An Exercise Facilitator to Break Down the Barriers to Physical Activity of End-stage Kidney Disease Patients. A Pragmatic Implementation Trial in a Nephrology Unit
Sponsor study identifier
interventional
144
1 country
1
Study Start
February 26, 2020
Actual (reported)Primary Completion
December 31, 2024
Actual (reported)Study Completion
February 28, 2025
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
February 28, 2025
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 3, 2020
Actual (reported)February 25, 2020
Actual (reported)February 26, 2020
Actual (reported)December 31, 2024
Actual (reported)February 28, 2025
Actual (reported)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
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
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
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.
Counselling on physical activity according to American College of Sports Medicine guidelines
Structured home-based low-intensity intermittent walking program
University Hospital of Ferrara
Ferrara, 44124, Italy
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.
Fabio Manfredini, MD
University of Ferrara and University Hospital of Ferrara
Alda Storari, MD
University Hospital of Ferrara
144 participants (actual enrollment reported by the registry).
First Submitted
February 3, 2020
First Posted
February 25, 2020
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.
Patients choosing this option will not start any physical activity program, but they will perform the outcome measures, acting as a control group.
Supervised exercise training program
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Study Start
February 26, 2020
Actual (reported)Primary Completion
December 31, 2024
Actual (reported)Study Completion
February 28, 2025
Actual (reported)Last Updated
August 11, 2025
Record last verified: 2025-05
Individual participant data that underlie the results published at the end of the trial after deidentification. The database of the study will be published in a public repository.
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.
Source retrieved: