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

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 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.

Study Overview

• Status: Completed
• Conditions: Muscle Atrophy; Intervertebral Disc Compression; Spine Injury
• Intervention / Treatment: Device: Hyper-buoyancy Floatation (HBF); Device: Axial Load after 4h of HBF

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.

• Study Type: Observational
• Enrollment (Actual): 16

Contacts and Locations

Study Locations

• Spain
  • Madrid, Spain, 28023
    • Universidad Autonoma de Madrid
• United Kingdom
  • London, United Kingdom, SE1 1UL
    • King's College London

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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); 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; Device: Axial 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.
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); 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; Device: Axial 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Height	Standing stature measured by a commercial stadiometer (Seca 217, Germany)	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intervertebral Disc Height	Disc height (L2-S1) measured by ultrasound	2 years
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.	2 years
Self-reported back pain	Pain rating scale (CHAPS) from 0 to 10	2 years

Collaborators and Investigators

• Sponsor: Universidad Autonoma de Madrid
• Collaborators: King's College London; Centro Superior de Estudios Universitarios Lasalle
• Investigators: Study Director: David Green, PhD, King's College London

Publications and helpful links

General 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.
• 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. Review.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 12, 2018
• Primary Completion (Actual): July 1, 2018
• Study Completion (Actual): March 1, 2022

Study Registration Dates

• First Submitted: October 18, 2022
• First Submitted That Met QC Criteria: October 20, 2022
• First Posted (Actual): October 21, 2022

Study Record Updates

• Last Update Posted (Estimate): December 6, 2022
• Last Update Submitted That Met QC Criteria: December 3, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Wounds and Injuries; Neuromuscular Manifestations; Pathological Conditions, Anatomical; Atrophy; Back Injuries; Body Weight; Muscular Atrophy; Spinal Injuries
• Other Study ID Numbers: HR-18/19-11548

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: Data is going to be shared between the investigators authors

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No