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

NCT ID: NCT04678128

Last Updated: 2024-12-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-01

Study Completion Date

2020-12-31

Brief Summary

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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

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Conditions

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ICD Anxiety Patient Engagement

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Dance4Healing Telehealth Live Zoom Sessions

Intervention Type BEHAVIORAL

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.

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.

Group Type EXPERIMENTAL

Dance4Healing Telehealth Live Zoom Sessions

Intervention Type BEHAVIORAL

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

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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 .
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sanjiv Narayan, MD, PhD

OTHER

Sponsor Role lead

Responsible Party

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Sanjiv Narayan, MD, PhD

Professor of Medicine

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Linda K Ottoboni, PhD

Role: PRINCIPAL_INVESTIGATOR

Stanford Healthcare

Locations

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Stanford Arrhythmia Clinic

Stanford, California, United States

Site Status

Countries

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United States

Other Identifiers

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IRB # 58348

Identifier Type: -

Identifier Source: org_study_id