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

NCT ID: NCT03912025

Last Updated: 2021-08-04

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 90 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-01-30
• Study Completion Date: 2021-04-25

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.

Detailed Description

Patients with congenital heart disease (CHD) have variable degrees of exercise capacity and levels of physical activity that is not necessarily related to disease severity (1,2) and is not fixed as supervised exercise training can achieve improved fitness across a spectrum of hemodynamic deficits (3-5). Effectiveness of training relates to frequency, intensity, time, and type of exercise as well as motivation to participate. Research in the psychology literature in athletes and in non-athletes alike has demonstrated that optimism and positive mentality result in improved exercise capacity, enhanced training results, and resilience to stress (6-11). Further, the general concept of resilience in children may be the sum result of the balance of positive and negative inputs (12), and these factors are also modifiable. The degree with which having a positive mindset impacts functional capacity irrespective of congenital heart disease severity is not known; if there is a correlation, then the idea that mindset could potentially be a target for an intervention to improve health in children with CHD is intriguing.

This study seeks to assess the correlation of positive thinking to physiological outcomes by comparing the degree of positive mindset of patients with congenital heart disease (as measured by questionnaire data to assess the balance of optimistic thinking to anxiety) with their functional capacity (as measured by peak oxygen consumption (peakVO2) on exercise testing). The ability to measure "mindset" in the clinic setting is now feasible after the recent release of a set of validated questionnaires for children (and parent-proxies) known as PROMIS (Patient-Reported Outcomes Measurement Information System), developed under the auspices of the National Institutes of Health (www.healthmeasures.net/explore-measurement-systems/promis). These questionnaires are short (4-8 questions), free, and integrate into the Research Electronic Data Capture (REDCap) database, making delivery Health Insurance Portability and Accountability Act (HIPAA) compliant and scoring automatic. In addition, the PROMIS measures contain both retrospective positive quality of life questions (life satisfaction, positive well-being) as well as a future facing tool measuring degree of optimism and purpose, making it ideally suited for the present research proposal. While PROMIS tools have been utilized in childhood chronic illnesses such as arthritis and kidney disease, they have not yet been reported in children with congenital heart disease. Thus, a secondary goal of this proposal is to assess the distribution of meaning and purpose scores and anxiety scores of children with CHD compared to the population norms.

Conditions

Congenital Heart Disease

Study Design

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

Study Groups

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.

Relationship between positive mindset and exercise capacity

Intervention Type: OTHER

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

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."

Relationship between positive mindset and exercise capacity

Intervention Type: OTHER

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

Interventions

Relationship between positive mindset and exercise capacity

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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)

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boston Children's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Naomi Gauthier

Pediatric Cardiologist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Naomi Gauthier, MD

Role: PRINCIPAL_INVESTIGATOR

Boston Children's Hospital

Locations

Boston Children's Hospital

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

P00030619

Identifier Type: -

Identifier Source: org_study_id