RBR-2fvw6v Analysis of motor response time, electromyography and muscle strength in volunteers from the group at risk for covid-19…

Date of registration: 11/16/2020 ^(mm/dd/yyyy)
Last approval date : 11/16/2020 ^(mm/dd/yyyy)

Study type:

Interventional

Scientific title:

Trial identification

• UTN code: U1111-1257-6957

• Public title:

  en

  Analysis of motor response time, electromyography and muscle strength in volunteers from the group at risk for covid-19 submitted to a home exercise protocol: randomized controlled clinical trial, cross over

  pt-br

  Análise do tempo de resposta motora, eletromiografia e força muscular em voluntários do grupo de risco para covid-19 submetidos a um protocolo de exercícios domiciliares: ensaio clínico randomizado, controlado, cross over

• Scientific acronym:

• Public acronym:
• Secondaries identifiers:
  • 36899320.7.0000.5142
    Issuing authority: Plataforma Brasil
  • 4.355.736
    Issuing authority: Comitê de Ética em Pesquisa da Universidade Federal de Alfenas

Sponsors

• Primary sponsor: Universidade Federal de Alfenas
• Secondary sponsor:
  • Institution: Universidade Federal de Alfenas
• Supporting source:
  • Institution: Universidade Federal de Alfenas

Health conditions

• Health conditions:

  en

  Volunteers with medical diagnosis of Type II Diabetes

  pt-br

  Voluntários com diagnóstico médico de Diabetes tipo II

• General descriptors for health conditions:

  en

  E00-E90 IV - Endocrine, nutritional and metabolic diseases

  pt-br

  E00-E90 IV - Doenças endócrinas, nutricionais e metabólicas

• Specific descriptors:

Interventions

• Interventions:

  en

  After initial data collection, the volunteers will be randomized into two groups: selective group (GS=10) and control group (CG=10), they will be reassessed (feedfoward) weekly through immersive virtual reality, using the PhysioPlay device. Volunteers must perform at least three weekly moments of the practice of the home exercise protocol and will be monitored through the virtual system. After 20 days of practice, they will be reassessed and then they will have a wash out period of two months, after which they will be relocated in a cross over way.

  pt-br

  Após coleta inicial de dados, os voluntários serão randomizados em dois grupos: grupo seletivo (GS= 10) e grupo controle (GC= 10), os mesmos serão reavaliados (feedfoward) semanalmente por meio realidade virtual imersiva, utilizando o dispositivo PhysioPlay. Os voluntários deverão cumprir no mínimo três momentos semanais da prática do protocolo de exercícios domiciliares e serão monitorados por meio do sistema virtual. Após 20 dias de prática serão reavaliados e cumprirão em seguida um período wash out de dois meses, após isto serão realocados de modo cross over.

• Descriptors:

  en

  L01.224.160.875 Virtual Reality

  pt-br

  L01.224.160.875 Realidade Virtual

  es

  L01.224.160.875 Realidad Virtual

  en

  E01.370.405.255 Electromyography

  pt-br

  E01.370.405.255 Eletromiografia

  es

  E01.370.405.255 Electromiografía

  en

  E02.760.169.063.500.387.875 Resistance Training

  pt-br

  E02.760.169.063.500.387.875 Treinamento de Resistência

  es

  E02.760.169.063.500.387.875 Entrenamiento de Resistencia

  en

  E02.760.169.063.500.891 Telerehabilitation

  pt-br

  E02.760.169.063.500.891 Telerreabilitação

  es

  E02.760.169.063.500.891 Telerrehabilitación

Recruitment

• Study status: Not yet recruiting
• Countries
  • Brazil
• Date first enrollment: 04/05/2021 ^(mm/dd/yyyy)
• Date last enrollment: 04/04/2022 ^(mm/dd/yyyy)

• Target sample size:	Gender:	Minimum age:	Maximum age:
  20	-	20 Y	70 Y

• Inclusion criteria:

  en

  Individuals diagnosed with type II DM, according to the criteria of the American Diabetes Association, between 20 and 70 years of age, of both sexes, under diet therapy or with oral antidiabetics (WORLD HEALTH ORGANIZATION, 2006) and signature of the term will be considered informed consent.

  pt-br

  Serão considerados indivíduos que tenham diagnóstico de DM tipo II, conforme os critérios da American Diabetes Association, entre 20 e 70 anos de idade, de ambos os sexos, em tratamento dietoterápico ou com antidiabéticos orais (WORLD HEALTH ORGANIZATION, 2006) e assinatura do termo de consentimento livre e esclarecido.

• Exclusion criteria:

  en

  Individuals with type II DM at very high risk, that is, those with previous ulcers and / or amputations, clinical diagnosis of hemiplegia, paraplegia, or Parkinson's disease; limb amputation; a history of alcohol or drugs; a herniated disc; leprosy; severe arthritis that prevents walking; insanity; intellectual disability; and other psychiatric disorders (IUNES, 2014).

  pt-br

  Indivíduos com DM tipo II com risco muito elevado, ou seja, aqueles com úlceras e/ou amputações prévias, diagnóstico clínico de hemiplegia, paraplegia, ou doença de Parkinson; amputação do membro; uma história de álcool ou drogas; uma hérnia de disco; lepra; artrite grave que impede a marcha; demência; deficiência intelectual; e outros transtornos psiquiátricos (IUNES, 2014).

Study type

• Study design:

• Expanded access program	Purpose	Intervention assignment	Number of arms	Masking type	Allocation	Study phase
  	Treatment	Cross-over	2	Open	Randomized-controlled	N/A

Outcomes

• Primary outcomes:

  en

  It is expected that telerehabilitation in times of pandemic, improves the intrinsic strength of the foot musculature and obtain greater effectiveness and proprioceptive benefits in the selective group evaluated through the load cell and baropodometry

  pt-br

  Espera-se que a telerreabilitação em tempos de pandemia, melhore a força intrínseca da musculatura do pé e obtenha maior efetividade e benefícios proprioceptivos no grupo seletivo avaliado através da célula de carga e baropodometria

• Secondary outcomes:

  en

  Improvement in muscle strength patterns and decreased motor response time is expected in individuals in the selective group assessed through electromyography and Physioplay

  pt-br

  Espera-se melhora dos padrões de força muscular e diminuição do tempo de resposta motora nos indivíduos do grupo seletivo avaliados através da eletromiografia e do Physioplay

Contacts

• Public contact
  • Full name: Leonardo Cesar Carvalho
  • • Address: Avenida Jovino Fernandes de Sales, 2600 - Santa Clara
    • City: Alfenas / Brazil
    • Zip code: 37133-840
  • Phone: +55-35-37011805
  • Email: leounifal@gmail.com
  • Affiliation: Universidade Federal de Alfenas
   
• Scientific contact
  • Full name: Leonardo Cesar Carvalho
  • • Address: Avenida Jovino Fernandes de Sales, 2600 - Santa Clara
    • City: Alfenas / Brazil
    • Zip code: 37133-840
  • Phone: +55-35-37011805
  • Email: leounifal@gmail.com
  • Affiliation: Universidade Federal de Alfenas
   
• Site contact
  • Full name: Leonardo Cesar Carvalho
  • • Address: Avenida Jovino Fernandes de Sales, 2600 - Santa Clara
    • City: Alfenas / Brazil
    • Zip code: 37133-840
  • Phone: +55-35-37011805
  • Email: leounifal@gmail.com
  • Affiliation: Universidade Federal de Alfenas
   

Additional links:

• Download in ICTRP format