Effect of Different Exercises on Quality of Life of Leukemia Patients.

Aerobic Training Versus Strength Exercises on Quality of Life and Functional Capacity on Children With Leukemia.

• 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.

Study Overview

• Status: Completed
• Conditions: Quality of Life; Exercise; Acute Lymphoblastic Leukemia
• Intervention / Treatment: Behavioral: Aerobic exercises; Behavioral: Modified strength training

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.

• Study Type: Interventional
• Enrollment (Actual): 75
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 11441
    • Children's Cancer Hospital Egypt 57357

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years to 12 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control group; Twenty five children who will not receive any physical therapy treatment.
Experimental: Study group A; Twenty five children who will receive physical therapy treatment which include aerobic exercises.	Behavioral: Aerobic exercises; 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).
Experimental: Study group B; Twenty five children who will receive physical therapy treatment which include modified strength training program.	Behavioral: Modified strength training; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	at week 20

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	at week 20

Collaborators and Investigators

• Sponsor: Children's Cancer Hospital Egypt 57357
• Investigators: Principal Investigator: Doaa M Khalifa, BSc, Children's Cancer Hospital Egypt CCHE 57357

Study record dates

Study Major Dates

• Study Start (Actual): March 5, 2017
• Primary Completion (Actual): December 27, 2019
• Study Completion (Actual): April 5, 2020

Study Registration Dates

• First Submitted: April 2, 2017
• First Submitted That Met QC Criteria: May 7, 2017
• First Posted (Actual): May 10, 2017

Study Record Updates

• Last Update Posted (Actual): July 21, 2020
• Last Update Submitted That Met QC Criteria: July 20, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Leukemia, Lymphoid; Leukemia; Precursor Cell Lymphoblastic Leukemia-Lymphoma
• Other Study ID Numbers: CCHE-ALL003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No