Resistance Training Program and Cardiovascular Exercise in Increasing Muscle Mass in Adolescent and Young Adult Stem Cell Transplant Survivors

Study Overview
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Brief Summary
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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
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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.

Official Title
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Pilot Study of a Resistance Training Intervention in Adolescent and Young Adult Hematopoietic Cell Transplant Survivors

Conditions
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Malignant Neoplasm

Intervention / Treatment
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* Behavioral: Exercise Intervention
* Other: Quality-of-Life Assessment
* Other: Questionnaire Administration
* Behavioral: Telephone-Based Intervention


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 13 Years
Maximum Age: 39 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Supportive Care (aerobic exercise and resistance training)<br>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. | Behavioral: Exercise Intervention<br>* Undergo resistance training program and cardiovascular exercise<br>Other: Quality-of-Life Assessment<br>* Ancillary studies<br>* Other names: Quality of Life Assessment;Other: Questionnaire Administration<br>* Ancillary studies<br>Behavioral: Telephone-Based Intervention<br>* Participate in phone calls with exercise physiologist<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Enrollment rate | Percentage of eligible, approached patients enrolling in program | 200 Days | 
| Completion rate | Percentage of enrolled participants completing the full intervention | At day +200 post hematopoietic cell transplant (HCT) | 
| Adherence rate | Percentage of participants completing weekly follow-up phone calls | At day +200 post hematopoietic cell transplant (HCT) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in physical activity | Measured using Actigraph activity monitor | Baseline to day +365 post HCT | 
| Change in physical activity | International Physical Activity Questionnaire (IPAQ) | Baseline to day +365 post HCT | 
| Change in anthropometrics (BMI) | Measured by BMI; weight and height will be combined to report BMI in kg/m^2 | Baseline to day +365 post HCT | 
| Change in cardiometabolic profile (Fasting Glucose, Insulin and Lipid Profile) | 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. | Baseline to day +365 post HCT | 
| Heart rate |  | Baseline to day +365 post HCT | 
| Change in body composition | 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. | Baseline to day +365 post HCT | 
| Change in muscular strength | 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. | Baseline to day +365 post HCT | 
| Blood pressure |  | Baseline to day +365 post HCT | 
| Change in quality of life (QOL) | Measured by the Patient-Reported Outcomes Measurement Information System | Baseline to day +365 post HCT | 
| Incidence of adverse events |  | Up to day +200 post HCT |