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Exercise Program for Adolescents and Young Adults With Cancer

Primary Purpose

Leukemia, Lymphoma

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Exercise program
Questionnaires
Sponsored by
M.D. Anderson Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Leukemia focused on measuring Leukemia, Lymphoma, Exercise, Quality of Life, Questionnaire, Survey

Eligibility Criteria

12 Years - 25 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Adolescents and young adults with leukemia/lymphoma between the ages of 12 and 25 years old.
  2. Leukemia/lymphoma patients admitted for chemotherapy with an anticipated hospital stay of at least three days.

Exclusion Criteria:

1. Patients with an underlying condition that precludes moderate exercise due to safety.

Sites / Locations

  • UT MD Anderson Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Exercise program

Arm Description

Daily (Monday-Friday) 45-minute group physical exercise program during each hospital admission for three months or individual 20 minute session bedside.

Outcomes

Primary Outcome Measures

Exercise Participation Rate
Participation in exercise program as measured through group attendance examined from study entry to three months later. Exercise participation rate was examined across 4 timepoints corresponding to inpatient chemotherapy treatments, and calculated as number of those exercising in each period divided by total participants in that period.

Secondary Outcome Measures

Full Information

First Posted
July 16, 2007
Last Updated
October 14, 2011
Sponsor
M.D. Anderson Cancer Center
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1. Study Identification

Unique Protocol Identification Number
NCT00502749
Brief Title
Exercise Program for Adolescents and Young Adults With Cancer
Official Title
Feasibility, Safety, and Effect of an Exercise Program for Adolescents and Young Adults With Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
October 2011
Overall Recruitment Status
Completed
Study Start Date
February 2003 (undefined)
Primary Completion Date
November 2007 (Actual)
Study Completion Date
October 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
M.D. Anderson Cancer Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This pilot study will examine the safety, feasibility, and effect on quality of life of moderate physical activity on adolescent and young adult patients who are admitted to the hospital periodically for routine chemotherapy. Patients will be asked to participate in daily physical exercise during hospital admissions over a three-month period. Exercise sessions will be monitored and guided by M.D. Anderson physical therapists, a personal trainer, and Dr. Michael Rytting, pediatric oncologist. The personal trainer will meet with each participant for reinforcement and to provide an opportunity for exercise between hospitalizations. If results are positive, the study will be extended to a larger cohort of patients.
Detailed Description
Patients who are staying at M.D. Anderson for inpatient chemotherapy treatment will take part in this study. Participants in this study will be asked to take part in either mild physical exercise by themselves for 20 minutes a day, or group exercise sessions of moderate intensity once a day. Each participant will be evaluated by a physical therapist before participation. Exercise programs will be designed for each individual. Participants will be encouraged to attend group sessions and continue the exercise program during the time they are outpatients. Participants will also have the opportunity to work with a personal trainer. The group exercise program takes from 45 minutes to one hour, and will be performed under the guidance of certified physical therapists and a personal trainer in the Pedi-Dome located on the ninth floor of the Alkek Tower of M.D. Anderson. Participants who are not feeling well enough to come to the Pedi-Dome on a given day will have the opportunity to exercise in their hospital rooms with a physical therapist or trainer for 20 minutes. The exercises are designed to promote flexibility, endurance, and strength. They include activities such as stretching, pilates-yoga, aerobics, step aerobic training, use of stationery bikes, and the use of therapeutic exercise balls, cuff weights, and dumbbells. The activities will be tailored to each individual's abilities and special needs. The total length of participation in this study is three months. Participants will be asked to exercise each day that they are an inpatient and well enough to participate. Participants will be encouraged to continue exercise and participation in the exercise program when they are outpatients, but it will not be required. Participants will fill out short questionnaires and be evaluated for quality of life, fatigue, physical strength, and medical and nutritional status four times: at the time of enrollment in the study, and at one, two, and three months after enrollment. The questionnaires will take about 15 minutes to complete. This is an investigational study. A total of 40 patients will take part in this study. All will be enrolled at M.D. Anderson.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Leukemia, Lymphoma
Keywords
Leukemia, Lymphoma, Exercise, Quality of Life, Questionnaire, Survey

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
37 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Exercise program
Arm Type
Experimental
Arm Description
Daily (Monday-Friday) 45-minute group physical exercise program during each hospital admission for three months or individual 20 minute session bedside.
Intervention Type
Behavioral
Intervention Name(s)
Exercise program
Intervention Description
Daily group or personal exercise programs designed to promote flexibility, endurance, and strength.
Intervention Type
Behavioral
Intervention Name(s)
Questionnaires
Other Intervention Name(s)
Survey
Intervention Description
Questionnaires taking 15 minutes to complete.
Primary Outcome Measure Information:
Title
Exercise Participation Rate
Description
Participation in exercise program as measured through group attendance examined from study entry to three months later. Exercise participation rate was examined across 4 timepoints corresponding to inpatient chemotherapy treatments, and calculated as number of those exercising in each period divided by total participants in that period.
Time Frame
Baseline to 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adolescents and young adults with leukemia/lymphoma between the ages of 12 and 25 years old. Leukemia/lymphoma patients admitted for chemotherapy with an anticipated hospital stay of at least three days. Exclusion Criteria: 1. Patients with an underlying condition that precludes moderate exercise due to safety.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Martha Askins, PhD
Organizational Affiliation
M.D. Anderson Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
UT MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.mdanderson.org
Description
MD Anderson Cancer Center

Learn more about this trial

Exercise Program for Adolescents and Young Adults With Cancer

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