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

Sponsor
Sanjiv Narayan, MD, PhD (Other)
Overall Status
Withdrawn
CT.gov ID
NCT04678128
Collaborator
(none)
0
1
2
12
0

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Dance4Healing Telehealth Live Zoom Sessions
  • Behavioral: Dance Buddy
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
0 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
Dance4Healing: A Pilot Study to Explore the Benefits of Tele-Dance in Individuals With an Implantable Cardioverter Defibrillator
Anticipated Study Start Date :
Jan 1, 2020
Actual Primary Completion Date :
Dec 31, 2020
Actual Study Completion Date :
Dec 31, 2020

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Dance4Healing control group

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.

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.

Experimental: Dance4Healing Buddy Group

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.

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.

Behavioral: 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.

Outcome Measures

Primary Outcome Measures

  1. Activity in hours/day from ICD interrogation as a measure of activity engagement over time [36 weeks]

  2. 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

  3. 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

  1. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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 .

Contacts and Locations

Locations

Site City State Country Postal Code
1 Stanford Arrhythmia Clinic Stanford California United States 94303

Sponsors and Collaborators

  • Sanjiv Narayan, MD, PhD

Investigators

  • Principal Investigator: Linda K Ottoboni, PhD, Stanford Healthcare

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Sanjiv Narayan, MD, PhD, Professor of Medicine, Stanford University
ClinicalTrials.gov Identifier:
NCT04678128
Other Study ID Numbers:
  • IRB # 58348
First Posted:
Dec 21, 2020
Last Update Posted:
May 6, 2021
Last Verified:
May 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Sanjiv Narayan, MD, PhD, Professor of Medicine, Stanford University

Study Results

No Results Posted as of May 6, 2021