RecruitingNot ApplicableNCT06621264

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


Sponsor

University Hospital of Ferrara

Enrollment

124 participants

Start Date

Oct 1, 2024

Study Type

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

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether a structured exercise program can help people who have both chronic kidney disease (CKD) and peripheral artery disease (reduced blood flow in the legs) move around more easily and feel better. Both conditions can make walking and physical activity very difficult. **You may be eligible if...** - You have moderate-to-severe chronic kidney disease (stage 3 or 4) - You also have peripheral artery disease (stages 1, 2, or 3) - You are able to walk on your own - You scored at least 20/30 on a basic mental ability test - You do not have conditions that would make exercise unsafe (like severe unstable chest pain) **You may NOT be eligible if...** - You have had a major amputation - You have a major surgery planned in the next 3 months - You have a condition likely to limit your survival to less than 2 years - You are unable or unwilling to follow the study protocol Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

BEHAVIORALEXERCISE 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.

OTHERControl (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

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06621264


Related Trials