Impact of the Use of FeelWell™ Compression Garment on Individuals With a BMI ≥35
15 de febrero de 2019 actualizado 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.
Descripción general del estudio
Estado
Desconocido
Condiciones
Intervención / Tratamiento
Descripción detallada
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 estudio
Intervencionista
Inscripción (Anticipado)
30
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Virginia
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Shirlington, Virginia, Estados Unidos, 22206
- Reclutamiento
- Washington Center for Weight Management and Research, Inc.
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Contacto:
- Rachel Trope, MS
- Número de teléfono: 7038070037
- Correo electrónico: rtrope@wtmgmt.com
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Contacto:
- Michelle Vaughan, MBA
- Número de teléfono: 703-807-0037
- Correo electrónico: mvaughan@wtmgmt.com
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Investigador principal:
- Domenica Rubino, MD
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Sub-Investigador:
- Rachel Trope, MS
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Sub-Investigador:
- Mike Reing, MS
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
18 años y mayores (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
Sí
Géneros elegibles para el estudio
Todos
Descripción
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
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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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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Otro: 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
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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6- minute walk test- distance walked
Periodo de tiempo: baseline, 1, 3, 6 and 12 months
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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
Periodo de tiempo: 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
Periodo de tiempo: 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.
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baseline, 3, 6 and 12 months
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30 Second Chair Stand
Periodo de tiempo: baseline, 1, 3, 6 and 12 months
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A test of leg strength and endurance.
The number of times a patient stands from a sitting position in 30 seconds is recorded.
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baseline, 1, 3, 6 and 12 months
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Brief Pain Inventory-Interference sub-score
Periodo de tiempo: baseline, 1, 3, 6 and 12 months
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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
Periodo de tiempo: baseline, 6 months and 1 year
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The number of steps per day will be recorded as a measure of daily activity and averaged at various time points throughout the trial.
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baseline, 6 months and 1 year
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Weight Self Stigma questionnaire
Periodo de tiempo: baseline, 1, 3, 6 and 12 months
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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.
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baseline, 1, 3, 6 and 12 months
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Lean body mass
Periodo de tiempo: 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
Periodo de tiempo: baseline, 12 months
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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
Periodo de tiempo: 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
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Domenica Rubino, MD, Washington Center for Weight Management and Research
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Publicaciones Generales
- 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.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
13 de febrero de 2019
Finalización primaria (Anticipado)
1 de julio de 2020
Finalización del estudio (Anticipado)
1 de julio de 2020
Fechas de registro del estudio
Enviado por primera vez
13 de diciembre de 2018
Primero enviado que cumplió con los criterios de control de calidad
7 de enero de 2019
Publicado por primera vez (Actual)
10 de enero de 2019
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
19 de febrero de 2019
Última actualización enviada que cumplió con los criterios de control de calidad
15 de febrero de 2019
Última verificación
1 de febrero de 2019
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- FeelWell2018
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
SÍ
Descripción del plan IPD
Once study is completed, data analyzed and published, data will be made available to any investigator who is interested upon written request.
Marco de tiempo para compartir IPD
Data will be available within 6 months of publication.
Criterios de acceso compartido de IPD
Researchers must provide evidence that the data are being requested for analysis in a scientific study.
Tipo de información de apoyo para compartir IPD
- PROTOCOLO DE ESTUDIO
- SAVIA
- CIF
- CÓDIGO_ANALÍTICO
- RSC
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
Sí
producto fabricado y exportado desde los EE. UU.
Sí
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .