RECRUITINGINTERVENTIONAL

Exercise Activity to Improve Mobility in Patients With CKD and PAD

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

About This Trial

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 May Be Eligible (Plain English)

Who May Qualify: - 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 willing to sign a consent form 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 Should NOT Join This Trial: - 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. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

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.

Treatments Being Tested

BEHAVIORAL

EXERCISE TRAINING WITH OR WITHOUT MEDICATION

Patients enrolled in this group will receive a detailed 6-month exercise prescription aimed at providing in-home low fatiguing walking 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.

OTHER

Control (Standard treatment)

Patients enrolled in the Co group will receive standard CKD-PAD care, including optimal medical therapy and nutritional advices

Locations (3)

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