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

Feelwell Compression

Status: Unknown

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

Treatments: Behavioral: Increase Mobility; Device: FeelWell™ Compression garment

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT03798873

FeelWell2018

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

FeelWell™ Compression garment use with increase mobility

Experimental group

Description:

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.

Treatment:

Behavioral: Increase Mobility

Device: FeelWell™ Compression garment

Increase mobility

Other group

Description:

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.

Treatment:

Behavioral: Increase Mobility