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

NCT ID: NCT04282616

Last Updated: 2025-08-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 144 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-02-26
• Study Completion Date: 2025-02-28

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.

Detailed Description

The assumption underlying the project is that a wider participation to physical activity programs (PAPs) of ESKD patients may be facilitated by the presence in the Renal Unit of an exercise specialist able to design tailored programs and that this intervention may lead to measurable benefits on physical fitness, quality of life and general health.

The possible different solutions offered by an expert of exercise in chronic diseases might reduce most of the barriers to exercise responsible of the sedentary behavior of the ESKD patients. Aim of the project is to test the impact of the regular presence of this facilitator in a Nephrology Unit in terms of applicability and feasibility as well to identify the preferred and the most effective pathways for the patients.

The identification of a novel cost-effective intervention may represent an important step to manage the change of lifestyle of ESKD patients, to slow down their physical and QoL decline and to reduce hospitalizations and negative outcomes affecting this population.

Conditions

Chronic Kidney Disease Stage 5 on Dialysis

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Home-based unstructured physical activity program

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

Group Type: EXPERIMENTAL

Home-based unstructured physical activity program

Intervention Type: OTHER

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

Home-based structured low-intensity physical activity program

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.

Group Type: EXPERIMENTAL

Home-based structured low-intensity physical activity program

Intervention Type: OTHER

Structured home-based low-intensity intermittent walking program

In-hospital structured supervised physical activity program

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.

Group Type: EXPERIMENTAL

In-hospital structured supervised physical activity program

Intervention Type: OTHER

Supervised exercise training program

No-training

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Home-based unstructured physical activity program

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

Intervention Type: OTHER

Home-based structured low-intensity physical activity program

Structured home-based low-intensity intermittent walking program

Intervention Type: OTHER

In-hospital structured supervised physical activity program

Supervised exercise training program

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Università degli Studi di Ferrara

OTHER

Sponsor Role: collaborator

University Hospital of Ferrara

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Fabio Manfredini, MD

Role: PRINCIPAL_INVESTIGATOR

University of Ferrara and University Hospital of Ferrara

Alda Storari, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital of Ferrara

Locations

University Hospital of Ferrara

Ferrara, , Italy

Countries

Italy

References

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.

Reference Type: DERIVED

PMID: 33470990 (View on PubMed)

Other Identifiers

48/2019/Sper/AOUFe

Identifier Type: -

Identifier Source: org_study_id