A Multifactorial Exercise Program to Reduce Falls in People With Parkinson Disease

Parkinson Disease Clinical Trial

Official title:

A Multifactorial Exercise Program to Reduce Falls in People With Parkinson Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02302144
• Other study ID #: BU-SAR-BAL
• Status: Completed
• Phase: N/A
• First received: November 24, 2014
• Last updated: July 18, 2017
• Start date: December 2011
• Est. completion date: June 2013

Study information

• Verified date: July 2017
• Source: Boston University Charles River Campus
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The primary objective of this study is to investigate the effects of a theoretically driven, highly challenging exercise program (balance and strengthening exercises) in reducing fall rate, improving balance and reducing fear of falling in persons with Parkinson's disease.

In this pilot, randomized, cross-over study, 32 participants with Parkinson disease will be randomly assigned to either an early start (immediately following enrollment) or late start (3 months after enrollment) multifactorial exercise program which will meet 2 times per week for 1.5 hours over 3 months. The exercise program will consist of balance and strengthening exercises which will be individualized depending on the ability of each participant. Fall rate, balance, walking ability, fear of falling, mood, anxiety, and quality of life will be measured prior to the start, at 3 months and 6 months after enrollment. Subjects will be enrolled for 6-7 months.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• have a diagnosis of idiopathic Parkinson's disease (using UK Brain Bank Criteria)

• have a Hoehn & Yahr stage of 2-4 during the "ON" state

• Mini mental status score > 26

• be 40 years of age or older, so as to represent the typical age range of PD

• be on a stable dose of Parkinson's medications for at least 2 weeks prior to study onset and during the 3 month study period.

• have experienced at least one fall in the past 3 months and greater or equal to 2 falls in the past one-year (A fall was defined as an unexpected event where the person inadvertently came to rest on the ground or other lower level not due to a major intrinsic or extrinsic event)

• able to walk without physical assistance or an assistive device for at least 5 continuous minutes

• able to understand, communicate with and be understood by recruitment personnel

• able to attend the exercise program twice per week at Sargent College

• be interested in participating and provide informed consent

Exclusion Criteria:

• have a diagnosis of atypical Parkinsonism

• have a Hoehn & Yahr stage of 1 or 5

• have had previous surgical management of PD (i.e., deep brain stimulation surgery; pallidotomy)

• serious co-morbidities that may interfere with ability to participate in an exercise program (i.e., musculoskeletal, cardiovascular, and neurological (other than Parkinson's))

• be pregnant

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

Behavioral:
• Balance & Strengthening Exercises
Progressive balance and strengthening exercises conducted in a group format yet tailored to each individual

Locations

Country	Name	City	State
United States	Center for Neurorehabilitation, College of Health & Rehabilitation Sciences, Sargent College, Boston University	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Boston University Charles River Campus

Country where clinical trial is conducted

United States, 

References & Publications (21)

Allen NE, Canning CG, Sherrington C, Lord SR, Latt MD, Close JC, O'Rourke SD, Murray SM, Fung VS. The effects of an exercise program on fall risk factors in people with Parkinson's disease: a randomized controlled trial. Mov Disord. 2010 Jul 15;25(9):1217-25. doi: 10.1002/mds.23082. — View Citation

Ashburn A, Fazakarley L, Ballinger C, Pickering R, McLellan LD, Fitton C. A randomised controlled trial of a home based exercise programme to reduce the risk of falling among people with Parkinson's disease. J Neurol Neurosurg Psychiatry. 2007 Jul;78(7):678-84. Epub 2006 Nov 21. — View Citation

Bloem BR, Beckley DJ, van Dijk JG, Zwinderman AH, Remler MP, Roos RA. Influence of dopaminergic medication on automatic postural responses and balance impairment in Parkinson's disease. Mov Disord. 1996 Sep;11(5):509-21. — View Citation

Cakit BD, Saracoglu M, Genc H, Erdem HR, Inan L. The effects of incremental speed-dependent treadmill training on postural instability and fear of falling in Parkinson's disease. Clin Rehabil. 2007 Aug;21(8):698-705. — View Citation

Chang JT, Morton SC, Rubenstein LZ, Mojica WA, Maglione M, Suttorp MJ, Roth EA, Shekelle PG. Interventions for the prevention of falls in older adults: systematic review and meta-analysis of randomised clinical trials. BMJ. 2004 Mar 20;328(7441):680. Review. — View Citation

