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

15. februar 2019 opdateret af: Feelwell Compression

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

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.

Studieoversigt

Status

Ukendt

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Forventet)

30

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • Virginia
      • Shirlington, Virginia, Forenede Stater, 22206
        • Rekruttering
        • Washington Center for Weight Management and Research, Inc.
        • Kontakt:
        • Kontakt:
        • Ledende efterforsker:
          • Domenica Rubino, MD
        • Underforsker:
          • Rachel Trope, MS
        • Underforsker:
          • Mike Reing, MS

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.
Enhed: 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.

Adfærdsmæssigt: Increase Mobility
Subjects will work with exercise physiologist and physical therapist to increase mobility, strength and activity
Andet: 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.
Adfærdsmæssigt: Increase Mobility
Subjects will work with exercise physiologist and physical therapist to increase mobility, strength and activity

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
6- minute walk test- distance walked
Tidsramme: baseline, 1, 3, 6 and 12 months
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
Tidsramme: baseline, 1, 3, 6 and 12 months
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
Tidsramme: baseline, 3, 6 and 12 months
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
Tidsramme: baseline, 1, 3, 6 and 12 months
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
Tidsramme: baseline, 1, 3, 6 and 12 months
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
Tidsramme: baseline, 6 months and 1 year
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
Tidsramme: baseline, 1, 3, 6 and 12 months
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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Lean body mass
Tidsramme: baseline, 12 months
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
Tidsramme: baseline, 12 months
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
Tidsramme: baseline, 12 months
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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Feelwell Compression

Samarbejdspartnere

Washington Center for Weight Management and Research, Inc.

Efterforskere

  • Ledende efterforsker: Domenica Rubino, MD, Washington Center for Weight Management and Research

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

13. februar 2019

Primær færdiggørelse (Forventet)

1. juli 2020

Studieafslutning (Forventet)

1. juli 2020

Datoer for studieregistrering

Først indsendt

13. december 2018

Først indsendt, der opfyldte QC-kriterier

7. januar 2019

Først opslået (Faktiske)

10. januar 2019

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

19. februar 2019

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

15. februar 2019

Sidst verificeret

1. februar 2019

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • FeelWell2018

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

Once study is completed, data analyzed and published, data will be made available to any investigator who is interested upon written request.

IPD-delingstidsramme

Data will be available within 6 months of publication.

IPD-delingsadgangskriterier

Researchers must provide evidence that the data are being requested for analysis in a scientific study.

IPD-deling Understøttende informationstype

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ja

produkt fremstillet i og eksporteret fra U.S.A.

Ja

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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