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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Enrollment
212
Patients who are randomized to the Self Care group will receive oral and written information, advice and support on following activities: excercise (from physiotherapist), nutrition (dietician) and symptom management (nurse), based on patient´s individual needs and abilities. The Self Care group will perform the activities daily at home. Once a week, patients come to the hospital to exercise with the support of a physiotherapist. Once a week or every other week patients will meet (at hospital or by phone) the dietician and nurse to solve possible problems and to follow-up food/nutrition intake and symptoms/symptom management.
Karolinska Universitetssjukhuset, Tema Inflammation och Åldrande
Huddinge, Sweden
Change in physical performance
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.
Time frame: 3 months
Symptom burden
Assessed by the questionnaire titled "The Memorial Symptom Assessment Scale- Heart Failure", that evaluates symptoms experienced by the patient in the last week (a total of 36 symptoms, for example pain, nausea, tiredness). A score of 0 is given to a symptom if it is absent. If the symptom is present, it is rated using a four-point rating scale (1-4) for frequency and severity, and a five-point rating scale (0-4) for distress of the symptom with higher scores indicating greater frequency, more severity and higher distress. For each symptom, the average of the frequency, severity and distress will be calculated to produce the outcome symptom burden (total scores ranging from minimum 0 to maximum 4, with higher scores indicating greater symptom burden).
Time frame: Baseline, 3 and 6 months
Health related quality of life
Assessed with the Euroqol questionnaire titled "The EQ-5D". It comprises five questions about mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Answer options are no problems (score 1), moderate problems (score 2), severe/extreme problems (score 3). The results are converted into a single index value (minimum value 0 to maximum value 1). Higher value indicate better health related quality of life
Time frame: Baseline, 3 and 6 months
Aerobic capacity/endurance
Assessed with the 6-minute walk test, the distance in meters covered over a time of 6 minutes
Time frame: Baseline, 3 and 6 months
Frailty
Assessed by the scale titled "Clinical Frailty Scale". From the minimum value 1 (patient is very fit) to the maximum value 9 (terminally ill). Higher score indicates more frailty
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Time frame: Baseline, 3 and 6 months
Perceived physical effort
Assessed with the scale titled "Borg Category Ratio-10 Scale" of perceived exertion. The minimum value is 0 (nothing at all) to the maximum value 10 (extremely strong or maximal). Higher value indicate worse physical effort
Time frame: Baseline, 3 and 6 months
Hand strength
Assessed with the hand-gripdynamometer (JAMAR)
Time frame: Baseline, 3 and 6 months
Hospital readmissions
The number of hospital readmissions during a 12 month period will be retrieved from the patients medical record
Time frame: 12 months
Lower body strength
Sit to stand test measure the number of uprising from a chair during 30 seconds
Time frame: Baseline, 3 and 6 months
Nutrition status
Assessed by the "Mini Nutritional Assessment" screening. The total score range from minimum 0 to maximum 14. Higher scores indicate better nutrition status
Time frame: Baseline, 3 and 6 months
Inflammation marker
Plasma C-reactive protein (mg/L), reference interval value below 3 mg/L. Higher value indicate inflammation in the body
Time frame: Baseline, 3 and 6 months
Sarcopenia
Measured by the criteria of European Working Group on Sarcopenia in Older People's
Time frame: Baseline, 3 and 6 months