Mobile Health Technology to Promote Physical Activity in Persons With Parkinson Disease
Study Details
Study Description
Brief Summary
Persons with Parkinson Disease (PD) face significant declines in function resulting in greater disability. Function can improve through participation in exercise, yet many people with PD are physically inactive. Given that people with PD live long lifespans following diagnosis; it is essential to include routine exercise into their lives over the long-term. Physical therapy is effective in improving function in persons with PD. However, participation in on-going physical therapy indefinitely is not a realistic option due to limited healthcare resources. Interventions using mobile health technologies allow physical therapists to stay connected to patients over time potentially improving their ability to meet the changing needs of patients with PD. Innovative approaches using mobile health technology may improve outcome; however, the effectiveness of different approaches to improve function and reduce disability in PD is unknown.
The purpose of this study is to compare the effectiveness of two interventions to improve function and health-related quality of life in 65 people with PD. In one study group, participants receive a home exercise program, in written format, to continue on an independent basis. In the other study group, participants are instructed to continue with an exercise program, in their home, delivered using videos of the exercises on a computer tablet device. This use of mobile-Health technology allows the physical therapist to remotely monitor participants' progress and modify the exercise program to meet the changing needs of each patient. The long-term objective of this research is to determine the most efficient and effective way to improve function that can be widely disseminated to persons with PD.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Mobile Health Technology Stretching and strengthening exercises provided via video using mobile health technology; walk daily using a pedometer; interact with a physical therapist remotely through an exercise application on a tablet device over 12 month period |
Behavioral: Mobile Health Technology
Behavioral: Stretching & Strengthening Exercises
Behavioral: Walking with Pedometer
|
| Active Comparator: Control Stretching and strengthening exercises provided using printed photographs; walk daily using a pedometer; interact with a physical therapist at the beginning of the 12 month study; no use of mobile technology |
Behavioral: Stretching & Strengthening Exercises
Behavioral: Walking with Pedometer
|
Outcome Measures
Primary Outcome Measures
- Change from Baseline in Physical Activity Level [52-54 weeks]
Physical activity level will be assessed using an activity monitor worn around the ankle over a 7-day period at the beginning and the end of the study
Secondary Outcome Measures
- Change from Baseline in BriefBEST Balance Test [52-54 weeks]
The BriefBEST balance test assesses balance using a series of tasks such as sitting and leaning, standing on compliant and non-compliant surfaces, stepping to the side, and walking on level surfaces
- Change from Baseline in Six Minute Walk Test [52-54 weeks]
Six Minute Walk Test is measure of the distance a participant is able to walk in a 6 minute time period
- Change from Baseline in Falls Self-Efficacy Scale International [52-54 weeks]
Falls Self-Efficacy Scale International is a self-administered questionnaire to assess the level of confidence in performing a series of 16 daily activities without falling
- Change from Baseline in Unified Parkinson's Disease Rating Scale [52-54 weeks]
Unified Parkinson's Disease Rating Scale assesses disability level related to the non-motor and motor signs in people with Parkinson's disease.
- Change from Baseline in Parkinson's Disease Questionnaire-39 [52-54 weeks]
Parkinson's Disease Questionnaire-39 is a self-administered questionnaire to assess the quality of life in people with Parkinson's disease
- Change from Baseline in Self-Efficacy Exercise Scale [52-54 weeks]
Self-Efficacy Exercise Scale is a self-administered questionnaire to assess confidence in ability to exercise
- Change from Baseline in Functional Gait Assessment [52-54 weeks]
Functional Gait Assessment assesses balance using a series of walking tasks, including walking in different directions, speeds, and around obstacles, including navigating stairs
- Change from Baseline in Fatigue Severity Scale [52-54 weeks]
Fatigue Severity Scale is a self-administered questionnaire where subjects are instructed to rate the impact of fatigue in their daily life over the prior week
- Change from Baseline in Geriatric Depression Scale [52-54 weeks]
Geriatric Depression Scale is a self-administered questionnaire to assess depression in individuals
- Change from Baseline Apathy Scale [52-54 weeks]
Apathy Scale is a self-administered questionnaire to assess apathy
- Change from Baseline in Godin Leisure-Time Exercise Questionnaire [52-54 weeks]
Godin Leisure-Time Exercise Questionnaire a self-administered questionnaire about the subjects leisure-time exercise habits over a typical seven day period
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Inactive over the last 3 months
-
Clinical diagnosis of idiopathic Parkinson's disease
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Mild to moderate disease severity
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Sufficient cognitive ability to follow study instructions
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Stable dose of Parkinson's medications for at least 2 weeks prior to study onset and during the 12 month study period unless medically necessary
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Able to walk without physical assistance or an assistive device for at least 6 continuous minutes
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Be interested in participating and provide informed consent
Exclusion Criteria:
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A diagnosis of atypical Parkinsonism
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Balance impairment (More than 2 falls in the previous month)
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Significant freezing
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Serious co-morbidities or medical conditions that may interfere with ability to participate in an exercise program (i.e., musculoskeletal, cardiovascular, and neurological (other than Parkinson's))
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Center for Neurorehabilitation, College of Health & Rehabilitation Sciences, Sargent College, Boston University | Boston | Massachusetts | United States | 02215 |
Sponsors and Collaborators
- Boston University Charles River Campus
Investigators
- Principal Investigator: Terry Ellis, PhD, PT, NCS, Boston University
- Principal Investigator: Nancy Latham, PhD, PT, Boston University
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
- Cavanaugh JT, Ellis TD, Earhart GM, Ford MP, Foreman KB, Dibble LE. Capturing ambulatory activity decline in Parkinson's disease. J Neurol Phys Ther. 2012 Jun;36(2):51-7. doi: 10.1097/NPT.0b013e318254ba7a.
