End Stage Renal DiseaseTABEX-CDNCT04076488
Feasibility of an Interactive Tablet-based Exercise Program for People With Chronical Diseases
A study testing Dividat Fit in people with End Stage Renal Disease, run by Zemp Damiano at 1 site in Switzerland.
Trial summary
End Stage Renal Disease (ESRD) is a potential outcome of Chronic Kidney Disease (CKD) that requires renal replacement therapy in the form of dialysis or transplantation.Despite the encouraging benefits seen in PHD who exercised, they may be confronted with more barriers to start and maintain an exercise program than… Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- End Stage Renal Disease
- What is being tested?
- Dividat Fit
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteSwitzerland
- Study dates
- 9 Sep 2019to 29 Oct 2020
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- haemodialysis patients older than 60 years
- able to walk 20 meters independently without walking aids
- currently exercising less than one training session per week
- maintenance of a stable medical regimen for 4 weeks prior to initiation of study and considered to maintain a stable regimen for the course of the study
- signed informed consent to participate in the study
Who cannot join
- clinically significant concomitant disease states
- contraindications to physical exercise
- known or suspected non-compliance, drug or alcohol abuse
- inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant
- participation in another study with investigational drug within the 30 days preceding and during the present study
Trial locations and contacts
1 site in 1 country.
About this study
End Stage Renal Disease (ESRD) is a potential outcome of Chronic Kidney Disease (CKD) that requires renal replacement therapy in the form of dialysis or transplantation.Despite the encouraging benefits seen in PHD who exercised, they may be confronted with more barriers to start and maintain an exercise program than healthy persons, e.g. due to reduced accessibility of specialised physiotherapists. Telerehabilitation (TR), a subfield of telemedicine, may help to overcome some of the barriers to exercise regularly and connect PHD with specialised physiotherapists. The primary objective of this study is to determine feasibility of this TR exercise approach in preparation of a future RCT. Focus of the study is recruitment, attrition and adherence to the intervention, data collection methods and acceptability/satisfaction of the intervention.
The secondary objectives are to evaluate potential impacts of this intervention approach on physical function and health-related disability and quality of life. The study intervention is an interactive tablet-based home exercise program. The program is called "Dividat Fit" and works interactive, meaning that the responsible specialised Physiotherapist (PT) supervises the training progression of her/his patient weekly and if necessary assists the patient via remote or through a visit at home.
Read the detailed description
End Stage Renal Disease (ESRD) is a potential outcome of Chronic Kidney Disease (CKD) that requires renal replacement therapy in the form of dialysis or transplantation. The prevalence rate of people undergoing dialysis is 296 of 1 Million. 90% of them receiving haemodialysis (HD). For haemodialytic therapy, patients need to receive dialyses 2-3 times a week in an outpatient hospital facility or a clinic lifelong or until kidney transplantation. A dialyses session last between 3 and 4 hours.
Nowadays, the beneficial effects of exercise in people undergoing haemodialysis (PHD) are well accepted and there is evidence that they profit from an exercise program.
Despite the encouraging benefits seen in PHD who exercised, they may be confronted with more barriers to start and maintain an exercise program than healthy persons, e.g. due to reduced accessibility of specialised physiotherapists. Telerehabilitation (TR), a subfield of telemedicine, may help to overcome some of the barriers to exercise regularly and connect PHD with specialised physiotherapists. TR is defined as the provision of rehabilitation services from a distance using telecommunication technologies as the delivery medium. This approach may optimize the timing, intensity and sequencing of interventions and provide opportunities for individuals to receive rehabilitation in their own social and professional environments from disease-specialised caregivers. An additional advantage of TR is the possibility to implement different persuasive technologies such as personalisation, self-monitoring, tailoring, goal setting, comparison and conditioning through positive and negative reinforcement in the development of exercise programmes. These technologies help to make exercise programmes more enjoyable and, therefore, enhance patients' motivation to exercise regularly.
Furthermore, the importance of individual and social support has been emphasized in several reviews evaluating health behaviour change for example becoming more active. This kind of support can be integrated in the design of a TR program.
To the best of our knowledge, there exist no TR programme especially designed for PHD. Therefore, the aim of this study is to evaluate feasibility of a tablet-based exercise program, called "Dividat Fit" for PHD.
The study intervention is an interactive tablet-based home exercise program. The program is called "Dividat Fit" and works interactive, meaning that the responsible specialised Physiotherapist (PT) supervises the training progression of her/his patient weekly and if necessary assists the patient via remote or through a visit at home.
During the first face-to-face session, the PT examines the patient, sets up an individually tailored physical exercise (PE) program with four to six exercises and practises these exercises with the patient. Before the patient will start with the 12-week home program, she/he receives a tablet-computer on which the physical exercises are programmed as well as an instruction how to use "Dividat Fit". During the whole training program, the PT tele-monitors each patient by checking the training diary weekly and providing written feedback to the exercises and the comments, if applicable. If needed, the PT contacts the participants (per phone).
