Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04076488 |
| Other study ID # |
2019-01161 CE 3497 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
September 9, 2019 |
| Est. completion date |
October 29, 2020 |
Study information
| Verified date |
January 2021 |
| Source |
Ente Ospedaliero Cantonale, Bellinzona |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical 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 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.
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.
