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In-Hospital Individualized Prescriptive Exercise Intervention for Acute Leukemia Patients Undergoing Chemotherapy


N/A
18 Years
60 Years
Not Enrolling
Both
Depression, Fatigue, Leukemia, Musculoskeletal Complications, Psychosocial Effects of Cancer and Its Treatment

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Trial Information

In-Hospital Individualized Prescriptive Exercise Intervention for Acute Leukemia Patients Undergoing Chemotherapy


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.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Newly diagnosed acute or relapsed myeloid or lymphoblastic leukemia

- Currently receiving re-induction therapy or designated for chemotherapy
treatment

- Expected hospital stay of 3-4 weeks or longer

- Participation in the study must be approved by the physician directly responsible for
the patient's care while at University of North Carolina Hospitals

PATIENT CHARACTERISTICS:

- No condition that would compromise the patient's ability to participate in the
exercise rehabilitation program, including any of the following:

- Immune deficiency

- Acute or chronic bone, joint, or muscular abnormalities

- Acute or chronic respiratory disease

- Cardiovascular disease

PRIOR CONCURRENT THERAPY:

- See Disease Characteristics

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Outcome Measure:

Effects of an individualized prescriptive exercise intervention

Outcome Description:

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

Outcome Time Frame:

6 weeks

Safety Issue:

No

Principal Investigator

Claudio L. Battaglini, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

UNC Lineberger Comprehensive Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

LCCC 0526

NCT ID:

NCT00499759

Start Date:

February 2006

Completion Date:

August 2009

Related Keywords:

  • Depression
  • Fatigue
  • Leukemia
  • Musculoskeletal Complications
  • Psychosocial Effects of Cancer and Its Treatment
  • fatigue
  • depression
  • psychosocial effects of cancer and its treatment
  • musculoskeletal complications
  • acute undifferentiated leukemia
  • adult acute myeloid leukemia with 11q23 (MLL) abnormalities
  • adult acute myeloid leukemia with inv(16)(p13;q22)
  • adult acute myeloid leukemia with t(15;17)(q22;q12)
  • adult acute myeloid leukemia with t(16;16)(p13;q22)
  • adult acute myeloid leukemia with t(8;21)(q22;q22)
  • untreated adult acute lymphoblastic leukemia
  • untreated adult acute myeloid leukemia
  • recurrent adult acute myeloid leukemia
  • secondary acute myeloid leukemia
  • recurrent adult acute lymphoblastic leukemia
  • Depression
  • Depressive Disorder
  • Fatigue
  • Leukemia
  • Leukemia, Lymphoid
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma
  • Leukemia, Myeloid

Name

Location
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill Chapel Hill, North Carolina  27599-7570