Individualized Exercise Programs for Patients Receiving Chemotherapy for Newly Diagnosed Acute or Relapsed Myeloid Leukemia or Lymphoblastic Leukemia

Not Applicable

Completed

• Conditions: Depression; Fatigue; Leukemia; Musculoskeletal Complications; Psychosocial Effects of Cancer and Its Treatment

• Registration Number: NCT00499759
• Lead Sponsor: UNC Lineberger Comprehensive Cancer Center

Brief Summary

RATIONALE: An individualized exercise program may be effective in lessening fatigue and depression and improving quality of life in patients undergoing chemotherapy for leukemia.

PURPOSE: This clinical trial is studying how well individualized exercise programs work in patients receiving chemotherapy for newly diagnosed acute or relapsed myeloid leukemia or lymphoblastic leukemia.

Detailed Description

OBJECTIVES:

Primary

* Determine the effects, in terms of fitness and blood parameters, fatigue levels, and quality of life, of an individualized prescriptive exercise intervention in patients with newly diagnosed acute or relapsed myeloid or lymphoblastic leukemia undergoing chemotherapy.

Secondary

* Determine the feasibility of developing an exercise program for these patients.

* Assess the changes in cardiovascular endurance, muscular strength, selected blood parameters, and response of inflammatory proteins to exercise in these patients.

* Evaluate fatigue, depression, and quality of life of these patients.

OUTLINE: This is a pilot study.

Patients participate in an individualized prescriptive exercise intervention 3 to 4 times per week for 6 weeks (4 weeks in hospital, 2 weeks at home). Exercise begins concurrently with the first course (induction therapy) of chemotherapy. Each exercise session consist of 3-5 minutes of light stretching (stretching component), 5-10 minutes of cycling on the recumbent bicycle (cardiorespiratory component), 5-15 minutes of resistance training including hand dumbbells, exercise tubing, rubber bands, and fit balls (resistance training component), and 5-10 minutes of abdominal exercises (core muscles component).

Quality of life, fatigue, and depression are assessed at baseline and weekly during study intervention.

Blood samples are collected at baseline and at weeks 3 and 6 for cytokine analysis.

Study Timeline

• Study Start: 2006-02
• Primary Completion: 2007-01
• Study First Submitted: 2007-07-10
• Study First Submitted QC: 2007-07-10
• Study First Posted: 2007-07-11
• Study Completion: 2009-08
• Status Verified: 2012-03
• Last Update Submitted: 2012-03-05
• Last Update Posted: 2012-03-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Effects of an individualized prescriptive exercise intervention	6 weeks	All patients will participate in an individualized prescriptive exercise intervention 3 to 4 times per week (depending on the physical status of each patient during each week) for a period of 6 weeks. The exercise intervention will begin on week 1 of the study, the day after the first battery of initial assessments is concluded. Each exercise session will be divided into two bouts. One bout will be administered in the morning and the second one late in the afternoon

Secondary Outcome Measures

Name	Time	Method
Number of subjects experiencing fatigue, depression, and quality of life issues	6 weeks	The Functional Assessment of Cancer Therapy-General (FACT-G) will be administered to assess the levels of fatigue, and quality of life on weeks 2, 3 and 5 of the 6 week trial. The Center for Epidemiologic Studies Depression Scale (CES-D) will be also administered to explore the effects of exercise on depression on weeks 2, 3 and 5 of the 6 week trial.

Trial Locations

Locations (1)

Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill; 🇺🇸 Chapel Hill, North Carolina, United States