH, Foltynie T, Brayne CE, Robbins TW, Barker RA. Evolution of cognitive dysfunction in an incident Parkinson's disease cohort. Brain J Neurol. 2007;130(Pt 7):1787-98.
37. Cools R, Barker RA, Sahakian BJ, Robbins TW. Mechanisms of cognitive set flexibility in Parkinson's disease. Brain J Neurol. 2001;124(Pt 12):2503-12.
38. Oosterman JM, Vogels RL, van Harten B, Gouw AA, Poggesi A, Scheltens P, et al. Assessing mental flexibility: neuroanatomical and neuropsychological correlates of the trail making test in elderly people. Clin Neuropsychol. 2010;24(2):203-19.
39. Dirnberger G, Jahanshahi M. Executive dysfunction in Parkinson's disease: a review. J Neuropsychol. 2013;7(2):193-224.
40. Silveira H, Moraes H, Oliveira N, Coutinho ES, Laks J, Deslandes A. Physical exercise and clinically depressed patients: a systematic review and meta-analysis. Neuropsychobiology. 2013;67(2):61-8.
41. Asmundson GJ, Fetzner MG, Deboer LB, Powers MB, Otto MW, Smits JA. Let's get physical: a contemporary review of the anxiolytic effects of exercise for anxiety and its disorders. Depress Anxiety. 2013;30(4):362-73.
42. Reid KJ, Baron KG, Lu B, Naylor E, Wolfe L, Zee PC. Aerobic exercise improves self-reported sleep and quality of life in older adults with insomnia. Sleep Med. 2010;11(9):934-40.
43. Costilla VC, Foxx-Orenstein AE. Constipation: understanding mechanisms and management. Clin Geriatr Med. 2014;30(1):107-15.
44. Edmonds M, McGuire H, Price J. Exercise therapy for chronic fatigue syndrome. Cochrane Database Syst Rev. 2004;3:CD003200.
45. Leentjens AF, Dujardin K, Marsh L, Richard IH, Starkstein SE, Martinez-Martin P. Anxiety rating scales in Parkinson's disease: a validation study of the Hamilton anxiety rating scale, the Beck anxiety inventory, and the hospital anxiety and depression scale. Mov Disord Off J Mov Disord Soc. 2011;26(3):407-15.
46. Hogl B, Arnulf I, Comella C, Ferreira J, Iranzo A, Tilley B, et al. Scales to assess sleep impairment in Parkinson's disease: critique and recommendations. Mov Disord Off J Mov Disord Soc. 2010;25(16):2704-16.
47. Verbaan D, Marinus J, Visser M, van Rooden SM, Stiggelbout AM, van Hilten JJ. Patient-reported autonomic symptoms in Parkinson disease. Neurology. 2007;69(4):333-41.
48. Friedman JH, Alves G, Hagell P, Marinus J, Marsh L, Martinez-Martin P, et al. Fatigue rating scales critique and recommendations by the movement disorders society task force on rating scales for Parkinson's disease. Mov Disord Off J Mov Disord Soc. 2010;25(7):805-22.
49. Hagell P, Nygren C. The 39 item Parkinson's disease questionnaire (PDQ-39) revisited: implications for evidence based medicine. J Neurol Neurosurg Psychiatry. 2007;78(11):1191-8.
50. Falvo MJ, Earhart GM. Six-minute walk distance in persons with Parkinson disease: a hierarchical regression model. Arch Phys Med Rehabil. 2009;90(6):1004-8.
51. Katzel LI, Sorkin JD, Macko RF, Smith B, Ivey FM, Shulman LM. Repeatability of aerobic capacity measurements in Parkinson disease. Med Sci Sports Exerc. 2011;43(12):2381-7.
52. Li F, Harmer P, Fitzgerald K, Eckstrom E, Stock R, Galver J, et al. Tai chi and postural stability in patients with Parkinson's disease. N Engl J Med. 2012;366(6):511-9.
53. Schenkman M, Cutson TM, Kuchibhatla M, Chandler J, Pieper CF, Ray L, et al. Exercise to improve spinal flexibility and function for people with Parkinson's disease: a randomized, controlled trial. J Am Geriatr Soc. 1998;46(10):1207-16.
54. Teerenstra S, Eldridge S, Graff M, de Hoop E, Borm GF. A simple sample size formula for analysis of covariance in cluster randomized trials. Stat Med. 2012;31(20):2169-78.
55. Canning CG, Allen NE, Dean CM, Goh L, Fung VS. Home-based treadmill training for individuals with Parkinson's disease: a randomized controlled pilot trial. Clin Rehabil. 2012;26(9):817-26.
56. Pickering RM, Fitton C, Ballinger C, Fazakarley L, Ashburn A. Self reported adherence to a home-based exercise programme among people with Parkinson's disease. Parkinsonism Relat Disord. 2013;19(1):66-71.
57. van Buuren S, Boshuizen HC, Knook DL. Multiple imputation of missing blood pressure covariates in survival analysis. Stat Med. 1999;18(6):681-94.
58. Gomez-Esteban JC, Zarranz JJ, Lezcano E, Tijero B, Luna A, Velasco F, et al. Influence of motor symptoms upon the quality of life of patients with Parkinson's disease. Eur Neurol. 2007;57(3):161-5.
59. Rascol O. Physical exercise in Parkinson disease: moving toward more robust evidence? Mov Disord Off J Mov Disord Soc. 2013;28(9):1173-5.
60. van Nimwegen M, Speelman AD, Overeem S, van de Warrenburg BP, Smulders K, Dontje ML, et al. Promotion of physical activity and fitness in sedentary patients with Parkinson's disease: randomised controlled trial. BMJ. 2013;346:f576.
61. Ene H, McRae C, Schenkman M. Attitudes toward exercise following participation in an exercise intervention study. J Neurol Phys Ther. 2011;35(1):34-40.
62. Petzinger GM, Fisher BE, McEwen S, Beeler JA, Walsh JP, Jakowec MW. Exercise-enhanced neuroplasticity targeting motor and cognitive circuitry in Parkinson's disease. Lancet Neurol. 2013;12(7):716-26.
63. Petzinger GM, Fisher BE, Van Leeuwen JE, Vukovic M, Akopian G, Meshul CK, et al. Enhancing neuroplasticity in the basal ganglia: the role of exercise in Parkinson's disease. Mov Disord Off J Mov Disord Soc. 2010;25 Suppl 1:S141-5.
64. Mirelman A, Rochester L, Reelick M, Nieuwhof F, Pelosin E, Abbruzzese G, et al. V-TIME: a treadmill training program augmented by virtual reality to decrease fall risk in older adults: study design of a randomized controlled trial. BMC Neurol. 2013;13:15.