Home-Based Walking Exercise Program to Improve Mobility and Quality of Life in Adults With Chronic Kidney Disease and Peripheral Artery Disease
Led by University Hospital of Ferrara · Updated on 2025-05-31
124
Participants Needed
3
Research Sites
58 weeks
Total Duration
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
Research Team
F
Fabio Manfredini Prof. Fabio Manfredini, MD, PhD
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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)
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
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
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.