Clinical trial NCT06981832: Physical Activity for Haemodialysis Patients: Evaluation of Personalised Support by an Adapted Physical Activity Teacher and an Advanced Practice Nurse
Official title: Physical Activity for Haemodialysis Patients: Evaluation of Personalised Support by an Adapted Physical Activity Teacher and an Advanced Practice Nurse
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Hemodialysis
Lead sponsor: Centre Hospitalier Departemental Vendee
Sponsor class: OTHER
First posted: 2025-05-21
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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'.

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.


Eligibility criteria: Pre-Inclusion Criteria:

* Patient over 18 years of age
* Patient who has been receiving haemodialysis for less than a year
* Patient with medical authorisation for physical activity
* Patient able to understand the protocol and having given oral informed consent to participate in the research,
* Patient affiliated to the social security system or entitled beneficiary

Inclusion Criteria:

* Patient with physical activity considered low or moderate according to the IPAQ questionnaire

Exclusion Criteria:

* 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
* 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

Primary outcomes:
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
timeFrame: 6 months after the start of the intervention
Secondary outcomes:
Other outcomes:
Locations:
city: La Roche Sur Yon
country: France
facility: Centre Hospitalier Departemental Vendée
Study officials:
affiliation: Centre H
name: Emilie VINCENT
role: PRINCIPAL_INVESTIGATOR
References: