Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04135859
Other study ID # IRB1600717
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 14, 2019
Est. completion date February 9, 2022

Study information

Verified date February 2023
Source Nationwide Children's Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study will adapt a physical activity lifestyle intervention to emerging adult congenital heart disease (CHD) survivors with the primary goal of increasing physical activity levels. The study will be split into 2 phases. In Phase 1, participants will be asked to complete questionnaires, wear an accelerometer around the waist for 7 days, and undergo an exercise stress test. The accelerometer and exercise stress test will be used to determine whether participants are eligible to be randomized for the intervention study. In Phase 2, participants will be randomized to one of two conditions: 1) receiving a physical activity tracker (a Fitbit) or 2) receiving a Fitbit AND engaging in videoconferencing sessions with a physical activity coach. During Phase 2, participants will also be asked to complete 3 assessments (weeks 9 and 22, and a 6-month follow-up). The week 9 assessment will consist of completing questionnaires and wearing an accelerometer for 7 days. Week 22 will be similar to week 9 with the addition of a final exercise stress test. The 6-month follow-up will mirror the week 9 assessment. Participants who are randomized to the videoconferencing condition will be asked to meet with a physical activity coach 8 times over the course of 20 weeks. Coaches will help participants to (1) change attitudes toward physical activity, (2) increase perception of others' approval of physical activity (e.g., family members, peers), and (3) increase participants' perceived control by troubleshooting barriers and increasing efficacy for physical activity. Coaches will use the Fitbit to facilitate self-monitoring and goal setting. Participants in the intervention arm will be asked to participate in a focus group at the conclusion of the study to share their experiences.


Recruitment information / eligibility

Status Completed
Enrollment 36
Est. completion date February 9, 2022
Est. primary completion date February 9, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 25 Years
Eligibility Inclusion Criteria: 1. Between the ages of 18-25 (if 18, must no longer be in high school and no longer living at home) 2. Are diagnosed with moderate or complex structural congenital heart disease 3. Live within 120 miles of Nationwide Children's Hospital Exclusion Criteria: 1. Do no speak or write proficiently in English 2. Have cognitive impairments that would interfere with the completion of study procedures 3. Are diagnosed with a genetic syndrome (e.g., Downs, Marfans) 4. Have been engaged in a formal exercise program within the past 6 months 5. Underwent open-heart surgery or have had a transcatheter valve replacement in the last 3 months 6. Are otherwise prohibited by their cardiologist to engage in at least moderate levels of physical activity 7. Are unable to complete a treadmill-based exercise stress test 8. Are currently pregnant 9. Have contraindications for exercise based on an exercise stress test (e.g., exercise-induced arrhythmias or evidence of cardiac ischemia) 10. >150 min/weekday of moderate-to-vigorous physical activity per the accelerometer 11. Do not have access or a device for videoconferencing with the coach

Study Design


Intervention

Behavioral:
Physical Activity Lifestyle Intervention
Coaches work with participants on three elements of behaviors change: (1) changing attitudes towards physical activity; (2) increase perceptions of other people's approval of physical activity for the participants; (3) increase perceptions of control over being physically active. These elements will be delivered using a non-judgmental stance accompanied by promoting appropriate goal-setting.
Physical Activity Monitoring
A physical activity monitor (Fitbit) will be provided to both groups.

Locations

Country Name City State
United States Nationwide Children's Hospital Columbus Ohio

Sponsors (1)

Lead Sponsor Collaborator
Jamie Jackson

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Moderate to Vigorous Physical Activity (MVPA) Baseline to follow-up change in number of minutes spent in moderate to vigorous physical activity as measured by an accelerometer From baseline to follow-up (approximately 22 weeks).
Secondary Sedentary Behavior Baseline to follow-up change in number of minutes spent being sedentary as measured by an accelerometer. From baseline to follow-up (approximately 22 weeks).
Secondary Exercise Tolerance Baseline to follow-up change in maximal oxygen utilization during physical activity as measured by VO2peak during an exercise stress test. From baseline to follow-up (approximately 22 weeks).
See also
  Status Clinical Trial Phase
Active, not recruiting NCT05661799 - Persistence of Physical Activity in People With Type 2 Diabetes Over Time. N/A
Active, not recruiting NCT03903874 - Testing Scalable, IVR-supported Cancer Prevention Interventions in the Rural Alabama Black Belt N/A
Recruiting NCT03662438 - HOPE (Home-based Oxygen [Portable] and Exercise) for Patients on Long Term Oxygen Therapy (LTOT) N/A
Withdrawn NCT04540523 - Home-Based Exergaming Intervention N/A
Recruiting NCT03250000 - Changes in Microcirculation and Functional Status During Exacerbation of COPD N/A
Recruiting NCT05563805 - Exploring Virtual Reality Adventure Training Exergaming N/A
Completed NCT03430648 - Is Tau Protein Linked to Mobility Function?
Completed NCT05019482 - Intervention Program Among University Student to Promote Physical Activity and Reduce the Sedentary Time N/A
Completed NCT03253406 - Health Wearables and College Student Health N/A
Not yet recruiting NCT05985460 - A Very Brief Intervention to Increase the Intention to Practice Physical Activity N/A
Completed NCT03700736 - The Healthy Moms Study: Comparison of a Post-Partum Weight Loss Intervention Delivered Via Facebook or In-Person Groups N/A
Completed NCT03380143 - Whole-of-Community Youth Population Physical Activity N/A
Completed NCT03170921 - Psychophysiological Characterization of Different Capoeira Performances in Experienced Individuals N/A
Completed NCT04973813 - Active Choice Intervention About Physical Activity for Physically Inactive Adults N/A
Completed NCT03982095 - Survey on Lifestyle, Perceived Barriers and Development of Change in Patients With Prostate Cancer
Completed NCT03271112 - Frailty Prevention in Elders From Reunion Island N/A
Completed NCT05670223 - Healthy Activities Improve Lives N/A
Completed NCT04894929 - Comprehensive Geriatric Assessment in the Monitoring of Functional Improvement N/A
Recruiting NCT04578067 - Empowering Immigrant Women for Active and Healthy Lifestyle N/A
Completed NCT03297567 - Physical Therapy Guidelines For Hospitalized Elderly N/A