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NCT Number: NCT04282616

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

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.

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Key information

Conditions

Chronic Kidney Disease Stage 5 on Dialysis Behavior Motor Activity

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital of Ferrara

Ferrara, 44124, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Home-based unstructured physical activity program

Other

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

Home-based structured low-intensity physical activity program

Other

Structured home-based low-intensity intermittent walking program

In-hospital structured supervised physical activity program

Other

Supervised exercise training program

Primary outcomes

  1. 6-minute walking test (Mobility)

    Time frame: Change at 3-month (end of training) respect to baseline

    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.

Secondary outcomes

  1. 10-meter walking test (gait speed)

    Time frame: Change at 3-month (end of training) respect to baseline

    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

  2. 5-time sit-to-stand test (lower limbs strength)

    Time frame: Change at 3-month (end of training) respect to baseline

    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.

  3. Short Form Health Survey (SF-36) (health-related quality of life)

    Time frame: Change at 3-month (end of training) respect to baseline

    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.

  4. Short Falls Efficacy Scale (sFES) (fear of falling)

    Time frame: Change at 3-month (end of training) respect to baseline

    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).

  5. Duke Activity Status Index (DASI) (Estimated functional capacity)

    Time frame: Change at 3-month (end of training) respect to baseline

    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.

  6. Beck Depression Inventory - II (BDI-II)

    Time frame: Change at 3-month (end of training) respect to baseline

    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)

  7. Number and rate of hospitalizations

    Time frame: 6-month and 12-month (follow up)

    Number and rate of all-cause hospitalizations within participants will be collected.

  8. Number and rate of mortality

    Time frame: 6-month and 12-month (follow up)

    Number and rate of all-cause mortality within participants will be collected.

  9. Rate of participation (qualitative outcome)

    Time frame: Baseline

    Rate of patients providing consent compared to the eligible ones will be calculated

  10. Rate of selection of different exercise program proposed (qualitative outcome)

    Time frame: Baseline

    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.

  11. Rate of training sessions completed

    Time frame: 3-month (end of program)

    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).

  12. 6-minute walking test (Mobility)

    Time frame: Change at 6-month (follow-up) respect to baseline

    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.

Sponsors and collaborators

Lead sponsor

University Hospital of Ferrara

Other

Collaborators

  • Università degli Studi di Ferrara

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2024
Study completion
2025
First posted
Feb 25, 2020
Registry last updated
Aug 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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