Dance4Healing: Explore the Benefits of Tele-Dance in Individuals With an Implantable Cardioverter-defibrillator (ICD)

Anxiety Clinical Trial

Official title:

Dance4Healing: A Pilot Study to Explore the Benefits of Tele-Dance in Individuals With an Implantable Cardioverter Defibrillator

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04678128
• Other study ID #: IRB # 58348
• Status: Withdrawn
• Phase: N/A
• Start date: January 1, 2020
• Est. completion date: December 31, 2020

Study information

• Verified date: May 2021
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is to determine if it is feasible to using a Telehealth Dance Platform with patients that have an implantable Cardioverter Defibrillator, and will compare the activity engagement, anxiety, and Quality of Life

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Patients that have had an ICD implanted for at least 1 month

2. Patients have access to web-based on-line programs

3. Patient can provide cardiac clearance for exercise from their treating physician OR they have written stress test results from within the last 6 months indicating no ischemia.

4. Patient is 18 years old or greater.

Exclusion Criteria:

1. Patient is non-English speaking.

2. Patient is assessed as having NYHA Class IV heart failure.

3. Patient had ventricular tachycardia (VT), ventricular fibrillation (VF) or has received "tachy" therapy from their ICD within last 4 weeks.

4. Patient has had a change in medical arrhythmia management or ablation procedure within the last 4 weeks.

5. Any medical issues that compromise walking or dancing, including cardiac, neurological or orthopedic .

Related Conditions & MeSH terms

• Anxiety
• ICD
• Patient Engagement

Intervention

Behavioral:
• Dance4Healing Telehealth Live Zoom Sessions
Week 1: 2-hour introduction session on Zoom platform with a live dance instructor at the participant's desired level of activity intensity (low, mild, or moderate). Weeks 2-8: All participants will be asked to participate in a 1 hour online, instructor-led live class.
• Dance Buddy
Following randomization (beginning of intervention period) half of the participants will be assigned a dance "buddy," and will be asked to dance with their buddies using the Dance4Healing TLVP at least 2 additional times/week. This group will have 24/7 access to Dance4Healing Platform during the intervention and post-intervention periods.

Locations

Country	Name	City	State
United States	Stanford Arrhythmia Clinic	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
Sanjiv Narayan, MD, PhD

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Activity in hours/day from ICD interrogation as a measure of activity engagement over time		36 weeks
Primary	Change in calculated score from Patient Activation as a measure of Patient Activity Engagement over time	Scores range from 0-100, higher scores represent higher engagement self reported survey	Baseline, Week 8(pre-intervention), Week 16 (post-intervention), Week 28 (long term)
Primary	Total Amount of Time spent accessing the dance platform in minutes as a measure of Activity Engagement during the study intervention	Total number of minutes that the participant accesses the Dance4Healing platform each week	Total time in minutes over the 8 week intervention period
Secondary	Change in Anxiety Score over time	Anxiety will be a calculated score from a 10 question self-reported questionnaire (Florida Shock Anxiety Scale) with a scoring range from 0-50, with higher scores indicating more anxiety.	Baseline, Week 8(pre-intervention), Week 16 (post-intervention), Week 28 (long term)