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CompletedNCT05590754Updated Dec 6, 2022

50% Body Weight Reverses Stature, Lumbar Disc Expansion and Vertebral Compliance by Hyper-Buoyancy Floatation.

An observational study in Intervertebral Disc Compression, Muscle Atrophy and Spine Injury, sponsored by Universidad Autonoma de Madrid. Completed at 2 sites in 2 countries. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-12-06.

Sponsored by Universidad Autonoma de Madrid · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
16
Ages
18 Years to 65 Years
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • Intervertebral Disc Compression
  • Muscle Atrophy
  • Spine Injury
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In context

Muscular Atrophy

412 studies on the registry are indexed under Muscular Atrophy; 77 are open to participants now.

This study's enrollment of 16 is below the median of 61 across 73 observational studies indexed under Muscular Atrophy.

Browse Muscular Atrophy studies →

Lead sponsor

Universidad Autonoma de Madrid is the lead sponsor of 51 studies on the registry; 7 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

NASA astronaut criteria (1.57-1.90m, 50-95kg)

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

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

Observational model
Case-control
Time perspective
Prospective
Enrollment
16 participants (actual)
Patient registry
No

Groups and cohorts

  • Experimental Group

    8 participants (4 males, 25.5±4.4 years, 63.5±10.6 kg, 163.2±5.6 cm)

    Device: Hyper-buoyancy Floatation (HBF) · Device: Axial Load after 4h of HBF

  • Observational Group

    8 participants (3 males, 27.0±2.0 years, 68.4±11.8 kg, 176.5±10.9 cm

    Device: Hyper-buoyancy Floatation (HBF) · Device: Axial Load after 4h of HBF

Interventions

  • DeviceHyper-buoyancy Floatation (HBF)

    Participants remained on a waterbed encased within a wooden frame partially (≈50%) filled with water super-saturated with magnesium sulphate at a temperature between 34-36°C regulated by an ultra-thin underbed heater. Participants remained supine and motionless when lay on the HBF except for temporary passive re-orientation to/and back from the prone position for vertebral compliance assessment

  • DeviceAxial Load after 4h of HBF

    Participants from observational sat upright in a chair without back support for 15 min before post testing (1G), whilst experimental group participants performed a 30s seated squat with 50% of their body weight (BW) before returning to the upright seated position.

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What researchers measure

Primary outcomes

  1. Height

    Standing stature measured by a commercial stadiometer (Seca 217, Germany)

    Time frame: 2 years

Secondary outcomes

  1. Intervertebral Disc Height

    Disc height (L2-S1) measured by ultrasound

    Time frame: 2 years

  2. Vertebral Stiffness

    Vertebral stiffness from L1 to L5 was assessed passively (in the prone position) with a handheld differential vertebral compliance transducer (PulStar, Sense Technology Inc., USA) in Newtons.

    Time frame: 2 years

  3. Self-reported back pain

    Pain rating scale (CHAPS) from 0 to 10

    Time frame: 2 years

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Study locations

2 sites
  • Universidad Autónoma de Madrid
    Madrid, 28023, Spain
  • King's College London
    London, SE1 1UL, United Kingdom
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References and documents

Publications

  • 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. PubMed 32982803 ↗
  • 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. PubMed 29403389 ↗
  • 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. PubMed 24135505 ↗
  • 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. PubMed 27779600 ↗

Individual participant data

Plan to share: No — Data is going to be shared between the investigators authors

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 6, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05590754
Lead sponsor
Universidad Autonoma de Madrid
Collaborators
Centro Superior de Estudios Universitarios Lasalle, King's College London
Responsible party
David Marcos (Principal Investigador, Universidad Autonoma de Madrid) — Principal investigator
First posted
Oct 21, 2022
Start date
Jun 12, 2018
Primary completion
Jul 1, 2018
Completion
Mar 1, 2022
Last update
Dec 6, 2022

Study contacts

David Green, PhD
study director · King's College London

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2022. You cannot join it, but the record below documents what was studied.

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