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Trial record 4 of 135 for:    heart OR vascular OR aortic OR ventricular | Recruiting Studies | university of colorado

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

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ClinicalTrials.gov Identifier: NCT02911493
Recruitment Status : Recruiting
First Posted : September 22, 2016
Last Update Posted : January 31, 2018
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Heart Failure Behavioral: Reducing Sedentary Behavior Behavioral: Physical Activity Group Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 72 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: Reducing Sedentary Time in Patients With Heart Failure
Study Start Date : September 2016
Estimated Primary Completion Date : February 2018
Estimated Study Completion Date : May 2018

Resource links provided by the National Library of Medicine


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.

Experimental: Sedentary Group-Interventional
The intervention group will use the activPAL data to see how sedentary they have been throughout a week where as the control group will not see this data until the end of the study.
Behavioral: Reducing Sedentary Behavior
The intervention group will use the activPAL data to see how sedentary they have been throughout a week where as the control group will not see this data until the end of the study.

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.




Primary Outcome Measures :
  1. Number of Subjects that are more active than Control. [ Time Frame: Monthly for 3 months ]


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Ages Eligible for Study:   65 Years to 100 Years   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02911493


Contacts
Contact: Blythe A Dollar, MPH 720-848-7561 blythe.dollar@ucdenver.edu

Locations
United States, Colorado
University of Colorado University Recruiting
Aurora, Colorado, United States, 80045
Contact: Blythe A Dollar, MPH    720-848-7561    blythe.dollar@gmail.com   
Principal Investigator: Rebecca Boxer, MS,MD         
Sponsors and Collaborators
University of Colorado, Denver
Investigators
Principal Investigator: Rebecca Boxer, MD, MSc University of Colorado, Denver

Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT02911493     History of Changes
Other Study ID Numbers: 16-1330
First Posted: September 22, 2016    Key Record Dates
Last Update Posted: January 31, 2018
Last Verified: January 2018

Keywords provided by University of Colorado, Denver:
sedentary time
number of steps/day
mobility
disability

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases