Identification of Factors Associated With Physical Activity Levels in Adult Muscle Diseases
29 de julho de 2020 atualizado por: Fatma Ayvat, Hacettepe University
Erişkin Kas hastalıklarında Fiziksel Aktivite Ile ilişkili faktörlerin Belirlenmesi
To evaluate physical activity levels and factors associated with physical activity levels in adult patients with muscle diseases.
Visão geral do estudo
Status
Concluído
Condições
Intervenção / Tratamento
Descrição detalhada
The same protocol will be applied all of the patients and healthy subjects.
Individuals will be informed in detail about the study and demographic and physical properties will recorded after receiving approval.
Evaluation programme that consisting of pain, fatigue, falls, activity limitations, quality of life, muscle strength assessment and functional assessment will be applied.
After the evaluation, individuals will be given detailed information on the use of SenseWear activity monitors.
Individuals will wear SenseWear activity monitors on right triceps muscle for 5 days.
The data stored on the device will be recorded in computer using the software.
Individuals will be given information of the resulting data (total number of steps, total energy expenditure, the number of daily steps and energy expenditure, physical activity duration in different intensity).
Physical activity levels will be assessed by subjective aspects of physical activity questionnaire.
Tipo de estudo
Intervencional
Inscrição (Real)
80
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
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Ankara, Peru, 06100
- Hacettepe University, Faculty of Health Sciences
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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
20 anos a 40 anos (Adulto)
Aceita Voluntários Saudáveis
Sim
Gêneros Elegíveis para o Estudo
Tudo
Descrição
Inclusion Criteria:
- Clinical diagnosis of muscle diseases
- Adult patients with muscle diseases who are able to walk independently
Exclusion Criteria:
- Clinical diagnosis of systemic problems
- Any orthopedic problems that will affect the performance of the physical activity
- Clinical diagnosis of neurological disease other than muscle disease
- Clinical diagnosis of cognitive impairment
- Individuals who underwent surgery in the last 6 month
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: Outro
- Alocação: Não randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
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Experimental: Muscle Disease Group
Adult patients with muscle diseases diagnosed by neurologist, will wear SenseWear activity monitor for 5 days
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Individuals will wear SenseWear activity monitors on right triceps muscle for 5 days.
The data stored on the device will be recorded in computer using the software.
Individuals will be given information of the resulting data (total number of steps, total energy expenditure, the number of daily steps and energy expenditure, physical activity duration in different intensity).
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Comparador Ativo: Healthy Individuals Group
Healthy individuals with similar demographic characteristics as adult patients with muscle diseases, will wear SenseWear activity monitor for 5 days
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Individuals will wear SenseWear activity monitors on right triceps muscle for 5 days.
The data stored on the device will be recorded in computer using the software.
Individuals will be given information of the resulting data (total number of steps, total energy expenditure, the number of daily steps and energy expenditure, physical activity duration in different intensity).
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Energy expenditure on SenseWear Activity Monitor
Prazo: 5 days
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The SenseWear software calculates energy expenditure based on a proprietary algorithm that incorporates subject height, weight, age, and sex which are entered prior to data analysis as well as the various measurements (two-axis accelerometry, galvanic skin response, heat flux, skin and near-body temperature).
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5 days
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Number of steps on SenseWear Activity Monitor
Prazo: 5 days
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The SenseWear software calculates number of steps based on a proprietary algorithm that incorporates subject height, weight, age, and sex which are entered prior to data analysis.
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5 days
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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International Physical Activity Scale (IPAQ)
Prazo: 10 minutes
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27 item self-reported measure of physical activity for use with individual adult patients aged 15 to 69 years old.
The IPAQ can be used clinically and in population research that compares physical activity levels between populations internationally.
Duration (minutes) and frequency (days) of physical activity in the last 7 days is measured in domains of: Job-related, transportation, housework, house maintenance, caring for family, recreation, sport, leisure-time and time spent sitting.
