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

NCT05590754 | Completed

• 1 other identifier: HR-18/19-11548
• Study Type: observational
• Target: 16
• Locations: 2 countries
• Sites: 2

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.

Conditions

Intervertebral Disc Compression; Muscle Atrophy; Spine Injury

Outcome Measures

Primary Outcomes (1)

• Height

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

  2 years

Secondary Outcomes (3)

• Intervertebral Disc Height

  2 years

• Vertebral Stiffness

  2 years

• Self-reported back pain

  2 years

Study Arms (2)

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

Hyper-buoyancy Floatation (HBF) DEVICE

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

Experimental Group; Observational Group

Axial Load after 4h of HBF DEVICE

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.

Experimental Group; Observational Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Centro Superior de Estudios Universitarios Lasalle: collaborator
• Universidad Autonoma de Madrid: lead
• King's College London: collaborator

Study Sites (2)

Universidad Autónoma de Madrid

Madrid, 28023, Spain

Location

King's College London

London, SE1 1UL, United Kingdom

Location

Related Publications (4)

• 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.

  PMID: 32982803 BACKGROUND

• 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.

  PMID: 29403389 RESULT

• 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.

  PMID: 24135505 RESULT

• 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.

  PMID: 27779600 RESULT

MeSH Terms

Conditions

Muscular Atrophy; Spinal Injuries

Condition Hierarchy (Ancestors)

Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Back Injuries; Wounds and Injuries

Study Officials

• David Green, PhD

  King's College London

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigador

Study Record Dates

• First Submitted: October 18, 2022
• First Posted: October 21, 2022
• Study Start: June 12, 2018
• Primary Completion: July 1, 2018
• Study Completion: March 1, 2022
• Last Updated: December 6, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1); ES (1)