Home-based walking program to improve mobility in people with stage 3–4 CKD and PAD

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.