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

NCT03672981 | Completed

• 4 other identifiers: 10046NCI-2018-01254P30CA015704RG1001740
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Malignant Neoplasm

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (10)

• Change in physical activity

  Baseline to day +365 post HCT

• Change in physical activity

  Baseline to day +365 post HCT

• Change in anthropometrics (BMI)

  Baseline to day +365 post HCT

• Change in cardiometabolic profile (Fasting Glucose, Insulin and Lipid Profile)

  Baseline to day +365 post HCT

• Heart rate

  Baseline to day +365 post HCT

Study Arms (1)

Supportive Care (aerobic exercise and resistance training)

EXPERIMENTAL

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; Other: Quality-of-Life Assessment; Other: Questionnaire Administration; Behavioral: Telephone-Based Intervention

Interventions

Exercise Intervention BEHAVIORAL

Undergo resistance training program and cardiovascular exercise

Supportive Care (aerobic exercise and resistance training)

Quality-of-Life Assessment OTHER

Ancillary studies

Also known as: Quality of Life Assessment

Supportive Care (aerobic exercise and resistance training)

Questionnaire Administration OTHER

Ancillary studies

Supportive Care (aerobic exercise and resistance training)

Telephone-Based Intervention BEHAVIORAL

Participate in phone calls with exercise physiologist

Supportive Care (aerobic exercise and resistance training)

Eligibility Criteria

• Age: 13 Years - 39 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• \> 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fred Hutchinson Cancer Center: lead
• National Cancer Institute (NCI): collaborator
• Conquer Cancer Foundation: collaborator

Study Sites (1)

Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, 98109, United States

Location

MeSH Terms

Conditions

Neoplasms

Study Officials

• Tyler Ketterl

  Fred Hutch/University of Washington Cancer Consortium

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 19, 2018
• First Posted: September 17, 2018
• Study Start: November 21, 2018
• Primary Completion: October 31, 2020
• Study Completion: October 31, 2020
• Last Updated: November 16, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)