Dorsey ER, Constantinescu R, Thompson JP, Biglan KM, Holloway RG, Kieburtz K, Marshall FJ, Ravina BM, Schifitto G, Siderowf A, Tanner CM. Projected number of people with Parkinson disease in the most populous nations, 2005 through 2030. Neurology. 2007 Jan 30;68(5):384-6. Epub 2006 Nov 2. — View Citation

Ebersbach G, Edler D, Kaufhold O, Wissel J. Whole body vibration versus conventional physiotherapy to improve balance and gait in Parkinson's disease. Arch Phys Med Rehabil. 2008 Mar;89(3):399-403. doi: 10.1016/j.apmr.2007.09.031. — View Citation

Genever RW, Downes TW, Medcalf P. Fracture rates in Parkinson's disease compared with age- and gender-matched controls: a retrospective cohort study. Age Ageing. 2005 Jan;34(1):21-4. — View Citation

Gillespie LD, Robertson MC, Gillespie WJ, Lamb SE, Gates S, Cumming RG, Rowe BH. Interventions for preventing falls in older people living in the community. Cochrane Database Syst Rev. 2009 Apr 15;(2):CD007146. doi: 10.1002/14651858.CD007146.pub2. Review. Update in: Cochrane Database Syst Rev. 2012;9:CD007146. — View Citation

Hely MA, Morris JG, Traficante R, Reid WG, O'Sullivan DJ, Williamson PM. The sydney multicentre study of Parkinson's disease: progression and mortality at 10 years. J Neurol Neurosurg Psychiatry. 1999 Sep;67(3):300-7. — View Citation

Horak FB. Postural orientation and equilibrium: what do we need to know about neural control of balance to prevent falls? Age Ageing. 2006 Sep;35 Suppl 2:ii7-ii11. Review. — View Citation

Jacobs JV, Horak FB. Cortical control of postural responses. J Neural Transm (Vienna). 2007;114(10):1339-48. Epub 2007 Mar 29. Review. — View Citation

Johnell O, Melton LJ 3rd, Atkinson EJ, O'Fallon WM, Kurland LT. Fracture risk in patients with parkinsonism: a population-based study in Olmsted County, Minnesota. Age Ageing. 1992 Jan;21(1):32-8. — View Citation

Melton LJ 3rd, Leibson CL, Achenbach SJ, Bower JH, Maraganore DM, Oberg AL, Rocca WA. Fracture risk after the diagnosis of Parkinson's disease: Influence of concomitant dementia. Mov Disord. 2006 Sep;21(9):1361-7. — View Citation

Pickering RM, Grimbergen YA, Rigney U, Ashburn A, Mazibrada G, Wood B, Gray P, Kerr G, Bloem BR. A meta-analysis of six prospective studies of falling in Parkinson's disease. Mov Disord. 2007 Oct 15;22(13):1892-900. — View Citation

Protas EJ, Mitchell K, Williams A, Qureshy H, Caroline K, Lai EC. Gait and step training to reduce falls in Parkinson's disease. NeuroRehabilitation. 2005;20(3):183-90. — View Citation

Rose DJ. Preventing falls among older adults: no "one size suits all" intervention strategy. J Rehabil Res Dev. 2008;45(8):1153-66. — View Citation

Spottke AE, Reuter M, Machat O, Bornschein B, von Campenhausen S, Berger K, Koehne-Volland R, Rieke J, Simonow A, Brandstaedter D, Siebert U, Oertel WH, Ulm G, Dodel R. Cost of illness and its predictors for Parkinson's disease in Germany. Pharmacoeconomics. 2005;23(8):817-36. — View Citation

Temlett JA, Thompson PD. Reasons for admission to hospital for Parkinson's disease. Intern Med J. 2006 Aug;36(8):524-6. — View Citation

Tinetti ME, Baker DI, McAvay G, Claus EB, Garrett P, Gottschalk M, Koch ML, Trainor K, Horwitz RI. A multifactorial intervention to reduce the risk of falling among elderly people living in the community. N Engl J Med. 1994 Sep 29;331(13):821-7. — View Citation

Wood BH, Bilclough JA, Bowron A, Walker RW. Incidence and prediction of falls in Parkinson's disease: a prospective multidisciplinary study. J Neurol Neurosurg Psychiatry. 2002 Jun;72(6):721-5. — View Citation

