Understanding the Implementation of Cued Exercise Using Wearable Devices and a Custom Smartphone Application Following Bone Marrow Transplant.
Pilot Study to Understand the Feasibility of Implementing a Wearable Device Cueing System Following Bone Marrow Transplant
1 other identifier
interventional
15
1 country
1
Brief Summary
The purpose of this study is to pilot test the feasibility of providing patients diagnosed with a hematologic malignancy, undergoing an allogeneic bone marrow transplant, a wearable device and smartphone app (similar to a Fitbit), that would send personalized reminders to move during their post-transplant inpatient hospital stay to promote physical recovery and well-being.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Oct 2024
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 14, 2024
CompletedFirst Posted
Study publicly available on registry
October 16, 2024
CompletedStudy Start
First participant enrolled
October 28, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 21, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2025
CompletedFebruary 14, 2025
November 1, 2024
3 months
October 14, 2024
February 13, 2025
Conditions
Outcome Measures
Primary Outcomes (2)
Pilot evaluation of intervention efficacy
Efficacy will be evaluated by examining the percentage of time participants responded to the cued exercise prompts.
cumulative percent from day 1 through discharge from hospital, on average day 30
Patient feedback from participation in the study
Patient experience will be evaluated by looking at the central tendencies of the ratings from the post-participation evaluation survey.
day 10
Study Arms (1)
Reminders to exercise through cues provided by wearable device + custom smartphone application
EXPERIMENTALEach participant receives 2 wearable devices and custom smartphone application. Participants will wear an activity monitor on their non-dominant wrist and contralateral ankle. Post-transplant inpatient days \~3-10, participants will schedule three cued exercise sessions each day using the smartphone application. At the scheduled time, the wearable devices will vibrate to indicate "time to exercise" and participants are encouraged to complete an exercise task for 15 minutes. Post-transplant inpatient hospital days \~1-2 and post-transplant inpatient hospital days \~11 until discharge patients will wear the devices but will not receive any cues. During these days, the monitors will only be measuring their movement without any intervention.
Interventions
Exercise intervention leveraging wearable devices and a custom smartphone application to cue exercise as a reminder during idle time during an inpatient hospital stay, post allogenic bone marrow transplant.
Eligibility Criteria
You may qualify if:
- At least 18 years of age
- Diagnosed with hematologic malignancy
- Scheduled to receive an alloBMT
- Physician consent to participate in the study
You may not qualify if:
- Inability to complete 15 minutes walking unassisted
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Froedtert Hospital
Milwaukee, Wisconsin, 53226, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
October 14, 2024
First Posted
October 16, 2024
Study Start
October 28, 2024
Primary Completion
January 21, 2025
Study Completion
September 1, 2025
Last Updated
February 14, 2025
Record last verified: 2024-11
Data Sharing
- IPD Sharing
- Will not share