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Completed

NCT Number: NCT03672981

Resistance Training Program and Cardiovascular Exercise in Increasing Muscle Mass in Adolescent and Young Adult Stem 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.

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Key information

Age range

13 year–39 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, 98109, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Exercise Intervention

Behavioral

Undergo resistance training program and cardiovascular exercise

Quality-of-Life Assessment

Other

Ancillary studies

Other names: Quality of Life Assessment

Questionnaire Administration

Other

Ancillary studies

Telephone-Based Intervention

Behavioral

Participate in phone calls with exercise physiologist

Primary outcomes

  1. Enrollment rate

    Time frame: 200 Days

    Percentage of eligible, approached patients enrolling in program

  2. Completion rate

    Time frame: At day +200 post hematopoietic cell transplant (HCT)

    Percentage of enrolled participants completing the full intervention

  3. Adherence rate

    Time frame: At day +200 post hematopoietic cell transplant (HCT)

    Percentage of participants completing weekly follow-up phone calls

Secondary outcomes

  1. Change in physical activity

    Time frame: Baseline to day +365 post HCT

    Measured using Actigraph activity monitor

  2. Change in physical activity

    Time frame: Baseline to day +365 post HCT

    International Physical Activity Questionnaire (IPAQ)

  3. Change in anthropometrics (BMI)

    Time frame: Baseline to day +365 post HCT

    Measured by BMI; weight and height will be combined to report BMI in kg/m^2

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

    Time frame: Baseline to day +365 post HCT

    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.

  5. Heart rate

    Time frame: Baseline to day +365 post HCT

  6. Change in body composition

    Time frame: Baseline to day +365 post HCT

    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.

  7. Change in muscular strength

    Time frame: Baseline to day +365 post HCT

    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.

  8. Blood pressure

    Time frame: Baseline to day +365 post HCT

  9. Change in quality of life (QOL)

    Time frame: Baseline to day +365 post HCT

    Measured by the Patient-Reported Outcomes Measurement Information System

  10. Incidence of adverse events

    Time frame: Up to day +200 post HCT

Sponsors and collaborators

Lead sponsor

Fred Hutchinson Cancer Center

Other

Collaborators

  • Conquer Cancer Foundation
  • National Cancer Institute (NCI)

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Sep 17, 2018
Registry last updated
Nov 16, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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