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

NCT ID: NCT06664736

Last Updated: 2024-10-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-30

Study Completion Date

2024-05-30

Brief Summary

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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.

Detailed Description

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Conditions

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Acute Lymphoblastic Leukemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Exercise

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.

Group Type EXPERIMENTAL

Exercise

Intervention Type 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.

Control

control group was advised to increase physical activity.

Group Type OTHER

Physical activity

Intervention Type BEHAVIORAL

The control group was advised to increase physical activity

Interventions

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Exercise

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.

Intervention Type BEHAVIORAL

Physical activity

The control group was advised to increase physical activity

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

6 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Gazi University

OTHER

Sponsor Role lead

Responsible Party

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Ilke Keser

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Gazi University Hospital

Ankara, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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419 Haspolat M

Identifier Type: -

Identifier Source: org_study_id

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