Mobile Health Technology to Promote Physical Activity in Persons With Parkinson Disease

NCT01955889 | Completed

• 1 other identifier: BU-SAR-635
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Parkinson Disease

Keywords

Exercise; Rehabilitation; Telemedicine

Outcome Measures

Primary Outcomes (1)

• Change from Baseline in Physical Activity Level

  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

  52-54 weeks

Secondary Outcomes (11)

• Change from Baseline in BriefBEST Balance Test

  52-54 weeks

• Change from Baseline in Six Minute Walk Test

  52-54 weeks

• Change from Baseline in Falls Self-Efficacy Scale International

  52-54 weeks

• Change from Baseline in Unified Parkinson's Disease Rating Scale

  52-54 weeks

• Change from Baseline in Parkinson's Disease Questionnaire-39

  52-54 weeks

Study Arms (2)

Mobile Health Technology

EXPERIMENTAL

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

Control

ACTIVE COMPARATOR

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

Interventions

Mobile Health Technology BEHAVIORAL

Mobile Health Technology

Stretching & Strengthening Exercises BEHAVIORAL

Control; Mobile Health Technology

Walking with Pedometer BEHAVIORAL

Control; Mobile Health Technology

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Inactive over the last 3 months
• Clinical diagnosis of idiopathic Parkinson's disease
• Mild to moderate disease severity
• Sufficient cognitive ability to follow study instructions
• 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
• Able to walk without physical assistance or an assistive device for at least 6 continuous minutes
• Be interested in participating and provide informed consent

You may not qualify if:

• A diagnosis of atypical Parkinsonism
• Balance impairment (More than 2 falls in the previous month)
• Significant freezing
• 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))

Sponsors & Collaborators

• Boston University Charles River Campus: lead

Study Sites (1)

Center for Neurorehabilitation, College of Health & Rehabilitation Sciences, Sargent College, Boston University

Boston, Massachusetts, 02215, United States

Location

Related Publications (21)

• 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.

  PMID: 22818941 BACKGROUND

• 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.

  PMID: 18361474 BACKGROUND

• 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. No abstract available.

  PMID: 22818934 BACKGROUND

• 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.

  PMID: 21750523 BACKGROUND

• 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.

  PMID: 22208412 BACKGROUND

• 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.

  PMID: 22592060 BACKGROUND

• 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.

  PMID: 22895932 BACKGROUND

• 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.

  PMID: 22003171 BACKGROUND

• 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.

  PMID: 23288910 BACKGROUND

• 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.

  PMID: 23552335 BACKGROUND

• 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. doi: 10.2165/00007256-200434010-00001.

  PMID: 14715035 BACKGROUND

• 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. doi: 10.1016/j.apmr.2004.08.008.

  PMID: 15827910 BACKGROUND

• 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.

  PMID: 22281837 BACKGROUND

• 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.

  PMID: 21820940 BACKGROUND

• 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.

  PMID: 18519873 BACKGROUND

• Shulman LM. Understanding disability in Parkinson's disease. Mov Disord. 2010;25 Suppl 1:S131-5. doi: 10.1002/mds.22789.

  PMID: 20187231 BACKGROUND

• 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.

  PMID: 11881269 BACKGROUND

• 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.

  PMID: 21937891 BACKGROUND

• 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. No abstract available.

  PMID: 21367643 BACKGROUND

• 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.

  PMID: 20077478 BACKGROUND

• Ellis TD, Cavanaugh JT, DeAngelis T, Hendron K, Thomas CA, Saint-Hilaire M, Pencina K, Latham NK. Comparative Effectiveness of mHealth-Supported Exercise Compared With Exercise Alone for People With Parkinson Disease: Randomized Controlled Pilot Study. Phys Ther. 2019 Feb 1;99(2):203-216. doi: 10.1093/ptj/pzy131.

  PMID: 30715489 DERIVED

Related Links

• Center for Neurorehabilitation at Boston University

MeSH Terms

Conditions

Parkinson Disease; Motor Activity

Interventions

Walking

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Behavior

Intervention Hierarchy (Ancestors)

Locomotion; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Exercise; Motor Activity

Study Officials

• Terry Ellis, PhD, PT, NCS

  Boston University

  PRINCIPAL INVESTIGATOR

• Nancy Latham, PhD, PT

  Boston University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor and Director of Center for Neurorehabilitation

Study Record Dates

• First Submitted: September 24, 2013
• First Posted: October 8, 2013
• Study Start: October 1, 2013
• Primary Completion: July 1, 2015
• Study Completion: July 1, 2015
• Last Updated: July 19, 2017

Record last verified: 2017-07

Locations

US (1)