- Ellis T, Boudreau JK, DeAngelis TR, Brown LE, Cavanaugh JT, Earhart GM, Ford MP, Foreman KB, Dibble LE. Barriers to exercise in people with Parkinson disease. Phys Ther. 2013 May;93(5):628-36. doi: 10.2522/ptj.20120279. Epub 2013 Jan 3.
- Ellis T, Cavanaugh JT, Earhart GM, Ford MP, Foreman KB, Dibble LE. Which measures of physical function and motor impairment best predict quality of life in Parkinson's disease? Parkinsonism Relat Disord. 2011 Nov;17(9):693-7. doi: 10.1016/j.parkreldis.2011.07.004. Epub 2011 Aug 5.
- Ellis T, Cavanaugh JT, Earhart GM, Ford MP, Foreman KB, Fredman L, Boudreau JK, Dibble LE. Factors associated with exercise behavior in people with Parkinson disease. Phys Ther. 2011 Dec;91(12):1838-48. doi: 10.2522/ptj.20100390. Epub 2011 Oct 14.
- Ellis T, de Goede CJ, Feldman RG, Wolters EC, Kwakkel G, Wagenaar RC. Efficacy of a physical therapy program in patients with Parkinson's disease: a randomized controlled trial. Arch Phys Med Rehabil. 2005 Apr;86(4):626-32.
- Ellis T, Latham NK, DeAngelis TR, Thomas CA, Saint-Hilaire M, Bickmore TW. Feasibility of a virtual exercise coach to promote walking in community-dwelling persons with Parkinson disease. Am J Phys Med Rehabil. 2013 Jun;92(6):472-81; quiz 482-5. doi: 10.1097/PHM.0b013e31828cd466.
- Kohl HW 3rd, Craig CL, Lambert EV, Inoue S, Alkandari JR, Leetongin G, Kahlmeier S; Lancet Physical Activity Series Working Group. The pandemic of physical inactivity: global action for public health. Lancet. 2012 Jul 21;380(9838):294-305. doi: 10.1016/S0140-6736(12)60898-8. Review.
- Muslimovic D, Post B, Speelman JD, Schmand B, de Haan RJ; CARPA Study Group. Determinants of disability and quality of life in mild to moderate Parkinson disease. Neurology. 2008 Jun 3;70(23):2241-7. doi: 10.1212/01.wnl.0000313835.33830.80.
- Resnick B, Nahm ES, Orwig D, Zimmerman SS, Magaziner J. Measurement of activity in older adults: reliability and validity of the Step Activity Monitor. J Nurs Meas. 2001 Winter;9(3):275-90.
- Rimmer JH, Marques AC. Physical activity for people with disabilities. Lancet. 2012 Jul 21;380(9838):193-5. doi: 10.1016/S0140-6736(12)61028-9.
- Schmidt AL, Pennypacker ML, Thrush AH, Leiper CI, Craik RL. Validity of the StepWatch Step Activity Monitor: preliminary findings for use in persons with Parkinson disease and multiple sclerosis. J Geriatr Phys Ther. 2011 Jan-Mar;34(1):41-5. doi: 10.1519/JPT.0b013e31820aa921.
- Shulman LM, Gruber-Baldini AL, Anderson KE, Vaughan CG, Reich SG, Fishman PS, Weiner WJ. The evolution of disability in Parkinson disease. Mov Disord. 2008 Apr 30;23(6):790-6. doi: 10.1002/mds.21879.
- Shulman LM. Understanding disability in Parkinson's disease. Mov Disord. 2010;25 Suppl 1:S131-5. doi: 10.1002/mds.22789. Review.
- Sisson SB, Camhi SM, Tudor-Locke C, Johnson WD, Katzmarzyk PT. Characteristics of step-defined physical activity categories in U.S. adults.. Am J Health Promot. 2012 Jan-Feb;26(3):152-9. doi: 10.4278/ajhp.100326-QUAN-95.
- 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 Jul 12;7(9):528-34. doi: 10.1038/nrneurol.2011.107. Review.
- Speelman AD, van Nimwegen M, Borm GF, Bloem BR, Munneke M. Monitoring of walking in Parkinson's disease: validation of an ambulatory activity monitor. Parkinsonism Relat Disord. 2011 Jun;17(5):402-4. doi: 10.1016/j.parkreldis.2011.02.006. Epub 2011 Mar 1.
- Tickle-Degnen L, Ellis T, Saint-Hilaire MH, Thomas CA, Wagenaar RC. Self-management rehabilitation and health-related quality of life in Parkinson's disease: a randomized controlled trial. Mov Disord. 2010 Jan 30;25(2):194-204. doi: 10.1002/mds.22940.
- Tomlinson CL, Patel S, Meek C, Clarke CE, Stowe R, Shah L, Sackley CM, Deane KH, Herd CP, Wheatley K, Ives N. Physiotherapy versus placebo or no intervention in Parkinson's disease. Cochrane Database Syst Rev. 2012 Aug 15;(8):CD002817. doi: 10.1002/14651858.CD002817.pub3. Review. Update in: Cochrane Database Syst Rev. 2013;(9):CD002817.
- Tudor-Locke C, Bassett DR Jr. How many steps/day are enough? Preliminary pedometer indices for public health. Sports Med. 2004;34(1):1-8. Review.
- Watson A, Bickmore T, Cange A, Kulshreshtha A, Kvedar J. An internet-based virtual coach to promote physical activity adherence in overweight adults: randomized controlled trial. J Med Internet Res. 2012 Jan 26;14(1):e1. doi: 10.2196/jmir.1629.
- BU-SAR-635