Exercise Activity to Improve Mobility in Patients With CKD and PAD

NCT06621264 | Recruiting

• 1 other identifier: PNRR-MAD-2022-12376611
• Study Type: interventional
• Target: 124
• Locations: 1 country
• Sites: 3

Brief 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. 1.Exercise program receiving two daily 10-minute interval walking sessions at a slow increasing speed.
2. 2.Control group: receiving usual care including optimal medical therapy and nutritional advice.

Conditions

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

Keywords

Exercise therapy;; Mobility; Ageing; Chronic Kidney Disease; Peripheral artery disease

Outcome Measures

Primary Outcomes (1)

• 6-minute walking test

  The patients will be instructed to walk back and forth on a 20-meter corridor aiming at covering as much distance as possible. The total distance covered (6MWD) will be measured in meters

  Baseline; End of program (6-month); Follow up (12-month)

Secondary Outcomes (11)

• Lower limbs perfusion

  Baseline; end of the program (6-month); Follow up (12-month).

• handgrip strength will be measured by a standard dynamometer

  Baseline; end of the program (6-month); Follow up (12-month).

• Quality of life will be assessed by the short-form 36 (SF-36) questionnaire

  Baseline; end of the program (6-month); Follow up (12-month).

• Bone mineral density

  Baseline; end of the program (6-month); Follow up (12-month).

• lower limbs strength assessed by the 5-time sit-to-stand test

  Baseline; end of the program (6-month); Follow up (12-month).

Study Arms (2)

Exercise group

EXPERIMENTAL

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.

Behavioral: EXERCISE TRAINING WITH OR WITHOUT MEDICATION

Control group

PLACEBO COMPARATOR

Patients enrolled in the Co group will receive standard CKD-PAD care, including optimal medical therapy and nutritional advices

Other: Control (Standard treatment)

Interventions

EXERCISE TRAINING WITH OR WITHOUT MEDICATION BEHAVIORAL

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.

Also known as: exercise, rehabilitation

Exercise group

Control (Standard treatment) OTHER

Patients enrolled in the Co group will receive standard CKD-PAD care, including optimal medical therapy and nutritional advices

Also known as: Usual care

Control group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital of Ferrara: lead
• University of Verona, Italy: collaborator
• Reggio Calabria: collaborator

Study Sites (3)

University Hospital of Ferrara

Ferrara, Italy, 44124, Italy

RECRUITING

Ospedale Pederzoli Peschiera del Garda

Peschiera del Garda, Italy, Italy

RECRUITING

Grande Ospedale Metropolitano Bianchi-Melacrino-Morelli

Reggio Calabria, Italy, Italy

RECRUITING

Related Publications (1)

• Manfredini F, Panuccio V, Battaglia Y, Storari A, Lamberti N, Piva G, Veronesi M, Tripepi R, Rinaldo N, Crepaldi A, Momente C, Piccinini A, Traina L, Fargion AT, Straudi S, Baroni A, De Giorgi A, Martinuzzi C, Monesi M, Capitanini A, Aucella F, Cupisti A, Mallamaci F, Zoccali C, Manfredini R. Exercise therapy to improve mobility, active behaviour and quality of life of chronic kidney disease patients with peripheral artery disease: study protocol for the EXACT-CKDPAD multicentre randomised controlled trial. BMJ Open Sport Exerc Med. 2025 Jul 15;11(3):e002740. doi: 10.1136/bmjsem-2025-002740. eCollection 2025.

  PMID: 40672525 DERIVED

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Peripheral Arterial Disease

Interventions

Exercise; Dosage Forms; Rehabilitation

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Pharmaceutical Preparations; Technology, Pharmaceutical; Investigative Techniques; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Roberto Manfredini Prof. Roberto Manfredini, MD, PhD

  Università degli Studi di Ferrara

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Fabio Manfredini Prof. Fabio Manfredini, MD, PhD

CONTACT

+390532236187; fabio.manfredini@unife.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 26, 2024
• First Posted: October 1, 2024
• Study Start: October 1, 2024
• Primary Completion: November 20, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: May 31, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: The study protocol, along with the statistical analysis plan will be available when published on an open access journal.

Locations

IT (3)