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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02821663
Other study ID # SSc-1-MM
Secondary ID
Status Recruiting
Phase N/A
First received June 24, 2016
Last updated April 12, 2017
Start date November 2014
Est. completion date February 2018

Study information

Verified date April 2017
Source Medical University of Vienna
Contact Michael Mickel, MD
Email michael.mickel@meduniwien.ac.at
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 10
Est. completion date February 2018
Est. primary completion date October 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Intervention

Behavioral:
vocal intervention
10 x 60 min. sessions of vocal intervention

Locations

Country Name City State
Austria Department of Physical Medicine and Rehabilitation, Medical University of Vienna Vienna

Sponsors (1)

Lead Sponsor Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. up to 4 weeks
Secondary Mouth open; in millimeter incisor to incisor; corner of mouth to corner of mouth; measurement by tape up to 4 weeks
Secondary 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. up to 4 weeks
Secondary 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. up to 4 weeks
Secondary Saliva cortisol; ng/ml Cortisol is a steroid hormone indicating changes in stress status. Collected by a swab placed in the mouth. up to 4 weeks
See also
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