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

Chronic Kidney Disease Stage 5 on Dialysis Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04282616
• Other study ID #: 48/2019/Sper/AOUFe
• Status: Recruiting
• Phase: N/A
• Start date: February 26, 2020
• Est. completion date: February 28, 2023

Study information

• Verified date: May 2022
• Source: University Hospital of Ferrara
• Contact: Fabio Manfredini, MD
• Phone: 00390532236187
• Email: fabio.manfredini[@]unife.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: February 28, 2023
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Kidney Disease Stage 5 on Dialysis
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

Other:
• Home-based unstructured physical activity program
Counselling on physical activity according to American College of Sports Medicine guidelines
• Home-based structured low-intensity physical activity program
Structured home-based low-intensity intermittent walking program
• In-hospital structured supervised physical activity program
Supervised exercise training program

Locations

Country	Name	City	State
Italy	University Hospital of Ferrara	Ferrara

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital of Ferrara	Università degli Studi di Ferrara

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Number and rate of hospitalizations	Number and rate of all-cause hospitalizations within participants will be collected.	6-month and 12-month (follow up)
Secondary	Number and rate of mortality	Number and rate of all-cause mortality within participants will be collected.	6-month and 12-month (follow up)
Secondary	Rate of participation (qualitative outcome)	Rate of patients providing consent compared to the eligible ones will be calculated	Baseline
Secondary	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
Secondary	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)
Secondary	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