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

Obesity Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03798873
• Other study ID #: FeelWell2018
• Status: Recruiting
• Phase: N/A
• Start date: February 13, 2019
• Est. completion date: July 2020

Study information

• Verified date: February 2019
• Source: Feelwell Compression
• Contact: Domenica Rubino, MD
• Phone: 17038070037
• Email: mvaughan[@]wtmgmt.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: July 2020
• Est. primary completion date: July 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Back Pain
• Body Composition
• Body Weight Changes
• Chronic Pain
• Exercise
• Inactivity
• Mobility Limitation
• Obesity
• Obesity, Abdominal
• Pain, Chronic
• Quality of Life
• Redundant Skin
• Weight Change, Body

Intervention

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

Locations

Country	Name	City	State
United States	Washington Center for Weight Management and Research, Inc.	Shirlington	Virginia

Sponsors (2)

Lead Sponsor	Collaborator
Feelwell Compression	Washington Center for Weight Management and Research, Inc.

Country where clinical trial is conducted

United States, 

References & 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. Erratum in: Am J Respir Crit Care Med. 2016 May 15;193(10):1185. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	Lean body mass	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.	baseline, 12 months
Secondary	Fat mass	Using DXA (Dual-energy X-ray Absorptiometry), fat mass will be measured at baseline and at end of study. Percent change will be reported.	baseline, 12 months
Secondary	Bone density	Using DXA (Dual-energy X-ray Absorptiometry), bone density will be measured at baseline and at end of study. Percent change will be reported.	baseline, 12 months