Clinical trial NCT05009706: Self-care in Older Frail Persons With Heart Failure Intervention
Official title: Self-care in Older Frail Persons With Heart Failure Intervention (SOPHI). Individualized Physical Exercise, Diet and Symptom Management- A Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Self Care
Heart Failure
Frailty
Keywords: self care
heart failure
symptom management
exercise
nutrition
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
Collaborators: name: Karolinska University Hospital
First posted: 2021-08-17
Enrollment: 212
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The overall purpose of the randomized controlled study is to evaluate the effects of physical exercise, nutrition and symptom management on physical capacity in older, frail persons with heart failure.

Detailed description: The randomized controlled study will be conducted in order to evaluate the effects of individual needs of physical exercise, nutrition, and symptom management in patients with heart failure who are frail and older. Patients discharged from a geriatric hospital will be recruited and included after informed consent. Two weeks after hospital discharge patients are randomized to intervention or control group. The intervention period is 3 months. With support from a physioterapeut, dietician and a registered nurse, the intervention will be performed in the participants´ home. Once a week participants will come to the hospital for physical exercise led by a physiotherapist. Once a week or every other week participants will meet a dietician and a nurse. Data will be collected at baseline, and 3 and 6 months after baseline. Data consist of e.g. study flow description, number of eligible patients, number of drop-outs, patients sociodemographic- and clinical data, physical function and performance, nutritional status, symptom burden, self-care, appetite, thirst, health-related quality of life. At 12 months after baseline, data will be collected on hospital admissions, reasons for hospital admissions, length of stay and mortality.

Eligibility criteria: Inclusion Criteria:

* Patients at geriatric clinic
* Diagnosed with heart failure (independent of Ejection Fraction (EF): both patients with preserved EF or reduced EF can be included
* New York Heart Association functional class II - III
* Clinical frailty level 4-6 (moderate frailty)
* Discharge from hospital to home

Exclusion Criteria:

* New York Heart Associacion functional class I or IV
* Clinical frailty level 1-3 (no/mild frailty) and 7-9 (severe frailty)
* The patient is unable to perform gait tests due to visual (see a TV screen at a 3 meter distance), cognitive (assessed by nurse or doctor) or motor impairment (the patient should be able to stand up from sitting and have the ability to walk with or without a walker or other walking aid).
* The patient is unable to follow instructions (assessed by nurse or doctor)

Primary outcomes:
measure: Change in physical performance
timeFrame: 3 months
Secondary outcomes:
measure: Symptom burden
timeFrame: Baseline, 3 and 6 months
measure: Health related quality of life
timeFrame: Baseline, 3 and 6 months
measure: Aerobic capacity/endurance
timeFrame: Baseline, 3 and 6 months
measure: Frailty
timeFrame: Baseline, 3 and 6 months
measure: Perceived physical effort
timeFrame: Baseline, 3 and 6 months
measure: Hand strength
timeFrame: Baseline, 3 and 6 months
measure: Hospital readmissions
timeFrame: 12 months
measure: Lower body strength
timeFrame: Baseline, 3 and 6 months
measure: Nutrition status
timeFrame: Baseline, 3 and 6 months
measure: Inflammation marker
timeFrame: Baseline, 3 and 6 months
measure: Sarcopenia
timeFrame: Baseline, 3 and 6 months
Other outcomes:
measure: Objective physical activity
timeFrame: Baseline, 3 and 6 months
measure: Subjective physical activity
timeFrame: Baseline, 3 and 6 months
measure: Experiences of patients
timeFrame: 3 months
measure: Self-care
timeFrame: Baseline, 3 and 6 months
measure: Appetite
timeFrame: Baseline, 3 and 6 months
measure: Thirst distress
timeFrame: Baseline, 3 and 6 months
Locations:
city: Huddinge
country: Sweden
facility: Karolinska Universitetssjukhuset, Tema Inflammation och Åldrande
Study officials:
affiliation: Karolinska Institutet
name: Nana Waldréus, PhD
role: PRINCIPAL_INVESTIGATOR
References: