Spinal Cord InjuryBALNEORESPINCT01831414
Effect of Immersion Level on Respiratory Function of Spinal Cord Injury Patients During Balneotherapy
A study testing Water immersion at cervical level and Water immersion at xyphoid level in people with Spinal Cord Injury, run by Centre d'Investigation Clinique et Technologique 805 at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spinal Cord Injury
- What is being tested?
- Water immersion at cervical level and Water immersion at xyphoid level
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteFrance
- Study dates
- Jun 2009to Apr 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult Patient
- complete tetraplegia from spinal cord injury
- initial spinal cord injury at leat 3 months before study
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Etude Pilote évaluant l'Effet du Niveau d'Immersion Sur la Fonction Respiratoire Des Patients tétraplégiques bénéficiant de balnéothérapie
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.
- Conditions
- Spinal Cord Injury
- Being tested
- Water immersion at cervical level, Water immersion at xyphoid level
- Keywords
- Lung function, Water immersion, Balneotherapy
- Medical subject headings
- Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Water immersion at cervical levelOther
balneotherapy session of spinal cord patients with a Water immersion at cervical level
Water immersion at xyphoid levelOther
balneotherapy session of spinal cord patients with a Water immersion at xyphoid level
| Study group | Role | What they receive |
|---|---|---|
| Water immersion at cervical level | Experimental | Lung function of spinal cord injury patients will be studied with a water immersion at cervical level Receives: Other: Water immersion at cervical level |
| Water immersion at xyphoid level | Experimental | Lung volumes of spinal cord injury patients will be studied with a Water immersion at xyphoid level Receives: Other: Water immersion at xyphoid level |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lung volumes
Measurement of lung volumes (Vital capacity, Forced Expiratory volume at 1 second and total lung capacity) measured by standard pulmonary function test
Measured: 1 hour
Secondary outcomes (1)
Respiratory comfort
Respiratory comfort is evaluated with a visual analogical scale (ranked from 0 to 10) and the Borg dyspnea score
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2013 (estimated)
- Study startJun 2009
- Primary completionApr 2013
- Study completionApr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre d'Investigation Clinique et Technologique 805
- Sponsor type
- University, hospital or other
- Collaborators
- Fondation Garches
- Responsible party
- Sponsor
- Investigators
- HELENE PRIGENT, MDPHD, Principal investigator, HOPITAL RAYMOND POINCARE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01831414
- Sponsor's protocol ID
- 2009-A00246-51
- Acronym
- BALNEORESPI
- Status last verified
- May 2013
- First submitted
- 11 Apr 2013
- Last updated
- 6 May 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Etude Pilote évaluant l'Effet du Niveau d'Immersion Sur la Fonction Respiratoire Des Patients tétraplégiques bénéficiant de balnéothérapie
- ClinicalTrials.gov ID
- NCT01831414
- Acronym / sponsor ID
- BALNEORESPI / 2009-A00246-51
- Conditions
- Spinal Cord Injury
- Keywords
- Lung function, Water immersion, Balneotherapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Centre d'Investigation Clinique et Technologique 805University, hospital or other
- Collaborators
- Fondation Garches
- Study start
- Jun 2009
- Primary completion
- Apr 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 15 Apr 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Water immersion at cervical level | Experimental | Other: Water immersion at cervical levelLung function of spinal cord injury patients will be studied with a water immersion at cervical level |
| Water immersion at xyphoid level | Experimental | Other: Water immersion at xyphoid levelLung volumes of spinal cord injury patients will be studied with a Water immersion at xyphoid level |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult Patient
- complete tetraplegia from spinal cord injury
- initial spinal cord injury at leat 3 months before study
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Water immersion at cervical levelbalneotherapy session of spinal cord patients with a Water immersion at cervical level | Other | Water immersion at cervical level |
| Water immersion at xyphoid levelbalneotherapy session of spinal cord patients with a Water immersion at xyphoid level | Other | Water immersion at xyphoid level |
Primary outcome
Lung volumes
Time frame: 1 hour
Measurement of lung volumes (Vital capacity, Forced Expiratory volume at 1 second and total lung capacity) measured by standard pulmonary function test
1 secondary outcome
Respiratory comfort
Time frame: 1 hour
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
HELENE PRIGENT, MDPHD principal investigator
HOPITAL RAYMOND POINCARE
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Water immersion at cervical level and Water immersion at xyphoid level in people with Spinal Cord Injury, run by Centre d'Investigation Clinique et Technologique 805 at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 May 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lung volumes (time frame: 1 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2013.