Aerobic and Strengthening Exercise for Acute Leukemia

NCT00766311 | Completed

• 1 other identifier: XRCISL
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 4

Brief Summary

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.

Conditions

Acute Lymphoblastic Leukemia

Outcome Measures

Primary Outcomes (1)

• 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.

  1 year

Study Arms (1)

1

OTHER

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

Other: Gross Motor Function; Other: Knee extension strength; Other: Hand grip strength; Other: Flexibility; Other: Ankle range of motion; Other: Aerobic capacity; Other: Body composition and vital signs

Interventions

Gross Motor Function OTHER

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.

1

Knee extension strength OTHER

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."

1

Hand grip strength OTHER

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.

1

Flexibility OTHER

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.

1

Ankle range of motion OTHER

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

1

Aerobic capacity OTHER

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

1

Body composition and vital signs OTHER

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

1

Eligibility Criteria

• Age: 5 Years - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• St. Jude Children's Research Hospital: lead

Study Sites (4)

Oregon Health and Science University

Portland, Oregon, 97239, United States

Location

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

St. Jude Children's Research Hospital

Memphis, Tennessee, 38105, United States

Location

Vanderbilt Ingram Cancer Center

Nashville, Tennessee, 37215, United States

Location

Related Links

• St. Jude Children's Research Hospital

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Interventions

Hand Strength; Pliability; Body Composition

Condition Hierarchy (Ancestors)

Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Muscle Strength; Physical Examination; Diagnostic Techniques and Procedures; Diagnosis; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Mechanical Phenomena; Physical Phenomena; Biochemical Phenomena; Chemical Phenomena; Metabolism; Body Constitution; Physiological Phenomena

Study Officials

• Kirsten Ness, PT, PhD

  St. Jude Children's Research Hospital

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: October 1, 2008
• First Posted: October 3, 2008
• Study Start: January 1, 2008
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: January 9, 2012

Record last verified: 2012-01

Locations

US (4)