Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, 98109, United States
NCT Number: NCT03672981
This pilot trial studies how well a resistance training program and cardiovascular exercise work in increasing muscle mass in adolescent and young adult stem cell transplant survivors. Resistance training and cardiovascular exercise may increase physical activity, muscular strength and improve lean body mass which is beneficial to improving the overall health of stem cell transplant survivors.
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Notify Me13 year–39 year
All sexes
Interventional
Not applicable
Seattle, Washington, 98109, United States
PRIMARY OBJECTIVES:
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Undergo resistance training program and cardiovascular exercise
Ancillary studies
Other names: Quality of Life Assessment
Ancillary studies
Participate in phone calls with exercise physiologist
Time frame: 200 Days
Percentage of eligible, approached patients enrolling in program
Time frame: At day +200 post hematopoietic cell transplant (HCT)
Percentage of enrolled participants completing the full intervention
Time frame: At day +200 post hematopoietic cell transplant (HCT)
Percentage of participants completing weekly follow-up phone calls
Time frame: Baseline to day +365 post HCT
Measured using Actigraph activity monitor
Time frame: Baseline to day +365 post HCT
International Physical Activity Questionnaire (IPAQ)
Time frame: Baseline to day +365 post HCT
Measured by BMI; weight and height will be combined to report BMI in kg/m^2
Time frame: Baseline to day +365 post HCT
Testing will be performed on patient blood samples. Changes will be calculated as score (approximately day +200) - score (approximately day+100). All variables will be described based on their distributions (means, standard deviations if normally distributed, medians and IQRs otherwise). A t-test will be used to compare means between baseline and follow-up time periods.
Time frame: Baseline to day +365 post HCT
Time frame: Baseline to day +365 post HCT
Measured using dual-energy x-ray absorptiometry (DXA). Changes will be calculated as score (approximately day +200) - score (approximately day+100). All variables will be described based on their distributions (means, standard deviations if normally distributed, medians and IQRs otherwise). A t-test will be used to compare means between baseline and follow-up time periods.
Time frame: Baseline to day +365 post HCT
Strength testing will include hand grip strength, one repetition maximum chest press, one repetition maximum leg press and the 6 minute walk test. Changes will be calculated as score (approximately day +200) - score (approximately day +100). All variables will be described based on their distributions (means, standard deviations if normally distributed, medians and IQRs otherwise). A t-test will be used to compare means between baseline and follow-up time periods.
Time frame: Baseline to day +365 post HCT
Time frame: Baseline to day +365 post HCT
Measured by the Patient-Reported Outcomes Measurement Information System
Time frame: Up to day +200 post HCT
Fred Hutchinson Cancer Center
Other
Pilot Study of a Resistance Training Intervention in Adolescent and Young Adult Hematopoietic Cell Transplant Survivors
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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