Reducing Sedentary Time in Patients With Heart Failure

NCT02911493 | Completed DMC

• 1 other identifier: 16-1330
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Failure

Keywords

sedentary time; number of steps/day; mobility; disability

Outcome Measures

Primary Outcomes (1)

• Number of Subjects that are more active than Control.

  Monthly for 3 months

Study Arms (2)

Sedentary Group-Experimental

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

Physical Activity Group

ACTIVE COMPARATOR

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

Interventions

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.

Sedentary Group-Experimental

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.

Physical Activity Group

Eligibility Criteria

• Age: 65 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Colorado, Denver: lead

Study Sites (1)

University of Colorado University

Aurora, Colorado, 80045, United States

Location

MeSH Terms

Conditions

Heart Failure; Sedentary Behavior

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Behavior

Study Officials

• Rebecca Boxer, MD, MSc

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 20, 2016
• First Posted: September 22, 2016
• Study Start: September 1, 2016
• Primary Completion: April 1, 2019
• Study Completion: April 1, 2019
• Last Updated: August 21, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)