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The Utility of Focused Frailty Interventions on Patients With Advanced Heart Failure

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03574662
Recruitment Status : Completed
First Posted : July 2, 2018
Last Update Posted : February 12, 2019
Sponsor:
Information provided by (Responsible Party):
Sudhir Kushwaha, Mayo Clinic

Study Description
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Brief Summary:
The Researchers are doing this study to find out if the cardiac rehabilitation program can improve measurements of frailty and improve independence, functional abilities, and feelings about health. Frailty can be measured by weakness (as measured by hand grip strength), slowness (as measured by walking speed), low level of physical activity, low energy or self-reported exhaustion, and unintentional weight loss.

Condition or disease Intervention/treatment Phase
Heart Failure Other: Frailty assessment Other: Quality of life assessment Not Applicable

Detailed Description:
Participants with advanced heart failure with a New York Heart Association class of III or IV symptoms within the last 3 months will be identified by either their outpatient heart failure clinic notes or inpatient cardiology notes. Patients will be approached for participation if cardiac rehab is mentioned in the notes and inclusion/exclusion criteria it met. Once the consent is signed, the baseline visit will be scheduled, this will be done before cardiac rehab has started. The baseline visit include frailty assessment measured by a walk time/gait speed test and handgrip strength test, and quality of life assessment measured using the Kansas City Cardiomyopathy Questionnaire (KCCQ) and Minnesota Living with Heart Failure (MLHF) questionnaire. Patients will then attend cardiac rehabilitation for six week program. The cardiac rehab program will be designed by the individual facility due to the variation in exercise tolerance of each patient, no universal protocol will be used. After the six weeks of cardiac rehab, up to 16 weeks post-completion, the patient will return to Mayo Clinic Rochester to complete the frailty and quality of life assessment.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: A Prospective Trial to Evaluate the Utility of Focused Frailty Interventions on Patients With Advanced Heart Failure
Actual Study Start Date : May 4, 2018
Actual Primary Completion Date : December 31, 2018
Actual Study Completion Date : December 31, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Arms and Interventions
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Arm Intervention/treatment
Experimental: Frailty assessment in Advanced heart failure
Subjects with advanced heart failure defined as current or recent (within the last 3 months) New York Heart Association (NYHA) class III or IV symptoms.
 Other: Frailty assessment
This assessment consists of a combination of gait speed measurement via infrared sensors as well as a grip strength assessment. Patients will then attend cardiac rehabilitation for an abbreviated six week program.

Other: Quality of life assessment
This assessment consists of two questionnaires, Kansas City Cardiomyopathy Questionnaire and Minnesota Living with Heart Failure questionnaire. Patients will then attend cardiac rehabilitation for an abbreviated six week program.


Outcome Measures
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Primary Outcome Measures :
  1. Change in gait speed [ Time Frame: baseline, 6 weeks ]
    The time it takes to walk a specified distance, as measured in meters per second

  2. Change in hand grip [ Time Frame: baseline, 6 weeks ]
    The amount of force that the hand can squeeze, as measured in kilograms

  3. Change in Kansas City Cardiomyopathy Questionnaire [ Time Frame: baseline, 6 weeks ]
    The KCCQ is a 23-item questionnaire that quantifies dyspnea, fatigue, and edema on physical, social, and emotional functions of the patient. Responses are categorized by 3 subscales (burden, limitations, and quality of life) with a possible range of scores from 0 to 100, 100 being the least burdened by their symptoms. This questionnaire independently measures the patient's perception of their health status, which includes heart failure symptoms, impact on physical and social functions, and how their heart failure impacts their quality of life within a two week recall period.

  4. Change in Minnesota Living with Heart Failure Questionnaire (MLHFQ) [ Time Frame: baseline, 6 weeks ]
    The MLHFQ asks each person to indicate using a 6-point (zero to five) Likert scale how much each of 21 facets prevents them from living as they desire. The questionnaire assesses the impact of frequent physical symptoms - shortness of breath, fatigue, peripheral edema, and difficulty sleeping - and psychological symptoms of anxiety and depression. In addition, the effects of heart failure on physical and social functioning are incorporated into the measure. Since treatments might have side effects in addition to ameliorating symptoms and functional limitations produced by heart failure, questions about side effects of medications, hospital stays and costs of care are also included to help measure the overall impact of a treatment on quality of life. Although the MLHFQ incorporates relevant aspects of the key dimensions of quality of life, the questionnaire was not designed to measure any particular dimension separately.


Secondary Outcome Measures :
  1. Delay in Left Ventricular Assist Device (LVAD) placement [ Time Frame: 16 weeks ]
    Number of days until LVAD placement

  2. Post surgical length of stay [ Time Frame: 16 weeks ]
    Number of days subject in hospital


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • Advanced heart failure patients.
  • These include patients with Current NYHA class III-IV symptoms at the current time or within the preceding three months.
  • Outpatient heart failure clinic with mention of cardiac rehab in patient medical record in the past year OR patients admitted to the hospital to any inpatient cardiology service (including the coronary care unit (CCU)) and mention of cardiac rehab from service.

Exclusion criteria:

  • Unable to perform physical activities due to anatomic or musculoskeletal comorbidities
  • Physical activity is contraindicated
Contacts and Locations
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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): NCT03574662


Locations
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United States, Minnesota
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Investigators
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Principal Investigator: Sudhir S Kushwaha Mayo Clinic
More Information
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Publications:

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Responsible Party: Sudhir Kushwaha, Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier: NCT03574662    
Other Study ID Numbers: 18-000665
First Posted: July 2, 2018    Key Record Dates
Last Update Posted: February 12, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sudhir Kushwaha, Mayo Clinic:
frailty
advanced
Additional relevant MeSH terms:
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Heart Failure
Frailty
Heart Diseases
Cardiovascular Diseases
Pathologic Processes