Actively Recruiting

Phase Not Applicable
Age: 5Years - 16Years
All Genders
ID06455592

Effect of Practicing Adapted Physical Activity on Sleep Quality in Children and Adolescents Aged 5 to 16 Undergoing Treatment for Blood Cancer

Led by University Hospital, Clermont-Ferrand · Updated on 2025-12-05

30

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating how adapted physical activity affects the sleep quality of children aged 5 to 16 who are undergoing treatment for blood cancer. Sleep problems are common in these children and negatively impact their quality of life. This trial aims to determine if daily practice of adapted physical activity can improve sleep compared to less frequent activity. The study compares two approaches: practicing adapted physical activity once during four days (control group) versus practicing it daily for four days (experimental group). This is a randomized, open-label trial conducted in a hospital and at home. The study lasts four weeks and includes a wash-out week after two weeks, allowing comparison of the two strategies. Participants will be monitored for sleep quality mornings and evenings over the study cycles. Researchers will also assess sleep duration, night awakenings, physical activity levels, quality of life, pain, fatigue, vigilance, and inflammation markers. These measurements will be taken at regular intervals during the two activity sessions. The trial aims to provide insights on the value of daily adapted physical activity in improving sleep for children with blood cancer.

CONDITIONS

Brief Title

Effect of APA on Sleep Quality in Children With Cancer From 5 to 16 Years

Who Can Participate

Age: 5Years - 16Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Children aged 5 to 16 years with hematological cancer undergoing treatment
  • Children and their parents who have been informed about the study and have given informed consent
  • Enrollment in the Social Security system
Not Eligible

You will not qualify if you...

  • Children receiving high-dose corticosteroids
  • Children under anxiolytic treatment
  • Children diagnosed with sleep disorders such as sleep apnea
  • Children taking melatonin or sleeping pills
  • Contraindications to adapted physical activity
  • Refusal to participate by the child or parents
  • Children under parental authority under curatorship, guardianship, or safeguard of justice
  • Pregnant or breastfeeding teenagers

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Outpatient Treatment

Duration - 4 days per treatment cycle, with 2 cycles separated by a 1-week wash-out period

Participants practice adapted physical activity either once or daily for four days, both at the hospital and at home, to evaluate the effect on sleep quality.

Daily visits or assessments for 4 days in each cycle

Follow-up

Duration - 1 week

Participants are monitored during the wash-out week between the two treatment cycles to assess changes and recovery.

No scheduled visits; monitoring occurs during wash-out period

Trial Site Locations

Total: 1 location

1

CHU de Clermont-Ferrand

Clermont-Ferrand, France

Actively Recruiting

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Research Team

L

Lise Laclautre

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

PREVENTION

Number of Arms

2

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