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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Early Multi-Ex-PD | Experimental | Immediately following enrollment, subjects will participate in a group balance and strengthening program (Multi-Ex-PD) 2x/week for 90 minutes over 3 months within the Center for Neurorehabilitation at Sargent College. Each of the exercises consists of a progression which ranges from less challenging to more challenging. The program will be individualized to the subject to appropriately match their abilities. Each subject will be progressed to a more challenging exercise once specific criteria are met. Resistance for the strengthening exercises will be applied using weighted vests. |
|
| Late Multi-Ex-PD | Experimental | Three months after enrollment, subjects will participate in a group balance and strengthening program (Multi-Ex-PD) 2x/week for 90 minutes over 3 months within the Center for Neurorehabilitation at Sargent College. Each of the exercises consists of a progression which ranges from less challenging to more challenging. The program will be individualized to the subject to appropriately match their abilities. Each subject will be progressed to a more challenging exercise once specific criteria are met. Resistance for the strengthening exercises will be applied using weighted vests. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Balance & Strengthening Exercises | Behavioral | Progressive balance and strengthening exercises conducted in a group format yet tailored to each individual |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Change in Falls Self-Efficacy |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Terry Ellis, PhD, PT, NCS | Boston University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center for Neurorehabilitation, College of Health & Rehabilitation Sciences, Sargent College, Boston University | Boston | Massachusetts | 02215 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19370674 | Background | 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. | |
| 12023412 | Background | 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. doi: 10.1136/jnnp.72.6.721. |
| Label | URL |
|---|---|
| Center for Neurorehabilitation at Boston University | View source |
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| D051346 | Mobility Limitation |
| D018476 | Hypokinesia |
| D009127 | Muscle Rigidity |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
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| 16703587 | Background | 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. doi: 10.1002/mds.20946. |
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| 16097843 | Background | 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. doi: 10.2165/00019053-200523080-00007. |
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| 8866492 | Background | 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. doi: 10.1002/mds.870110506. |
| 15031239 | Background | 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. doi: 10.1136/bmj.328.7441.680. |
| 8078528 | Background | 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. doi: 10.1056/NEJM199409293311301. |
| 19235117 | Background | Rose DJ. Preventing falls among older adults: no "one size suits all" intervention strategy. J Rehabil Res Dev. 2008;45(8):1153-66. |
| 17119004 | Background | 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. doi: 10.1136/jnnp.2006.099333. Epub 2006 Nov 21. |
| 17588236 | Background | 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. doi: 10.1002/mds.21598. |
| 18295614 | Background | 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. |
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| 17846069 | Background | 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. doi: 10.1177/0269215507077269. |
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| 38588457 | Derived | 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. |
| 36602886 | Derived | 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. |
| 26655100 | Derived | Sparrow D, DeAngelis TR, Hendron K, Thomas CA, Saint-Hilaire M, Ellis T. Highly Challenging Balance Program Reduces Fall Rate in Parkinson Disease. J Neurol Phys Ther. 2016 Jan;40(1):24-30. doi: 10.1097/NPT.0000000000000111. |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D020820 | Dyskinesias |
| D009461 | Neurologic Manifestations |
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D009122 | Muscle Hypertonia |
| D020879 | Neuromuscular Manifestations |