Impact of the Use of FeelWell™ Compression Garment on Individuals With a BMI ≥35
NCT ID: NCT03798873
Last Updated: 2019-02-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
30 participants
INTERVENTIONAL
2019-02-13
2020-07-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
FeelWell™ Compression garment
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.
Increase Mobility
Subjects will work with exercise physiologist and physical therapist to increase mobility, strength and activity
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.
Increase Mobility
Subjects will work with exercise physiologist and physical therapist to increase mobility, strength and activity
Interventions
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FeelWell™ Compression garment
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.
Increase Mobility
Subjects will work with exercise physiologist and physical therapist to increase mobility, strength and activity
Eligibility Criteria
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Inclusion Criteria
* Subjects with a BMI of ≥ 35.
* Subjects in any stage of weight loss or maintenance.
Exclusion Criteria
* 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
18 Years
ALL
Yes
Sponsors
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Washington Center for Weight Management and Research, Inc.
UNKNOWN
Feelwell Compression
INDUSTRY
Responsible Party
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Principal Investigators
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Domenica Rubino, MD
Role: PRINCIPAL_INVESTIGATOR
Washington Center for Weight Management and Research
Locations
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Washington Center for Weight Management and Research, Inc.
Shirlington, Virginia, United States
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
Other Identifiers
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FeelWell2018
Identifier Type: -
Identifier Source: org_study_id
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