Impact of the Use of FeelWell™ Compression Garment on Individuals With a BMI ≥35
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
1 other identifier
interventional
30
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable obesity
Started Feb 2019
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 13, 2018
CompletedFirst Posted
Study publicly available on registry
January 10, 2019
CompletedStudy Start
First participant enrolled
February 13, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2020
CompletedFebruary 19, 2019
February 1, 2019
1.4 years
December 13, 2018
February 15, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (7)
6- minute walk test- distance walked
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.
baseline, 1, 3, 6 and 12 months
6- minute walk test- Perceived exertion
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.
baseline, 1, 3, 6 and 12 months
SF-36 physical component sub-score
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
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
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.
baseline, 1, 3, 6 and 12 months
Steps per day measured by accelerometer
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
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
Secondary Outcomes (3)
Lean body mass
baseline, 12 months
Fat mass
baseline, 12 months
Bone density
baseline, 12 months
Study Arms (2)
FeelWell™ Compression garment use with increase mobility
EXPERIMENTALSubjects 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.
Increase mobility
OTHERFor 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.
Interventions
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
Eligibility Criteria
You may qualify if:
- Male or female, over 18 years old.
- Subjects with a BMI of ≥ 35.
- Subjects in any stage of weight loss or maintenance.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Washington Center for Weight Management and Research, Inc.
Shirlington, Virginia, 22206, United States
Related Publications (5)
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.
PMID: 12091180BACKGROUNDCamarri 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.
PMID: 16229997BACKGROUNDGrodin 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.
PMID: 25175697BACKGROUNDJakicic 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.
PMID: 29158251BACKGROUNDHebert-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.
PMID: 28886865BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Domenica Rubino, MD
Washington Center for Weight Management and Research
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 13, 2018
First Posted
January 10, 2019
Study Start
February 13, 2019
Primary Completion
July 1, 2020
Study Completion
July 1, 2020
Last Updated
February 19, 2019
Record last verified: 2019-02
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
- Time Frame
- Data will be available within 6 months of publication.
- Access Criteria
- Researchers must provide evidence that the data are being requested for analysis in a scientific study.
Once study is completed, data analyzed and published, data will be made available to any investigator who is interested upon written request.