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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

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

Intervention / Treatment
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* Device: FeelWell™ Compression garment
* Behavioral: Increase Mobility


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: FeelWell™ Compression garment use with increase mobility<br>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<br>* 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.<br>Behavioral: Increase Mobility<br>* Subjects will work with exercise physiologist and physical therapist to increase mobility, strength and activity<br>|
| Other: Increase mobility<br>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<br>* Subjects will work with exercise physiologist and physical therapist to increase mobility, strength and activity<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Compression garment, Physical therapy, Obesity, Movement, Abdominal binder