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

19 de janeiro de 2021 atualizado por: Zemp Damiano

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.

Visão geral do estudo

Status

Concluído

Intervenção / Tratamento

Descrição detalhada

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.

Tipo de estudo

Intervencional

Inscrição (Real)

21

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

      • Bellinzona, Suíça
        • Ente Ospedaliero Cantonale

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

60 anos e mais velhos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Descrição

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

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Prevenção
  • Alocação: N / D
  • Modelo Intervencional: Atribuição de grupo único
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: Dividat FIT: Computer based exercise
Tablet based interactive physical training.
tablet based, remote assisted home-training

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Adherence
Prazo: 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)
Will be assessed approximately 6 months after start of study
Feasibility of the training
Prazo: Will be assessed approximately 6 months after start of study
Technology Acceptance Model
Will be assessed approximately 6 months after start of study

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Functional Test
Prazo: At baseline and after 3 months of training
Short Physical Performance Battery
At baseline and after 3 months of training
Performance Test
Prazo: At baseline and after 3 months of training
Timed Up & Go Test
At baseline and after 3 months of training

Outras medidas de resultado

Medida de resultado
Descrição da medida
Prazo
Autonomy evaluation
Prazo: At baseline and after 3 months of training
De Morton Mobiity Index
At baseline and after 3 months of training
Health and quality of life parameters
Prazo: At baseline and after 3 months of training
SF-12
At baseline and after 3 months of training
Endurance
Prazo: At baseline and after 3 months of training
1 minute stand up test
At baseline and after 3 months of training

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Investigadores

  • Investigador principal: Damiano Zemp, MSc, Ente Ospedaliero Cantonale, Bellinzona

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

9 de setembro de 2019

Conclusão Primária (Real)

29 de outubro de 2020

Conclusão do estudo (Real)

29 de outubro de 2020

Datas de inscrição no estudo

Enviado pela primeira vez

16 de agosto de 2019

Enviado pela primeira vez que atendeu aos critérios de CQ

30 de agosto de 2019

Primeira postagem (Real)

3 de setembro de 2019

Atualizações de registro de estudo

Última Atualização Postada (Real)

22 de janeiro de 2021

Última atualização enviada que atendeu aos critérios de controle de qualidade

19 de janeiro de 2021

Última verificação

1 de janeiro de 2021

Mais Informações

Termos relacionados a este estudo

Outros números de identificação do estudo

  • 2019-01161 CE 3497

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

Ensaios clínicos em Dividat Fit

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