Home-based walking program to improve mobility in people with stage 3–4 CKD and PAD
EXercise ACTivity to Improve Mobility, Active Behavior and Quality of Life of Chronic Kidney Disease Patients With Peripheral Artery Disease: the EXACTckd-pad Multicenter Randomized Controlled Trial
This project will test whether a 6-month home-based walking program improves walking ability for adults with stage 3–4 chronic kidney disease who also have peripheral artery disease.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 124 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | University Hospital of Ferrara Academic / other |
| Locations | 3 sites (Ferrara, Italy and 2 other locations) |
| Trial ID | NCT06621264 on ClinicalTrials.gov |
What this trial studies
This multicenter randomized trial will enroll about 100 adults with KDOQI stage III–IV chronic kidney disease and Rutherford stage I–III peripheral artery disease and randomly assign them to a 6-month home-based, structured walking program or to usual care with optimal medical therapy and nutritional advice. The exercise intervention consists of two daily 10-minute interval walking sessions with a slowly increasing pace performed at home. Participants will be evaluated at baseline, at the end of the 6-month intervention, and at 12 months for the primary outcome of 6-minute walk distance and secondary outcomes including lower-limb perfusion, body composition, quality of life, laboratory measures, and hospitalizations. Inclusion requires independent walking ability, capacity to consent, and no absolute contraindications to exercise; major amputations, imminent major surgery, very limited survival expectancy, or inability to follow the protocol are excluded.
Who should consider this trial
Good fit: Adults over 18 with stage 3 or 4 CKD and mild-to-moderate PAD (Rutherford I–III) who can walk independently, can give informed consent, and have no contraindications to exercise are ideal candidates.
Not a fit: People with unstable cardiac disease, NYHA class IV heart failure, severe anemia, recent major surgery, major amputations, very limited life expectancy, or inability/unwillingness to follow the program are unlikely to benefit from this intervention.
Why it matters
Potential benefit: If successful, the program could increase walking distance and functional mobility, improve limb perfusion and quality of life, and reduce hospitalizations for people with CKD and PAD.
How similar studies have performed: Exercise programs have improved walking distance and symptoms in PAD and have shown benefits on physical function in CKD separately, but rigorous randomized data specifically targeting the combined CKD–PAD population with a home-based program are limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * chronic kidney disease at KDOQI stages III or IV and concomitant Peripheral artery disease at stages I, II, III; * ability to walk independently; * cognitive function to give informed consent identified by a Mini Mental Status Examination score greater or equal to 20/30 * absence of clinical conditions contraindicating exercise therapy (e.g., unstable angina, severe heart failure at NYHA class IV, anemia with lower than 10.0 g/dl). Exclusion Criteria: * major amputations; * major surgery planned in the next 3 months; * known comorbid conditions that may limit survival to less than 2 years; * inability or unwillingness to comply with protocol requirements.
Where this trial is running
Ferrara, Italy and 2 other locations
- University Hospital of Ferrara — Ferrara, Italy, Italy (Recruiting)
- Ospedale Pederzoli Peschiera del Garda — Peschiera del Garda, Italy, Italy (Recruiting)
- Grande Ospedale Metropolitano Bianchi-Melacrino-Morelli — Reggio Calabria, Italy, Italy (Recruiting)
Study contacts
- Principal investigator: Roberto Manfredini Prof. Roberto Manfredini, MD, PhD — Università degli Studi di Ferrara
- Study coordinator: Fabio Manfredini Prof. Fabio Manfredini, MD, PhD
- Email: fabio.manfredini@unife.it
- Phone: +390532236187
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.