NCT03915457: DI-Cuff

Thigh Cuffs to Prevent the Deconditioning Induced by 5 Days of Dry Immersion

Completed NA Last updated 21 August 2019

What this trial tests

NA trial testing Dry immersion Control Group in Weightlessness in 20 participants. Completed in 23 March 2019.

Timeline

18 November 2018

Primary endpoint
22 March 2019

23 March 2019

Quick facts

Lead sponsor	Centre National d'Etudes Spatiales
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	basic science
Enrollment	20
Start date	18 November 2018
Primary completion	22 March 2019
Estimated completion	23 March 2019
Sites	1 location across France

Drugs / interventions tested

• Dry immersion Control Group
• Thigh cuffs intervention

Conditions studied

• Weightlessness — all drugs for Weightlessness →
• Weightlessness; Adverse Effect — all drugs for Weightlessness; Adverse Effect →

Sponsor

Centre National d'Etudes Spatiales — full company profile →

Who can join

Adults 20 to 45, male only, with Weightlessness or Weightlessness; Adverse Effect. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The objective of the study is to investigate whether thigh cuffs help to prevent and/or reduce the deconditioning induced by 5 days of dry immersion and in particular the fluid shift and its related ophthalmological disorders. During a randomized 5 day dry-immersion study in 20 healthy male adults the two following aims will be undertaken:

* Ten scientific protocols will assess the changes in the cerebral, ocular, cardiovascular, metabolism, cognitive, muscle and bone systems.
* In the above mentioned systems, the potential beneficial effects of the countermeasure protocol will also be investigated.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Microgravity-Related Changes in Bone Density and Treatment Options: A Systematic Review.
   Baran R, Wehland M, Schulz H, Heer M, et al · · 2022 · cited 27× · PMID 35955775 · DOI 10.3390/ijms23158650
2. Does Physical Inactivity Induce Significant Changes in Human Gut Microbiota? New Answers Using the Dry Immersion Hypoactivity Model.
   Jollet M, Nay K, Chopard A, Bareille MP, et al · · 2021 · cited 23× · PMID 34836120 · DOI 10.3390/nu13113865
3. DI-5-CUFFS: Venoconstrictive Thigh Cuffs Limit Body Fluid Changes but Not Orthostatic Intolerance Induced by a 5-Day Dry Immersion.
   Robin A, Auvinet A, Degryse B, Murphy R, et al · · 2020 · cited 18× · PMID 32431622 · DOI 10.3389/fphys.2020.00383
4. Early Deconditioning of Human Skeletal Muscles and the Effects of a Thigh Cuff Countermeasure.
   Fovet T, Guilhot C, Stevens L, Montel V, et al · · 2021 · cited 15× · PMID 34769492 · DOI 10.3390/ijms222112064
5. Effects of Venoconstrictive Thigh Cuffs on Dry Immersion-Induced Ophthalmological Changes.
   Kermorgant M, Sadegh A, Geeraerts T, Varenne F, et al · · 2021 · cited 15× · PMID 34335300 · DOI 10.3389/fphys.2021.692361
6. Severe Muscle Deconditioning Triggers Early Extracellular Matrix Remodeling and Resident Stem Cell Differentiation into Adipocytes in Healthy Men.
   Guilhot C, Fovet T, Delobel P, Dargegen M, et al · · 2022 · cited 13× · PMID 35628300 · DOI 10.3390/ijms23105489
7. DI-5-Cuffs: Lumbar Intervertebral Disc Proteoglycan and Water Content Changes in Humans after Five Days of Dry Immersion to Simulate Microgravity.
   Treffel L, Navasiolava N, Mkhitaryan K, Jouan E, et al · · 2020 · cited 13× · PMID 32466473 · DOI 10.3390/ijms21113748
8. DI-5-Cuffs: Bone Remodelling and Associated Metabolism Markers in Humans After Five Days of Dry Immersion to Simulate Microgravity.
   Linossier MT, Peurière L, Fernandez P, Normand M, et al · · 2022 · cited 8× · PMID 35574450 · DOI 10.3389/fphys.2022.801448