Reducing Sedentary Time in Patients With Heart Failure

NCT ID: NCT02911493

Last Updated: 2019-08-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-09-30

Study Completion Date

2019-04-30

Brief Summary

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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

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Conditions

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Heart Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Investigators

Study Groups

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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.

Group Type EXPERIMENTAL

Reducing Sedentary Behavior

Intervention Type 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

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.

Group Type ACTIVE_COMPARATOR

Physical Activity Group

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

65 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Colorado, Denver

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Rebecca Boxer, MD, MSc

Role: PRINCIPAL_INVESTIGATOR

University of Colorado, Denver

Locations

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University of Colorado University

Aurora, Colorado, United States

Site Status

Countries

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United States

Other Identifiers

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16-1330

Identifier Type: -

Identifier Source: org_study_id

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