Clinical trial NCT04282616: An Exercise Facilitator to Activate Simple Training Programs in the Dialysis Center
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Kidney Disease Stage 5 on Dialysis
Keywords: exercise
rehabilitation
exercise testing
Lead sponsor: University Hospital of Ferrara
Sponsor class: OTHER
Collaborators: name: Università degli Studi di Ferrara
First posted: 2020-02-25
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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).
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: 6-minute walking test (Mobility)
timeFrame: Change at 3-month (end of training) respect to baseline
Secondary outcomes:
measure: 10-meter walking test (gait speed)
timeFrame: Change at 3-month (end of training) respect to baseline
measure: 5-time sit-to-stand test (lower limbs strength)
timeFrame: Change at 3-month (end of training) respect to baseline
measure: Short Form Health Survey (SF-36) (health-related quality of life)
timeFrame: Change at 3-month (end of training) respect to baseline
measure: Short Falls Efficacy Scale (sFES) (fear of falling)
timeFrame: Change at 3-month (end of training) respect to baseline
measure: Duke Activity Status Index (DASI) (Estimated functional capacity)
timeFrame: Change at 3-month (end of training) respect to baseline
measure: Beck Depression Inventory - II (BDI-II)
timeFrame: Change at 3-month (end of training) respect to baseline
measure: Number and rate of hospitalizations
timeFrame: 6-month and 12-month (follow up)
measure: Number and rate of mortality
timeFrame: 6-month and 12-month (follow up)
measure: Rate of participation (qualitative outcome)
timeFrame: Baseline
measure: Rate of selection of different exercise program proposed (qualitative outcome)
timeFrame: Baseline
measure: Rate of training sessions completed
timeFrame: 3-month (end of program)
measure: 6-minute walking test (Mobility)
timeFrame: Change at 6-month (follow-up) respect to baseline
Other outcomes:
Locations:
city: Ferrara
country: Italy
facility: University Hospital of Ferrara
Study officials:
affiliation: University of Ferrara and University Hospital of Ferrara
name: Fabio Manfredini, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital of Ferrara
name: Alda Storari, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.