Impact of the Use of FeelWell™ Compression Garment on Individuals With a BMI ≥35
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
연구 개요
상태
상세 설명
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.
연구 유형
등록 (예상)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Virginia
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Shirlington, Virginia, 미국, 22206
- 모병
- Washington Center for Weight Management and Research, Inc.
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연락하다:
- Rachel Trope, MS
- 전화번호: 7038070037
- 이메일: rtrope@wtmgmt.com
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연락하다:
- Michelle Vaughan, MBA
- 전화번호: 703-807-0037
- 이메일: mvaughan@wtmgmt.com
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수석 연구원:
- Domenica Rubino, MD
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부수사관:
- Rachel Trope, MS
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부수사관:
- Mike Reing, MS
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: 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. |
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.
Subjects will work with exercise physiologist and physical therapist to increase mobility, strength and activity
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다른: 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.
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Subjects will work with exercise physiologist and physical therapist to increase mobility, strength and activity
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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6- minute walk test- distance walked
기간: baseline, 1, 3, 6 and 12 months
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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.
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baseline, 1, 3, 6 and 12 months
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6- minute walk test- Perceived exertion
기간: baseline, 1, 3, 6 and 12 months
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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.
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baseline, 1, 3, 6 and 12 months
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SF-36 physical component sub-score
기간: baseline, 3, 6 and 12 months
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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.
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baseline, 3, 6 and 12 months
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30 Second Chair Stand
기간: baseline, 1, 3, 6 and 12 months
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A test of leg strength and endurance.
The number of times a patient stands from a sitting position in 30 seconds is recorded.
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baseline, 1, 3, 6 and 12 months
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Brief Pain Inventory-Interference sub-score
기간: baseline, 1, 3, 6 and 12 months
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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.
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baseline, 1, 3, 6 and 12 months
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Steps per day measured by accelerometer
기간: baseline, 6 months and 1 year
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The number of steps per day will be recorded as a measure of daily activity and averaged at various time points throughout the trial.
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baseline, 6 months and 1 year
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Weight Self Stigma questionnaire
기간: baseline, 1, 3, 6 and 12 months
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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.
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baseline, 1, 3, 6 and 12 months
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Lean body mass
기간: baseline, 12 months
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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.
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baseline, 12 months
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Fat mass
기간: baseline, 12 months
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Using DXA (Dual-energy X-ray Absorptiometry), fat mass will be measured at baseline and at end of study.
Percent change will be reported.
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baseline, 12 months
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Bone density
기간: baseline, 12 months
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Using DXA (Dual-energy X-ray Absorptiometry), bone density will be measured at baseline and at end of study.
Percent change will be reported.
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baseline, 12 months
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공동 작업자 및 조사자
수사관
- 수석 연구원: Domenica Rubino, MD, Washington Center for Weight Management and Research
간행물 및 유용한 링크
일반 간행물
- 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. doi: 10.1164/ajrccm.166.1.at1102. No abstract available. 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. doi: 10.1016/j.rmed.2005.08.003. 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.
- Hebert-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.
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (예상)
연구 완료 (예상)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- FeelWell2018
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
IPD 공유 기간
IPD 공유 액세스 기준
IPD 공유 지원 정보 유형
- 연구_프로토콜
- 수액
- ICF
- ANALYTIC_CODE
- CSR
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