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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Chronic Kidney Disease Stage 5 on Dialysis

Intervention / Treatment
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* Other: Home-based unstructured physical activity program
* Other: Home-based structured low-intensity physical activity program
* Other: In-hospital structured supervised physical activity program


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional 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).
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Home-based unstructured physical activity program<br>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<br>* Counselling on physical activity according to American College of Sports Medicine guidelines<br>|
| Experimental: Home-based structured low-intensity physical activity program<br>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<br>* Structured home-based low-intensity intermittent walking program<br>|
| Experimental: In-hospital structured supervised physical activity program<br>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<br>* Supervised exercise training program<br>|
| No Intervention: No-training<br>Patients choosing this option will not start any physical activity program, but they will perform the outcome measures, acting as a control group. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 10-meter walking test (gait speed) | Patients will be positioned at the start of a 10-meter corridor marked with four lines, respectively at 0, 2, 8 and 10 meters from the start. Patients will be asked to walk as fast as they can, but safely, from the first to the last line, using their habitual walking device. A skilled operator will record the time within the two middle lines, that will be converted into speed. Two trails are allowed for this test, and the mean of the two results will be considered | Change at 3-month (end of training) respect to baseline | 
| 5-time sit-to-stand test (lower limbs strength) | This test consists in moving from a sitting position to a standing position on a 42- cm high chair as quick as possible, for five times, with arms folded across the chest. Time will be taken when the test starts, and when the patient lay his/her buttocks on the chair for the fifth time. | Change at 3-month (end of training) respect to baseline | 
| Short Form Health Survey (SF-36) (health-related quality of life) | This questionnaire consists of 36 items with a score ranging from 0 to 100 divided into 8 domains examining various aspects of health-related QoL. Higher scores correspond to better quality of life. | Change at 3-month (end of training) respect to baseline | 
| Short Falls Efficacy Scale (sFES) (fear of falling) | This scale is composed of seven 4-point Likert questions about how concerned the patients is about the possibility of falling. The total score ranges from 7 (no concerned about falling) to 28 (highest concern about falling). | Change at 3-month (end of training) respect to baseline | 
| Duke Activity Status Index (DASI) (Estimated functional capacity) | This is an assessment tool to evaluate the functional capacity of patients through 12 dichotomous (yes/no) questions covering various aspect of life. The total score, ranges from 0 to 58.2 with higher scores that indicate a higher functional capacity. | Change at 3-month (end of training) respect to baseline | 
| Beck Depression Inventory - II (BDI-II) | This questionnaire, composed of 21 multiple-choice questions, is suitable for measuring the gravity of clinical depression in adults and in diseased populations. The score ranges from 0 (no depression) to 63 (severe depression) | Change at 3-month (end of training) respect to baseline | 
| Number and rate of hospitalizations | Number and rate of all-cause hospitalizations within participants will be collected. | 6-month and 12-month (follow up) | 
| Number and rate of mortality | Number and rate of all-cause mortality within participants will be collected. | 6-month and 12-month (follow up) | 
| Rate of participation (qualitative outcome) | Rate of patients providing consent compared to the eligible ones will be calculated | Baseline | 
| Rate of selection of different exercise program proposed (qualitative outcome) | The rate of patients choosing each of the training option proposed will be calculated to determine patients willingness to exercise and patients preferences about training. | Baseline | 
| Rate of training sessions completed | Adherence to the physical activity program chosen will be assessed at the end of the 3-month training period. The total number of training sessions completed in relation to the prescribed ones will be measured by a ratio. The total adherence will range from 0 (0 sessions completed out of 24) to 100% (24 sessions completed out of 24). | 3-month (end of program) | 
| 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 6-month (follow-up) respect to baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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exercise, rehabilitation, exercise testing