Fitness in Allogeneic Stem Cell Transplantation

Completed · Not applicable

Conditions studied: Hematopoietic Stem Cell Transplantation

In brief

Purpose: The primary hypothesis of this study is that the combination of interval exercise training (IET) as well as motivational accelerometry (MA) delivered both as a 5-12 week intervention that will improve cardiorespiratory fitness in patients preparing to undergo allogeneic hematopoietic cell transplantation (alloHCT). MA is not an established term, but in respect to this study, MA refers to the use of wearable accelerometry paired with regular intervals of physical activity coaching from members of the study staff during the IET training. The study will also look at several secondary endpoints including the association of the intervention with changes in cyclin-dependent kinase inhibitor 2A, multiple tumor suppressor 1 (p16INK4a), and the association of the intervention with changes in symptoms and quality of life before and after transplant. Participants: 60 patients will be randomized into two groups, 30 in the intervention group consisting of both IET and MA, and 30 in the control group applying usual care and use of wearable accelerometry without motivational physical activity coaching. Procedures (methods): Results of this study will inform a randomized, multi-site study of a pre-transplant exercise intervention.

Key facts

Study ID

NCT02564458

Run by

UNC Lineberger Comprehensive Cancer Center

People needed

35

Starts

2015-09-01

Expected to finish

2018-06-01

Last updated by the study team

2018-07-06

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 18 to 75 years of age, inclusive
• Verification of a functioning email address and access to electronic device(s) with the ability to charge and sync the FitBit Surge
• Planned allogeneic stem cell transplant with schedule that accommodates at least a 5 week exercise intervention, but not greater than 12 weeks
• Ability to understand and communicate in English
• Ability to understand and comply with study procedures for the entire length of the study
• Willing and able to provide written informed consent

You may not qualify if…

• Dementia, altered mental status, or psychiatric condition that would prohibit the understanding or rendering of informed consent
• Co-morbid illness that would contraindicate maximal effort exercise testing or participation in regular exercise programming as determined by the treating physician or exercise physiologist
• Concurrent radiation, chemotherapeutic, or investigational therapy other than transplant related therapy
• Concurrent enrollment in LCCC 1404

Where it is running

• Lineberger Comprehensive Cancer Center — Chapel Hill, North Carolina, United States

Full record on ClinicalTrials.gov

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