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Completed

NCT Number: NCT06664736

Effects of Home-Based Exercise Program in Children After Acute Lymphoblastic Leukemia

This prospective randomized controlled study aimed to investigate the effects of a home-based exercise program on physical functions, inflammatory markers, and Brain-Derived Neurotrophic Factor (BDNF) in children followed after Acute Lymphoblastic Leukemia (ALL) treatments. Ankle dorsiflexion range of motion (ROM), dorsiflexion and knee extensor muscle strength, hand grip strength, aerobic endurance, and functional mobility were assessed using a goniometer, digital dynamometer; hand dynamometer, 6 Minute Walk Test (6 MWT), Timed Up and Go Test respectively. Interleukin-1 Beta, Tumor Necrosis Factor-Alpha, Interleukin-6 (IL-6), and BDNF values were examined using ELISA kits. 20 patients will be included in the study. The patients randomly divided into 2 groups: exercise (n:10) and control (n:10). The exercise group performed a home-based exercise program consisting of aerobics 3 days a week and strengthening and stretching exercises 2 days a week, with videos and infographics, for 8 weeks. The control group was advised to increase physical activity.

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Key information

Conditions

Acute Lymphoblastic Leukemia Behavior Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Inflammation Leukemia Leukemia, Lymphoid Lymphatic Diseases Lymphoproliferative Disorders Motor Activity Neoplasms Neoplasms by Histologic Type Pathologic Processes Pathological Conditions, Signs and Symptoms Precursor Cell Lymphoblastic Leukemia-Lymphoma

Age range

6 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Gazi University Hospital

Ankara, 06560, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Being between the ages of 6-18,
  • Having clinical diagnose of Acute Lymphoblastic Leukemia,
  • Being completed medical treatment

Exclusion criteria

  • Having a history of neurological, developmental, or genetic disorders,
  • Communicating problems
  • Medical conditions such as advanced cardiac damage, decreased bone quality, acute infection, and cancer recurrence.

Children who could not accomplish the exercises and evaluations, who did not want to continue the study, who could not be contacted for more than 2 weeks, and who disrupted the exercise program for more than 2 weeks were excluded from the study.

Treatment and study plan

Exercise

Behavioral

The exercise group performed a home-based exercise program consisting of aerobics 3 days a week with videos and strengthening and stretching exercises 2 days a week with infographics, for 8 weeks.

Physical activity

Behavioral

The control group was advised to increase physical activity

Primary outcomes

  1. Difference between baseline and final active ankle dorsiflexion range of motion

    Time frame: 8 weeks

    Active ankle dorsiflexion ROM was evaluated with a Baseline® (Aurora, IL, USA) brand goniometer in a supine position, with the knee supported by a pillow and the knee flexed and recorded in degrees

  2. Difference between baseline and final muscle strength

    Time frame: 8 weeks

    Knee extensor and ankle dorsiflexor muscle strength were assessed using a digital handheld dynamometer (Lafayette Instrument Company, Lafayette, Indiana). The "break" technique was used to measure muscle strength.

  3. Difference between baseline and final handgrip strength

    Time frame: 8 weeks

    Handgrip strength was evaluated using a hand dynamometer (J-Tech Commander Grip Track Dynamometer, JTECH Medical, Midvale, UT, US).The patient was positioned in a sitting position with the shoulder adducted and neutrally rotated, the elbow at 90° flexion, and the forearm and wrist in neutral. The patient was asked to squeeze the device as hard as he could for 5 seconds, and during the measurement, the child was given verbal encouragement such as "squeeze as hard as you can." Measurements were repeated 3 times and the average value was recorded in Newtons.

  4. Difference between baseline and final aerobic endurance

    Time frame: 8 weeks

    Aerobic endurance was evaluated using the 6-minute walk test (6MWT). 6MWT was performed by the American Thoracic Society guidelines. During the test, the patient was asked to walk in the corridor as fast as he could without running, jumping, or jumping within the determined limits for 6 minutes. Total walking distance was recorded in meters

  5. Difference between baseline and final functional mobility

    Time frame: 8 weeks

    Functional mobility was assessed with the Timed Up and Go Test. While the patient was in a sitting position on an armless chair, he was asked to get up on command, walk 3 meters, return, and sit on the chair again. The elapsed time was recorded in seconds.

  6. Difference between baseline and final serum inflammatory markers and brain derived neurotrophic factor levels

    Time frame: 8 weeks

    Serum samples required to examine levels of inflammatory markers (IL-6, TNF-a, and IL-1b) and BDNF were obtained during blood collection at the patients' routine hospital visits.Data about serum IL-6 and TNF-a were recorded from the hospital information system. Serum IL-1b and BDNF levels were analyzed using ELISA kits provided by the researchers.

Sponsors and collaborators

Lead sponsor

Gazi University

Other

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Oct 29, 2024
Registry last updated
Oct 29, 2024

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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