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

NCT06664736 | Completed

• 1 other identifier: 419 Haspolat M
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Acute Lymphoblastic Leukemia

Keywords

leukemia; acute lymphoblastic; interleukins; inflammation; exercise

Outcome Measures

Primary Outcomes (6)

• Difference between baseline and final active ankle dorsiflexion range of motion

  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

  8 weeks

• Difference between baseline and final muscle strength

  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.

  8 weeks

• Difference between baseline and final handgrip strength

  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.

  8 weeks

• Difference between baseline and final aerobic endurance

  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

  8 weeks

• Difference between baseline and final functional mobility

  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.

  8 weeks

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

  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.

  8 weeks

Study Arms (2)

Exercise

EXPERIMENTAL

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.

Behavioral: Exercise

Control

OTHER

control group was advised to increase physical activity.

Behavioral: Physical activity

Interventions

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.

Exercise

Physical activity BEHAVIORAL

The control group was advised to increase physical activity

Control

Eligibility Criteria

• Age: 6 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Gazi University: lead

Study Sites (1)

Gazi University Hospital

Ankara, 06560, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia; Inflammation; Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Leukemia, Lymphoid; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavior

Intervention Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 20, 2024
• First Posted: October 29, 2024
• Study Start: May 30, 2023
• Primary Completion: May 30, 2024
• Study Completion: May 30, 2024
• Last Updated: October 29, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)