Dilated Cardiomyopathy
Conditions
Brief summary
Study evaluates the relationships between daily physical activity levels (PAL) and functional capacity (VO2peak) in patients with dilated cardiomyopathy (DCM)
Detailed description
The study will evaluate the daily physical activity with the use of activity monitor, heart rate monitor and event monitor in patients with dilated cardiomyopathy (DCM). These wearables track the heart rate, heart rhythm, tracks activity and step count. The VO2 peak will be measured via the exercise test.
Interventions
DEVICECardea SOLO
Participants will be asked to wear everyday for 7 days after the Baseline visit. the monitor attaches to the skin with adhesive and records heart rate and heart rhythm.
DEVICEActiGraph wGT3X-BT
Participants will be asked to wear everyday for 2 weeks after the Baseline visit. The wearable tracks activity and the step count during the day.
DEVICEWavelet Wristband
Participants will be asked to wear everyday for 2 weeks after the Baseline visit. The wearable measures the activity and the heart rate as measured by PPG sensor.
Sponsors
Stanford University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Intervention model description
All participants enrolled in the study will receive the wearables and will be evaluated for the relationship between daily physical activity levels and functional capacity (VO2 peak).
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Males and females, 18-75 years of age 2. Diagnosis of dilated cardiomyopathy * (Unexplained left ventricular enlargement (left ventricular end diastolic dimension (LVEDD) \>95th percentile for gender and height by echo or MRI) * (Left ventricular ejection fraction (LVEF) less than 50%) 3. CPET within 14 days prior to baseline visit with no intervening change in therapy 4. Echocardiogram or cardiac MRI within 1 year prior to baseline 5. Able to walk \>100ft without limitation 6. More than 30 minutes of exercise per week for at least 3 months prior to study enrollment, and plan to continue exercising for the next two weeks (duration of study). 7. Ability to provide informed consent and willingness to complete the study (including weekly phone follow-up)
Exclusion criteria
1. Heart failure hospitalization within four weeks prior to enrollment 2. Non-cardiac limitation of activity 4\. Prior exercise-induced syncope or exercise-induced sudden death 5. Primary exercise mode is swimming or stationary biking 6. Participation in competitive or high intensity exercise against medical advice 7. Implantable Cardiverter Defibrillator (ICD) placement in the 2 months prior to enrollment 8. Plan for surgery, device implantation, or significant change in clinical management during the two weeks of the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| VO2max correlation with daily physical activity | 2 weeks | Maximal exercise capacity as measured by Max VO2 via CPET correlation with wearable device measures of daily physical activity |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| NYHA correlation with daily step count | 2 weeks | Correlation between NYHA score and daily step count or maximal walking speed |
| KCCQ correlation with daily step count | 2 weeks | Correlation between KCCQ score and daily step count or maximal walking speed |
Outcome results
None listed