NCT06645132

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

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 14, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 16, 2024

Completed
12 days until next milestone

Study Start

First participant enrolled

October 28, 2024

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 21, 2025

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2025

Completed
Last Updated

February 14, 2025

Status Verified

November 1, 2024

Enrollment Period

3 months

First QC Date

October 14, 2024

Last Update Submit

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

EXPERIMENTAL

Each 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.

Behavioral: exercise 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.

Reminders to exercise through cues provided by wearable device + custom smartphone application

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

Location

MeSH Terms

Conditions

Hematologic Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsHematologic DiseasesHemic and Lymphatic Diseases

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

Locations