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CompletedNCT02646215Updated Apr 20, 2016

Inspiratory Muscle Training in Ehlers Danlos Patients

An interventional study of Threshold inspiratory muscle training in Ehlers Danlos, sponsored by Cliniques universitaires Saint-Luc- Université Catholique de Louvain. Completed at 1 site in Belgium. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2016-04-20.

Sponsored by Cliniques universitaires Saint-Luc- Université Catholique de Louvain · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study summary

Evaluation of the effect of inspiratory muscle training in Ehlers Danlos patients

02

Conditions studied

  • Ehlers Danlos
03

In context

Lead sponsor

Cliniques universitaires Saint-Luc- Université Catholique de Louvain is the lead sponsor of 348 studies on the registry; 62 are open to participants now.

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04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • a diagnosis for Ehlers Danlos syndrome combining genetics and clinical examination
  • no infectious exacerbation in the last four weeks

Exclusion criteria

Exclusion Criteria:

  • respiratory comorbidities
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
20 participants (actual)

Study arms

  • Active comparator
    Inspiratory muscle training group

    Threshold inspiratory muscle training

    Device: Threshold inspiratory muscle training

  • No intervention
    Control group

    No training

Interventions

  • DeviceThreshold inspiratory muscle training

    Inspiratory muscle training

06

What researchers measure

Primary outcomes

  1. inspiratory muscle strength measured by sniff nasal inspiratory pressure

    Time frame: 2 minutes

Secondary outcomes

  1. walked distance measured by six minutes walking test

    Time frame: 6 minutes

  2. lung function by spirometry

    Time frame: 5 minutes

  3. anxiety by hospital anxiety depression scale

    Time frame: 2 minutes

07

Study locations

1 site
  • Clinique universitaire Saint-Luc
    Brussels, Belgium
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Aug 2015, a primary completion of Oct 2015 and a completion of Oct 2015. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 4, 2016
First posted
Jan 5, 2016
Start
Aug 2015
Primary completionActual
Oct 2015
CompletionActual
Oct 2015
Last update
Apr 20, 2016
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 20, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02646215
Lead sponsor
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Responsible party
Sponsor
First posted
Jan 5, 2016
Start date
Aug 2015
Primary completion
Oct 2015
Completion
Oct 2015
Last update
Apr 20, 2016

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Apr 2016. You cannot join it, but the record below documents what was studied.

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