Assessment of the Benefits of Adapted Physical Activity in Pediatric Hemodialysis Patients

NCT07118007 | Not Yet Recruiting

• 1 other identifier: 69HCL25_0588
• Study Type: interventional
• Target: 15
• Locations: 0 countries
• Sites: N/A

Brief Summary

Children, adolescents, and young adults undergoing pediatric hemodialysis often experience functional limitations in daily life. Their level of physical activity is generally lower than that of healthy peers of the same age, due to the lack of sports programs adapted both to their medical conditions and to the constraints of dialysis (notably, having to remain in bed for several hours, several times a week). These limitations affect not only their cardiovascular function but also their quality of life. Through the implementation of an Adapted Physical Activity (APA) program for dialysis patients, we aim to assess the potential benefits of this approach on muscle strength, functional abilities, cardiovascular health, and quality of life

Conditions

Hemodialysis

Keywords

Hemodialysis; physical activity

Outcome Measures

Primary Outcomes (1)

• mass-to-muscle mass ratio between M0 and M6

  Change in the mass-to-muscle mass ratio between M0 and M6, measured at the end of the hemodialysis session using bioelectrical impedance analysis.

  Between baseline (M0) and month 6 (M6)

Study Arms (1)

Patient requiring hemodialysis for end-stage renal disease

OTHER

Patient requiring hemodialysis for end-stage renal disease aged 5 to 20 years

Other: adapted physical activity

Interventions

adapted physical activity OTHER

adapted physical activity for 30 to 45 minutes twice per week

Patient requiring hemodialysis for end-stage renal disease

Eligibility Criteria

• Age: 5 Years - 20 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Patient requiring hemodialysis sessions for end-stage renal disease
• Patient aged between 5 and 20 years
• Patient followed in the pediatric nephrology department at hospital Lyon (HFME : Hôpital Femme Mère Enfant)
• Adult patient or parents/legal guardians informed about the study and having provided written consent for participation
• Patient covered by a social security

You may not qualify if:

• Medical or surgical contraindications to adapted physical activity.
• Persons deprived of liberty by judicial or administrative decision.
• Persons undergoing psychiatric care.
• Persons admitted to a healthcare or social facility for reasons other than research participation.
• Adults under legal protection measures (curators)
• Persons not affiliated with a social security scheme or beneficiaries of a similar system
• Pregnant women.

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Central Study Contacts

Melodie MOSCA, MD

CONTACT

04 27 85 67 49; melodie.mosca@chu-lyon.fr

Sacha FLAMMIER

CONTACT

04 72 68 13 49; Sacha.flammier@chu-lyon.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 5, 2025
• First Posted: August 12, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): March 1, 2029
• Study Completion (Estimated): March 1, 2029
• Last Updated: August 12, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share