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

Study Overview
=================
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.

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

Conditions
-----------------
Intervertebral Disc Compression, Muscle Atrophy, Spine Injury

Intervention / Treatment
-----------------
* Device: Hyper-buoyancy Floatation (HBF)
* Device: Axial Load after 4h of HBF


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental Group<br>8 participants (4 males, 25.5±4.4 years, 63.5±10.6 kg, 163.2±5.6 cm) | Device: Hyper-buoyancy Floatation (HBF)<br>* 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<br>Device: Axial Load after 4h of HBF<br>* 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.<br>|
| Observational Group<br>8 participants (3 males, 27.0±2.0 years, 68.4±11.8 kg, 176.5±10.9 cm | Device: Hyper-buoyancy Floatation (HBF)<br>* 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<br>Device: Axial Load after 4h of HBF<br>* 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.<br>|

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 |