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

Completed

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

• Registration Number: NCT05590754
• Lead Sponsor: Universidad Autonoma de Madrid

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.

Study Timeline

• Study Start: 2018-06-12
• Primary Completion: 2018-07-01
• Study Completion: 2022-03-01
• Study First Submitted: 2022-10-18
• Study First Submitted QC: 2022-10-20
• Study First Posted: 2022-10-21
• Status Verified: 2022-12
• Last Update Submitted: 2022-12-03
• Last Update Posted: 2022-12-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Experimental Group	Hyper-buoyancy Floatation (HBF)	8 participants (4 males, 25.5±4.4 years, 63.5±10.6 kg, 163.2±5.6 cm)
Observational Group	Axial Load after 4h of HBF	8 participants (3 males, 27.0±2.0 years, 68.4±11.8 kg, 176.5±10.9 cm
Experimental Group	Axial Load after 4h of HBF	8 participants (4 males, 25.5±4.4 years, 63.5±10.6 kg, 163.2±5.6 cm)
Observational Group	Hyper-buoyancy Floatation (HBF)	8 participants (3 males, 27.0±2.0 years, 68.4±11.8 kg, 176.5±10.9 cm

Primary Outcome Measures

Name	Time	Method
Height	2 years	Standing stature measured by a commercial stadiometer (Seca 217, Germany)

Secondary Outcome Measures

Name	Time	Method
Self-reported back pain	2 years	Pain rating scale (CHAPS) from 0 to 10
Intervertebral Disc Height	2 years	Disc height (L2-S1) measured by ultrasound
Vertebral Stiffness	2 years	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.

Trial Locations

Locations (2)

Universidad Autónoma de Madrid; 🇪🇸 Madrid, Spain

King's College London; 🇬🇧 London, United Kingdom