Effect of Immersion Level on Respiratory Function of Spinal Cord Injury Patients During Balneotherapy

Etude Pilote évaluant l'Effet du Niveau d'Immersion Sur la Fonction Respiratoire Des Patients tétraplégiques bénéficiant de balnéothérapie

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01831414

Acronym

BALNEORESPI

Enrollment

Registered

2013-04-15

Start date

2009-06-30

Completion date

2013-04-30

Last updated

2013-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Spinal Cord Injury

Keywords

Lung function, Water immersion, Balneotherapy

Brief summary

Balneotherapy is a physiotherapy technique which allows patients to work out in a weightless environment and which is often used in patients with spinal cord injury. In normal subjects, water immersion generates a reduction in lung volumes. The effects of water immersion on the respiratory function of spinal cord injury patient (who are liable to present a respiratory failure secondary to paralysis) are not well known. They could be deleterious (by majoring respiratory failure)or beneficial (by mimicking the effect of a corset and improving respiratory function). Therefore, we are planning to study the effect of different water immersion levels on the respiratory function of spinal cord injury patients.

Interventions

OTHERWater immersion at cervical level

balneotherapy session of spinal cord patients with a Water immersion at cervical level

OTHERWater immersion at xyphoid level

balneotherapy session of spinal cord patients with a Water immersion at xyphoid level

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Adult Patient * complete tetraplegia from spinal cord injury * initial spinal cord injury at leat 3 months before study

Exclusion criteria

* contra indication to a balneotherapy session (bed-sore, skin infection or irritation, urinary or fecal incontinency, tracheostomy, ongoing infection) * unstable respiratory state (patient free of respiratory infection or encumbrance) * refusal to participate to the protocol * pregnancy

Design outcomes

Primary

Measure	Time frame	Description
Lung volumes	1 hour	Measurement of lung volumes (Vital capacity, Forced Expiratory volume at 1 second and total lung capacity) measured by standard pulmonary function test

Secondary

Measure	Time frame	Description
Respiratory comfort	1 hour	Respiratory comfort is evaluated with a visual analogical scale (ranked from 0 to 10) and the Borg dyspnea score

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026