Exercise Activity to Improve Mobility in Patients With CKD and PAD
Recruiting · NCT06621264 · Interventional (participants receive a specific treatment) · Lead sponsor: University Hospital of Ferrara
View the official record on ClinicalTrials.gov →Interventions studied
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.
Who can take part
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 is running
3 locations listed.
- University Hospital of Ferrara - Ferrara, Italy, Italy
- Ospedale Pederzoli Peschiera del Garda - Peschiera del Garda, Italy, Italy
- Grande Ospedale Metropolitano Bianchi-Melacrino-Morelli - Reggio Calabria, Italy, Italy