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

NCT04076488 | Completed

• 1 other identifier: 2019-01161 CE 3497
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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.

Conditions

End Stage Renal Disease

Keywords

Telemedicine; Exercise; Feasibility

Outcome Measures

Primary Outcomes (2)

• Adherence

  Attrition and adherence rate (attrition rate and reasons of drop-out, adherence rate, adherence to the described exercises)

  Will be assessed approximately 6 months after start of study

• Feasibility of the training

  Technology Acceptance Model

  Will be assessed approximately 6 months after start of study

Secondary Outcomes (2)

• Functional Test

  At baseline and after 3 months of training

• Performance Test

  At baseline and after 3 months of training

Other Outcomes (3)

• Autonomy evaluation

  At baseline and after 3 months of training

• Health and quality of life parameters

  At baseline and after 3 months of training

• Endurance

  At baseline and after 3 months of training

Study Arms (1)

Dividat FIT: Computer based exercise

EXPERIMENTAL

Tablet based interactive physical training.

Other: Dividat Fit

Interventions

Dividat Fit OTHER

tablet based, remote assisted home-training

Dividat FIT: Computer based exercise

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Zemp Damiano: lead
• Ente Ospedaliero Cantonale, Bellinzona: collaborator
• ETH Zurich: collaborator

Study Sites (1)

Ente Ospedaliero Cantonale

Bellinzona, Switzerland

Location

Related Publications (1)

• 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.

  PMID: 36561924 DERIVED

MeSH Terms

Conditions

Kidney Failure, Chronic; Motor Activity

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavior

Study Officials

• Damiano Zemp, MSc

  Ente Ospedaliero Cantonale, Bellinzona

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 16, 2019
• First Posted: September 3, 2019
• Study Start: September 9, 2019
• Primary Completion: October 29, 2020
• Study Completion: October 29, 2020
• Last Updated: January 22, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)