Clinical trial NCT06306768: Remote Therapeutic Monitoring Exercise Tracking
Official title: Remote Therapeutic Monitoring for Longitudinal Exercise and Self-Efficacy Tracking in Persons With Parkinson's Disease and Multiple Sclerosis.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Parkinson Disease
Multiple Sclerosis
Keywords: physical activity
exercise tracking
remote therapeutic monitoring
quality of life
self-efficacy
Lead sponsor: Shirley Ryan AbilityLab
Sponsor class: OTHER
First posted: 2024-03-12
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to examine physical activity and exercise behaviors in people with Parkinson's Disease and Multiple Sclerosis over the course of 1-year using a cloud-based remote monitoring platform.

Detailed description: Remote therapeutic monitoring (RTM) is a reimbursable clinical service. Pilot investigation conducted by our lab demonstrated promise that this service is feasible to add to clinical care. It is unclear still if RTM is able to provide clinical benefit to patients including improving and sustaining physical activity (PA) and exercise behaviors over a longer period of time (\>1 year). Our central hypothesis is that the addition of RTM to physical activity, both in a skilled rehabilitation program and within a home program, will improve long term outcomes related to physical activity including self-efficacy for exercise, consistent participation in home exercise recommendations, and quality of life in people living with PD and MS. Thus the specific aims of this study are as follows:

1. To assess PA and exercise behaviors over 1-year period using a remote therapeutic monitoring platform

   a. We will track steps per day, minutes of aerobic activity per week, and frequency of workouts including flexibility, balance, and resistance training.
2. To understand how engagement with RTM for PA tracking affects overall self-efficacy for exercise, readiness for exercise behavior change, and quality of life.

   1. Assessed through monthly self-report of usability survey for RTM and self-efficacy for exercise survey.

Eligibility criteria: Inclusion Criteria:

* Are ambulatory as their primary means of mobility without an assistive device except for single point cane or walking sticks in community
* Have a diagnosis of Parkinson's disease (Hoehn and Yahr 1-3), Parkinsonism, or Multiple Sclerosis
* Personal goal and willingness to address physical activity
* Have a smart phone (Datos Health app is compatible with any Smart phone device)
* Willing to accept Datos' Terms and Conditions

Exclusion Criteria:

* Individuals with cognitive or communication disorders (including dementia) which would limit their ability to interact with the RTM

Primary outcomes:
measure: Physical Activity Metric 1
timeFrame: Daily, through study completion, average 1 year
measure: Physical Activity Metric 2
timeFrame: Daily, through study completion, average 1 year
Secondary outcomes:
measure: Exercise Self Efficacy
timeFrame: Completed every other month, through study completion, average of 1 year
measure: Quality of Life from PROMIS 10-b
timeFrame: Completed every 3 months, through study completion, average of 1 year
measure: Quality of Life from PROMIS-29
timeFrame: Completed every 3 months, through study completion, average of 1 year
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Shirley Ryan AbilityLab
state: Illinois
Study officials:
affiliation: Shirley Ryan AbilityLab
name: Miriam Rafferty, PT, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Block VA, Pitsch E, Tahir P, Cree BA, Allen DD, Gelfand JM. Remote Physical Activity Monitoring in Neurological Disease: A Systematic Review. PLoS One. 2016 Apr 28;11(4):e0154335. doi: 10.1371/journal.pone.0154335. eCollection 2016.
citation: Proschinger S, Kuhwand P, Rademacher A, Walzik D, Warnke C, Zimmer P, Joisten N. Fitness, physical activity, and exercise in multiple sclerosis: a systematic review on current evidence for interactions with disease activity and progression. J Neurol. 2022 Jun;269(6):2922-2940. doi: 10.1007/s00415-021-10935-6. Epub 2022 Jan 27.
citation: 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.