Physical Activity in Transfusion Dependent Patients With Myelodysplastic Syndrome
- Conditions
- Myelodysplastic Syndromes
- Registration Number
- NCT04969367
- Lead Sponsor
- Thomas Jefferson University
- Brief Summary
This study assesses feasibility and patient acceptability of using a Fitbit to monitor step count and heart rate in transfusion dependent patients with myelodysplastic syndrome. Information from this study may help researchers understand if there is any correlation between activity level and anemia.
- Detailed Description
This study assesses feasibility and patient acceptability of using a Fitbit to monitor step count and heart rate in transfusion dependent patients with myelodysplastic syndrome. Information from this study may help researchers understand if there is any correlation between activity level and anemia.
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
- Confirmed pathologic diagnosis of MDS
- Requiring >= 2 blood transfusions in the past month if previously diagnosed or hemoglobin =< 8 g/dL if newly diagnosed
- Age >= 18
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
- Ambulatory (use of a walking aid, such as a cane or rollator, is acceptable)
- Able to give informed consent
- Willing to comply with all study procedures and available for the duration of the study
- Able to read and/or understand English
- Have access to an iPhone 4S or later, iPad 3 generation or later, Android 5.0 or later, or Windows 10 device
- Have access to Bluetooth low energy (LE) and internet connection for syncing
• Uncontrolled illness including, but not limited to, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method compliance with device Up to 90 days compliance with device (80% of the 90-day intervention time)
Acceptability Up to 90 days Acceptability will be measured by an interview addressing participant satisfaction
Accrual rate Up to 90 days accrual rate will be measured by counting subjects
retention rate Up to 90 days retention rate of subjects will be measured by counting at 90 days
- Secondary Outcome Measures
Name Time Method Fact-An score (assessed twice a week), Up to 90 days Fact-An score (assessed twice a week),
Daily step count Up to 90 days Daily step count
Average daily resting heart rate Up to 90 days average daily resting heart rate
Hemoglobin level measured by CBC twice a week Up to 90 days Hemoglobin level measured by CBC twice a week
Trial Locations
- Locations (1)
Sidney Kimmel Cancer Center at Thomas Jefferson University
🇺🇸Philadelphia, Pennsylvania, United States
Sidney Kimmel Cancer Center at Thomas Jefferson University🇺🇸Philadelphia, Pennsylvania, United States