Impact of the Use of FeelWell™ Compression Garment on Individuals With a BMI ≥35
15 de fevereiro de 2019 atualizado por: Feelwell Compression
Examining the Impact of the Use of a Custom-fitted, FeelWell™ Compression Garment to Improve the Quality of Life of Individuals With a BMI ≥35
To assess the effect of wearing a custom-fitted, FDA-registered, Class I device, compression garment (Obesinov, S.A.R.L.) by an individual with a BMI ≥ 35 on his/her day-to-day quality of life over a period of one year.
Various measures of quality of life will be taken, including assessing an individual's level of pain, mood, self-stigma and comfort with the use of a compression garment.
Additionally, to assess the impact of the compression garment on activity, strength, posture and movement of an individual with a BMI ≥35 over the period of one year.
Visão geral do estudo
Status
Desconhecido
Condições
Intervenção / Tratamento
Descrição detalhada
Individuals suffering with obesity often experience daily pain and discomfort which limits movement, a critical factor in managing weight, cardio-metabolic health, mood, sleep, self-esteem and ultimately overall quality of life. Many individuals who experience weight gain have an abdominal or central distribution of weight which affects body mechanics leading to back pain, poor posture, difficulty walking with altered gait, knee, foot, ankle and leg pain (IT band, meralgia paresthetica) and other non-specific chronic pain. Chronic pain impedes mobility often incorporating depression and low motivation in an endless cycle. Furthermore, as individuals are losing weight, they often suffer from excess skin which also aggravates by chafing (arms, inner thighs), hanging down and interfering with gait.
The Investigators will examine the effect of wearing a custom-fitted, FDA-registered, Class I device, compression garment (Obesinov, S.A.R.L.) by participants with a BMI ≥ 35 on day-to-day quality of life over a period of one year. Various measures of quality of life will be taken, including assessing the participant's level of pain, mood, self-stigma and comfort with the use of a compression garment. Additional assessments include impact of the compression garment on activity, strength, posture and movement as well as potential impact of the use of this garment on weight loss and change in laboratory measures of metabolic health.
Tipo de estudo
Intervencional
Inscrição (Antecipado)
30
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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Virginia
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Shirlington, Virginia, Estados Unidos, 22206
- Recrutamento
- Washington Center for Weight Management and Research, Inc.
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Contato:
- Rachel Trope, MS
- Número de telefone: 7038070037
- E-mail: rtrope@wtmgmt.com
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Contato:
- Michelle Vaughan, MBA
- Número de telefone: 703-807-0037
- E-mail: mvaughan@wtmgmt.com
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Investigador principal:
- Domenica Rubino, MD
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Subinvestigador:
- Rachel Trope, MS
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Subinvestigador:
- Mike Reing, MS
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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
18 anos e mais velhos (Adulto, Adulto mais velho)
Aceita Voluntários Saudáveis
Sim
Gêneros Elegíveis para o Estudo
Tudo
Descrição
Inclusion Criteria:
- Male or female, over 18 years old.
- Subjects with a BMI of ≥ 35.
- Subjects in any stage of weight loss or maintenance.
Exclusion Criteria:
- Inability to put on or have help in putting on garment.
- Inability to participate in movement and exercise intervention.
- Panniculus grade >3 at baseline or other body habitus that limits mobility.
- Duke Activity Status Index (DASI) score < 3.62
- Medical condition limiting participation in trial or basic mobility.
- Current participation in a physical therapy program.
- Unwillingness to participate fully in trial.
- Participation in another trial at the same time.
- Patient Health Questionnaire (PHQ)-9≥15.
- Current or expected pregnancy
- Investigator's discretion
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: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: FeelWell™ Compression garment use with increase mobility
Subjects are randomized to wear custom-fitted FeelWell™ Compression garment daily during regular and exercise activities. Subjects will work with physical therapist and exercise physiologist to increase strength, mobility and activity. |
Registered FDA class I device: The FeelWell™ Compression garment is a custom-made orthopedic abdominal binder with full or half-body support. The garments are made of 70% polyamide and 30% elastane and OEKO-TEX certified confirming human-ecological safety of textiles. The company uses a wrap knitting to ensure an optimal compression and durability. The garment has two 360 degrees whalebones in the front and two in the back to provide support for the posture, reinforcing compression on the abdomen and lower-back.
Subjects will work with exercise physiologist and physical therapist to increase mobility, strength and activity
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Outro: Increase mobility
For the control group, subjects will work with physical therapist and exercise physiologist to increase strength, mobility and activity.
The control group will not be assigned a compression garment during the trial.
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Subjects will work with exercise physiologist and physical therapist to increase mobility, strength and activity
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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6- minute walk test- distance walked
Prazo: baseline, 1, 3, 6 and 12 months
|
6-min walk test is a sub-maximal exercise test measuring the total distance walked by a subject in a period of 6 minutes to assess functional capacity of a subject's cardio-respiratory systems and reflects their ability to perform Activities of Daily Living.
Total distance walked will be measured and change recorded from baseline.
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baseline, 1, 3, 6 and 12 months
|
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6- minute walk test- Perceived exertion
Prazo: baseline, 1, 3, 6 and 12 months
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The Borg Rate of Perceived Exertion scale of 1-10 will be used for the subject to record their exertion level from 1 (no exertion)-10 (maximal exertion) and change will be noted from baseline.
