Clinical trial NCT02331524: Interventions to Improve Daily Activity in Heart Failure
Official title: Exercise and Psychosocial-Based Interventions to Improve Daily Activity in Heart Failure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure
Keywords: exercise
daily activity
Lead sponsor: Grand Valley State University
Sponsor class: OTHER
Collaborators: name: Spectrum Health Hospitals
First posted: 2015-01-06
Enrollment: 16
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: There are few studies that demonstrate how to best improve daily activity in people with heart failure (HF). Exercise alone has been shown to be ineffective, but other techniques such as daily activity feedback with encouragement or health coaching may be helpful. This research study will investigate two different treatment approaches for improving daily activity: 1) daily activity feedback and encouragement, and 2) health coaching with an individualized home exercise program. Both treatment approaches are hypothesized to result in improved daily activity compared to a control group.

Detailed description: Few studies have been able to demonstrate intervention efficacy for improving daily activity in heart failure (HF). Exercise alone is ineffective, though psychosocial-based interventions including health coaching and daily activity feedback appear to be promising. Therefore, the primary purpose of the present proposed study is to investigate the effect of two different intervention approaches (1. daily activity feedback with associated encouragement, and 2. health coaching with an associated individualized home exercise program) on daily activity, exercise tolerance, HF-related health status, and lower extremity functional strength. A secondary purpose is to compare daily activity as recorded by Medtronic® implanted cardioverter defibrillator (ICDs) and cardiac resynchronization therapy (CRT) devices to daily activity recorded by a well-established triaxial accelerometer.

This will be a single-blinded randomized trial, with subject randomization stratified by age and baseline activity level. Subjects will be randomized to one of three groups: 1) A control group receiving usual care, 2) a group receiving only feedback with associated encouragement about their daily activity, and 3) an intervention group that will receive health coaching with an associated individualized home exercise program.

The study will consist of a 3 month intervention period and a 6 month follow-up/ retention period (total study enrollment period of 9 months). The primary study endpoint is Medtronic device-measured daily activity. All study endpoints will be assessed at baseline, 3 months, and 9 months. The investigators who are conducting study measurements will be blinded to group assignment.

Using a previously established minimum clinically important difference (MCID) of 1.08 hours per day for improvement in daily activity (effect size=1.54) as measured by Medtronic ICDs/CRTs, a total of 8 subjects per group would be needed to achieve a statistical power (1-β) of 0.80 (two-tailed, α=0.05) for a between-groups comparison utilizing two groups. Therefore, depending on the observed effect size in the proposed study, utilizing 3 groups with approximately 10 subjects in each group should provide adequate statistical power for a between-groups comparison with 3 groups.

Statistical analyses will be conducted to meet the planned study objectives. With regard to intervention effects, one way analysis of variance with planned contrasts will be used to examine between-group differences for each of the continuous variables \[Patient Activity, Kansas City Cardiomyopathy Questionnaire (KCCQ), Patient Health Questionnaire (PHQ-9), six-minute walk test (6MWT), 30 second timed chair rise (30-s TCR), heart rate variability, Optivol Fluid Index\]. If the data do not meet the requisite assumptions, the Kruskal-Wallis analysis of variance by ranks will be used. Baseline to 3 months data will be used to assess immediate intervention effects and to 9 month follow-up will be used to assess retention effects.

With regard to concurrent validity of the Medtronic Patient Activity measurement, the Pearson correlation coefficient will be calculated between the daily Patient Activity (minutes per day) and two Actigraph parameters: daily activity count and steps per day. Correlation coefficients will be calculated for the baseline, 3-month, and 9-month monitoring periods to provide a greater number of sampling days. Correlation coefficients will also be calculated for changes in daily activity measurements between baseline and 3 months and baseline and 9 months to determine concurrent validity of change in daily activity measurements.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of heart failure with subsequent placement of a Medtronic® ICD or Cardiac Resynchronization Therapy (CRT) device at least 6 months prior to study enrollment
* New York Heart Association Functional Class II to III symptoms on optimal medical therapy

Exclusion Criteria:

* Any comorbid medical disease that would prevent safe participation in an individualized exercise program such as severe osteo-, rheumatoid-, and gout-related arthritis, unstable angina, exercise-induced arrhythmias, uncontrollable diabetes, or atrial fibrillation with rapid ventricular rate in the preceding 30 days.
* Recent (\<6 weeks) or planned (\<6 months) major cardiovascular events or procedures
* Current participation in a regular exercise training program
* HF due to severe, uncorrected primary valvular disease, congenital heart disease, or obstructive cardiomyopathy
* Adults unable to consent (e.g. cognitively impaired), pregnant women, and prisoners

Primary outcomes:
measure: Change in Medtronic Implanted Device Patient Activity Measure
timeFrame: Change from baseline to 3 and 9 months
Secondary outcomes:
measure: Change in ActiGraph Daily Activity
timeFrame: Change from baseline to 3 and 9 months
measure: Change in Six-Minute Walk Test
timeFrame: Change from baseline to 3 and 9 months
measure: Change in 30 Second Timed Chair Rise
timeFrame: Change from baseline to 3 and 9 months
measure: Change in Kansas City Cardiomyopathy Questionnaire
timeFrame: Change from baseline to 3 and 9 months
measure: Change in 9 Item Patient Health Questionnaire
timeFrame: Change from baseline to 3 and 9 months
measure: Change in Health Care Utilization
timeFrame: Change from baseline to 3 and 9 months
Other outcomes:
Locations:
city: Grand Rapids
country: United States
facility: Spectrum Health Heart and Lung Specialized Care Clinic
state: Michigan
Study officials:
affiliation: Grand Valley State University
name: Michael Shoemaker, DPT, PhD
role: PRINCIPAL_INVESTIGATOR
References: