Clinical trial NCT03912025: The Relationship Between Having a Positive Mindset and Exercise Capacity in Patients With Congenital Heart Disease
Official title: The Relationship Between Having a Positive Mindset and Exercise Capacity in Patients With Congenital Heart Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Congenital Heart Disease
Lead sponsor: Boston Children's Hospital
Sponsor class: OTHER
First posted: 2019-04-11
Enrollment: 90
Sex: ALL
Minimum age (years): 8
Maximum age (years): 17
Standard ages: CHILD
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Congenital Heart disease Patients

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.

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)

Primary outcomes:
measure: Patient Reported Outcomes Measurement Information System (PROMIS) Pediatric Meaning and Purpose Score
timeFrame: up to 60 minutes
measure: Patient Reported Outcomes Measurement Information System Pediatric Anxiety Score
timeFrame: up to 60 minutes
measure: Ratio of Meaning and Purpose Score to Anxiety Score
timeFrame: up to 60 minutes
Secondary outcomes:
measure: Patient Reported Outcomes Measurement Information System Physical Activity Questionnaire
timeFrame: up to 60 minutes
measure: Patient Reported Outcomes Measurement Information System Pediatric Life Satisfaction Score
timeFrame: up to 60 minutes
measure: Patient Reported Outcomes Measurement Information System Pediatric Positive Affect/Well Being Score
timeFrame: up to 60 minutes
measure: Pediatric Cardiac Quality of Life Inventory Questionnaire (PCQLI)
timeFrame: up to 60 minutes
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston Children's Hospital
state: Massachusetts
Study officials:
affiliation: Boston Children's Hospital
name: Naomi Gauthier, MD
role: PRINCIPAL_INVESTIGATOR
References: