Back to resultsAn Exercise Facilitator to Activate Simple Training Programs in the Dialysis Center
Primary Purpose
Chronic Kidney Disease Stage 5 on Dialysis
Status
Recruiting
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Home-based unstructured physical activity program
Home-based structured low-intensity physical activity program
In-hospital structured supervised physical activity program
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Kidney Disease Stage 5 on Dialysis focused on measuring exercise, rehabilitation, exercise testing
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.
Sites / Locations
- University Hospital of FerraraRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
No Intervention
Arm Label
Home-based unstructured physical activity program
Home-based structured low-intensity physical activity program
In-hospital structured supervised physical activity program
No-training
Arm Description
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
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.
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.
Patients choosing this option will not start any physical activity program, but they will perform the outcome measures, acting as a control group.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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
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.
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.
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).
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.
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)
Number and rate of hospitalizations
Number and rate of all-cause hospitalizations within participants will be collected.
Number and rate of mortality
Number and rate of all-cause mortality within participants will be collected.
Rate of participation (qualitative outcome)
Rate of patients providing consent compared to the eligible ones will be calculated
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.
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).
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.
Full Information
NCT ID
NCT04282616
First Posted
February 3, 2020
Last Updated
November 2, 2022
Sponsor
University Hospital of Ferrara
Collaborators
Università degli Studi di Ferrara
1. Study Identification
Unique Protocol Identification Number
NCT04282616
Brief Title
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
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 26, 2020 (Actual)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
February 28, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital of Ferrara
Collaborators
Università degli Studi di Ferrara
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Disease Stage 5 on Dialysis
Keywords
exercise, rehabilitation, exercise testing
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Outcomes Assessor
Masking Description
Outcome measures assessors will be blinded to group allocation
Allocation
Non-Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Home-based unstructured physical activity program
Arm Type
Experimental
Arm Description
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
Arm Title
Home-based structured low-intensity physical activity program
Arm Type
Experimental
Arm Description
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.
Arm Title
In-hospital structured supervised physical activity program
Arm Type
Experimental
Arm Description
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.
Arm Title
No-training
Arm Type
No Intervention
Arm Description
Patients choosing this option will not start any physical activity program, but they will perform the outcome measures, acting as a control group.
Intervention Type
Other
Intervention Name(s)
Home-based unstructured physical activity program
Intervention Description
Counselling on physical activity according to American College of Sports Medicine guidelines
Intervention Type
Other
Intervention Name(s)
Home-based structured low-intensity physical activity program
Intervention Description
Structured home-based low-intensity intermittent walking program
Intervention Type
Other
Intervention Name(s)
In-hospital structured supervised physical activity program
Intervention Description
Supervised exercise training program
Primary Outcome Measure Information:
Title
6-minute walking test (Mobility)
Description
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.
Time Frame
Change at 3-month (end of training) respect to baseline
Secondary Outcome Measure Information:
Title
10-meter walking test (gait speed)
Description
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
Time Frame
Change at 3-month (end of training) respect to baseline
Title
5-time sit-to-stand test (lower limbs strength)
Description
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.
Time Frame
Change at 3-month (end of training) respect to baseline
Title
Short Form Health Survey (SF-36) (health-related quality of life)
Description
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.
Time Frame
Change at 3-month (end of training) respect to baseline
Title
Short Falls Efficacy Scale (sFES) (fear of falling)
Description
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).
Time Frame
Change at 3-month (end of training) respect to baseline
Title
Duke Activity Status Index (DASI) (Estimated functional capacity)
Description
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.
Time Frame
Change at 3-month (end of training) respect to baseline
Title
Beck Depression Inventory - II (BDI-II)
Description
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)
Time Frame
Change at 3-month (end of training) respect to baseline
Title
Number and rate of hospitalizations
Description
Number and rate of all-cause hospitalizations within participants will be collected.
Time Frame
6-month and 12-month (follow up)
Title
Number and rate of mortality
Description
Number and rate of all-cause mortality within participants will be collected.
Time Frame
6-month and 12-month (follow up)
Title
Rate of participation (qualitative outcome)
Description
Rate of patients providing consent compared to the eligible ones will be calculated
Time Frame
Baseline
Title
Rate of selection of different exercise program proposed (qualitative outcome)
Description
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.
Time Frame
Baseline
Title
Rate of training sessions completed
Description
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).
Time Frame
3-month (end of program)
Title
6-minute walking test (Mobility)
Description
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.
Time Frame
Change at 6-month (follow-up) respect to baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Fabio Manfredini, MD
Phone
00390532236187
Email
fabio.manfredini@unife.it
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fabio Manfredini, MD
Organizational Affiliation
University of Ferrara and University Hospital of Ferrara
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Alda Storari, MD
Organizational Affiliation
University Hospital of Ferrara
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital of Ferrara
City
Ferrara
ZIP/Postal Code
44124
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fabio Manfredini, MD
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
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.
IPD Sharing Time Frame
Study protocol will be available upon acceptance by a peer-reviewed journal. IPD will be available beginning 6 months following study results publication.
IPD Sharing Access Criteria
Anyone who wishes to access the data.
Citations:
PubMed Identifier
33470990
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.
Results Reference
derived
Learn more about this trial
An Exercise Facilitator to Activate Simple Training Programs in the Dialysis Center
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