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Completed

NCT Number: NCT03574662

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

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.

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Key information

Conditions

Heart Failure Cardiovascular Diseases Frailty Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Frailty Assessment

Other

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.

Quality of Life Assessment

Other

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.

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

A Prospective Trial to Evaluate the Utility of Focused Frailty Interventions on Patients With Advanced Heart Failure

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Jul 2, 2018
Registry last updated
Feb 12, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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