NCT02646215

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2015

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2015

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 4, 2016

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 5, 2016

Completed
Last Updated

April 20, 2016

Status Verified

April 1, 2016

Enrollment Period

2 months

First QC Date

January 4, 2016

Last Update Submit

April 19, 2016

Conditions

Ehlers Danlos

Outcome Measures

Primary Outcomes (1)

  • inspiratory muscle strength measured by sniff nasal inspiratory pressure

    2 minutes

Secondary Outcomes (3)

  • walked distance measured by six minutes walking test

    6 minutes

  • lung function by spirometry

    5 minutes

  • anxiety by hospital anxiety depression scale

    2 minutes

Study Arms (2)

Inspiratory muscle training group

ACTIVE COMPARATOR

Threshold inspiratory muscle training

Device: Threshold inspiratory muscle training

Control group

NO INTERVENTION

No training

Interventions

Threshold inspiratory muscle trainingDEVICE

Inspiratory muscle training

Inspiratory muscle training group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • respiratory comorbidities

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinique universitaire Saint-Luc

Brussels, Belgium

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 4, 2016

First Posted

January 5, 2016

Study Start

August 1, 2015

Primary Completion

October 1, 2015

Study Completion

October 1, 2015

Last Updated

April 20, 2016

Record last verified: 2016-04

Data Sharing

IPD Sharing
Will not share

Locations

BE(1)