Interventions to Improve Daily Activity in Heart Failure

NCT02331524 | Completed

• 1 other identifier: 14-180-H
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Failure

Keywords

exercise; daily activity

Outcome Measures

Primary Outcomes (1)

• Change in Medtronic Implanted Device Patient Activity Measure

  Change from baseline to 3 and 9 months

Secondary Outcomes (6)

• Change in ActiGraph Daily Activity

  Change from baseline to 3 and 9 months

• Change in Six-Minute Walk Test

  Change from baseline to 3 and 9 months

• Change in 30 Second Timed Chair Rise

  Change from baseline to 3 and 9 months

• Change in Kansas City Cardiomyopathy Questionnaire

  Change from baseline to 3 and 9 months

• Change in 9 Item Patient Health Questionnaire

  Change from baseline to 3 and 9 months

Study Arms (3)

Control/Usual Care

NO INTERVENTION

Usual care only

Activity Feedback and Encouragement

EXPERIMENTAL

Weekly Feedback about daily activity using the FitBit Zip

Behavioral: Activity Feedback and Encouragement

Health Coaching/Home Exercise

EXPERIMENTAL

Weekly contact from physical therapist to develop and progress home exercise program and by health coach for goal setting and support

Other: Health Coaching/Home Exercise

Interventions

Activity Feedback and Encouragement BEHAVIORAL

The Daily Activity Feedback/ Encouragement group will receive weekly feedback and encouragement regarding daily activity using the Fitbit Zip® for 3 months. Visual feedback and verbal encouragement will be provided. Visual feedback will provide graphics showing current and historical daily activity trends since the start of the intervention period. Subjects in the Feedback group will also receive standardized verbal feedback based upon the Fitbit Zip data. For example, subjects demonstrating a trend of increasing daily activity will be encouraged to "Continue what you are doing. You are doing great!"

Activity Feedback and Encouragement

Health Coaching/Home Exercise OTHER

The Health Coaching/Home Exercise group will receive 12 weekly health coaching and physical therapy visits for 3 months. Health coaching will be provided by a trained, highly experienced health and wellness coach. In-home health coaching sessions will be provided monthly (total of 3) with the remaining 9 sessions provided telephonically. Initial health coaching sessions will include the utilization of motivational interviewing to establish individualized, three-month goals related to symptoms, function, and/or daily activity, with subsequent sessions celebrating successes in and/or identifying barriers to achieving these goals.

Health Coaching/Home Exercise

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Grand Valley State University: lead
• Corewell Health West: collaborator

Study Sites (1)

Spectrum Health Heart and Lung Specialized Care Clinic

Grand Rapids, Michigan, 49503, United States

Location

MeSH Terms

Conditions

Heart Failure; Motor Activity

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Behavior

Study Officials

• Michael Shoemaker, DPT, PhD

  Grand Valley State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Physical Therapy

Study Record Dates

• First Submitted: December 27, 2014
• First Posted: January 6, 2015
• Study Start: October 1, 2014
• Primary Completion: July 1, 2016
• Study Completion: July 1, 2016
• Last Updated: February 23, 2017

Record last verified: 2017-02

Locations

US (1)