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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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.

Switzerland1 site
  • Ente Ospedaliero Cantonale

    Bellinzona

Other trials in Switzerland

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.

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 groups in NCT04076488
Study groupRoleWhat they receive
Dividat FIT: Computer based exerciseExperimentalTablet 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.

  1. 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

  2. Feasibility of the training

    Technology Acceptance Model

    Measured: Will be assessed approximately 6 months after start of study

Secondary outcomes (2)
  1. Functional Test

    Short Physical Performance Battery

    Measured: At baseline and after 3 months of training

  2. 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.

  1. First posted3 Sep 2019
  2. Study start9 Sep 2019
  3. Primary completion29 Oct 2020
  4. Study completion29 Oct 2020

Resources

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)
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

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.

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