Exercise Program to Improve Walking in People With Kidney and Leg Artery Disease
Tests a walking exercise program in adults with chronic kidney disease and peripheral artery disease.
Key facts
- Who runs it
- University Hospital of Ferrara
- Where
- Ferrara, Peschiera del Garda, and Reggio Calabria, ItalySee the 3 sites
- Trial code
- Registry title
- Exercise Activity to Improve Mobility in Patients With CKD and PAD
- Status
- Recruiting
- People taking part
- 124 people, planned
- Started
- 1 Oct 2024
- Expected to end
- 31 Dec 2026
- Type of study
- Interventional, 2 groupsOne group gets a placebo (a dummy treatment), for comparison.
- Treatments tested
- EXERCISE TRAINING WITH OR WITHOUT MEDICATION
- Control (Standard treatment)
- Record updated
- 31 May 2025
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with chronic kidney disease (stage III or IV) who also have peripheral artery disease and can walk on their own. It tests a walking exercise program against usual care.
- Age
- 18 Years to 80 Years
- Sex
- All sexes can join.
- Disease stage
- Chronic kidney disease at KDOQI stage III or IV, together with peripheral artery disease at stage I, II or III.
Main reasons for not taking part
- Major amputations
- Major surgery planned in the next 3 months
- Other health problems that may limit survival to less than 2 years
- Health conditions that rule out exercise therapy (for example unstable angina, severe heart failure at NYHA class IV, anemia with lower than 10.0 g/dl)
- Cannot or will not follow the trial requirements
The registry criteria, word for word
Show all 8 criteriaShow less
Who can take part
- 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)
Who cannot take part
- major surgery planned in the next 3 months
- known comorbid conditions that may limit survival to less than 2 years
- major amputations
- inability or unwillingness to comply with protocol requirements
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 80 years old?
Where in Italy
- University Hospital Of FerraraFerrara, ItalyContact: Fabio Manfredini Prof. Fabio Manfredini, MD PhDTaking people
- Ospedale Pederzoli Peschiera del GardaPeschiera del Garda, ItalyContact: Yuri Battaglia Prof. Yuri Battaglia, MD PhDTaking people
- Grande Ospedale Metropolitano Bianchi Melacrino MorelliReggio Calabria, ItalyContact: Vincenzo Panuccio Dr. Vincenzo Panuccio, MDTaking people
About the trial
What the trial wants to find out
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.
Read full original descriptionShow less
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.
The 2 groups in the trial
- Exercise groupTreatment being tested
Patients enrolled in this group will receive a detailed 6-month exercise prescription aimed at providing in-home low fatiguingwalking training (at light-moderate intensity, or 2-3 out of 10 of the CR10 Borg's scale). The program consists of a two daily 10-minute interval walking sessions (1 minute walking : 1 minute resting) at a prescribed speed controlled by a digital metronome (https://www.youtube.com/watch?v=ki8YX\_t-0jA). The training speed will be set up according to the patients baseline walking capacity (approximately 50% lower than the habitual gait speed) and will be weekly increased until reaching the habitual gait speed. The training time will be maintained constant throughout the entire program. Exercise prescription will be updated during two intermediate hospital visits at the 1st and 3rd months. Patients will be provided with a digital application properly developed to keep pacing and to record the correct training execution.
Treatment: EXERCISE TRAINING WITH OR WITHOUT MEDICATION
- Control groupPlacebo, for comparison
Patients enrolled in the Co group will receive standard CKD-PAD care, including optimal medical therapy and nutritional advices
Treatment: Control (Standard treatment)
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- 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
- Plain-language title
- Exercise Program to Improve Walking in People With Kidney and Leg Artery DiseaseGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Fit questions
- Built from NCT06621264, who can take part
- Record updated
- 31 May 2025