Overall score calculated using responses to all questions (Score is obtained by multiplying duration and frequency for each question) and total MET-min/week score obtained.
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10 minutes
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Visual Analog Scale
Prazo: 2 minutes
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10 cm line anchored at both ends with words descriptive of the maximal and minimal extremes of the pain being measured.
Individuals mark their pain intensity on a line numbered 0-10.
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2 minutes
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Fatigue Severity Scale
Prazo: 5 minutes
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The 9-item scale which measures the severity of fatigue and its effect on a person's activities and lifestyle in patients with a variety of disorders..
The items are scored on a 7 point scale with 1 = strongly disagree and 7= strongly agree.
The minimum score = 9 and maximum score possible = 63.
Higher the score = greater fatigue severity.
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5 minutes
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ACTIVLIM questionaire
Prazo: 5 minutes
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The ACTIVLIM questionnaire explores difficulties of performing daily activities that required the use of upper limbs or/and the use of lower limbs.
The adult patients and the parents of affected children fill in either the adult form or the child form of the questionnaire.
They are asked to provide their perceived difficulty in performing each activity using a three-level scale: impossible (0), difficult (1), easy (2).
Each activity must be completed without technical or human assistance.
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5 minutes
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Medical Outcomes Short-Form Health Survey
Prazo: 10 minutes
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The SF-36 is a generic patient-reported outcome measure aimed at quantifying health status, and is often used as a measure of health-related quality of life.
The SF-36 is a 36-item questionnaire that measures the physical and mental health constructs of health status.
These constructs are measured through 8 subscales.
The physical component (PCS) is made up of physical functioning (PF), role-physical (RP), bodily pain (BP), and general health (GH).
The Mental component (MCS) is made up of vitality (VT), social functioning (SF), role-emotional (RE), and mental health (ME).
Each of the 36 items is answered using a Likert-type scale and a 4-week recall period, with a total score of 0-100 possible.
A higher score indicates better health status.
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10 minutes
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Hand Held Dynamometry
Prazo: 20 minutes
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A quantitative and objective method for assessment of muscular strength using a portable hand held dynamometer.
"Break Test" option is used in the study.
"Break Test" where the tester applies a force to just overcome the strength of the person being tested, producing an eccentric muscular contraction and scored using force production in Newtons. 3 maximum voluntary isometric contractions are completed and scores summed.
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20 minutes
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Six Minutes Walk Test
Prazo: 10 minutes
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Assesses distance walked over 6 minutes as a sub-maximal test of aerobic capacity/endurance.
Walk of cover as far a distance as possible over 6 minute.
Assistive devices can be used but kept consistent from test to test.
Individual should be able to ambulate without physical assistance.
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10 minutes
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Timed Up and Go Test
Prazo: 2 minutes
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Assesses mobility, balance, walking ability, and fall risk.
The patient sits in the chair with his/her back against the chair back.
On the command "go", the patient rises from the chair, walks 3 meters at a comfortable and safe pace, turns, walks back to the chair and sits down.
Timing begins at the instruction "go" and stops when the patient is seated.
Patient must use the same assistive device each time he/she is tested to be able to compare scores.
3 trials are completed and scores summed.
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2 minutes
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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Investigadores
- Investigador principal: Fatma Ayvat, Msc, Hacettepe University
- Investigador principal: Muhammed Kılınç, Assoc Prof, Hacettepe University
- Diretor de estudo: Sibel Aksu Yıldırım, Prof, Hacettepe University
Publicações e links úteis
A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.
Publicações Gerais
- Ware JE Jr, Sherbourne CD. The MOS 36-item short-form health survey (SF-36). I. Conceptual framework and item selection. Med Care. 1992 Jun;30(6):473-83.
- Shumway-Cook A, Brauer S, Woollacott M. Predicting the probability for falls in community-dwelling older adults using the Timed Up & Go Test. Phys Ther. 2000 Sep;80(9):896-903.