* Note: There are 21 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Falls Diary	Subjects will be asked to record each falling episode in the falls diary at the time of the fall or as soon as possible in relation to the actual time that the fall occurred. Subjects will be interviewed regarding fall episodes at each treatment session.	6-7 Months
Secondary	Change in Activities-specific Balance Confidence	Activities-specific Balance Confidence (ABC) Scale is a self-administered questionnaire in which subjects rate their level of confidence in performing a series of 16 activities.	6-7 Months
Secondary	Change in Falls Self-Efficacy	The Falls Self-Efficacy Scale is a self-administered questionnaire in which subjects rate their level of concern about falling when performing designated activities.	6-7 Months
Secondary	Change in Balance Evaluation Systems Test (BESTest)	The Balance Evaluation Systems Test (BESTest) is a 36 item test which is used to assess postural control / balance. Subjects are asked to perform a series of tasks such as sitting and leaning, standing on compliant and noncompliant surfaces, stepping forward, backward and to the side and walking on level and unlevel surfaces, while turning the head and while negotiating obstacles.	6-7 Months
Secondary	Change in Six-Minute Walk Test	The six-minute walk test (6MWT) is a measure of the distance a participant walks in a 6 minute time period. The 6-minute walk test is a safe, simple and useful measure of walking ability in patients with Parkinson's disease. The test will be carried out on level, obstacle-free enclosed corridors.	6-7 Months
Secondary	Change in Freezing of Gait Questionnaire	The Freezing of Gait Questionnaire (FOG) is a 6-item test in which the patient is interviewed and asked questions about their walking ability.	6-7 Months
Secondary	Change in Unified Parkinson's Disease Rating Scale	Section I, II, III and IV of the Unified Parkinson's Disease Rating Scale (UPDRS) will be utilized to assess nonmotor and motor signs.	6-7 Months
Secondary	Change in Scales for Outcomes in Parkinson Disease	The Scales for Outcomes in Parkinson Disease (SCOPA-AUT) consists of 26 items assessing autonomic function including gastrointestinal, urinary, cardiovascular, thermoregulatory, pupillomotor and sexual function.	6-7 Months
Secondary	Change in Parkinson's Disease Questionnaire-39	The Parkinson's Disease Questionnaire-39 (PDQ-39) is a quality of life instrument that contains 39-self-report items and was specifically developed for people with Parkinson's disease. The PDQ-39 measures the degree of healthy, competent, and satisfying participation in daily life activities.	6-7 Months
Secondary	Change in Beck Anxiety Inventory	The Beck Anxiety Inventory (BAI) is a measure of the severity of anxiety in adolescents and adults. The items assess typical features of anxiety, and the measure.	6-7 Months
Secondary	Changes in Beck Depression Inventory Second Edition	The Beck Depression Inventory Second Edition (BDI-II) is a measure of the severity of depression in adolescents and adults. The items target common symptoms of depression.	6-7 Months
Secondary	Changes in Penn State Worry Questionnaire	The Penn State Worry Questionnaire (PSWQ) is a measure of the worry characteristic of generalized anxiety disorder (GAD). Specifically, this measure of pathological worry assesses three areas of worry (generality, excessiveness, and uncontrollability).	6-7 Months
Secondary	Change in Panic Disorder Severity Scale	The Panic Disorder Severity Scale (PDSS) is a questionnaire designed to measure the overall severity of panic disorder. The items assess the severity of seven dimensions of panic disorder and associated symptoms: frequency of panic attacks, distress during panic attacks, panic-focused anticipatory anxiety, phobic avoidance of situations, phobic avoidance of physical sensations, and impairment and interference in work and social functioning.	6-7 Months
Secondary	Changes in Anxiety Sensitivity Index	The Anxiety Sensitivity Index (ASI) is an instrument on which respondents rate the degree to which they fear negative consequences resulting from anxiety symptoms. It yields a total score, representing the global-order anxiety sensitivity factor, as well as three lower-order factor scores, representing physical, psychological, and social concerns.	6-7 Months
Secondary	Changes in Social Phobia Inventor	The Social Phobia Inventory (SPIN) is a self-report questionnaire used to measure symptoms of social phobia (or social anxiety disorder). The SPIN specifically evaluates the spectrum of fear (e.g. fear of being embarrassed), avoidance (e.g. avoidance of parties), and physiological (e.g. blushing) symptoms associated with social phobia.	6-7 Months
Secondary	Changes in Social Interaction Anxiety Scale	The Social Interaction Anxiety Scale (SIAS) is a self-report questionnaire used to measure general fears of social interaction and fears of being scrutinized during activities and performance tasks. The scale is intended to measure affective, behavioral, and cognitive reactions in 20 social interaction situations.	6-7 Months

External Links

•   Center for Neurorehabilitation at Boston University