Actively Recruiting

Phase Not Applicable
Age: 18Years - 80Years
All Genders
NCT06621264

Exercise Activity to Improve Mobility in Patients With CKD and PAD

Led by University Hospital of Ferrara · Updated on 2025-05-31

124

Participants Needed

3

Research Sites

117 weeks

Total Duration

On this page

Sponsors

U

University Hospital of Ferrara

Lead Sponsor

U

Universita di Verona

Collaborating Sponsor

AI-Summary

What this Trial Is About

People affected by chronic kidney disease and concomitant diagnosed peripheral artery disease at intermediate stages, without contraindications to exercise therapy will be invited to participate in the study. Whose providing informed consent, will be randomly assigned to one of two groups: 1. Exercise program receiving two daily 10-minute interval walking sessions at a slow increasing speed. 2. Control group: receiving usual care including optimal medical therapy and nutritional advice. Patients of both groups will be measured at baseline, after the end of the exercise program (6-month) and at follow up (12-month). Outcome measures will include walking ability by the 6-minute walking test (primary outcome) and lower limbs perfusion, body composition, quality of life, laboratory outcomes and long-term hospitalizations.

CONDITIONS

Official Title

Exercise Activity to Improve Mobility in Patients With CKD and PAD

Who Can Participate

Age: 18Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Chronic kidney disease at KDOQI stages III or IV and peripheral artery disease at Rutherford stages I, II, or III
  • Ability to walk independently
  • Cognitive function sufficient to provide informed consent, with Mini Mental Status Examination score of 20 or higher
  • No clinical conditions that prevent exercise therapy (e.g., unstable angina, severe heart failure NYHA class IV, anemia with hemoglobin under 10.0 g/dl)
Not Eligible

You will not qualify if you...

  • Major limb amputations
  • Planned major surgery within the next 3 months
  • Comorbid conditions likely to limit survival to less than 2 years
  • Inability or unwillingness to follow study protocol requirements

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 3 locations

1

University Hospital of Ferrara

Ferrara, Italy, Italy, 44124

Actively Recruiting

2

Ospedale Pederzoli Peschiera del Garda

Peschiera del Garda, Italy, Italy

Actively Recruiting

3

Grande Ospedale Metropolitano Bianchi-Melacrino-Morelli

Reggio Calabria, Italy, Italy

Actively Recruiting

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Research Team

F

Fabio Manfredini Prof. Fabio Manfredini, MD, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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