Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Activity Levels in Bone Marrow Transplant Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04115241
Recruitment Status : Recruiting
First Posted : October 3, 2019
Last Update Posted : October 3, 2019
Sponsor:
Information provided by (Responsible Party):
Melissa Bates, University of Iowa

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
Participants in this study will be receiving a bone marrow transplant. This study is designed to evaluate correlations between activity levels and length of stay, quality of life, and hand grip strength.

Condition or disease Intervention/treatment
Bone Marrow Transplant Device: Actigraph Other: Grip strength test

Detailed Description:
Participants in this study will be receiving a bone marrow transplant. Participants will be given actigraphs to wear around their waists starting 3 weeks prior to bone marrow transplants until they are discharged from the hospital. Participants will be asked to complete quality of life questionnaires and hand grip tests at three separate time points during their hospitalizations. All data gathered from these activities will be compared with patients' activity levels gathered from the actigraphs both before and during the hospitalization. This study is designed to determine the relationship between activity levels and length of stay, quality of life, and hand grip strength.
Study Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Activity Levels in Bone Marrow Transplant Patients
Actual Study Start Date : May 23, 2019
Estimated Primary Completion Date : May 23, 2024
Estimated Study Completion Date : May 23, 2024

Resource links provided by the National Library of Medicine


Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Intervention Details:
  • Device: Actigraph
    Actigraphs are non-invasive, wearable devices that measure activity levels using an accelerometer
  • Other: Grip strength test
    The purpose of this test is to measure the maximum isometric strength of the hand and forearm muscles

Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. To determine the correlation between activity levels and length of stay in hospital [ Time Frame: From study intitiation for up to 5 years ]
    Participants will be given actigraphs to wear around their waists starting 3 weeks prior to bone marrow transplants until they are discharged from the hospital. Activity prior to and during hospitalization will be correlated with length of stay.

  2. To determine the correlation between activity levels and quality of life [ Time Frame: From study intitiation for up to 5 years ]
    Participants will be given actigraphs to wear around their waists starting 3 weeks prior to bone marrow transplants until they are discharged from the hospital. They will be provided with quality of life questionnaires at three time points during hospitalization. Activity prior to and during hospitalization will be correlated with quality of life

  3. To determine the correlation between activity levels and hand grip strength [ Time Frame: From study intitiation for up to 5 years ]
    Participants will be given actigraphs to wear around their waists starting 3 weeks prior to bone marrow transplants until they are discharged from the hospital. Hand grip strength will be measured at three time points during hospitalization. Activity prior to and during hospitalization will be correlated with hand grip strength.


Secondary Outcome Measures :
  1. To determine barriers to activity for patients recovering from bone marrow transplantation and design an intervention to increase activity levels in patients post-transplantation [ Time Frame: From study intitiation for up to 5 years ]
    Barriers to physical activity will be determined using a validated questionnaire at three time points during hospitalization.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients who will be receiving a bone marrow transplant
Criteria
Patients who will be receiving a bone marrow transplant are eligible for this study
Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04115241


Contacts
Layout table for location contacts
Contact: Melissa Bates, PhD 319-335-7972 melissa-bates@uiowa.edu
Contact: Tina Knutson 319-384-5287 tina-knutson@uiowa.edu

Locations
Layout table for location information
United States, Iowa
University of Iowa Recruiting
Iowa City, Iowa, United States, 52242
Contact: Melissa Bates, PhD    319-384-5287    melissa-bates@uiowa.edu   
Contact: Tina Knutson    319-384-5287    tina-knutson@uiowa.edu   
Sponsors and Collaborators
Melissa Bates
Investigators
Layout table for investigator information
Principal Investigator: Melissa Bates, PhD University of Iowa
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Melissa Bates, Assistant Professor, University of Iowa
ClinicalTrials.gov Identifier: NCT04115241    
Other Study ID Numbers: 201807760-B
First Posted: October 3, 2019    Key Record Dates
Last Update Posted: October 3, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Melissa Bates, University of Iowa:
leukemia
multiple myeloma
myelodysplastic syndrome
stem cell transplant