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

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

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.

Study Overview

• Status: Completed
• Conditions: Malignant Neoplasm
• Intervention / Treatment: Other: Quality-of-Life Assessment; Other: Questionnaire Administration; Behavioral: Exercise Intervention; Behavioral: Telephone-Based Intervention

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.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Washington
    • Seattle, Washington, United States, 98109
      • Fred Hutch/University of Washington Cancer Consortium

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 13 years to 39 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: 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.

Other: Quality-of-Life Assessment; Ancillary studies; Other Names: Quality of Life Assessment; Other: Questionnaire Administration; Ancillary studies; Behavioral: Exercise Intervention; Undergo resistance training program and cardiovascular exercise; Behavioral: Telephone-Based Intervention; Participate in phone calls with exercise physiologist

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Fred Hutchinson Cancer Center
• Collaborators: National Cancer Institute (NCI); Conquer Cancer Foundation
• Investigators: Principal Investigator: Tyler Ketterl, Fred Hutch/University of Washington Cancer Consortium

Study record dates

Study Major Dates

• Study Start (Actual): November 21, 2018
• Primary Completion (Actual): October 31, 2020
• Study Completion (Actual): October 31, 2020

Study Registration Dates

• First Submitted: July 19, 2018
• First Submitted That Met QC Criteria: September 13, 2018
• First Posted (Actual): September 17, 2018

Study Record Updates

• Last Update Posted (Actual): November 16, 2020
• Last Update Submitted That Met QC Criteria: November 13, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: 10046 (Registry Identifier: DAIDS ES); P30CA015704 (U.S. NIH Grant/Contract); NCI-2018-01254 (Registry Identifier: CTRP (Clinical Trial Reporting Program)); RG1001740 (Other Identifier: Fred Hutch/University of Washington Cancer Consortium)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No