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
University Hospital of Ferrara
124 participants
Oct 1, 2024
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria4
- 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 Criteria4
- 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.
Interventions
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.
Patients enrolled in the Co group will receive standard CKD-PAD care, including optimal medical therapy and nutritional advices
Locations(3)
View Full Details on ClinicalTrials.gov
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NCT06621264