HemodialysisDIALAPANCT07118007
Assessment of the Benefits of Adapted Physical Activity in Pediatric Hemodialysis Patients
A study testing adapted physical activity in people with Hemodialysis, run by Hospices Civils de Lyon.
Trial 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… Read more about this study
- Who is it for?
- Ages 5 to 20 years
- Conditions the study is for
- Hemodialysis
- What is being tested?
- adapted physical activity
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2025to 1 Mar 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 20 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Assessment of the Benefits of Adapted Physical Activity in Pediatric Hemodialysis Patients-DIALAPA Study
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
- Being tested
- adapted physical activity
- Keywords
- Hemodialysis, physical activity
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
adapted physical activityOther
adapted physical activity for 30 to 45 minutes twice per week
| Study group | Role | What they receive |
|---|---|---|
| Patient requiring hemodialysis for end-stage renal disease | Other | Patient requiring hemodialysis for end-stage renal disease aged 5 to 20 years Receives: Other: adapted physical activity |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Between baseline (M0) and month 6 (M6)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2025
- Study start1 Oct 2025 (estimated)
- Primary completion1 Mar 2029 (estimated)
- Study completion1 Mar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HemodialysisStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07118007
- Sponsor's protocol ID
- 69HCL25_0588
- Acronym
- DIALAPA
- Status last verified
- Aug 2025
- First submitted
- 5 Aug 2025
- Last updated
- 12 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Benefits of Adapted Physical Activity in Pediatric Hemodialysis Patients-DIALAPA Study
- ClinicalTrials.gov ID
- NCT07118007
- Acronym / sponsor ID
- DIALAPA / 69HCL25_0588
- Conditions
- Hemodialysis
- Keywords
- Hemodialysis, physical activity
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 1 Oct 2025 (estimated)
- Primary completion
- 1 Mar 2029 (estimated)
- Study completion
- 1 Mar 2029 (estimated)
- First posted
- 12 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient requiring hemodialysis for end-stage renal disease | Other | Other: adapted physical activityPatient requiring hemodialysis for end-stage renal disease aged 5 to 20 years |
Who may qualify
- Ages
- 5 to 20 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| adapted physical activityadapted physical activity for 30 to 45 minutes twice per week | Other | Patient requiring hemodialysis for end-stage renal disease |
Primary outcome
mass-to-muscle mass ratio between M0 and M6
Time frame: Between baseline (M0) and month 6 (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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing adapted physical activity in people with Hemodialysis, run by Hospices Civils de Lyon.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 12 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Melodie MOSCA, MD (04 27 85 67 49 ext. +33, melodie.mosca@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
mass-to-muscle mass ratio between M0 and M6 (time frame: Between baseline (M0) and month 6 (M6)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2025.