Actively Recruiting

Phase Not Applicable
Age: 18Years - 80Years
All Genders
ID06621264

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

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

124

Participants Needed

3

Research Sites

58 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

This research aims to evaluate the effects of a home-based exercise program on people with chronic kidney disease (CKD) at stages III or IV who also have peripheral artery disease (PAD) at stages I to III. These conditions together increase cardiovascular risk and complications like mortality and limb amputations. The study focuses on improving physical function and quality of life by comparing exercise therapy to usual care in a randomized controlled trial involving 100 patients aged 18 to 80 years without contraindications to exercise. Participants will be randomly assigned to one of two groups. The exercise group will follow a 6-month home walking program involving two daily 10-minute interval walking sessions at an increasing speed controlled by a digital metronome. Training intensity is light to moderate, with two hospital visits at 1 and 3 months to adjust the exercise plan and encourage adherence via a digital app. The control group will receive standard care including optimal medical treatment and nutritional advice. Patients in both groups will be assessed at the start, at 6 months when the exercise ends, and at 12 months for follow-up. Researchers will measure walking ability using the 6-minute walking test as the primary outcome, along with limb blood flow, strength, body composition, bone density, quality of life, kidney function, hospitalizations, and mortality. Assessments are done by blinded evaluators to track the effects of the intervention over time.

CONDITIONS

Brief 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 stages I, II, or III
  • Ability to walk independently
  • Cognitive ability to provide informed consent with a Mini Mental Status Examination score of 20/30 or higher
  • No clinical conditions that contraindicate exercise therapy (e.g., unstable angina, severe heart failure NYHA class IV, anemia with hemoglobin below 10.0 g/dl)
Not Eligible

You will not qualify if you...

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

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 6 months

Participants in the exercise group follow a 6-month home-based structured walking program consisting of two daily 10-minute interval walking sessions at a prescribed speed. Exercise prescription is updated during two intermediate hospital visits at the 1st and 3rd months. Participants in the control group receive standard CKD-PAD care including medical therapy and nutritional advice.

2 visits (in-person) during the program

Follow-up

Duration - Up to 30 months after treatment

Participants are monitored after the treatment program to assess mobility, physical function, quality of life, kidney function, and long-term outcomes including hospitalizations and survival.

Visits at 12, 18, 24, and 36 months after baseline

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

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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Published Research Related To This Trial

Exercise therapy to improve mobility, active behaviour and quality of life of chronic kidney disease patients with peripheral artery disease: study protocol for the EXACT-CKDPAD multicentre randomised controlled trial.

Fabio Manfredini, Vincenzo Panuccio, Yuri Battaglia...

https://pubmed.ncbi.nlm.nih.gov/40672525