Exercise Program for Adolescents and Young Adults With Cancer

October 14, 2011 updated by: M.D. Anderson Cancer Center

Feasibility, Safety, and Effect of an Exercise Program for Adolescents and Young Adults With Cancer

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

37

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • UT MD Anderson Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years to 25 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Exercise program
Daily (Monday-Friday) 45-minute group physical exercise program during each hospital admission for three months or individual 20 minute session bedside.
Behavioral: Exercise program
Daily group or personal exercise programs designed to promote flexibility, endurance, and strength.
Behavioral: Questionnaires
Questionnaires taking 15 minutes to complete.
Other Names:
  • Survey

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Exercise Participation Rate
Time Frame: Baseline to 3 months
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.
Baseline to 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

M.D. Anderson Cancer Center

Investigators

  • Principal Investigator: Martha Askins, PhD, M.D. Anderson Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2003

Primary Completion (Actual)

November 1, 2007

Study Completion (Actual)

October 1, 2010

Study Registration Dates

First Submitted

July 16, 2007

First Submitted That Met QC Criteria

July 17, 2007

First Posted (Estimate)

July 18, 2007

Study Record Updates

Last Update Posted (Estimate)

October 17, 2011

Last Update Submitted That Met QC Criteria

October 14, 2011

Last Verified

October 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ID02-329

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe