HYPOXI for Women With Lipedema

Vetëm përdoruesit e regjistruar mund të përkthejnë artikuj

Identifikohuni Regjistrohu

Lidhja ruhet në kujtesën e fragmenteve

StatusiNuk është ende rekrutimi

Sponsorët

University of Arizona

TRAJTIM KLINIKAL: NCT03853083

BioSeek: NCT03853083

Fjalë kyçe

Abstrakt

The proposed study is for women with lipedema, a painful fat disorder where fat cannot be lost from the legs and hips with diet and exercise. The study will compare the use of the specialized exercise equipment called HYPOXI, which is like a bike but you lie down and air circulates around the participant's legs like a vacuum with pressure increasing and decreasing in cycles over time. The goal of the study is to see if using a HYPOXI bike compared to a regular recumbent (sit down) bike helps women with lipedema lose weight. The women with lipedema in the study will have the option to use a whole-body suit that works like a pump and was designed to improve blood circulation in the body. The body suit is called Dermology and can be used before the HYPOXI exercise equipment but will be optional for the women in the study. The study is 16 weeks long for 20 women with lipedema. Ten women with lipedema will exercise with HYPOXI for 8 weeks then switch to a recumbent bike for the second 8 weeks. The other 10 women will exercise on a recumbent bike for 8 weeks then switch to HYPOXI for 8 weeks in the second half of the study. Baseline, mid-study, and end of study data will be collected including measurements of body composition and shape, a blood draw at the beginning, middle and end, and questionnaires. This study will be listed on clinicaltrials.gov for more information.

Datat

Verifikuar së fundmi:	01/31/2019
Paraqitur së pari:	01/30/2019
Regjistrimi i vlerësuar u dorëzua:	02/20/2019
Postuar së pari:	02/24/2019
Përditësimi i fundit i paraqitur:	02/20/2019
Përditësimi i fundit i postuar:	02/24/2019
Data e fillimit të studimit aktual:	03/31/2019
Data e vlerësuar e përfundimit primar:	03/31/2020
Data e vlerësimit të përfundimit të studimit:	03/31/2021

Gjendja ose sëmundja

Lipedema

Ndërhyrja / trajtimi

Device: Hypoxi Equipment

Device: Recumbent Bicycle

Faza

Grupet e krahëve

Krah	Ndërhyrja / trajtimi
Experimental: Hypoxi Equipment	Device: Hypoxi Equipment Using the Hypoxi exercise equipment to try and improve lipedema fat tissue
Active Comparator: Recumbent Bicycle	Device: Recumbent Bicycle Recumbent bike is a piece of exercise equipment used as the comparison group

Kriteret e pranimit

Moshat e pranueshme për studim	18 Years Për të 18 Years
Gjinitë e pranueshme për studim	Female
Pranon Vullnetarë të Shëndetshëm	po
Kriteret	Inclusion Criteria - Female - 18-65 years of age - Lipedema any stage - Weight < 300 lbs. - Able to participate for 4 months - Self-reported weight stable - Able to use Hypoxi equipment & recumbent bike - Able to undergo baseline, mid- and end-study in Tucson. Exclusion Criteria - Hip width > 30 inches (76.2 cm) - Waist width > 46 inches - Pregnancy - Use of weight loss medication within 3 months of the study - History of myocardial infarction - New York Heart Association Functional Class II or above congestive heart failure - Sustained tachycardia above calculated maximum heart rate limit

Rezultati

Masat Kryesore të Rezultateve

1. Bioimpedence Scale Assessment of Total Body Lean Body Mass [Change in muscle mass from baseline to end of study arm (8 weeks)]

Whole body muscle content in kilograms

2. Bioimpedence Scale Assessment of Total Body Fat Mass [Change in fat mass from baseline to end of study arm (8 weeks)]

Whole body fat mass in kilograms

3. Bioimpedence Scale Assessment of Total Body Water [Change in total body water from baseline to end of study arm (8 weeks)]

Total body water in kilograms

Masat dytësore të rezultateve

1. Resting energy expenditure [Change in resting energy expenditure from baseline to end of study arm (8 weeks)]

Resting energy expenditure by MedGem Device in kcal/day

2. Waist/Hip ratio [Change in waist/hip ratio from baseline to end of study arm (8 weeks)]

Waist and hip measurements using a tape measure; this is a ratio with no units