Reducing Sedentary Time in Patients With Heart Failure

Not Applicable

Completed

• Conditions: Heart Failure
• Interventions: Behavioral: Reducing Sedentary Behavior; Behavioral: Physical Activity Group

• Registration Number: NCT02911493
• Lead Sponsor: University of Colorado, Denver

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-09
• Study First Submitted: 2016-09-20
• Study First Submitted QC: 2016-09-20
• Study First Posted: 2016-09-22
• Primary Completion: 2019-04
• Study Completion: 2019-04
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-19
• Last Update Posted: 2019-08-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sedentary Group-Experimental	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.
Physical Activity Group	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.

Primary Outcome Measures

Name	Time	Method
Number of Subjects that are more active than Control.	Monthly for 3 months

Trial Locations

Locations (1)

University of Colorado University; 🇺🇸 Aurora, Colorado, United States