Functional Capacity and Quality of Life in Patients With Vascular Ring

NCT ID: NCT04781738

Last Updated: 2021-03-04

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 30 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-03-15
• Study Completion Date: 2022-02-28

Brief 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.

Detailed 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).

Conditions

Vascular Ring

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

patients with history of vascular ring who didn't have corrective surgery

patients with history of vascular ring who didn't have corrective surgery

Cardiopulmonary exercise test

Intervention Type: DIAGNOSTIC_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).

patients with history of vascular ring who underwent corrective surgery

patients with history of vascular ring who underwent corrective surgery

Cardiopulmonary exercise test

Intervention Type: DIAGNOSTIC_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).

Interventions

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).

Intervention Type: DIAGNOSTIC_TEST

Other Intervention Names

6 minute walk test; quality of life questionnaire (sf-36)

Eligibility Criteria

Inclusion Criteria

• patients with history of vascular ring

Exclusion Criteria

• refusal to participate
• inability to complete cardiopulmonary testing

• Minimum Eligible Age: 5 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Rambam Health Care Campus

OTHER

Sponsor Role: lead

Responsible Party

l_bentur

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Lea Bentur, MD

Role: PRINCIPAL_INVESTIGATOR

Head of Pediatric Pulmonary Institute

Locations

Rambam health care campus

Haifa, , Israel

Site Status: RECRUITING

Countries

Israel

Central Contacts

Lea Bentur, MD

Role: CONTACT

l_bentur@rambam.health.gov.il

+972-4-7774360

Vered Nir, MD

Role: CONTACT

v_nir@rambam.health.gov.il

+972-4-7774360

Facility Contacts

Lea Bentur, Prof.

Role: primary

l_bentur@rambam.health.gov.il

972-4-777-4360

References

Nir V, Bentur L, Zucker-Toledano M, Gur M, Adler Z, Hanna M, Toukan Y, Masarweh K, Hakim F, Bar-Yoseph R. Functional capacity and quality of life in patients with vascular ring. Pediatr Pulmonol. 2022 Dec;57(12):2946-2953. doi: 10.1002/ppul.26112. Epub 2022 Sep 14.

Reference Type: DERIVED

PMID: 35971243 (View on PubMed)

Other Identifiers

RMB-0218-17

Identifier Type: -

Identifier Source: org_study_id