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RECRUITING
NCT06621264
NA

Exercise Activity to Improve Mobility in Patients With CKD and PAD

Sponsor: University Hospital of Ferrara

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

124

Start Date

2024-10-01

Completion Date

2026-12-31

Last Updated

2025-05-31

Healthy Volunteers

No

Interventions

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