Back to resultsEffect of Different Exercises on Quality of Life of Leukemia Patients.
Primary Purpose
Quality of Life, Acute Lymphoblastic Leukemia, Exercise
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Aerobic exercises
Modified strength training
Sponsored by
About this trial
This is an interventional other trial for Quality of Life
Eligibility Criteria
Inclusion Criteria:
- Age range from8-12years.
- Children during 3rd phase( maintenance phase of the treatment). According San et al(2007) who found children with Acute Lymphoblastic Leukemia in maintenance phase of treatment can safely perform both aerobic and resistance training .
- Time elapsed since the start of the maintenance phase >20weeks.
- Children with muscle weakness due to chemotherapy.
- The height , weight and body mass index of the child will take on standard scale.
- preserved cardiac structure and function as assisted by echo-cardiogram.
- The children have ability to walk.
Exclusion Criteria:
Children who have one or more of the following criteria will be excluded from the study:
- Receiving more intensive chemotherapy.
- Mental disabled.
- Sever cardiomyopathy (ejection fraction <40%, ECG will be used as a pretest as it might be a more sensitive tool to exclude angina pectoris).
- Low blood platelet levels (< 50.000 per µl).
- Marked anemia (hemoglobin < 8 g/dl).
- Severe cachexia (i.e., weight mass loss > 35%).
- Pain in bone.
- Inability to walk.
- Sensory disturbance.
- Peripheral neuropathy.
Sites / Locations
- Children's Cancer Hospital Egypt 57357
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
No Intervention
Experimental
Experimental
Arm Label
Control group
Study group A
Study group B
Arm Description
Twenty five children who will not receive any physical therapy treatment.
Twenty five children who will receive physical therapy treatment which include aerobic exercises.
Twenty five children who will receive physical therapy treatment which include modified strength training program.
Outcomes
Primary Outcome Measures
Improvement of quality of life
The pediatric quality of life inventory (PedsQL) is a modular approach to measure health-related quality of life in healthy children and adolescents and those with acute and chronic health conditions.
Secondary Outcome Measures
Improvement of functional capacity
6 minute walk test is a test to measure functional capacity by using pulse oximeter to detect percentage of oxygen saturation at peripheral capillaries.
Full Information
NCT ID
NCT03147365
First Posted
April 2, 2017
Last Updated
July 20, 2020
Sponsor
Children's Cancer Hospital Egypt 57357
1. Study Identification
Unique Protocol Identification Number
NCT03147365
Brief Title
Effect of Different Exercises on Quality of Life of Leukemia Patients.
Official Title
Aerobic Training Versus Strength Exercises on Quality of Life and Functional Capacity on Children With Leukemia.
Study Type
Interventional
2. Study Status
Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
March 5, 2017 (Actual)
Primary Completion Date
December 27, 2019 (Actual)
Study Completion Date
April 5, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Children's Cancer Hospital Egypt 57357
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
To compare between modified strength training program and aerobic exercises on quality of life on children with Acute Lymphoblastic Leukemia.
To compare between modified strength training program and aerobic exercises on functional capacity on children with Acute Lymphoblastic Leukemia.
Detailed Description
This study will be done to determine any exercise from aerobic exercises or modified strength training program will be more effective on quality of life and functional capacity on children with Acute Lymphoblastic Leukemia .Acute Lymphoblastic Leukemia is wide spread in the world and the children with this disease are fragile so must know the most program effect.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Quality of Life, Acute Lymphoblastic Leukemia, Exercise
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Experimental controlled randomization using Block Stratified Randomized Software program, after obtaining informed consent from illegible patient or his caregiver.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
75 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Twenty five children who will not receive any physical therapy treatment.
Arm Title
Study group A
Arm Type
Experimental
Arm Description
Twenty five children who will receive physical therapy treatment which include aerobic exercises.
Arm Title
Study group B
Arm Type
Experimental
Arm Description
Twenty five children who will receive physical therapy treatment which include modified strength training program.
Intervention Type
Behavioral
Intervention Name(s)
Aerobic exercises
Intervention Description
Aerobic exercises will do by using treadmill for children of study group A. it will consist of (max.incline15% - max. speed - heart rate grips and wireless chest strap - smooth virtual fitness trainer - smooth drop folding frame - impression shock absorption cushioning system).
Intervention Type
Behavioral
Intervention Name(s)
Modified strength training
Intervention Description
Dumbbells will be used to conduct the modified strength training program for children of group B. This exercises included five exercises for the main muscle groups: bench press, leg press, seat row, leg extension and lat pull down.
Primary Outcome Measure Information:
Title
Improvement of quality of life
Description
The pediatric quality of life inventory (PedsQL) is a modular approach to measure health-related quality of life in healthy children and adolescents and those with acute and chronic health conditions.
Time Frame
at week 20
Secondary Outcome Measure Information:
Title
Improvement of functional capacity
Description
6 minute walk test is a test to measure functional capacity by using pulse oximeter to detect percentage of oxygen saturation at peripheral capillaries.
Time Frame
at week 20
10. Eligibility
Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age range from8-12years.
Children during 3rd phase( maintenance phase of the treatment). According San et al(2007) who found children with Acute Lymphoblastic Leukemia in maintenance phase of treatment can safely perform both aerobic and resistance training .
Time elapsed since the start of the maintenance phase >20weeks.
Children with muscle weakness due to chemotherapy.
The height , weight and body mass index of the child will take on standard scale.
preserved cardiac structure and function as assisted by echo-cardiogram.
The children have ability to walk.
Exclusion Criteria:
Children who have one or more of the following criteria will be excluded from the study:
Receiving more intensive chemotherapy.
Mental disabled.
Sever cardiomyopathy (ejection fraction <40%, ECG will be used as a pretest as it might be a more sensitive tool to exclude angina pectoris).
Low blood platelet levels (< 50.000 per µl).
Marked anemia (hemoglobin < 8 g/dl).
Severe cachexia (i.e., weight mass loss > 35%).
Pain in bone.
Inability to walk.
Sensory disturbance.
Peripheral neuropathy.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Doaa M Khalifa, BSc
Organizational Affiliation
Children's Cancer Hospital Egypt CCHE 57357
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's Cancer Hospital Egypt 57357
City
Cairo
ZIP/Postal Code
11441
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effect of Different Exercises on Quality of Life of Leukemia Patients.
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