Personalised exercise support for people on hemodialysis.
Physical Activity for Haemodialysis Patients: Evaluation of Personalised Support by an Adapted Physical Activity Teacher and an Advanced Practice Nurse
This project will test whether personalised coaching from an adapted physical activity teacher together with an advanced practice nurse helps adults who recently started hemodialysis become more active than standard nurse support.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 70 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Centre Hospitalier Departemental Vendee Academic / other |
| Locations | 1 site (La Roche-sur-Yon) |
| Trial ID | NCT06981832 on ClinicalTrials.gov |
What this trial studies
Adults on hemodialysis for less than one year who report low-to-moderate activity by the IPAQ are randomized to either personalised support from an adapted physical activity teacher plus an advanced practice nurse, or to standard support from an advanced practice nurse alone. The personalised arm provides tailored adapted physical activity coaching alongside nursing follow-up, while the control arm receives usual nurse-led guidance for prescribed activity. The trial measures changes in activity behaviour and adherence, and collects feasibility data during follow-up visits at the hospital. The intervention is delivered at Centre Hospitalier Départemental Vendée after informed consent and requires a medical prescription for physical activity.
Who should consider this trial
Good fit: Adults receiving hemodialysis for under one year with a medical prescription for physical activity, low-to-moderate activity on the IPAQ, capacity to consent, and French social security coverage are ideal candidates.
Not a fit: Patients with medical contraindications to adapted physical activity, lower limb amputation, those on or planning peritoneal dialysis, pregnant or unprotected individuals, or participants in conflicting research are unlikely to benefit or are ineligible.
Why it matters
Potential benefit: If successful, the programme could help patients on hemodialysis increase daily physical activity, which may improve cardiovascular health, strength, and quality of life.
How similar studies have performed: Exercise programs in dialysis patients have previously improved fitness and cardiovascular measures, but the specific combination of an adapted physical activity teacher plus an advanced practice nurse for personalised coaching is less well studied.
Eligibility criteria
Show full inclusion / exclusion criteria
Pre-Inclusion Criteria: * Patient over 18 years of age * Patient who has been receiving haemodialysis for less than a year * Patient with medical prescription for physical activity * Patient able to understand the protocol and having given 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
Where this trial is running
La Roche-sur-Yon
- Centre Hospitalier Departemental Vendée — La Roche-sur-Yon, France (Recruiting)
Study contacts
- Principal investigator: Emilie VINCENT — Centre H
- Study coordinator: Chloé MOREAU
- Email: chloe.moreau@ght85.fr
- Phone: 0251446327
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.