Impact of the Use of FeelWell™ Compression Garment on Individuals With a BMI ≥35

• ClinicalTrials.gov Identifier: NCT03798873
• Recruitment Status: Unknown
• First Posted: January 10, 2019
• Last Update Posted: February 19, 2019
• Sponsor: Feelwell Compression
• Collaborator: Washington Center for Weight Management and Research, Inc.
• Information provided by (Responsible Party): Feelwell Compression

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Obesity; Obesity, Abdominal; Mobility Limitation; Quality of Life; Back Pain; Pain, Chronic; Weight Change, Body; Inactivity; Exercise; Body Composition; Redundant Skin	Device: FeelWell™ Compression garment; Behavioral: Increase Mobility	Not Applicable

Detailed Description:

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 30 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Test group treated with the FeelWell™ Compression garment and control group without compression garment. All subjects will receive the same intervention working with exercise physiologist and physical therapist in order to improve mobility.
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: 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
• Actual Study Start Date: February 13, 2019
• Estimated Primary Completion Date: July 2020
• Estimated Study Completion Date: July 2020

Arms and Interventions

Arm	Intervention/treatment
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.	Device: 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.; Behavioral: 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.	Behavioral: Increase Mobility; Subjects will work with exercise physiologist and physical therapist to increase mobility, strength and activity

Outcome Measures

Primary Outcome Measures :

1. 6- minute walk test- distance walked [ Time Frame: 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.
2. 6- minute walk test- Perceived exertion [ Time Frame: baseline, 1, 3, 6 and 12 months ]
   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.
3. SF-36 physical component sub-score [ Time Frame: 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.
4. 30 Second Chair Stand [ Time Frame: 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.
5. Brief Pain Inventory-Interference sub-score [ Time Frame: 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.
6. Steps per day measured by accelerometer [ Time Frame: 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.
7. Weight Self Stigma questionnaire [ Time Frame: 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.

Secondary Outcome Measures :

1. Lean body mass [ Time Frame: 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.
2. Fat mass [ Time Frame: 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.
3. Bone density [ Time Frame: baseline, 12 months ]
   Using DXA (Dual-energy X-ray Absorptiometry), bone density will be measured at baseline and at end of study. Percent change will be reported.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

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

Contacts and Locations

Contacts

Contact: Domenica Rubino, MD; 17038070037; mvaughan@wtmgmt.com

Contact: Rachel Trope, MS; 7038070037; rtrope@wtmgmt.com

Locations

United States, Virginia

Washington Center for Weight Management and Research, Inc.; Recruiting

Shirlington, Virginia, United States, 22206

Contact: Michelle Vaughan, MBA 703-807-0037 mvaughan@wtmgmt.com

Contact: Rachel Trope, MS 7038070037 rtrope@wtmgmt.com

Principal Investigator: Domenica Rubino, MD

Sub-Investigator: Rachel Trope, MS

Sub-Investigator: Mike Reing, MS

Sponsors and Collaborators

Feelwell Compression

Washington Center for Weight Management and Research, Inc.

Investigators

• Principal Investigator: Domenica Rubino, MD; Washington Center for Weight Management and Research

More Information

Publications:

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. 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. 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. Review.

Hébert-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.

• Responsible Party: Feelwell Compression
• ClinicalTrials.gov Identifier: NCT03798873
• Other Study ID Numbers: FeelWell2018
• First Posted: January 10, 2019
• Last Update Posted: February 19, 2019
• Last Verified: February 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: Once study is completed, data analyzed and published, data will be made available to any investigator who is interested upon written request.
• Supporting Materials: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF); Clinical Study Report (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.

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by Feelwell Compression:

Compression garment; Physical therapy; Obesity; Movement; Abdominal binder

Additional relevant MeSH terms:

Obesity; Obesity, Abdominal; Body Weight Changes; Chronic Pain; Mobility Limitation; Overnutrition; Nutrition Disorders; Overweight; Body Weight; Pain; Neurologic Manifestations