Clinical trial NCT05590754: 50% Body Weight Reverses Stature, Lumbar Disc Expansion and Vertebral Compliance by Hyper-Buoyancy Floatation.
Official title: Acute 50% Body Weight Static Axial Loading Reverses Stature Increases, Lumbar Disc Expansion and Vertebral Compliance Modulation Induced by 4 Hours of Hyper-buoyancy Floatation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Intervertebral Disc Compression
Muscle Atrophy
Spine Injury
Lead sponsor: Universidad Autonoma de Madrid
Sponsor class: OTHER
Collaborators: name: Centro Superior de Estudios Universitarios Lasalle
name: King's College London
First posted: 2022-10-21
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: NASA astronaut criteria (1.57-1.90m, 50-95kg)

Brief summary: Study with the aim to see the effect on a space ground analogue , Hyper-Buoyancy Floatation (HBF) on lumbar column and the effect of a supplementary 50% of an axial load.

Detailed description: the aim of this study was to determine the effect of 15min of 1g reloading following 4h HBF unloading with, and without 30s of seated static 50% BW axial loading upon stature, lumbar Intervertebral Disc height (via ultrasound), vertebral compliance changes, and back pain.

Eligibility criteria: Inclusion Criteria:

* physical requirements (1.57-1.90m, 50-95kg)

Exclusion Criteria:

* current back/neck pain, musculoskeletal disorder, cardiovascular disease, spine surgery and being, or suspected to be pregnant

Primary outcomes:
measure: Height
timeFrame: 2 years
Secondary outcomes:
measure: Intervertebral Disc Height
timeFrame: 2 years
measure: Vertebral Stiffness
timeFrame: 2 years
measure: Self-reported back pain
timeFrame: 2 years
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Universidad Autónoma de Madrid
city: London
country: United Kingdom
facility: King's College London
Study officials:
affiliation: King's College London
name: David Green, PhD
role: STUDY_DIRECTOR
References:
citation: Swanenburg J, Langenfeld A, Easthope CA, Meier ML, Ullrich O, Schweinhardt P. Microgravity and Hypergravity Induced by Parabolic Flight Differently Affect Lumbar Spinal Stiffness. Front Physiol. 2020 Sep 2;11:562557. doi: 10.3389/fphys.2020.562557. eCollection 2020.
citation: Green DA, Scott JPR. Spinal Health during Unloading and Reloading Associated with Spaceflight. Front Physiol. 2018 Jan 18;8:1126. doi: 10.3389/fphys.2017.01126. eCollection 2017.
citation: Marshburn TH, Hadfield CA, Sargsyan AE, Garcia K, Ebert D, Dulchavsky SA. New heights in ultrasound: first report of spinal ultrasound from the international space station. J Emerg Med. 2014 Jan;46(1):61-70. doi: 10.1016/j.jemermed.2013.08.001. Epub 2013 Oct 15.
citation: Chang DG, Healey RM, Snyder AJ, Sayson JV, Macias BR, Coughlin DG, Bailey JF, Parazynski SE, Lotz JC, Hargens AR. Lumbar Spine Paraspinal Muscle and Intervertebral Disc Height Changes in Astronauts After Long-Duration Spaceflight on the International Space Station. Spine (Phila Pa 1976). 2016 Dec 15;41(24):1917-1924. doi: 10.1097/BRS.0000000000001873.