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

Malignant Neoplasm Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03672981
• Other study ID #: 10046
• Secondary ID: NCI-2018-0125410
• Status: Completed
• Phase: N/A
• Start date: November 21, 2018
• Est. completion date: October 31, 2020

Study information

• Verified date: November 2020
• Source: Fred Hutchinson Cancer Research Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: October 31, 2020
• Est. primary completion date: October 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 13 Years to 39 Years

Eligibility

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.

Related Conditions & MeSH terms

• Malignant Neoplasm
• Neoplasms

Intervention

Behavioral:
• Exercise Intervention
Undergo resistance training program and cardiovascular exercise

Other:
• Quality-of-Life Assessment
Ancillary studies
• Questionnaire Administration
Ancillary studies

Behavioral:
• Telephone-Based Intervention
Participate in phone calls with exercise physiologist

Locations

Country	Name	City	State
United States	Fred Hutch/University of Washington Cancer Consortium	Seattle	Washington

Sponsors (3)

Lead Sponsor	Collaborator
Fred Hutchinson Cancer Research Center	Conquer Cancer Foundation, National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Enrollment rate	Percentage of eligible, approached patients enrolling in program	200 Days
Primary	Completion rate	Percentage of enrolled participants completing the full intervention	At day +200 post hematopoietic cell transplant (HCT)
Primary	Adherence rate	Percentage of participants completing weekly follow-up phone calls	At day +200 post hematopoietic cell transplant (HCT)
Secondary	Change in physical activity	Measured using Actigraph activity monitor	Baseline to day +365 post HCT
Secondary	Change in physical activity	International Physical Activity Questionnaire (IPAQ)	Baseline to day +365 post HCT
Secondary	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
Secondary	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
Secondary	Heart rate		Baseline to day +365 post HCT
Secondary	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
Secondary	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
Secondary	Blood pressure		Baseline to day +365 post HCT
Secondary	Change in quality of life (QOL)	Measured by the Patient-Reported Outcomes Measurement Information System	Baseline to day +365 post HCT
Secondary	Incidence of adverse events		Up to day +200 post HCT