- ATS Committee on Proficiency Standards for Clinical Pulmonary Function Laboratories. ATS statement: guidelines for the six-minute walk test. Am J Respir Crit Care Med. 2002 Jul 1;166(1):111-7. doi: 10.1164/ajrccm.166.1.at1102. No abstract available. Erratum In: Am J Respir Crit Care Med. 2016 May 15;193(10):1185.
- Price DD, Bush FM, Long S, Harkins SW. A comparison of pain measurement characteristics of mechanical visual analogue and simple numerical rating scales. Pain. 1994 Feb;56(2):217-226. doi: 10.1016/0304-3959(94)90097-3.
- McDonald CM. Physical activity, health impairments, and disability in neuromuscular disease. Am J Phys Med Rehabil. 2002 Nov;81(11 Suppl):S108-20. doi: 10.1097/00002060-200211001-00012.
- McCrory MA, Kim HR, Wright NC, Lovelady CA, Aitkens S, Kilmer DD. Energy expenditure, physical activity, and body composition of ambulatory adults with hereditary neuromuscular disease. Am J Clin Nutr. 1998 Jun;67(6):1162-9. doi: 10.1093/ajcn/67.6.1162.
- Kilmer DD, Wright NC, Aitkens S. Impact of a home-based activity and dietary intervention in people with slowly progressive neuromuscular diseases. Arch Phys Med Rehabil. 2005 Nov;86(11):2150-6. doi: 10.1016/j.apmr.2005.07.288.
- Mulligan HF, Hale LA, Whitehead L, Baxter GD. Barriers to physical activity for people with long-term neurological conditions: a review study. Adapt Phys Activ Q. 2012 Jul;29(3):243-65. doi: 10.1123/apaq.29.3.243.
- Scheers T, Philippaerts R, Lefevre J. Variability in physical activity patterns as measured by the SenseWear Armband: how many days are needed? Eur J Appl Physiol. 2012 May;112(5):1653-62. doi: 10.1007/s00421-011-2131-9. Epub 2011 Aug 28.
- Saglam M, Arikan H, Savci S, Inal-Ince D, Bosnak-Guclu M, Karabulut E, Tokgozoglu L. International physical activity questionnaire: reliability and validity of the Turkish version. Percept Mot Skills. 2010 Aug;111(1):278-84. doi: 10.2466/06.08.PMS.111.4.278-284.
- Brinkmann JR. Comparison of a hand-held and fixed dynamometer in measuring strength of patients with neuromuscular disease. J Orthop Sports Phys Ther. 1994 Feb;19(2):100-4. doi: 10.2519/jospt.1994.19.2.100.
- Armutlu K, Korkmaz NC, Keser I, Sumbuloglu V, Akbiyik DI, Guney Z, Karabudak R. The validity and reliability of the Fatigue Severity Scale in Turkish multiple sclerosis patients. Int J Rehabil Res. 2007 Mar;30(1):81-5. doi: 10.1097/MRR.0b013e3280146ec4.
- Vandervelde L, Van den Bergh PY, Goemans N, Thonnard JL. ACTIVLIM: a Rasch-built measure of activity limitations in children and adults with neuromuscular disorders. Neuromuscul Disord. 2007 Jun;17(6):459-69. doi: 10.1016/j.nmd.2007.02.013. Epub 2007 Apr 11.
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
1 de março de 2016
Conclusão Primária (Real)
1 de junho de 2017
Conclusão do estudo (Real)
1 de julho de 2017
Datas de inscrição no estudo
Enviado pela primeira vez
15 de janeiro de 2017
Enviado pela primeira vez que atendeu aos critérios de CQ
21 de janeiro de 2017
Primeira postagem (Estimativa)
25 de janeiro de 2017
Atualizações de registro de estudo
Última Atualização Postada (Real)
30 de julho de 2020
Última atualização enviada que atendeu aos critérios de controle de qualidade
29 de julho de 2020
Última verificação
1 de julho de 2020
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- GO 14/617
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
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 .