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OpenTrials
Completed

NCT Number: NCT02911493

Reducing Sedentary Time in Patients With Heart Failure

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.

Completed

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Key information

Conditions

Heart Failure Behavior Cardiovascular Diseases Heart Diseases Sedentary Behavior

Age range

65 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Colorado University

Aurora, Colorado, 80045, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Reducing Sedentary Behavior

Behavioral

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.

Physical activity group

Behavioral

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.

Primary outcomes

  1. Number of Subjects that are more active than Control.

    Time frame: Monthly for 3 months

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Registry information

Acronym: Rest-HF

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Sep 22, 2016
Registry last updated
Aug 21, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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