Back to resultsVocal Intervention in Systemic Sclerosis
Primary Purpose
Systemic Sclerosis
Status
Unknown status
Phase
Not Applicable
Locations
Austria
Study Type
Interventional
Intervention
vocal intervention
Sponsored by
About this trial
This is an interventional treatment trial for Systemic Sclerosis
Eligibility Criteria
Inclusion Criteria:
- positive criteria for Systemic Sclerosis according to the American College of Rheumatology/European League Against Rheumatism
Exclusion Criteria:
- affection of the vocal apparatus
- dyspnea at rest
- oxygen prescription
Sites / Locations
- Department of Physical Medicine and Rehabilitation, Medical University of ViennaRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Vocal intervention
Arm Description
Vocal intervention
Outcomes
Primary Outcome Measures
MOS 36-Item Short Form Health Survey
The SF-36 - a patient-reported survey of patient health - consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight.
Secondary Outcome Measures
Mouth open; in millimeter
incisor to incisor; corner of mouth to corner of mouth; measurement by tape
6-minutes walk test
The 6-minute walk test assess changes in functional exercise capacity with the primary outcome reported being the distance walked during the test.
Secretory immunoglobulin A; mg/l
Immunoglobulin A is an antibody that plays a role in immune function in the mucous membranes. Indicates changes in immune status. Collected by a swab placed in the mouth.
Saliva cortisol; ng/ml
Cortisol is a steroid hormone indicating changes in stress status. Collected by a swab placed in the mouth.
Full Information
NCT ID
NCT02821663
First Posted
June 24, 2016
Last Updated
April 12, 2017
Sponsor
Medical University of Vienna
1. Study Identification
Unique Protocol Identification Number
NCT02821663
Brief Title
Vocal Intervention in Systemic Sclerosis
Official Title
Rehabilitation in Patients Suffering From Systemic Sclerosis by Vocal Intervention: A Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
April 2017
Overall Recruitment Status
Unknown status
Study Start Date
November 2014 (undefined)
Primary Completion Date
October 2017 (Anticipated)
Study Completion Date
February 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of Vienna
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Systemic sclerosis is a systemic connective tissue disease with physical and mental disturbances. Based on a pilot study the feasibility and effectiveness of a novel, self-developed concept of vocal intervention in Systemic Sclerosis under vocal pedagogical guidance and music therapy is assessed.
Detailed Description
This concept aims at functional improvement of respiration and mouth-opening, enhancement of Quality of Life, and reduction of stress carried out by a music therapist and singer with pedagogical formation.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Systemic Sclerosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Vocal intervention
Arm Type
Experimental
Arm Description
Vocal intervention
Intervention Type
Behavioral
Intervention Name(s)
vocal intervention
Intervention Description
10 x 60 min. sessions of vocal intervention
Primary Outcome Measure Information:
Title
MOS 36-Item Short Form Health Survey
Description
The SF-36 - a patient-reported survey of patient health - consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight.
Time Frame
up to 4 weeks
Secondary Outcome Measure Information:
Title
Mouth open; in millimeter
Description
incisor to incisor; corner of mouth to corner of mouth; measurement by tape
Time Frame
up to 4 weeks
Title
6-minutes walk test
Description
The 6-minute walk test assess changes in functional exercise capacity with the primary outcome reported being the distance walked during the test.
Time Frame
up to 4 weeks
Title
Secretory immunoglobulin A; mg/l
Description
Immunoglobulin A is an antibody that plays a role in immune function in the mucous membranes. Indicates changes in immune status. Collected by a swab placed in the mouth.
Time Frame
up to 4 weeks
Title
Saliva cortisol; ng/ml
Description
Cortisol is a steroid hormone indicating changes in stress status. Collected by a swab placed in the mouth.
Time Frame
up to 4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
positive criteria for Systemic Sclerosis according to the American College of Rheumatology/European League Against Rheumatism
Exclusion Criteria:
affection of the vocal apparatus
dyspnea at rest
oxygen prescription
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Michael Mickel, MD
Email
michael.mickel@meduniwien.ac.at
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Mickel, MD
Organizational Affiliation
Deptartment of Physical Medicine and Rehabilitation, MUW
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Physical Medicine and Rehabilitation, Medical University of Vienna
City
Vienna
ZIP/Postal Code
A-1090
Country
Austria
Individual Site Status
Recruiting
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Vocal Intervention in Systemic Sclerosis
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