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临床试验/NCT06819059
NCT06819059已完成不适用

Safety and Efficacy of Pediatric Cardiac Telerehabilitation in Adolescents with Heart Disease

Columbia University1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2023年5月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
50
试验地点
1
主要终点
Number of Sessions Completed

研究概览

简要总结

Cardiac telerehabilitation is a much-needed pediatric therapy; however, a lack of randomized controlled trials has limited the development of and reimbursement for this valuable service. Through this prospective, randomized controlled trial, the investigators aim to demonstrate the safety and efficacy of PCTR in a clinically diverse population of children and adolescents with heart disease.

详细描述

This is a single center, prospective, randomized, controlled pilot of a pediatric cardiac telerehabilitation program in adolescents with acquired or congenital heart disease.

Because of the known benefits of exercise, controls were offered the opportunity to participate in the intervention group after completing the 12 weeks in the control group.

Participants were randomized in a 2:1 ratio (intervention: control) to maximize participation in the exercise intervention. Participants were from three core populations: primary or secondary pulmonary hypertension (PH), structural congenital heart disease (CHD), and post-orthotopic heart transplant (OHT). PCTR was "semi-supervised", where one day per week the participant exercised one-on-one with a physical therapist or exercise physiologist via virtual platform and 2 days per week they exercised independently. Participants wore an activity tracker with heart rate monitoring 24 hours a day and a single lead, chest-based electrocardiogram (ECG) device while exercising. A physician or program director reviewed ECGs after all sessions. An adult had to be available in case of an emergency during each session. Controls received weekly check-ins and a Fitbit but did not receive a formal exercise prescription. All participants underwent baseline and post-study assessments including the cardiopulmonary stress test (CPET) and questionnaires and wore their Fitbits for the duration of the study.

Compliance was measured by attendance of Zoom appointments, Fitbit activity data, Wellue single lead electrocardiogram (ECG) data, and self-reported activity performed. Efficacy was measured by CPET results, validated questionnaire data and activity levels as determined by Fitbit data.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
10 Years 至 25 Years(Child, Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Age 10 -25 yrs
  • •Not participating in organized sports of physical fitness programs
  • •Able to follow basic directions and express symptoms
  • •Dx of pulmonary hypertension, congenital heart disease, and transplant programs
  • •Clinically stable as deemed by the referring cardiologist

排除标准

  • •Clinical instability as demonstrated by recent medication escalation (within 3 months prior to starting the program)
  • •Hemodynamic instability
  • •Significant arrhythmia or ST segment or T wave abnormalities
  • •End-tidal carbon dioxide less than 20 mmHg with exercise, or exercise-induced symptoms that would limit ability to participate in the intervention safely

研究组 & 干预措施

Arm 1 is the treatment arm that receives 12 weeks of weekly cardiac telerehabilitation sessions

Experimental

The participants randomized to study Arm 1 were enrolled in the 12 weeks of cardiac telerehabilitation which included weekly one-on-one sessions with the exercise physiologist or physical therapist. Participants in this arm also received fitness activity trackers to record heart rate, active minutes, steps and sleep data.

干预措施: Pediatric Cardiac Telerehabilitation (Behavioral)

Arm 1 is the treatment arm that receives 12 weeks of weekly cardiac telerehabilitation sessions

Experimental

The participants randomized to study Arm 1 were enrolled in the 12 weeks of cardiac telerehabilitation which included weekly one-on-one sessions with the exercise physiologist or physical therapist. Participants in this arm also received fitness activity trackers to record heart rate, active minutes, steps and sleep data.

干预措施: Fitness Tracker Only (Behavioral)

Arm 2 was the study arm for participants randomized to the control group

Active Comparator

Participants randomized to Arm 2 received fitness activity trackers that provided the patient with heart rate data, steps and sleep data but received no formal exercise training.

干预措施: Fitness Tracker Only (Behavioral)

结局指标

主要结局

Number of Sessions Completed

时间窗: 12 weeks

The primary outcome of this study was compliance measured by drop out rate of the cardiac rehabilitation group and any adverse events that occurred with exercise.

次要结局

  • Change in exercise time(12 weeks)
  • Change in Anxiety associated with exercise (ESQ -18)(12 weeks)
  • Change in Disease Burden by lower Quality of Life Measure(12 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Aimee Layton

Associate Professor of Applied Physiology in Pediatrics

Columbia University

研究点 (1)

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