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baseline, 1, 3, 6 and 12 months
|
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SF-36 physical component sub-score
Prazo: baseline, 3, 6 and 12 months
|
SF-36 consists of 8 sub-scales of health-related quality of life measuring various aspects of functioning.
The summary score for physical component includes physical functioning, physical role, bodily pain and general health scores.
This sub-score is reported on a scale from 0-100 with higher numbers indicating better physical functioning.
|
baseline, 3, 6 and 12 months
|
|
30 Second Chair Stand
Prazo: baseline, 1, 3, 6 and 12 months
|
A test of leg strength and endurance.
The number of times a patient stands from a sitting position in 30 seconds is recorded.
|
baseline, 1, 3, 6 and 12 months
|
|
Brief Pain Inventory-Interference sub-score
Prazo: baseline, 1, 3, 6 and 12 months
|
A measure of pain and the interference of such pain on daily function.
A sub-score on a scale of 0 (no interference)- 10 (maximal interference) will be recorded.
The mean score of the 7 items will be recorded.
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baseline, 1, 3, 6 and 12 months
|
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Steps per day measured by accelerometer
Prazo: baseline, 6 months and 1 year
|
The number of steps per day will be recorded as a measure of daily activity and averaged at various time points throughout the trial.
|
baseline, 6 months and 1 year
|
|
Weight Self Stigma questionnaire
Prazo: baseline, 1, 3, 6 and 12 months
|
A questionnaire designed to explore both internalized self stigma (internalized self-devaluation) and enacted stigma (directly experienced stigma) on function will be administered.
The scale is comprised of 12 questions, and the subject responds on a scale from 1-5 with a greater score indicating greater experienced stigma.
|
baseline, 1, 3, 6 and 12 months
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Lean body mass
Prazo: baseline, 12 months
|
Using DXA (Dual-energy X-ray Absorptiometry), lean body mass (LBM) or fat-free mass will be measured at baseline and at end of study.
Percent change will be reported.
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baseline, 12 months
|
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Fat mass
Prazo: baseline, 12 months
|
Using DXA (Dual-energy X-ray Absorptiometry), fat mass will be measured at baseline and at end of study.
Percent change will be reported.
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baseline, 12 months
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Bone density
Prazo: baseline, 12 months
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Using DXA (Dual-energy X-ray Absorptiometry), bone density will be measured at baseline and at end of study.
Percent change will be reported.
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baseline, 12 months
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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Investigadores
- Investigador principal: Domenica Rubino, MD, Washington Center for Weight Management and Research
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
- 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.
- Camarri B, Eastwood PR, Cecins NM, Thompson PJ, Jenkins S. Six minute walk distance in healthy subjects aged 55-75 years. Respir Med. 2006 Apr;100(4):658-65. doi: 10.1016/j.rmed.2005.08.003. Epub 2005 Oct 17.
- Grodin JL, Hammadah M, Fan Y, Hazen SL, Tang WH. Prognostic value of estimating functional capacity with the use of the duke activity status index in stable patients with chronic heart failure. J Card Fail. 2015 Jan;21(1):44-50. doi: 10.1016/j.cardfail.2014.08.013. Epub 2014 Aug 28.
- Jakicic JM, Rogers RJ, Davis KK, Collins KA. Role of Physical Activity and Exercise in Treating Patients with Overweight and Obesity. Clin Chem. 2018 Jan;64(1):99-107. doi: 10.1373/clinchem.2017.272443. Epub 2017 Nov 20.
- Hebert-Losier K, Wessman C, Alricsson M, Svantesson U. Updated reliability and normative values for the standing heel-rise test in healthy adults. Physiotherapy. 2017 Dec;103(4):446-452. doi: 10.1016/j.physio.2017.03.002. Epub 2017 Mar 21.
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)
13 de fevereiro de 2019
Conclusão Primária (Antecipado)
1 de julho de 2020
Conclusão do estudo (Antecipado)
1 de julho de 2020
Datas de inscrição no estudo
Enviado pela primeira vez
13 de dezembro de 2018
Enviado pela primeira vez que atendeu aos critérios de CQ
7 de janeiro de 2019
Primeira postagem (Real)
10 de janeiro de 2019
Atualizações de registro de estudo
Última Atualização Postada (Real)
19 de fevereiro de 2019
Última atualização enviada que atendeu aos critérios de controle de qualidade
15 de fevereiro de 2019
Última verificação
1 de fevereiro de 2019
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- FeelWell2018
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
SIM
Descrição do plano IPD
Once study is completed, data analyzed and published, data will be made available to any investigator who is interested upon written request.
Prazo de Compartilhamento de IPD
Data will be available within 6 months of publication.
Critérios de acesso de compartilhamento IPD
Researchers must provide evidence that the data are being requested for analysis in a scientific study.
Tipo de informação de suporte de compartilhamento de IPD
- PROTOCOLO DE ESTUDO
- SEIVA
- CIF
- ANALYTIC_CODE
- CSR
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
Sim
produto fabricado e exportado dos EUA
Sim
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 .