ICDNCT04678128
Dance4Healing: Explore the Benefits of Tele-Dance in Individuals with an Implantable Cardioverter-defibrillator (ICD)
A study testing Dance4Healing Telehealth Live Zoom Sessions and Dance Buddy in people with ICD and Anxiety, run by Sanjiv Narayan, MD, PhD at 1 site in United States.
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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ICD, Anxiety, Patient Engagement
- What is being tested?
- Dance4Healing Telehealth Live Zoom Sessions and Dance Buddy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2020to 31 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients that have had an ICD implanted for at least 1 month
- Patients have access to web-based on-line programs
- 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.
- Patient is 18 years old or greater.
Who cannot join
- Patient is non-English speaking.
- Patient is assessed as having NYHA Class IV heart failure.
- Patient had ventricular tachycardia (VT), ventricular fibrillation (VF) or has received "tachy" therapy from their ICD within last 4 weeks.
- Patient has had a change in medical arrhythmia management or ablation procedure within the last 4 weeks.
- Any medical issues that compromise walking or dancing, including cardiac, neurological or orthopedic .
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford Arrhythmia Clinic
Stanford, California, 94303
About this study
Official title: Dance4Healing: a Pilot Study to Explore the Benefits of Tele-Dance in Individuals with an Implantable Cardioverter Defibrillator
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
- Conditions
- ICD, Anxiety, Patient Engagement
- Being tested
- Dance4Healing Telehealth Live Zoom Sessions, Dance Buddy
- Keywords
- ICD, Anxiety, QOL, Engagement
- Medical subject headings
- Anxiety Disorders, Patient Participation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dance4Healing Telehealth Live Zoom SessionsBehavioural
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 BuddyBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Dance4Healing control group | Active comparator | 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. Receives: Behavioral: Dance4Healing Telehealth Live Zoom Sessions |
| Dance4Healing Buddy Group | Experimental | 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. Receives: Behavioral: Dance4Healing Telehealth Live Zoom Sessions; Behavioral: Dance Buddy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Activity in hours/day from ICD interrogation as a measure of activity engagement over time
Measured: 36 weeks
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
Measured: Baseline, Week 8(pre-intervention), Week 16 (post-intervention), Week 28 (long term)
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
Measured: Total time in minutes over the 8 week intervention period
Secondary outcomes (1)
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.
Measured: Baseline, Week 8(pre-intervention), Week 16 (post-intervention), Week 28 (long term)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2020
- Study start1 Jan 2020
- Primary completion31 Dec 2020
- Study completion31 Dec 2020
Why it stopped: Unable to establish contract with Dance For Healing platform, so had to withdraw study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ICDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanjiv Narayan, MD, PhD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Sanjiv Narayan, MD, PhD, Stanford University
- Investigators
- Linda K Ottoboni, PhD, Principal investigator, Stanford Healthcare
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04678128
- Sponsor's protocol ID
- IRB # 58348
- Status last verified
- Nov 2024
- First submitted
- 9 Dec 2020
- Last updated
- 2 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dance4Healing: a Pilot Study to Explore the Benefits of Tele-Dance in Individuals with an Implantable Cardioverter Defibrillator
- ClinicalTrials.gov ID
- NCT04678128
- Acronym / sponsor ID
- IRB # 58348
- Conditions
- ICD, Anxiety, Patient Engagement
- Keywords
- ICD, Anxiety, QOL, Engagement
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Unable to establish contract with Dance For Healing platform, so had to withdraw study
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Sanjiv Narayan, MD, PhDUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 21 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dance4Healing control group | Active comparator | Behavioral: Dance4Healing Telehealth Live Zoom SessionsParticipants 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. |
| Dance4Healing Buddy Group | Experimental | Behavioral: Dance4Healing Telehealth Live Zoom Sessions, Behavioral: Dance BuddyParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients that have had an ICD implanted for at least 1 month
- Patients have access to web-based on-line programs
- 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.
- Patient is 18 years old or greater.
Key exclusion criteria (5 listed)
- Patient is non-English speaking.
- Patient is assessed as having NYHA Class IV heart failure.
- Patient had ventricular tachycardia (VT), ventricular fibrillation (VF) or has received "tachy" therapy from their ICD within last 4 weeks.
- Patient has had a change in medical arrhythmia management or ablation procedure within the last 4 weeks.
- Any medical issues that compromise walking or dancing, including cardiac, neurological or orthopedic .
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dance4Healing Telehealth Live Zoom SessionsWeek 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. | Behavioural | Dance4Healing Buddy Group, Dance4Healing control group |
| Dance BuddyFollowing 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. | Behavioural | Dance4Healing Buddy Group |
Primary outcome
Activity in hours/day from ICD interrogation as a measure of activity engagement over time
Time frame: 36 weeks
Change in calculated score from Patient Activation as a measure of Patient Activity Engagement over time
Time frame: 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
Total Amount of Time spent accessing the dance platform in minutes as a measure of Activity Engagement during the study intervention
Time frame: Total time in minutes over the 8 week intervention period
Total number of minutes that the participant accesses the Dance4Healing platform each week
1 secondary outcome
Change in Anxiety Score over time
Time frame: Baseline, Week 8(pre-intervention), Week 16 (post-intervention), Week 28 (long term)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Linda K Ottoboni, PhD principal investigator
Stanford Healthcare
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dance4Healing Telehealth Live Zoom Sessions and Dance Buddy in people with ICD and Anxiety, run by Sanjiv Narayan, MD, PhD at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 2 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Activity in hours/day from ICD interrogation as a measure of activity engagement over time (time frame: 36 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2024.