The Relationship Between Having a Positive Mindset and Exercise Capacity in Patients With Congenital Heart Disease

NCT03912025 | Completed

• 1 other identifier: P00030619
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

A cross sectional study utilizing congenital heart disease patients presenting for clinically indicated cardiopulmonary exercise test. Baseline questionnaires (see below) will be administered prior to the exercise test. Exercise test data and clinical data will be recorded. Questionnaire data will be compared to clinical data in and between disease severity groups. Disease severity will be determined based on hemodynamic (not anatomic) classification according to an algorithm adapted from the European Society of Cardiology.

Conditions

Congenital Heart Disease

Outcome Measures

Primary Outcomes (3)

• Patient Reported Outcomes Measurement Information System (PROMIS) Pediatric Meaning and Purpose Score

  A series of 8 questions that ask about future hopes, created and validated by a branch of the National Institutes of Health (www.healthmeasures.net). The final score is represented by the T-score, a standardized score with a mean of 50 and a standard deviation (SD) of 10. A higher PROMIS T-score represents more of the concept being measured. For positively-worded concepts like Meaning and Purpose, a T-score of 60 is one SD better than average. By comparison, a Meaning and Purpose T-score of 40 is one SD worse than average.

  up to 60 minutes

• Patient Reported Outcomes Measurement Information System Pediatric Anxiety Score

  A series of 8 questions to assess the degree of anxiety felt in the past week, created and validated by a branch of the National Institutes of Health (www.healthmeasures.net). The final score is represented by the T-score, a standardized score with a mean of 50 and a standard deviation (SD) of 10. For negatively-worded concepts like anxiety, a T-score of 60 is one SD worse than average. By comparison, an anxiety T-score of 40 is one SD better than average.

  up to 60 minutes

• Ratio of Meaning and Purpose Score to Anxiety Score

  Since positive mindset is represented by a high score on the Meaning and Purpose scale, and a low score on the Anxiety scale, patients with high ratios (greater than 1) will have the most positive mindsets, while those with low ratios (less than 1) will have the least positive mindsets.

  up to 60 minutes

Secondary Outcomes (4)

• Patient Reported Outcomes Measurement Information System Physical Activity Questionnaire

  up to 60 minutes

• Patient Reported Outcomes Measurement Information System Pediatric Life Satisfaction Score

  up to 60 minutes

• Patient Reported Outcomes Measurement Information System Pediatric Positive Affect/Well Being Score

  up to 60 minutes

• Pediatric Cardiac Quality of Life Inventory Questionnaire (PCQLI)

  up to 60 minutes

Study Arms (2)

Mild hemodynamic CHD

"Mild" severity category will be defined in terms of hemodynamic parameters rather than anatomic diagnoses, as outlined in the European Society of Cardiology Section on Sports Cardiology consensus guidelines (Budts W, Borjesson M, Chessa M, van Buuren F, Trindade PT, Corrado D, Heidbuchel H, Web G, Holm J, Papadakis M. 2013). They define functional parameters such as systolic function, oxygen saturation, rhythm disorders, elevated pressure or volume load, etc. to divide patients into 3 hemodynamic groups. Based on their model, we define "mild CHD" as ones falling into the group that can train at "High Intensity" exercise levels.

Other: Relationship between positive mindset and exercise capacity

Moderate hemodynamic CHD

"Moderate" severity category will be defined in terms of hemodynamic parameters rather than anatomic diagnoses. Based on their model, we define "moderate CHD" as those that can train at "Moderate Intensity."

Other: Relationship between positive mindset and exercise capacity

Interventions

Relationship between positive mindset and exercise capacity OTHER

No intervention. Cross-sectional study looking at the relationships between questionnaire scores and outcomes

Mild hemodynamic CHD; Moderate hemodynamic CHD

Eligibility Criteria

• Age: 8 Years - 17 Years
• Sex: all
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Congenital Heart disease Patients

You may qualify if:

• Patients age 8-17 with congenital heart disease
• Classified as mild or moderate hemodynamic severity
• Presenting to outpatient department for clinically indicated cardiopulmonary exercise test

You may not qualify if:

• Patients on beta blockers or negative inotropes
• Patients with pacemakers/ICDs
• Patients with active arrhythmias
• Patients with significant musculoskeletal or pulmonary disease
• Patients unable to complete a maximal exercise test or for whom an exercise test is contraindicated
• Patients who are not fluent in English
• Patients unable to complete the questionnaire
• Patients who have severely hemodynamic debilitation or at risk (severe systolic dysfunction, severe ventricular hypertrophy, severe pressure load, severe volume load, severe pulmonary hypertension, malignant arrhythmia, significant central cyanosis)

Sponsors & Collaborators

• Boston Children's Hospital: lead

Study Sites (1)

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Heart Defects, Congenital

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Naomi Gauthier, MD

  Boston Children's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pediatric Cardiologist

Study Record Dates

• First Submitted: April 10, 2019
• First Posted: April 11, 2019
• Study Start: January 30, 2020
• Primary Completion: April 12, 2021
• Study Completion: April 25, 2021
• Last Updated: August 4, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)