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

Fred Hutchinson Cancer Center (FHCC) logo

Fred Hutchinson Cancer Center (FHCC)

Status

Completed

Conditions

Malignant Neoplasm

Treatments

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

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT03672981
NCI-2018-01254 (Registry Identifier)
P30CA015704 (U.S. NIH Grant/Contract)
RG1001740 (Other Identifier)
10046 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment

20 patients

Sex

All

Ages

13 to 39 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Supportive Care

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

20 participants in 1 patient group

Supportive Care (aerobic exercise and resistance training)
Experimental group
Description:
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.
Treatment:
Behavioral: Exercise Intervention
Other: Quality-of-Life Assessment
Other: Questionnaire Administration
Behavioral: Telephone-Based Intervention

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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