NCT00502749

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
37

participants targeted

Target at P25-P50 for not_applicable leukemia

Timeline
Completed

Started Feb 2003

Longer than P75 for not_applicable leukemia

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2003

Completed
4.5 years until next milestone

First Submitted

Initial submission to the registry

July 16, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 18, 2007

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2007

Completed
2.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2010

Completed
Last Updated

October 17, 2011

Status Verified

October 1, 2011

Enrollment Period

4.8 years

First QC Date

July 16, 2007

Last Update Submit

October 14, 2011

Conditions

Keywords

LeukemiaLymphomaExerciseQuality of LifeQuestionnaireSurvey

Outcome Measures

Primary Outcomes (1)

  • 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.

    Baseline to 3 months

Study Arms (1)

Exercise program

EXPERIMENTAL

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

Behavioral: Exercise programBehavioral: Questionnaires

Interventions

Daily group or personal exercise programs designed to promote flexibility, endurance, and strength.

Exercise program
QuestionnairesBEHAVIORAL

Questionnaires taking 15 minutes to complete.

Also known as: Survey
Exercise program

Eligibility Criteria

Age12 Years - 25 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UT MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

MeSH Terms

Conditions

LeukemiaLymphomaMotor Activity

Interventions

Resistance TrainingSurveys and Questionnaires

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesBehavior

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesPhysical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaData CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Martha Askins, PhD

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 16, 2007

First Posted

July 18, 2007

Study Start

February 1, 2003

Primary Completion

November 1, 2007

Study Completion

October 1, 2010

Last Updated

October 17, 2011

Record last verified: 2011-10

Locations