Malignant Neoplasm
Conditions
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALExercise Intervention
Undergo resistance training program and cardiovascular exercise
OTHERQuality-of-Life Assessment
Ancillary studies
OTHERQuestionnaire Administration
Ancillary studies
BEHAVIORALTelephone-Based Intervention
Participate in phone calls with exercise physiologist
Sponsors
National Cancer Institute (NCI)
Conquer Cancer Foundation
Fred Hutchinson Cancer Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
13 Years to 39 Years
Healthy volunteers
No
Inclusion criteria
* \> 80 days but less than \<120 days post-autologous or allogeneic HCT for a malignancy. * 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
* Individuals who are determined by the investigators or primary treating physician to not be physically able to participate in an independent exercise intervention such as hospitalized, wheel chair bound, unable to ambulate independently, on oxygen. * Women who are pregnant will be excluded.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adherence rate | At day +200 post hematopoietic cell transplant (HCT) | Percentage of participants completing weekly follow-up phone calls |
| Enrollment rate | 200 Days | Percentage of eligible, approached patients enrolling in program |
| Completion rate | At day +200 post hematopoietic cell transplant (HCT) | Percentage of enrolled participants completing the full intervention |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Heart rate | Baseline to day +365 post HCT | — |
| Change in body composition | 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. |
| Change in muscular strength | 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. |
| Change in physical activity | Baseline to day +365 post HCT | Measured using Actigraph activity monitor |
| Change in quality of life (QOL) | Baseline to day +365 post HCT | Measured by the Patient-Reported Outcomes Measurement Information System |
| Incidence of adverse events | Up to day +200 post HCT | — |
| Blood pressure | Baseline to day +365 post HCT | — |
| Change in anthropometrics (BMI) | Baseline to day +365 post HCT | Measured by BMI; weight and height will be combined to report BMI in kg/m\^2 |
| Change in cardiometabolic profile (Fasting Glucose, Insulin and Lipid Profile) | 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. |
Countries
United States
Outcome results
None listed