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

Quality of Life Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03147365
• Other study ID #: CCHE-ALL003
• Status: Completed
• Phase: N/A
• Start date: March 5, 2017
• Est. completion date: April 5, 2020

Study information

• Verified date: January 2020
• Source: Children's Cancer Hospital Egypt 57357
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: April 5, 2020
• Est. primary completion date: December 27, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years to 12 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acute Lymphoblastic Leukemia
• Exercise
• Leukemia
• Precursor Cell Lymphoblastic Leukemia-Lymphoma
• Quality of Life

Intervention

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).
• 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.

Locations

Country	Name	City	State
Egypt	Children's Cancer Hospital Egypt 57357	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Children's Cancer Hospital Egypt 57357

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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