Clinical trial NCT03672981: Resistance Training Program and Cardiovascular Exercise in Increasing Muscle Mass in Adolescent and Young Adult Stem Cell Transplant Survivors
Official title: Pilot Study of a Resistance Training Intervention in Adolescent and Young Adult Hematopoietic Cell Transplant Survivors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Malignant Neoplasm
Lead sponsor: Fred Hutchinson Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
name: Conquer Cancer Foundation
First posted: 2018-09-17
Enrollment: 20
Sex: ALL
Minimum age (years): 13
Maximum age (years): 39
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Enrollment rate
timeFrame: 200 Days
measure: Completion rate
timeFrame: At day +200 post hematopoietic cell transplant (HCT)
measure: Adherence rate
timeFrame: At day +200 post hematopoietic cell transplant (HCT)
Secondary outcomes:
measure: Change in physical activity
timeFrame: Baseline to day +365 post HCT
measure: Change in physical activity
timeFrame: Baseline to day +365 post HCT
measure: Change in anthropometrics (BMI)
timeFrame: Baseline to day +365 post HCT
measure: Change in cardiometabolic profile (Fasting Glucose, Insulin and Lipid Profile)
timeFrame: Baseline to day +365 post HCT
measure: Heart rate
timeFrame: Baseline to day +365 post HCT
measure: Change in body composition
timeFrame: Baseline to day +365 post HCT
measure: Change in muscular strength
timeFrame: Baseline to day +365 post HCT
measure: Blood pressure
timeFrame: Baseline to day +365 post HCT
measure: Change in quality of life (QOL)
timeFrame: Baseline to day +365 post HCT
measure: Incidence of adverse events
timeFrame: Up to day +200 post HCT
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Fred Hutch/University of Washington Cancer Consortium
state: Washington
Study officials:
affiliation: Fred Hutch/University of Washington Cancer Consortium
name: Tyler Ketterl
role: PRINCIPAL_INVESTIGATOR
References: