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Feasibility of an Interactive Tablet-based Exercise Program for People With Chronical Diseases (TABEX-CD)

Primary Purpose

End Stage Renal Disease

Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Dividat Fit
Sponsored by
Zemp Damiano
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for End Stage Renal Disease focused on measuring Telemedicine, Exercise, Feasibility

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Sites / Locations

  • Ente Ospedaliero Cantonale

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Dividat FIT: Computer based exercise

Arm Description

Tablet based interactive physical training.

Outcomes

Primary Outcome Measures

Adherence
Attrition and adherence rate (attrition rate and reasons of drop-out, adherence rate, adherence to the described exercises)
Feasibility of the training
Technology Acceptance Model

Secondary Outcome Measures

Functional Test
Short Physical Performance Battery
Performance Test
Timed Up & Go Test

Full Information

First Posted
August 16, 2019
Last Updated
January 19, 2021
Sponsor
Zemp Damiano
Collaborators
Ente Ospedaliero Cantonale, Bellinzona, ETH Zurich
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1. Study Identification

Unique Protocol Identification Number
NCT04076488
Brief Title
Feasibility of an Interactive Tablet-based Exercise Program for People With Chronical Diseases
Acronym
TABEX-CD
Official Title
Feasibility of an Interactive Tablet-based Exercise Program for People With Chronical Diseases
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
September 9, 2019 (Actual)
Primary Completion Date
October 29, 2020 (Actual)
Study Completion Date
October 29, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Zemp Damiano
Collaborators
Ente Ospedaliero Cantonale, Bellinzona, ETH Zurich

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
End Stage Renal Disease
Keywords
Telemedicine, Exercise, Feasibility

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
21 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dividat FIT: Computer based exercise
Arm Type
Experimental
Arm Description
Tablet based interactive physical training.
Intervention Type
Other
Intervention Name(s)
Dividat Fit
Intervention Description
tablet based, remote assisted home-training
Primary Outcome Measure Information:
Title
Adherence
Description
Attrition and adherence rate (attrition rate and reasons of drop-out, adherence rate, adherence to the described exercises)
Time Frame
Will be assessed approximately 6 months after start of study
Title
Feasibility of the training
Description
Technology Acceptance Model
Time Frame
Will be assessed approximately 6 months after start of study
Secondary Outcome Measure Information:
Title
Functional Test
Description
Short Physical Performance Battery
Time Frame
At baseline and after 3 months of training
Title
Performance Test
Description
Timed Up & Go Test
Time Frame
At baseline and after 3 months of training
Other Pre-specified Outcome Measures:
Title
Autonomy evaluation
Description
De Morton Mobiity Index
Time Frame
At baseline and after 3 months of training
Title
Health and quality of life parameters
Description
SF-12
Time Frame
At baseline and after 3 months of training
Title
Endurance
Description
1 minute stand up test
Time Frame
At baseline and after 3 months of training

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Damiano Zemp, MSc
Organizational Affiliation
Ente Ospedaliero Cantonale, Bellinzona
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ente Ospedaliero Cantonale
City
Bellinzona
Country
Switzerland

12. IPD Sharing Statement

Plan to Share IPD
No

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Feasibility of an Interactive Tablet-based Exercise Program for People With Chronical Diseases

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