An Exercise Facilitator to Activate Simple Training Programs in the Dialysis Center

NCT04282616 | Completed

• 1 other identifier: 48/2019/Sper/AOUFe
• Study Type: interventional
• Target: 144
• Locations: 1 country
• Sites: 1

Brief Summary

Low physical activity levels and progressive poor functional capacity affect quality of life and clinical outcomes of Chronic Kidney Disease (CKD) patients. Interventions to prevent the functional decline associated with a sedentary lifestyle or to relief from deconditioning are crucial, considering the significant beneficial effects of exercise in all CKD patients, especially in End-stage Kidney Disease patients (ESKD). Unfortunately, physical and psychological barriers to exercise are present and physical activity management is not routinely addressed in the patient's care. For the first time the project aims to test the impact of the regular presence of an exercise specialist in the Nephrology Unit. This facilitator, evaluating capacity, motivation and preferences of each patient, will design tailored solutions and assess the related outcomes. Several design of training programs will be proposed to dialysis patients, that can choose the exercise option that best fits their needing. The study will determine the feasibility of the project, the patients' adherence and the effectiveness of the programs proposed to improve the patients' lifestyle.

Conditions

Chronic Kidney Disease Stage 5 on Dialysis

Keywords

exercise; rehabilitation; exercise testing

Outcome Measures

Primary Outcomes (1)

• 6-minute walking test (Mobility)

  Subjects will be instructed to walk as far as possible on a 22m walkway in 6 minutes, with their habitual walking device, with the possibility to slow down and rest if necessary. The total distance walked, the pain-free walking distance, and the perceived exertion at the end of the test will be recorded.

  Change at 3-month (end of training) respect to baseline

Secondary Outcomes (12)

• 10-meter walking test (gait speed)

  Change at 3-month (end of training) respect to baseline

• 5-time sit-to-stand test (lower limbs strength)

  Change at 3-month (end of training) respect to baseline

• Short Form Health Survey (SF-36) (health-related quality of life)

  Change at 3-month (end of training) respect to baseline

• Short Falls Efficacy Scale (sFES) (fear of falling)

  Change at 3-month (end of training) respect to baseline

• Duke Activity Status Index (DASI) (Estimated functional capacity)

  Change at 3-month (end of training) respect to baseline

Study Arms (4)

Home-based unstructured physical activity program

EXPERIMENTAL

According to each patient's baseline physical activity level, the facilitator will advise patients to start or to increase their spontaneous activity by giving counselling on total exercise time, mode, intensity and frequency as suggested by the American College of Sport Medicine guidelines. Every patient will be provided with a log-book and a wearable physical activity monitor, which has to be returned in the subsequent controls, to favor adherence and objectively measure the exercise activities

Other: Home-based unstructured physical activity program

Home-based structured low-intensity physical activity program

EXPERIMENTAL

According to each patient's baseline physical activity level, a semi-personalized walking program, will be provided. This program, derived from previous experience on renal patients, includes a 10-min session/day of intermittent walking (1- or 2-min work and 1-min seated rest) to be performed at home at prescribed speed. The speed, converted into walking cadence and followed by a metronome, is weekly increased. Patients will be provided with a daily log containing the detailed exercise prescription and spaces to give a feedback on training execution and related symptoms.

Other: Home-based structured low-intensity physical activity program

In-hospital structured supervised physical activity program

EXPERIMENTAL

Patients will join the room properly equipped for the exercise program in groups of maximum four subjects for a 2-time/week thirty minutes training sessions, to be performed for dialysis patients immediately before or after the dialysis treatment, or in non-dialysis according to their preferences. Each sessions will include low-intensity walking exercises (similar to the structured home-based training), resistance and power exercises with elastic bands and light weights. Each sessions will begin and end with a warm-up and cool-down period of stretching. The total duration of the session will be about 30 minutes. Rate of perceived exertion will be collected and the training intensity will be set according to the patient's baseline capacity and weekly increased.

Other: In-hospital structured supervised physical activity program

No-training

NO INTERVENTION

Patients choosing this option will not start any physical activity program, but they will perform the outcome measures, acting as a control group.

Interventions

Home-based unstructured physical activity program OTHER

Counselling on physical activity according to American College of Sports Medicine guidelines

Home-based unstructured physical activity program

Home-based structured low-intensity physical activity program OTHER

Structured home-based low-intensity intermittent walking program

Home-based structured low-intensity physical activity program

In-hospital structured supervised physical activity program OTHER

Supervised exercise training program

In-hospital structured supervised physical activity program

Eligibility Criteria

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

You may qualify if:

• male and females aged \> 18 years;
• ability to walk assisted or unassisted at least for 6 meters;
• cognitive functioning to give informed consent identified by a Mini Mental Status Examination score ≥18/30.

You may not qualify if:

• severe cardio-respiratory (e.g. unstable angina; severe heart failure identified by New York Heart Association class III or IV);
• neurological or musculoskeletal conditions (e.g. above knee amputation) contraindicating or inhibiting exercise training.

Sponsors & Collaborators

• University Hospital of Ferrara: lead
• Università degli Studi di Ferrara: collaborator

Study Sites (1)

University Hospital of Ferrara

Ferrara, 44124, Italy

Location

Related Publications (1)

• Manfredini F, Lamberti N, Battaglia Y, Straudi S, Belvederi Murri M, Donadi M, Piva G, Fabbian F, Lopez-Soto PJ, Grassi L, Manfredini R, Basaglia N, Storari A. A Personalized Patient-Centered Intervention to Empower through Physical Activity the Patient in the Dialysis Center: Study Protocol for a Pragmatic Nonrandomized Clinical Trial. Methods Protoc. 2020 Dec 6;3(4):83. doi: 10.3390/mps3040083.

  PMID: 33470990 DERIVED

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Fabio Manfredini, MD

  University of Ferrara and University Hospital of Ferrara

  PRINCIPAL INVESTIGATOR

• Alda Storari, MD

  University Hospital of Ferrara

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcome measures assessors will be blinded to group allocation
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: End-stage kidney disease patients will be proposed to choose between one of the three organizational models of exercise (counselling; home-based prescription; supervised) or to take part in the project as a control group (no exercise).

Study Record Dates

• First Submitted: February 3, 2020
• First Posted: February 25, 2020
• Study Start: February 26, 2020
• Primary Completion: December 31, 2024
• Study Completion: February 28, 2025
• Last Updated: August 11, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Study protocol will be available upon acceptance by a peer-reviewed journal. IPD will be available beginning 6 months following study results publication.
• Access Criteria: Anyone who wishes to access the data.

Locations

IT (1)