Chronic Kidney Disease Stage 5 on DialysisNCT04282616
An Exercise Facilitator to Activate Simple Training Programs in the Dialysis Center
A study testing Home-based unstructured physical activity program, Home-based structured low-intensity physical activity program and In-hospital structured supervised physical activity program in people with Chronic Kidney Disease Stage 5 on Dialysis, run by University Hospital of Ferrara at 1 site in Italy.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Kidney Disease Stage 5 on Dialysis
- What is being tested?
- Home-based unstructured physical activity program, Home-based structured low-intensity physical activity program and In-hospital structured supervised physical activity program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 144 participants
- Where
- 1 siteItaly
- Study dates
- 26 Feb 2020to 28 Feb 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read more
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.
Read the 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.
- Being tested
- Home-based unstructured physical activity program, Home-based structured low-intensity physical activity program, In-hospital structured supervised physical activity program
- Keywords
- exercise, rehabilitation, exercise testing
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home-based unstructured physical activity programOther
Counselling on physical activity according to American College of Sports Medicine guidelines
Home-based structured low-intensity physical activity programOther
Structured home-based low-intensity intermittent walking program
In-hospital structured supervised physical activity programOther
Supervised exercise training program
| Study group | Role | What they receive |
|---|---|---|
| Home-based unstructured physical activity program | Experimental | 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 Receives: Other: Home-based unstructured physical activity program |
| Home-based structured low-intensity physical activity program | Experimental | 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. Receives: Other: Home-based structured low-intensity physical activity program |
| In-hospital structured supervised physical activity program | Experimental | 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. Receives: Other: In-hospital structured supervised physical activity program |
| No-training | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change at 3-month (end of training) respect to baseline
Secondary outcomes (12)
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
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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)
Measured: 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.
Measured: 6-month and 12-month (follow up)
Number and rate of mortality
Number and rate of all-cause mortality within participants will be collected.
Measured: 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
Measured: 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.
Measured: 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).
Measured: 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.
Measured: Change at 6-month (follow-up) respect to baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2020
- Study start26 Feb 2020
- Primary completion31 Dec 2024
- Study completion28 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Kidney Disease Stage 5 on DialysisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Outcomes assessor
- Enrolment
- 144 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital of Ferrara
- Sponsor type
- University, hospital or other
- Collaborators
- Università degli Studi di Ferrara
- Responsible party
- Sponsor
- Investigators
- Fabio Manfredini, MD, Principal investigator, University of Ferrara and University Hospital of FerraraAlda Storari, MD, Principal investigator, University Hospital of Ferrara
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04282616
- Sponsor's protocol ID
- 48/2019/Sper/AOUFe
- Status last verified
- May 2025
- First submitted
- 3 Feb 2020
- Last updated
- 11 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 33470990
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04282616
- Acronym / sponsor ID
- 48/2019/Sper/AOUFe
- Keywords
- exercise, rehabilitation, exercise testing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 144 participants (actual)
- Lead sponsor
- University Hospital of FerraraUniversity, hospital or other
- Collaborators
- Università degli Studi di Ferrara
- Study start
- 26 Feb 2020 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 28 Feb 2025 (actual)
- First posted
- 25 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
- 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).
| Arm | Type | Receives |
|---|---|---|
| Home-based unstructured physical activity program | Experimental | Other: Home-based unstructured physical activity programAccording 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 |
| Home-based structured low-intensity physical activity program | Experimental | Other: Home-based structured low-intensity physical activity programAccording 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. |
| In-hospital structured supervised physical activity program | Experimental | Other: In-hospital structured supervised physical activity programPatients 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. |
| No-training | No intervention | –Patients choosing this option will not start any physical activity program, but they will perform the outcome measures, acting as a control group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Home-based unstructured physical activity programCounselling on physical activity according to American College of Sports Medicine guidelines | Other | Home-based unstructured physical activity program |
| Home-based structured low-intensity physical activity programStructured home-based low-intensity intermittent walking program | Other | Home-based structured low-intensity physical activity program |
| In-hospital structured supervised physical activity programSupervised exercise training program | Other | In-hospital structured supervised physical activity program |
Primary outcome
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.
12 secondary outcomes
10-meter walking test (gait speed)
Time frame: Change at 3-month (end of training) respect to baseline
5-time sit-to-stand test (lower limbs strength)
Time frame: Change at 3-month (end of training) respect to baseline
Short Form Health Survey (SF-36) (health-related quality of life)
Time frame: Change at 3-month (end of training) respect to baseline
Short Falls Efficacy Scale (sFES) (fear of falling)
Time frame: Change at 3-month (end of training) respect to baseline
Duke Activity Status Index (DASI) (Estimated functional capacity)
Time frame: Change at 3-month (end of training) respect to baseline
Beck Depression Inventory - II (BDI-II)
Time frame: Change at 3-month (end of training) respect to baseline
Number and rate of hospitalizations
Time frame: 6-month and 12-month (follow up)
Number and rate of mortality
Time frame: 6-month and 12-month (follow up)
Rate of participation (qualitative outcome)
Time frame: Baseline
Rate of selection of different exercise program proposed (qualitative outcome)
Time frame: Baseline
Rate of training sessions completed
Time frame: 3-month (end of program)
6-minute walking test (Mobility)
Time frame: Change at 6-month (follow-up) respect to baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2025.
- Derived from this study: PubMed 33470990Manfredini 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.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fabio Manfredini, MD principal investigator
University of Ferrara and University Hospital of Ferrara
Alda Storari, MD principal investigator
University Hospital of Ferrara
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Home-based unstructured physical activity program, Home-based structured low-intensity physical activity program and In-hospital structured supervised physical activity program in people with Chronic Kidney Disease Stage 5 on Dialysis, run by University Hospital of Ferrara at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
6-minute walking test (Mobility) (time frame: Change at 3-month (end of training) respect to baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04282616, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2025.