10-15 participants will be recruited. For feasibility studies, a sample size calculation is not possible. There are different rules of thumb for the sample size of feasibility studies. One general rule of thumbs recommends 12 participants for a feasibility study. Another recommendation is based on the estimated effect size: they recommend 15 or 10 patients for standardized effect sizes that are medium (0.5) or large (0.8), respectively.
- Conditions
- End Stage Renal Disease
- Being tested
- Dividat Fit
- Keywords
- Telemedicine, Exercise, Feasibility
- Medical subject headings
- Kidney Failure, Chronic, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dividat FitOther
tablet based, remote assisted home-training
| Study group | Role | What they receive |
|---|---|---|
| Dividat FIT: Computer based exercise | Experimental | Tablet based interactive physical training. Receives: Other: Dividat Fit |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence
Attrition and adherence rate (attrition rate and reasons of drop-out, adherence rate, adherence to the described exercises)
Measured: Will be assessed approximately 6 months after start of study
Feasibility of the training
Technology Acceptance Model
Measured: Will be assessed approximately 6 months after start of study
Secondary outcomes (2)
Functional Test
Short Physical Performance Battery
Measured: At baseline and after 3 months of training
Performance Test
Timed Up \& Go Test
Measured: At baseline and after 3 months of training
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2019
- Study start9 Sep 2019
- Primary completion29 Oct 2020
- Study completion29 Oct 2020
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 End Stage Renal DiseaseStudies 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zemp Damiano
- Sponsor type
- University, hospital or other
- Collaborators
- Ente Ospedaliero Cantonale, Bellinzona, ETH Zurich
- Responsible party
- Sponsor-investigator, Zemp Damiano, Ente Ospedaliero Cantonale, Bellinzona
- Investigators
- Damiano Zemp, MSc, Principal investigator, Ente Ospedaliero Cantonale, Bellinzona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04076488
- Sponsor's protocol ID
- 2019-01161 CE 3497
- Other IDs
- 2019
- Acronym
- TABEX-CD
- Status last verified
- Jan 2021
- First submitted
- 16 Aug 2019
- Last updated
- 22 Jan 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zemp DD, Baschung Pfister P, Knols RH, Quadri P, Bianchi G, Giunzioni D, Lavorato S, Giannini O, de Bruin ED. A blended e-health intervention for improving functional capacity in elderly patients on haemodialysis: A feasibility study. Front Digit Health. 2022 Dec 6;4:1054932. doi: 10.3389/fdgth.2022.1054932. eCollection 2022.
PubMed 36561924
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of an Interactive Tablet-based Exercise Program for People With Chronical Diseases
- ClinicalTrials.gov ID
- NCT04076488
- Acronym / sponsor ID
- TABEX-CD / 2019-01161 CE 3497
- Conditions
- End Stage Renal Disease
- Keywords
- Telemedicine, Exercise, Feasibility
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Zemp DamianoUniversity, hospital or other
- Collaborators
- Ente Ospedaliero Cantonale, Bellinzona, ETH Zurich
- Study start
- 9 Sep 2019 (actual)
- Primary completion
- 29 Oct 2020 (actual)
- Study completion
- 29 Oct 2020 (actual)
- First posted
- 3 Sep 2019 (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.
End Stage Renal Disease (ESRD) is a potential outcome of Chronic Kidney Disease (CKD) that requires renal replacement therapy in the form of dialysis or transplantation.Despite the encouraging benefits seen in PHD who exercised, they may be confronted with more barriers to start and maintain an exercise program than healthy persons, e.g. due to reduced accessibility of specialised physiotherapists. Telerehabilitation (TR), a subfield of telemedicine, may help to overcome some of the barriers to exercise regularly and connect PHD with specialised physiotherapists. The primary objective of this study is to determine feasibility of this TR exercise approach in preparation of a future RCT. Focus of the study is recruitment, attrition and adherence to the intervention, data collection methods and acceptability/satisfaction of the intervention.
The secondary objectives are to evaluate potential impacts of this intervention approach on physical function and health-related disability and quality of life. The study intervention is an interactive tablet-based home exercise program. The program is called "Dividat Fit" and works interactive, meaning that the responsible specialised Physiotherapist (PT) supervises the training progression of her/his patient weekly and if necessary assists the patient via remote or through a visit at home.
Detailed description
End Stage Renal Disease (ESRD) is a potential outcome of Chronic Kidney Disease (CKD) that requires renal replacement therapy in the form of dialysis or transplantation. The prevalence rate of people undergoing dialysis is 296 of 1 Million. 90% of them receiving haemodialysis (HD). For haemodialytic therapy, patients need to receive dialyses 2-3 times a week in an outpatient hospital facility or a clinic lifelong or until kidney transplantation. A dialyses session last between 3 and 4 hours.
Nowadays, the beneficial effects of exercise in people undergoing haemodialysis (PHD) are well accepted and there is evidence that they profit from an exercise program.
