Individualized Exercise Programs for Patients Receiving Chemotherapy for Newly Diagnosed Acute or Relapsed Myeloid Leukemia or Lymphoblastic Leukemia
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.
Psychosocial Effects of Cancer and Its Treatment
Behavioral: Resting vitals
Behavioral: Body Composition
Behavioral: Timed Get-up and Go test (TGUG).
Behavioral: Cardiorespiratory assessment
Behavioral: Handgrip evaluation
Behavioral: Dynamic muscular endurance
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
|Official Title:||In-Hospital Individualized Prescriptive Exercise Intervention for Acute Leukemia Patients Undergoing Chemotherapy|
- Effects of an individualized prescriptive exercise intervention [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]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
- Number of subjects experiencing fatigue, depression, and quality of life issues [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]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.
|Study Start Date:||February 2006|
|Study Completion Date:||August 2009|
|Primary Completion Date:||January 2007 (Final data collection date for primary outcome measure)|
Behavioral: Resting vitals
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00499759
|United States, North Carolina|
|Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill|
|Chapel Hill, North Carolina, United States, 27599-7295|
|Principal Investigator:||Claudio L. Battaglini, PhD||UNC Lineberger Comprehensive Cancer Center|