Functional Capacity and Quality of Life in Patients With Vascular Ring

Vascular Ring Clinical Trial

Official title:

Functional Capacity and Quality of Life in Patients With Vascular Ring

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04781738
• Other study ID #: RMB-0218-17
• Status: Recruiting
• Start date: March 15, 2018
• Est. completion date: February 2022

Study information

• Verified date: February 2021
• Source: Rambam Health Care Campus
• Contact: Lea Bentur, MD
• Phone: +972-4-7774360
• Email: l_bentur[@]rambam.health.gov.il
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

To investigate the long term functional capacity and quality of life of patients with a history of vascular ring whether they did or did not have corrective surgery. Patients will perform pulmonary function test, 6 minute walk test, cardiopulmonary exercise test and will fill a quality of life questionnaire.

Description:

Vascular rings are congenital vascular anomalies of the aortic arch that compress the esophagus and the trachea. The most common vascular rings are double aortic arch and right aortic arch with left ligamentum. Pulmonary artery sling is less common. Another cause of tracheal compression occurring only in infants is the innominate artery compression syndrome. When patients are symptomatic, surgical correction should be performed.

data regarding long term functional capacity and quality of life is lacking. our aim is to investigate the long term functional capacity and quality of life of patients with history of vascular ring whether they did or did not have corrective surgery.

Methods: a prospective study evaluating functional capacity and quality of life the patients will perform pulmonary function test, 6 minute walk test, cardiopulmonary exercise test and will fill a quality of life questionnaire (sf-36).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: February 2022
• Est. primary completion date: December 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years and older

Eligibility

Inclusion Criteria:

• patients with history of vascular ring

Exclusion Criteria:

• refusal to participate

• inability to complete cardiopulmonary testing

Related Conditions & MeSH terms

• Vascular Ring

Intervention

Diagnostic Test:
• Cardiopulmonary exercise test
CPET using a cycle ergometer (COSMED, Rome, Italy) beginning with no resistance warmup lasting 1-3 minutes followed with an incrementing resistance adapted to the patient's functional capacities according to the examiner's free judgment by successive stages Six minute walk test - patients will be instructed to walk as far as possible for six minutes in a 30-meter long enclosed corridor with a flat and hard surface, marked at every meter. Meters will be calculated at the end of the test. SF-36 is a questionnaire that contains eight domains - physical functioning (10 items); role limitations due to physical functioning (4 items); role limitations due to emotional problems (3 items); energy and vitality (4 items); mental health (5 items); social functioning (2 items); bodily pain (2 items); and general health perceptions (5 items). Scores are summed for each domain and were transformed into scores of between 0 (worst possible health state) to 100 (best possible health state).

Locations

Country	Name	City	State
Israel	Rambam health care campus	Haifa

Sponsors (1)

Lead Sponsor	Collaborator
Rambam Health Care Campus

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Exercise capacity	Oxygen uptake evaluated by cardiopulmonary exercise testing (CPET)	Measured continuously during 15 minutes of the exercise test (CPET)
Secondary	Six minute walk test	The distance gained after six minute of habitual walking.	Six minutes of evaluation, completed pre cardiopulmonary exercise test (CPET)
Secondary	Quality of life - SF-36	The calculated result of SF-36 questionnaire	Five minutes of evaluation, completed pre cardiopulmonary exercise test (CPET)