Reducing Sedentary Time in Patients With Heart Failure (Rest-HF)

August 19, 2019 updated by: University of Colorado, Denver
To determine the change in sedentary time and number of steps/day for older patients with heart failure at risk for mobility disability who receive a program to decrease sedentary behavior versus a standard program to increase exercise.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Colorado
      • Aurora, Colorado, United States, 80045
        • University of Colorado University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years to 100 years (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • NYHA II-IV,
  • Age ≥ 65,

  • SPPB score of > 4 and ≤ 10 of 12,

    • and deemed (by 1° cardiologist) to be at maximal tolerated dose of heart failure medication (ACE-inhibitor (ACE-I)/angiotensin receptor blocker and beta blocker (BB) for patients with HF with reduced ejection fraction (HFrEF), and
    • blood pressure controlled for HF with preserved ejection fraction (HFpEF) according to the American Heart Failure Association HF guidelines.

Exclusion Criteria:

  • Patients requiring medication titration such as ACE-I or BB, (will return to their cardiologist and be eligible after 3 months of stable medication.)
  • Oxygen dependent lung disease,
  • Orthopedic or neurologic disease that severely limits mobility,
  • Active cancer diagnosis except non-melanoma skin cancer,
  • Geriatric Depression Scale (GDS) score of ≥ 9 ,
  • Limited life-expectancy of <6 months,
  • Known dementia or disease that effects ability to learn/follow directions, or
  • Failed MiniCog test.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Sedentary Group-Experimental
The experimental group will wear an activPAL and have counseling sessions that use the Health Belief Model and Motivational Interviewing strategies to reduce sedentary time.
Behavioral: Reducing Sedentary Behavior
The experimental group will wear an activPAL and have counseling sessions that use the Health Belief Model and Motivational Interviewing strategies to reduce sedentary time.
Active Comparator: Physical Activity Group
The Active Comparative group will wear an activPAL and have counseling sessions that use the Health Belief Model and Motivational Interviewing strategies to increase exercise time.
Behavioral: Physical Activity Group
The Active Comparative group will wear an activPAL and have counseling sessions that use the Health Belief Model and Motivational Interviewing strategies to increase exercise time.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of Subjects that are more active than Control.
Time Frame: Monthly for 3 months
Monthly for 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Colorado, Denver

Investigators

  • Principal Investigator: Rebecca Boxer, MD, MSc, University of Colorado, Denver

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2016

Primary Completion (Actual)

April 1, 2019

Study Completion (Actual)

April 1, 2019

Study Registration Dates

First Submitted

September 20, 2016

First Submitted That Met QC Criteria

September 20, 2016

First Posted (Estimate)

September 22, 2016

Study Record Updates

Last Update Posted (Actual)

August 21, 2019

Last Update Submitted That Met QC Criteria

August 19, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 16-1330

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Heart Failure

Clinical Trials on Reducing Sedentary Behavior

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Belgium

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe