Clinical trial NCT03574662: The Utility of Focused Frailty Interventions on Patients With Advanced Heart Failure
Official title: A Prospective Trial to Evaluate the Utility of Focused Frailty Interventions on Patients With Advanced Heart Failure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure
Keywords: frailty
advanced
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2018-07-02
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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.

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.

Eligibility 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

Primary outcomes:
measure: Change in gait speed
timeFrame: baseline, 6 weeks
measure: Change in hand grip
timeFrame: baseline, 6 weeks
measure: Change in Kansas City Cardiomyopathy Questionnaire
timeFrame: baseline, 6 weeks
measure: Change in Minnesota Living with Heart Failure Questionnaire (MLHFQ)
timeFrame: baseline, 6 weeks
Secondary outcomes:
measure: Delay in Left Ventricular Assist Device (LVAD) placement
timeFrame: 16 weeks
measure: Post surgical length of stay
timeFrame: 16 weeks
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Sudhir S Kushwaha
role: PRINCIPAL_INVESTIGATOR
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