Exercise Activity to Improve Mobility in Patients With CKD and PAD

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.

Conditions

• Chronic Kidney Disease Stage 3 and 4
• Peripheral Artery Disease (PAD)

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

Sponsors & Collaborators

• University of Verona, Italy

  collaborator UNKNOWN

• Reggio Calabria

  collaborator OTHER

• University Hospital of Ferrara

  lead OTHER

Principal Investigators

• Roberto Manfredini Prof. Roberto Manfredini, MD, PhD · Università degli Studi di Ferrara

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-10-01

Primary Completion

2025-11-20

Completion

2026-12-31

Countries

• Italy

Study Locations