Cervical Changes by 4h of Hyper-buoyancy Flotation and Followed by 15 Mins 1g Re-loading

NCT05296200 | Completed

• 1 other identifier: CSEULS-PI-032/2020
• Study Type: observational
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

Study with the aim to see the effect on a space ground anaologue, Hyperbuoyancy Floatation (HBF) on cervical column.

Conditions

Intervertebral Disc Herniation; Stiffness; Spine

Outcome Measures

Primary Outcomes (1)

• Height

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

  up to 2 years

Secondary Outcomes (4)

• Height of cervical Intervertebral Discs

  up to 2 years

• Longus Collis and Semispinalis Cervicis thickness and cross-sectional area.

  up to 2 years

• Vertebral Stiffness

  up to 2 years

• Self-reported neck pain

  up to 2 years

Study Arms (1)

Observacional group

Subjects must remain to the exposure of gravity (1G) after 4h of hyperbuoyancy floatation(spine unloading)

Device: Hyperbuoyancy Floatation

Interventions

Hyperbuoyancy Floatation DEVICE

Subjects are laid supine upon a HBF waterbed encased within a wooden frame partially (50%) filled with water (at 36ºC to maintain thermal comfort) super-saturated with magnesium sulphate. Thus, subjects are buoyant, sinking passively into the bed in proportion to their segmental mass.

Observacional group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: 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

• Universidad Autonoma de Madrid: lead
• Centro Superior de Estudios Universitarios Lasalle: collaborator

Study Sites (1)

CSEU-Lasalle

Madrid, 28029, Spain

Location

Related Publications (4)

• 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 BACKGROUND

• 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

• 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 RESULT

• McNamara KP, Greene KA, Tooze JA, Dang J, Khattab K, Lenchik L, Weaver AA. Neck Muscle Changes Following Long-Duration Spaceflight. Front Physiol. 2019 Sep 13;10:1115. doi: 10.3389/fphys.2019.01115. eCollection 2019.

  PMID: 31572205 RESULT

MeSH Terms

Conditions

Intervertebral Disc Displacement

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Alfonso Gil Martinez, PhD

  Centro Superior de Estudios Universitarios Lasalle

  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: February 23, 2022
• First Posted: March 25, 2022
• Study Start: March 13, 2020
• Primary Completion: July 25, 2020
• Study Completion: February 10, 2022
• Last Updated: March 25, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)