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

Muscle Atrophy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05590754
• Other study ID #: HR-18/19-11548
• Status: Completed
• Start date: June 12, 2018
• Est. completion date: March 1, 2022

Study information

• Verified date: December 2022
• Source: Universidad Autonoma de Madrid
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: March 1, 2022
• Est. primary completion date: July 1, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Body Weight
• Muscle Atrophy
• Muscular Atrophy
• Spinal Injuries
• Spine Injury

Intervention

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
• 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.

Locations

Country	Name	City	State
Spain	Universidad Autónoma de Madrid	Madrid
United Kingdom	King's College London	London

Sponsors (3)

Lead Sponsor	Collaborator
Universidad Autonoma de Madrid	Centro Superior de Estudios Universitarios Lasalle, King's College London

Countries where clinical trial is conducted

Spain,  United Kingdom, 

References & Publications (4)

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 Spac — View 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. Review. — View 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 — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Height	Standing stature measured by a commercial stadiometer (Seca 217, Germany)	2 years
Secondary	Intervertebral Disc Height	Disc height (L2-S1) measured by ultrasound	2 years
Secondary	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
Secondary	Self-reported back pain	Pain rating scale (CHAPS) from 0 to 10	2 years