Functional Capacity and Quality of Life in Patients With Vascular Ring

NCT04781738 | Unknown

• 1 other identifier: RMB-0218-17
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Vascular Ring

Keywords

Cardiopulmonary exercise testing,; Double aortic arch

Outcome Measures

Primary Outcomes (1)

• Exercise capacity

  Oxygen uptake evaluated by cardiopulmonary exercise testing (CPET)

  Measured continuously during 15 minutes of the exercise test (CPET)

Secondary Outcomes (2)

• Six minute walk test

  Six minutes of evaluation, completed pre cardiopulmonary exercise test (CPET)

• Quality of life - SF-36

  Five minutes of evaluation, completed pre cardiopulmonary exercise test (CPET)

Study Arms (2)

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

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

Diagnostic Test: Cardiopulmonary exercise test

patients with history of vascular ring who underwent corrective surgery

patients with history of vascular ring who underwent corrective surgery

Diagnostic Test: Cardiopulmonary exercise test

Interventions

Cardiopulmonary exercise test 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).

Also known as: 6 minute walk test, quality of life questionnaire (sf-36)

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

Eligibility Criteria

• Age: 5 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients with history of vascualr ring

You may qualify if:

• patients with history of vascular ring

You may not qualify if:

• refusal to participate
• inability to complete cardiopulmonary testing

Sponsors & Collaborators

• Rambam Health Care Campus: lead

Study Sites (1)

Rambam health care campus

Haifa, Israel

RECRUITING

Related Publications (1)

• 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.

  PMID: 35971243 DERIVED

MeSH Terms

Conditions

Vascular Ring

Interventions

Exercise Test; Walk Test

Condition Hierarchy (Ancestors)

Vascular Malformations; Cardiovascular Abnormalities; Cardiovascular Diseases; Aortic Arch Syndromes; Aortic Diseases; Vascular Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Heart Function Tests; Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis; Respiratory Function Tests; Diagnostic Techniques, Respiratory System; Ergometry; Investigative Techniques

Study Officials

• Lea Bentur, MD

  Head of Pediatric Pulmonary Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lea Bentur, MD

CONTACT

+972-4-7774360; l_bentur@rambam.health.gov.il

Vered Nir, MD

CONTACT

+972-4-7774360; v_nir@rambam.health.gov.il

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 21, 2021
• First Posted: March 4, 2021
• Study Start: March 15, 2018
• Primary Completion: December 1, 2021
• Study Completion: February 1, 2022
• Last Updated: March 4, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)