HemodialysisHE-MOVENCT06981832
Physical Activity for Haemodialysis Patients: Evaluation of Personalised Support by an Adapted Physical Activity Teacher and an Advanced Practice Nurse
A study testing Personalised support (advanced practice nurse and adapted physical activity teacher) and Standard support (advanced practice nurse) in people with Hemodialysis, run by Centre Hospitalier Departemental Vendee at 1 site in France.
Trial summary
Physical activity is defined as 'any bodily movement produced by skeletal muscles that results in an energy expenditure greater than that of the resting metabolism'. Physical activity includes 'activities of daily living, physical exercise and sporting activities'. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hemodialysis
- What is being tested?
- Personalised support (advanced practice nurse and adapted physical activity teacher) and Standard support (advanced practice nurse)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteFrance
- Study dates
- 28 Oct 2025to Apr 2028
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient with physical activity considered low or moderate according to the IPAQ questionnaire
Who cannot join
- Patients with medical contraindications to adapted physical activity
- Patients with a lower limb amputation
- Patients undergoing peritoneal dialysis
- Patient with a peritoneal dialysis project
- Patient participating in another clinical research protocol with an impact on the research objectives
- Patient already randomised in the study
Show all 11Show fewer
- Patient who is pregnant, parturient, breastfeeding or able to procreate without effective contraception at the time of inclusion*.
- Patients under guardianship, curatorship or deprived of liberty
- Patient under activated future protection mandate
- Patient under family habilitation
- Patient under court protection
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Centre Hospitalier Departemental Vendée
La Roche-sur-Yon, 85925
Emilie VINCENT
About this study
Physical activity is defined as 'any bodily movement produced by skeletal muscles that results in an energy expenditure greater than that of the resting metabolism'. Physical activity includes 'activities of daily living, physical exercise and sporting activities'.
The scientific community is agreed in recognising the benefits of physical activity, both in healthy individuals and in those suffering from chronic diseases.
Read more
With this in mind, the law of 2 March 2022 allows doctors to prescribe Adapted Physical Activity.
In the case of chronic renal failure, there are a number of factors that can limit physical activity in haemodialysis patients, such as anaemia, nutritional status and post-dialysis fatigue.
However, the risks associated with a sedentary lifestyle play a role in the development of chronic disease, in particular hypertension and diabetes. The benefits of physical activity have been widely identified in chronic renal failure, particularly in terms of cardiovascular and muscular function.
More generally, physical activity has a positive impact on physical, psychological and social quality of life (increase in overall quality of life score, improved sleep, reduced pain, etc.).
Physical activity should therefore be encouraged in patients with chronic renal failure, whether on dialysis or not, whatever their age.
The aim of this study is to assess whether individualised support (from an advanced practice nurse and an adapted physical activity teacher) improves the practice of physical activity at home in patients who have been on haemodialysis for less than a year, and whether this improvement is sustainable over time.
- Conditions
- Hemodialysis
- Being tested
- Personalised support (advanced practice nurse and adapted physical activity teacher), Standard support (advanced practice nurse)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Personalised support (advanced practice nurse and adapted physical activity teacher)Behavioural
Personalised support (advanced practice nurse and adapted physical activity teacher)
Standard support (advanced practice nurse)Behavioural
Standard support (advanced practice nurse)
| Study group | Role | What they receive |
|---|---|---|
| Personalised support (advanced practice nurse and adapted physical activity teacher) | Experimental | Not described Receives: Behavioral: Personalised support (advanced practice nurse and adapted physical activity teacher) |
| Standard support (advanced practice nurse) | Active comparator | Not described Receives: Behavioral: Standard support (advanced practice nurse) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patients with a level of physical activity considered moderate or high, assessed using the physical activity questionnaire (IPAQ) 6 months after the start of the intervention
The level of physical activity according to the IPAQ questionnaire is defined as follows:
- - Low
- No activity is reported OR
- Some activity is reported but without reaching levels 2 or 3.
- - Moderate Corresponds to one of the following 3 criteria:
- 3 or more days of intense activity lasting at least 20 minutes a day OR
- 5 days or more of moderate intensity activity and/or walking for at least 30 minutes a day OR
- 5 days or more of activity combining walking, moderate or high intensity activities, thus achieving at least 600 MET-minutes/week.
- - High Corresponds to one of the 2 following criteria:
- Intense activity on at least 3 days a week, achieving at least 1500 MET-minutes/week OR
- 7 or more days of activity combining walking and moderate or high-intensity activities, achieving at least 3000 MET-minutes/week.
