Aerobic and Strengthening Exercise for Acute Leukemia - Full Text View

Sponsored by:	St. Jude Children's Research Hospital
Information provided by:	St. Jude Children's Research Hospital
ClinicalTrials.gov Identifier:	NCT00766311

Purpose

Survivors of childhood leukemia have muscle weakness and impaired mobility (physical performance), a higher than expected frequency of obesity, and early mortality from cardiovascular disease. Treatment related neuropathy, cardiotoxicity and general cachexia may complicate physical performance and establish a pattern of sedentary behavior that may lead to a lifetime of inactivity. There is limited evidence that children being treated for leukemia benefit from home exercise programs during the maintenance phase of therapy, particularly in terms of muscle strength and range of motion. However, there are no established guidelines regarding the prescription of exercise for children diagnosed with leukemia. We propose to test the feasibility of an exercise intervention among children being treated for acute lymphoblastic leukemia (ALL) and hypothesize that children who participate in the exercise intervention will demonstrate improvements in gross motor function, strength, flexibility, and cardio respiratory fitness, and that they will have more favorable body composition when compared to the children who are assigned to the usual activity group.

Condition	Intervention
Acute Lymphoblastic Leukemia	Other: Gross Motor Function Other: Knee extension strength Other: Hand grip strength Other: Flexibility Other: Ankle range of motion Other: Aerobic capacity Other: Body compositon and vital signs

MedlinePlus related topics: Exercise and Physical Fitness Leukemia, Childhood

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Supportive Care, Open Label, Single Group Assignment
Official Title:	Aerobic and Strengthening Exercise for Acute Leukemia

Further study details as provided by St. Jude Children's Research Hospital:

Primary Outcome Measures:

To determine the feasibility of an aerobic and strengthening exercise intervention trial among children during maintenance therapy for childhood ALL by evaluating participant accrual, participant compliance and burden to institutional staff. [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment:	20
Study Start Date:	January 2008
Estimated Primary Completion Date:	March 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1 This single-arm feasibility trial will evaluate the administration of an aggressive exercise regimen.	Other: Gross Motor Function The Bruinicks-Osteretsky Test of Motor Proficiency Version 2 (BOT-2) will be used to measure participants' motor function. The test is norm- referenced and designed to test motor function in children and adolescents 4 -21 years of age. The motor composite score describes overall motor abilities and is comprised of fine motor control, manual coordination, body coordination, and strength and agility.We will use the total motor composite to describe overall motor function. Other: Knee extension strength Maximum isometric knee extension strength will be measured with the subject seated in an adjustable straight-back chair. The pelvis will be fixed by an adjustable strap and the knee flexed to 45 degrees. The participant will exert a maximal voluntary force until their contraction is "broken." Other: Hand grip strength Hand grip strength in kilograms will be measured using a Jamar hand held dynamometer (Sammons Preston Rolyan, Nottinghamshire, UK). Participants will be seated with the shoulder at 0-10 degrees and the elbow in 90 degrees of flexion. The forearm will be positioned in neutral. Each participant will complete three trials, and the average used for analysis. Other: Flexibility Flexibility will be measured by having the participant perform the sit and reach test. A yardstick is placed on a firm flat surface and tape is placed across it at a right angle to the 15 inch mark. The participant sits with the yardstick between the legs with legs extended at right angles to the taped line on the floor. The heels of the feet touch the edge of the taped line and are 10-12 inches apart. The participant reaches forward with both hands as far as possible, keeping the hands parallel. The best value for three trials, in centimeters, at the most distant point of the fingertips is recorded. Other: Ankle range of motion Ankle dorsiflexion active and passive range of motion will be measured with a goniometer. The goniometer is a reliable and valid measure of active and passive range of motion if the rater uses standard procedures Other: Aerobic capacity Participants will complete the modified Cooper test where they walk in a corridor as fast as possible for six minutes. The distance is recorded in meters and can also be used to estimate peak V02 Other: Body compositon and vital signs Height, body mass index, waist circumference, and blood pressure will be measured.

Arms

Assigned Interventions

1

This single-arm feasibility trial will evaluate the administration of an aggressive exercise regimen.

Other: Gross Motor Function

The Bruinicks-Osteretsky Test of Motor Proficiency Version 2 (BOT-2) will be used to measure participants' motor function. The test is norm- referenced and designed to test motor function in children and adolescents 4 -21 years of age. The motor composite score describes overall motor abilities and is comprised of fine motor control, manual coordination, body coordination, and strength and agility.We will use the total motor composite to describe overall motor function.

