NCT04115241

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.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
49mo left

Started May 2019

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
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

Study Progress63%
May 2019May 2030

Study Start

First participant enrolled

May 23, 2019

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

October 1, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 3, 2019

Completed
10.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 23, 2030

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 23, 2030

Last Updated

November 10, 2025

Status Verified

November 1, 2025

Enrollment Period

11 years

First QC Date

October 1, 2019

Last Update Submit

November 5, 2025

Conditions

Keywords

leukemiamultiple myelomamyelodysplastic syndromestem cell transplant

Outcome Measures

Primary Outcomes (3)

  • To determine the correlation between activity levels and length of stay in hospital

    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.

    From study intitiation for up to 5 years

  • To determine the correlation between activity levels and quality of life

    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

    From study intitiation for up to 5 years

  • To determine the correlation between activity levels and hand grip strength

    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.

    From study intitiation for up to 5 years

Secondary Outcomes (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

    From study intitiation for up to 5 years

Interventions

ActigraphDEVICE

Actigraphs are non-invasive, wearable devices that measure activity levels using an accelerometer

The purpose of this test is to measure the maximum isometric strength of the hand and forearm muscles

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients who will be receiving a bone marrow transplant

Patients who will be receiving a bone marrow transplant are eligible for this study

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

University of Iowa

Iowa City, Iowa, 52242, United States

RECRUITING

MeSH Terms

Conditions

LeukemiaMultiple MyelomaMyelodysplastic Syndromes

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesNeoplasms, Plasma CellHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHemorrhagic DisordersLymphoproliferative DisordersImmunoproliferative DisordersImmune System DiseasesBone Marrow Diseases

Study Officials

  • Michael Tomasson, MD

    University of Iowa

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Michael Tomasson, MD

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor Internal Medicine

Study Record Dates

First Submitted

October 1, 2019

First Posted

October 3, 2019

Study Start

May 23, 2019

Primary Completion (Estimated)

May 23, 2030

Study Completion (Estimated)

May 23, 2030

Last Updated

November 10, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

Locations