Effectiveness of Exercise After an ICD
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Washington
About this trial
This study will test an exercise intervention (E-ICD) following an implantable cardioverter defibrillator.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
ICD implantation for primary or secondary prevention of sudden cardiac arrest, -ability to read, speak and write English,-
access to a reliable phone for 6 months after study entry,
able to ambulate without assist devices for at least 5-10 minutes/day
greater than 18 years of age.
Disqualifiers
current diagnosis of serious mental disorder,
regular non-medical use of illicit drugs (opiates, cocaine, amphetamines, etc.), -unstable angina, myocardial infarction, ICD shock or heart surgery within previous 3 months
pregnancy
concurrent participation in an exercise program > 5 days/week.
Trial design
Design model
Parallel
Treatments tested in this trial
E-ICD Intervention
BehavioralHome walking 3 days/week x 12 weeks
Treatment groups
210 Participants
are divided into 2 treatment groupsGroup A: E-ICD InterventionExperimental treatment 1 intervention
Group B: Usual CareNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Daily activity
average steps/day measured on Step Watch activity monitor
Time frame
Baseline, 3, 6, and 12 monthsSecondary outcomes
1
General Health
PROMIS Global v1.2 measures 5 domains of global health and quality of life, including physical, mental, and social health. Two factors physical health (GPH) and mental health (GMH) are derived.
Time frame
Baseline, 3, 6, and 12 months2
Mobility
PROMIS Mobility V2.1 measures general mobility of lower extremities in adults, relating to overall physical functioning
Time frame
Baseline, 3, 6, and 12 months3
Self-Efficacy for Walking
Self-Efficacy for Exercise Scale (9-items, α=0.92) assesses self-efficacy expectations related to one's ability to walk in the face of barriers to exercise \[22\], was used in the pilot and found to be sensitive to change with the intervention.
Time frame
Baseline, 3, 6, and 12 months4
ICD shock anxiety
Florida Shock Anxiety Scale (FSAS), assesses anxiety about receiving an ICD shock \[23\], is sensitive to change across time.
Time frame
Baseline, 3, 6, and 12 monthsOther outcomes
1
Long Term Maintenance
Measure of innovation-specific implementation intentions (MISII) scale (3 items) completed by CR staffs and site staff, measures the providers' intentions to use the E-ICD program in routine care.
Time frame
12 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov