Self-care in Older Frail Persons With Heart Failure Intervention (SOPHI). Individualized Physical Exercise, Diet and Symptom Management- A Randomized Controlled Trial.
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Self Care
- Sponsor
- Karolinska Institutet
- Enrollment
- 212
- Locations
- 1
- Primary Endpoint
- Change in physical performance
- Status
- Enrolling by Invitation
- Last Updated
- 4 years ago
Overview
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.
Investigators
Nana Waldreus
Principal Investigator
Karolinska Institutet
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)
Outcomes
Primary Outcomes
Change in physical performance
Time Frame: 3 months
The "Short Physical Performance Battery" is composed of "standing balance", "gait speed", and "timed repeated chair rise". The total score range from minimum 0 to maximum 12, with higher scores indicating better physical performance.
Secondary Outcomes
- Perceived physical effort(Baseline, 3 and 6 months)
- Aerobic capacity/endurance(Baseline, 3 and 6 months)
- Frailty(Baseline, 3 and 6 months)
- Hand strength(Baseline, 3 and 6 months)
- Sarcopenia(Baseline, 3 and 6 months)
- Symptom burden(Baseline, 3 and 6 months)
- Lower body strength(Baseline, 3 and 6 months)
- Inflammation marker(Baseline, 3 and 6 months)
- Health related quality of life(Baseline, 3 and 6 months)
- Hospital readmissions(12 months)
- Nutrition status(Baseline, 3 and 6 months)