Exercise Program for Adolescents and Young Adults With Cancer

Sponsor

M.D. Anderson Cancer Center (Other)

Overall Status

Completed

CT.gov ID

NCT00502749

Collaborator

(none)

Enrollment

Location

Arm

Duration (Months)

0.4

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Leukemia Lymphoma	Behavioral: Exercise program Behavioral: Questionnaires	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

37 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

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

Study Start Date :

Feb 1, 2003

Actual Primary Completion Date :

Nov 1, 2007

Actual Study Completion Date :

Oct 1, 2010

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Exercise Participation Rate [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

12 Years to 25 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.