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

Not Applicable

Withdrawn

• Conditions: ICD; Anxiety; Patient Engagement
• Interventions: Behavioral: Dance4Healing Telehealth Live Zoom Sessions; Behavioral: Dance Buddy

• Registration Number: NCT04678128
• Lead Sponsor: Sanjiv Narayan, MD, PhD

Brief 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

Detailed Description

Not available

Study Timeline

• Study Start: 2020-01-01
• Study First Submitted: 2020-12-09
• Study First Submitted QC: 2020-12-16
• Study First Posted: 2020-12-21
• Primary Completion: 2020-12-31
• Study Completion: 2020-12-31
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-27
• Last Update Posted: 2024-12-02

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 .

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dance4Healing Buddy Group	Dance Buddy	Participants will monitor their heart rate for 8 weeks (pre-intervention period), then engage in weekly live zoom dance sessions on digital Dance4Healing platform for 8 consecutive weeks (intervention period), then may elect to continue with monitoring for an additional 12 weeks (3-month post-intervention period for long-term results). During the intervention period, this group will have a dance buddy.
Dance4Healing Buddy Group	Dance4Healing Telehealth Live Zoom Sessions	Participants will monitor their heart rate for 8 weeks (pre-intervention period), then engage in weekly live zoom dance sessions on digital Dance4Healing platform for 8 consecutive weeks (intervention period), then may elect to continue with monitoring for an additional 12 weeks (3-month post-intervention period for long-term results). During the intervention period, this group will have a dance buddy.
Dance4Healing control group	Dance4Healing Telehealth Live Zoom Sessions	Participants will monitor their heart rate for 8 weeks (pre-intervention period), then engage in weekly live zoom dance sessions on digital Dance4Healing platform for 8 consecutive weeks (intervention period), then may elect to continue with monitoring for an additional 12 weeks (3-month post-intervention period for long-term results). During the intervention period, this group will not have a dance buddy.

Primary Outcome Measures

Name	Time	Method
Change in calculated score from Patient Activation as a measure of Patient Activity Engagement over time	Baseline, Week 8(pre-intervention), Week 16 (post-intervention), Week 28 (long term)	Scores range from 0-100, higher scores represent higher engagement self reported survey
Activity in hours/day from ICD interrogation as a measure of activity engagement over time	36 weeks
Total Amount of Time spent accessing the dance platform in minutes as a measure of Activity Engagement during the study intervention	Total time in minutes over the 8 week intervention period	Total number of minutes that the participant accesses the Dance4Healing platform each week

Secondary Outcome Measures

Name	Time	Method
Change in Anxiety Score over time	Baseline, Week 8(pre-intervention), Week 16 (post-intervention), Week 28 (long term)	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.

Trial Locations

Locations (1)

Stanford Arrhythmia Clinic; 🇺🇸 Stanford, California, United States