Ignite Creation Date:
2025-12-24 @ 2:35 PM
Ignite Modification Date:
2026-01-02 @ 8:49 AM
Study NCT ID:
NCT00499759
Status:
COMPLETED
Last Update Posted:
2012-03-06
First Post:
2007-07-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Individualized Exercise Programs for Patients Receiving Chemotherapy for Newly Diagnosed Acute or Relapsed Myeloid Leukemia or Lymphoblastic Leukemia
Sponsor:
UNC Lineberger Comprehensive Cancer Center
Organization:
Study Overview
Official Title:
In-Hospital Individualized Prescriptive Exercise Intervention for Acute Leukemia Patients Undergoing Chemotherapy
Status:
COMPLETED
Status Verified Date:
2012-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| CDR0000551972 | OTHER | PDQ number | View |