Resistance Training Program and Cardiovascular Exercise in Increasing Muscle Mass in Adolescent and Young Adult Stem Cell Transplant Survivors
NCT ID: NCT03672981
Last Updated: 2020-11-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
20 participants
INTERVENTIONAL
2018-11-21
2020-10-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
I. Determine the feasibility of a 12-week resistance training (RT) intervention in adolescent and young adult (AYA) hematopoietic cell transplant (HCT) survivors starting +100 days post-HCT.
SECONDARY OBJECTIVES:
I. Examine the change from baseline of a RT intervention on muscle strength and body composition at day +200 and day +365.
II. Determine the effectiveness of RT exercise on improving the cardio-metabolic risk factor profile at day +200 and day +365.
III. Determine the effectiveness of RT exercise on improving quality of life (QOL) measures.
IV. Compare day +80 and day +365 assessments to subjects in a historical control population.
OUTLINE:
Patients undergo moderately intense aerobic/cardiovascular exercise over 30-60 minutes and complete 1-2 sets of 8 to 10 resistance/strength training exercises, 8 to 12 repetitions of each exercise, 3 days per week for 12 weeks. Patients also participate in weekly phone calls with an exercise physiologist to ensure adherence to the program and to provide support.
After completion of study intervention, patients are followed up within 2 weeks, then at 365 days post HCT.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
SUPPORTIVE_CARE
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Supportive Care (aerobic exercise and resistance training)
Patients undergo moderately intense aerobic/cardiovascular exercise over 30-60 minutes and complete 1-2 sets of 8 to 10 resistance/strength training exercises, 8 to 12 repetitions of each exercise, 3 days per week for 12 weeks. Patients also participate in weekly phone calls with an exercise physiologist to ensure adherence to the program and to provide support.
Exercise Intervention
Undergo resistance training program and cardiovascular exercise
Quality-of-Life Assessment
Ancillary studies
Questionnaire Administration
Ancillary studies
Telephone-Based Intervention
Participate in phone calls with exercise physiologist
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Exercise Intervention
Undergo resistance training program and cardiovascular exercise
Quality-of-Life Assessment
Ancillary studies
Questionnaire Administration
Ancillary studies
Telephone-Based Intervention
Participate in phone calls with exercise physiologist
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Platelet transfusion independent.
* Fully mobile on an independent basis.
* For patients who have been on steroid therapy for graft versus (vs) host disease, doses of prednisone must be =\< 1.0 mg/kg/day and they must be on a tapering schedule.
* English speaking.
Exclusion Criteria
* Women who are pregnant will be excluded.
13 Years
39 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
National Cancer Institute (NCI)
NIH
Conquer Cancer Foundation
OTHER
Fred Hutchinson Cancer Center
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Tyler Ketterl
Role: PRINCIPAL_INVESTIGATOR
Fred Hutch/University of Washington Cancer Consortium
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
NCI-2018-01254
Identifier Type: REGISTRY
Identifier Source: secondary_id
10046
Identifier Type: OTHER
Identifier Source: secondary_id
RG1001740
Identifier Type: OTHER
Identifier Source: secondary_id
10046
Identifier Type: -
Identifier Source: org_study_id