NCT07137091

Brief Summary

CRF influences engagement in everyday activities, mood, sleep, social relations, school attendance, academic achievement, and quality of life . It was significantly associated with low health-related quality of life in pediatric cancer patients including leukemia . Since attention to managing cRF has been drawn, only a few non-pharmacological strategies were tested for their effectiveness in reducing cRF among children. Physical activity (Pa) has been proven to be the most effective strategy . Yet adherence to Pa remains problematic.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 16, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 22, 2025

Completed
1 month until next milestone

Study Start

First participant enrolled

October 1, 2025

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2026

Completed
4 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 5, 2026

Completed
Last Updated

March 3, 2026

Status Verified

February 1, 2026

Enrollment Period

4 months

First QC Date

August 16, 2025

Last Update Submit

February 28, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Pediatric quality of life multidimensional fatigue scale (peds QLMFS):

    CRF was measured using the valid and reliable Arabic version of peds QlMFs . It is an 18-item questionnaire including 'general fatigue', 'sleep/rest fatigue', and 'cognitive fatigue'. The three child self-report versions were used depending on the child's age: 5-7 years (young child), 8-12 years (child), and 13-18 years (adolescent). Higher scores indicate less intense fatigue symptoms . Before the cOViD-19 pandemic, a paper-based appropriate version of the scale was completed by children. During the pandemic, the questionnaires were offered to the participants through a link sent to the parent's phones to eliminate cross-infection.

    at baseline and at 8 weeks

Secondary Outcomes (3)

  • The six-minute walk test (6-MWT)

    at baseline and at 8 weeks

  • Emotional Well-Being

    at baseline and at 8 weeks

  • Blood panel test

    at baseline and at 8 weeks

Study Arms (2)

Gyrokinesis exercise

EXPERIMENTAL

Structure of a Gyrokinesis Session 1. Warm-Up: * Begin with gentle seated movements to prepare the body. * Focus on awakening the spine with small circles and undulating motions, coordinating with deep breathing. 2. Seated Exercises: * Perform a series of exercises on a stool or chair. * Emphasize spinal articulation, pelvic tilts, and side bends while maintaining rhythmic breathing. 3. Floor Work: * Transition to mat-based exercises focusing on core strength and flexibility. * Incorporate movements like leg lifts, spirals, and arching motions to engage different muscle groups. 4. Standing Series: * Conclude with standing exercises to enhance balance and full-body integration. * Use spiral movements and weight shifts to energize the body and improve posture.

Other: Gyrokinesis exercise

control group

NO INTERVENTION

No intervention

Interventions

1. Warm-Up: * Begin with gentle seated movements to prepare the body. * Focus on awakening the spine with small circles and undulating motions, coordinating with deep breathing. 2. Seated Exercises: * Perform a series of exercises on a stool or chair. * Emphasize spinal articulation, pelvic tilts, and side bends while maintaining rhythmic breathing. 3. Floor Work: * Transition to mat-based exercises focusing on core strength and flexibility. * Incorporate movements like leg lifts, spirals, and arching motions to engage different muscle groups. 4. Standing Series: * Conclude with standing exercises to enhance balance and full-body integration. * Use spiral movements and weight shifts to energize the body and improve posture.

Gyrokinesis exercise

Eligibility Criteria

Age12 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Diagnosed and treated for a brain tumor during childhood or adolescence (0-≤18 years).
  • Treated for a PBT during the previous 10 years, starting from date of diagnosis.
  • Aged ≥6 years 0 months at the start of the trial.
  • Off therapy/active treatment for pediatric brain tumor (PBT) for 12 months at the start of the trial.
  • No known signs of clinical or radiological tumor progression at last follow-up.
  • Danish is the sole or primary language (enabling provision of validated assessment tools).

You may not qualify if:

  • History of recent poorly controlled seizures.
  • Motor tics or Tourette syndrome (including family history of tic disorder).
  • Known diagnosis of Attention Deficit/Hyperactivity Disorder or Autism Spectrum Disorder.
  • Known diagnosis of Full Scale Intelligence Quotient (FSIQ) of \<50.
  • Pregnancy. Participants known to be pregnant or breastfeeding at screening/registration will not enrolled

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

faculty of physical therapy ,Cairo University

Cairo, 3753450, Egypt

Location

MeSH Terms

Conditions

Fatigue

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: RCT
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assisstant professor

Study Record Dates

First Submitted

August 16, 2025

First Posted

August 22, 2025

Study Start

October 1, 2025

Primary Completion

February 1, 2026

Study Completion

February 5, 2026

Last Updated

March 3, 2026

Record last verified: 2026-02

Locations