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

NCT ID: NCT03147365

Last Updated: 2020-07-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 75 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-03-05
• Study Completion Date: 2020-04-05

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.

Conditions

Quality of Life; Acute Lymphoblastic Leukemia; Exercise

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Control group

Twenty five children who will not receive any physical therapy treatment.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Study group A

Twenty five children who will receive physical therapy treatment which include aerobic exercises.

Group Type: EXPERIMENTAL

Aerobic exercises

Intervention Type: BEHAVIORAL

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).

Study group B

Twenty five children who will receive physical therapy treatment which include modified strength training program.

Group Type: EXPERIMENTAL

Modified strength training

Intervention Type: BEHAVIORAL

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.

Interventions

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).

Intervention Type: 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.

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Children's Cancer Hospital Egypt 57357

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Doaa M Khalifa, BSc

Role: PRINCIPAL_INVESTIGATOR

Children's Cancer Hospital Egypt CCHE 57357

Locations

Children's Cancer Hospital Egypt 57357

Cairo, , Egypt

Countries

Egypt

Other Identifiers

CCHE-ALL003

Identifier Type: -

Identifier Source: org_study_id