Recruiting

FeelWell™ Compression

Sponsor:

Feelwell Compression

Code:

NCT03798873

Conditions

Obesity

Obesity, Abdominal

Mobility Limitation

Quality of Life

Back Pain

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

FeelWell™ Compression garment

Increase Mobility

Study Details

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.

Conditions

Obesity

Obesity, Abdominal

Mobility Limitation

Quality of Life

Back Pain

Study ID

NCT03798873

Start date

Feb 13, 2019

Status verified date

Feb, 2019

Completion date

Jul, 2020

Anticipated

Primary completion date

Jul, 2020

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

30 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

other: 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.

Interventions

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.

Increase Mobility

Subjects will work with exercise physiologist and physical therapist to increase mobility, strength and activity

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Domenica Rubino, MD

17038070037mvaughan@wtmgmt.com

Rachel Trope, MS

7038070037rtrope@wtmgmt.com

Locations

Washington Center for Weight Management and Research, Inc.

Recruiting

Shirlington, Virginia, United States, 22206

Contacts

Michelle Vaughan, MBA

703-807-0037mvaughan@wtmgmt.com

Rachel Trope, MS

7038070037rtrope@wtmgmt.com

Principal Investigator:

Domenica Rubino, MD

More Information

Sponsor

Feelwell Compression

Last update posted

Feb 19, 2019

Last verified

Feb, 2019

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Feelwell Compression on 2019-02-19.