Despite the encouraging benefits seen in PHD who exercised, they may be confronted with more barriers to start and maintain an exercise program than healthy persons, e.g. due to reduced accessibility of specialised physiotherapists. Telerehabilitation (TR), a subfield of telemedicine, may help to overcome some of the barriers to exercise regularly and connect PHD with specialised physiotherapists. TR is defined as the provision of rehabilitation services from a distance using telecommunication technologies as the delivery medium. This approach may optimize the timing, intensity and sequencing of interventions and provide opportunities for individuals to receive rehabilitation in their own social and professional environments from disease-specialised caregivers. An additional advantage of TR is the possibility to implement different persuasive technologies such as personalisation, self-monitoring, tailoring, goal setting, comparison and conditioning through positive and negative reinforcement in the development of exercise programmes. These technologies help to make exercise programmes more enjoyable and, therefore, enhance patients' motivation to exercise regularly.
Furthermore, the importance of individual and social support has been emphasized in several reviews evaluating health behaviour change for example becoming more active. This kind of support can be integrated in the design of a TR program.
To the best of our knowledge, there exist no TR programme especially designed for PHD. Therefore, the aim of this study is to evaluate feasibility of a tablet-based exercise program, called "Dividat Fit" for PHD.
The study intervention is an interactive tablet-based home exercise program. The program is called "Dividat Fit" and works interactive, meaning that the responsible specialised Physiotherapist (PT) supervises the training progression of her/his patient weekly and if necessary assists the patient via remote or through a visit at home.
During the first face-to-face session, the PT examines the patient, sets up an individually tailored physical exercise (PE) program with four to six exercises and practises these exercises with the patient. Before the patient will start with the 12-week home program, she/he receives a tablet-computer on which the physical exercises are programmed as well as an instruction how to use "Dividat Fit". During the whole training program, the PT tele-monitors each patient by checking the training diary weekly and providing written feedback to the exercises and the comments, if applicable. If needed, the PT contacts the participants (per phone).
10-15 participants will be recruited. For feasibility studies, a sample size calculation is not possible. There are different rules of thumb for the sample size of feasibility studies. One general rule of thumbs recommends 12 participants for a feasibility study. Another recommendation is based on the estimated effect size: they recommend 15 or 10 patients for standardized effect sizes that are medium (0.5) or large (0.8), respectively.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dividat FIT: Computer based exercise | Experimental | Other: Dividat FitTablet based interactive physical training. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- haemodialysis patients older than 60 years
- able to walk 20 meters independently without walking aids
- currently exercising less than one training session per week
- maintenance of a stable medical regimen for 4 weeks prior to initiation of study and considered to maintain a stable regimen for the course of the study
- signed informed consent to participate in the study
Key exclusion criteria (5 listed)
- clinically significant concomitant disease states
- contraindications to physical exercise
- known or suspected non-compliance, drug or alcohol abuse
- inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant
- participation in another study with investigational drug within the 30 days preceding and during the present study
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 |
|---|---|---|
| Dividat Fittablet based, remote assisted home-training | Other | Dividat FIT: Computer based exercise |
Primary outcome
Adherence
Time frame: Will be assessed approximately 6 months after start of study
Attrition and adherence rate (attrition rate and reasons of drop-out, adherence rate, adherence to the described exercises)
Feasibility of the training
Time frame: Will be assessed approximately 6 months after start of study
Technology Acceptance Model
2 secondary outcomes
Functional Test
Time frame: At baseline and after 3 months of training
Performance Test
Time frame: At baseline and after 3 months of training
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 22 Jan 2021.
- Derived from this study: PubMed 36561924Zemp DD, Baschung Pfister P, Knols RH, Quadri P, Bianchi G, Giunzioni D, Lavorato S, Giannini O, de Bruin ED. A blended e-health intervention for improving functional capacity in elderly patients on haemodialysis: A feasibility study. Front Digit Health. 2022 Dec 6;4:1054932. doi: 10.3389/fdgth.2022.1054932. eCollection 2022.
- Individual participant dataSharing planned: No
Related trials for End Stage Renal Disease
Recruiting
Dry Weight Reduction Intervention Via Extra Ultrafiltration
Fluid Accumulation, Blood Pressure Management
Not yet recruiting
Cycling During Dialysis: A Feasibility and Safety Study
Hemodialysis, Kidney Disease, End-Stage
Active, not recruitingPhase 2
Management of Iron Deficiency Anemia in Hemodialysis Patients
Iron Deficiency Anemia (IDA), ESRD (End Stage Renal Disease)
Not yet recruiting
Effects of Horticultural Therapy on Acute Stress and Salivary Cortisol Levels in Hemodialysis Patients
End-Stage Renal Disease, Renal Dialysis
RecruitingPhase 4
Empagliflozin in Heart Failure With Reduced Ejection Fraction and End Stage Renal Disease
Heart Failure With Reduced Ejection Fraction, End Stage Renal Disease on Dialysis
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.
Damiano Zemp, MSc principal investigator
Ente Ospedaliero Cantonale, Bellinzona
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dividat Fit in people with End Stage Renal Disease, run by Zemp Damiano at 1 site in Switzerland.
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 5 inclusion and 5 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 22 Jan 2021. 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 Switzerland. 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?
Adherence (time frame: Will be assessed approximately 6 months after start of study). The study lists 2 primary outcomes in all. 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 NCT04076488, 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 22 Jan 2021.