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

Not Applicable

Completed

• Conditions: Heart Failure
• Interventions: Other: Frailty assessment; Other: Quality of life assessment

• Registration Number: NCT03574662
• Lead Sponsor: Mayo Clinic

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.

Study Timeline

• Study Start: 2018-05-04
• Study First Submitted: 2018-06-21
• Study First Submitted QC: 2018-06-21
• Study First Posted: 2018-07-02
• Primary Completion: 2018-12-31
• Study Completion: 2018-12-31
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-08
• Last Update Posted: 2019-02-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Frailty assessment in Advanced heart failure	Frailty assessment	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.
Frailty assessment in Advanced heart failure	Quality of life assessment	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.

Primary Outcome Measures

Name	Time	Method
Change in Minnesota Living with Heart Failure Questionnaire (MLHFQ)	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.
Change in gait speed	baseline, 6 weeks	The time it takes to walk a specified distance, as measured in meters per second
Change in hand grip	baseline, 6 weeks	The amount of force that the hand can squeeze, as measured in kilograms
Change in Kansas City Cardiomyopathy Questionnaire	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.

Secondary Outcome Measures

Name	Time	Method
Post surgical length of stay	16 weeks	Number of days subject in hospital
Delay in Left Ventricular Assist Device (LVAD) placement	16 weeks	Number of days until LVAD placement

Trial Locations

Locations (1)

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States