Other: Knee extension strength

Maximum isometric knee extension strength will be measured with the subject seated in an adjustable straight-back chair. The pelvis will be fixed by an adjustable strap and the knee flexed to 45 degrees. The participant will exert a maximal voluntary force until their contraction is "broken."

Other: Hand grip strength

Hand grip strength in kilograms will be measured using a Jamar hand held dynamometer (Sammons Preston Rolyan, Nottinghamshire, UK). Participants will be seated with the shoulder at 0-10 degrees and the elbow in 90 degrees of flexion. The forearm will be positioned in neutral. Each participant will complete three trials, and the average used for analysis.

Other: Flexibility

Flexibility will be measured by having the participant perform the sit and reach test. A yardstick is placed on a firm flat surface and tape is placed across it at a right angle to the 15 inch mark. The participant sits with the yardstick between the legs with legs extended at right angles to the taped line on the floor. The heels of the feet touch the edge of the taped line and are 10-12 inches apart. The participant reaches forward with both hands as far as possible, keeping the hands parallel. The best value for three trials, in centimeters, at the most distant point of the fingertips is recorded.

Other: Ankle range of motion

Ankle dorsiflexion active and passive range of motion will be measured with a goniometer. The goniometer is a reliable and valid measure of active and passive range of motion if the rater uses standard procedures

Other: Aerobic capacity

Participants will complete the modified Cooper test where they walk in a corridor as fast as possible for six minutes. The distance is recorded in meters and can also be used to estimate peak V02

Other: Body compositon and vital signs

Height, body mass index, waist circumference, and blood pressure will be measured.

Show Detailed Description

Eligibility

Ages Eligible for Study:	5 Years to 10 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Diagnosed with childhood ALL when age greater than 1 and less than 10 at diagnosis, white blood cell count less than 50,000 cells/microliter and receiving continuation/maintenance therapy based on the original disease classification
In first remission
Maintenance phase of therapy (Eligibility extends from Day 0 of maintenance therapy up to six months prior to the completion of therapy)
Current age 5-10 years
Modified Lansky performance scale must score 60 or higher at time of enrollment
Written informed consent

Exclusion Criteria:

Lower extremity amputation or congenital deformity of lower limb
History of pre-existing neuron-motor or neuro-developmental disorder prior to diagnosis of childhood ALL, such as mental retardation, Down syndrome, cerebral palsy, and traumatic brain injury
Pre-existing heart or lung disease by clinical history
Children with specific contraindications to exercise will be offered enrollment after this transient condition is resolved: severe anemia (Hemoglobin less than 8 g/dl), fever greater than 38 degrees Centigrade, platelets less than 50*109/ul, neutrophil counts less than 0.5*109/ul.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00766311

Contacts

Contact: Kirsten Ness, PT,PhD

866-278-5833

info@stjude.org

Locations

United States, Minnesota
University of Minnesota	Not yet recruiting
Minneapolis, Minnesota, United States, 55404
Contact: Joseph Neglia, MD, MPH 612-813-5940
Principal Investigator: Joseph Neglia, MD, MPH
United States, Oregon
Oregon Health and Science University	Not yet recruiting
Portland, Oregon, United States, 97239
Contact: Linda Stork, MD 503-494-1543
Principal Investigator: Linda Stork, MD
United States, Pennsylvania
The Children's Hospital of Philadelphia	Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Jill Ginsberg, MD 215-590-1000
Principal Investigator: Jill Ginsberg, MD
United States, Tennessee
St. Jude Children's Research Hospital	Recruiting
Memphis, Tennessee, United States, 38105
Contact: Kirsten Ness, PT, PhD 866-278-5833 info@stjude.org
Principal Investigator: Kirsten Ness, PT, PhD

Sponsors and Collaborators

St. Jude Children's Research Hospital

Investigators

Principal Investigator:

Kirsten Ness, PT, PhD

St. Jude Children's Research Hospital

More Information

Related Info This link exits the ClinicalTrials.gov site

Responsible Party:	St. Jude Children's Research Hospital ( Kirsten Ness, PT, PhD )
Study ID Numbers:	XRCISL
Study First Received:	October 1, 2008
Last Updated:	October 2, 2008
ClinicalTrials.gov Identifier:	NCT00766311
Health Authority:	United States: Institutional Review Board

Study placed in the following topic categories:

Lymphatic Diseases
Leukemia
Leukemia, Lymphoid
Immunoproliferative Disorders

Precursor Cell Lymphoblastic Leukemia-Lymphoma
Lymphoproliferative Disorders
Lymphoma

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Histologic Type
Immune System Diseases

ClinicalTrials.gov processed this record on January 16, 2009