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

NCT03147365 | Completed DMC

• 1 other identifier: CCHE-ALL003
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

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.

Conditions

Quality of Life; Acute Lymphoblastic Leukemia; Exercise

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Improvement of functional capacity

  at week 20

Study Arms (3)

Control group

NO INTERVENTION

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

Study group A

EXPERIMENTAL

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

Behavioral: Aerobic exercises

Study group B

EXPERIMENTAL

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

Behavioral: Modified strength training

Interventions

Modified strength training 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.

Study group B

Aerobic exercises 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 A

Eligibility Criteria

• Age: 8 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Children's Cancer Hospital Egypt 57357: lead

Study Sites (1)

Children's Cancer Hospital Egypt 57357

Cairo, 11441, Egypt

Location

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma; Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Doaa M Khalifa, BSc

  Children's Cancer Hospital Egypt CCHE 57357

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Experimental controlled randomization using Block Stratified Randomized Software program, after obtaining informed consent from illegible patient or his caregiver.

Study Record Dates

• First Submitted: April 2, 2017
• First Posted: May 10, 2017
• Study Start: March 5, 2017
• Primary Completion: December 27, 2019
• Study Completion: April 5, 2020
• Last Updated: July 21, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)