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

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Behavioral, Other
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• 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).

Locations
Other Locations
Italy
University Hospital of Ferrara
RECRUITING
Ferrara
Ospedale Pederzoli Peschiera del Garda
RECRUITING
Peschiera Del Garda
Grande Ospedale Metropolitano Bianchi-Melacrino-Morelli
RECRUITING
Reggio Calabria
Contact Information
Primary
Fabio Manfredini Prof. Fabio Manfredini, MD, PhD
fabio.manfredini@unife.it
+390532236187
Time Frame
Start Date: 2024-10-01
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 124
Treatments
Experimental: Exercise group
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.
Placebo_comparator: Control group
Patients enrolled in the Co group will receive standard CKD-PAD care, including optimal medical therapy and nutritional advices
Sponsors
Collaborators: University of Verona, Italy, Reggio Calabria
Leads: University Hospital of Ferrara

This content was sourced from clinicaltrials.gov