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Completed

NCT Number: NCT03147365

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

* 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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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).

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.

Primary outcomes

  1. Improvement of quality of life

    Time frame: at week 20

    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 outcomes

  1. Improvement of functional capacity

    Time frame: at week 20

    6 minute walk test is a test to measure functional capacity by using pulse oximeter to detect percentage of oxygen saturation at peripheral capillaries.

Sponsors and collaborators

Lead sponsor

Children's Cancer Hospital Egypt 57357

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2019
Study completion
2020
First posted
May 10, 2017
Registry last updated
Jul 21, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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