Measured: 6 months after the start of the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2025
- Study start28 Oct 2025
- Primary completionOct 2027 (estimated)
- Study completionApr 2028 (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.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Departemental Vendee
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Emilie VINCENT, Principal investigator, Centre H
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06981832
- Sponsor's protocol ID
- CHD25_0004
- Acronym
- HE-MOVE
- Status last verified
- Dec 2025
- First submitted
- 13 May 2025
- Last updated
- 23 Dec 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 23 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physical Activity for Haemodialysis Patients: Evaluation of Personalised Support by an Adapted Physical Activity Teacher and an Advanced Practice Nurse
- ClinicalTrials.gov ID
- NCT06981832
- Acronym / sponsor ID
- HE-MOVE / CHD25_0004
- Conditions
- Hemodialysis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Centre Hospitalier Departemental VendeeUniversity, hospital or other
- Study start
- 28 Oct 2025 (actual)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Apr 2028 (estimated)
- First posted
- 21 May 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.
Physical activity is defined as 'any bodily movement produced by skeletal muscles that results in an energy expenditure greater than that of the resting metabolism'. Physical activity includes 'activities of daily living, physical exercise and sporting activities'.
The scientific community is agreed in recognising the benefits of physical activity, both in healthy individuals and in those suffering from chronic diseases.
With this in mind, the law of 2 March 2022 allows doctors to prescribe Adapted Physical Activity.
In the case of chronic renal failure, there are a number of factors that can limit physical activity in haemodialysis patients, such as anaemia, nutritional status and post-dialysis fatigue.
However, the risks associated with a sedentary lifestyle play a role in the development of chronic disease, in particular hypertension and diabetes. The benefits of physical activity have been widely identified in chronic renal failure, particularly in terms of cardiovascular and muscular function.
More generally, physical activity has a positive impact on physical, psychological and social quality of life (increase in overall quality of life score, improved sleep, reduced pain, etc.).
Physical activity should therefore be encouraged in patients with chronic renal failure, whether on dialysis or not, whatever their age.
The aim of this study is to assess whether individualised support (from an advanced practice nurse and an adapted physical activity teacher) improves the practice of physical activity at home in patients who have been on haemodialysis for less than a year, and whether this improvement is sustainable over time.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Personalised support (advanced practice nurse and adapted physical activity teacher) | Experimental | Behavioral: Personalised support (advanced practice nurse and adapted physical activity teacher) |
| Standard support (advanced practice nurse) | Active comparator | Behavioral: Standard support (advanced practice nurse) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patient with physical activity considered low or moderate according to the IPAQ questionnaire
Key exclusion criteria (11 listed)
- Patients with medical contraindications to adapted physical activity
- Patients with a lower limb amputation
- Patients undergoing peritoneal dialysis
- Patient with a peritoneal dialysis project
- Patient participating in another clinical research protocol with an impact on the research objectives
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 |
|---|---|---|
| Personalised support (advanced practice nurse and adapted physical activity teacher)Personalised support (advanced practice nurse and adapted physical activity teacher) | Behavioural | Personalised support (advanced practice nurse and adapted physical activity teacher) |
| Standard support (advanced practice nurse)Standard support (advanced practice nurse) | Behavioural | Standard support (advanced practice nurse) |
Primary outcome
Patients with a level of physical activity considered moderate or high, assessed using the physical activity questionnaire (IPAQ) 6 months after the start of the intervention
Time frame: 6 months after the start of the intervention
The level of physical activity according to the IPAQ questionnaire is defined as follows: 1. - Low * No activity is reported OR * Some activity is reported but without reaching levels 2 or 3. 2. - Moderate Corresponds to one of the following 3 criteria: * 3 or more days of intense activity lasting at least 20 minutes a day OR * 5 days or more of moderate intensity activity and/or walking for at least 30 minutes a day OR * 5 days or more of activity combining walking, moderate or high intensity activities, thus achieving at least 600 MET-minutes/week. 3. - High Corresponds to one of the 2 following criteria: * Intense activity on at least 3 days a week, achieving at least 1500 MET-minutes/week OR * 7 or more days of activity combining walking and moderate or high-intensity activities, achieving at least 3000 MET-minutes/week.
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 23 Dec 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.
Emilie VINCENT principal investigator
Centre H
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Personalised support (advanced practice nurse and adapted physical activity teacher) and Standard support (advanced practice nurse) in people with Hemodialysis, run by Centre Hospitalier Departemental Vendee at 1 site in France.
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 1 inclusion and 11 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: looking for participants now, as of the sponsor's last update on 23 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Chloé MOREAU (0251446327, chloe.moreau@ght85.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patients with a level of physical activity considered moderate or high, assessed using the physical activity questionnaire (IPAQ) 6 months after the start of the intervention (time frame: 6 months after the start of the intervention). 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 23 Dec 2025.