Community-acquired infections such as community-acquired pneumonia (CAP) and urinary tract infection (UTI) remain leading causes of hospitalization and death due to infections in older persons in Europe. Hospitalization often results in further disabilities and frailty for older and frail individuals, from which some may never recover. Physical activity is well-established as a cornerstone in the primary prevention and treatment of several noncommunicable diseases. However, there is currently no established rehabilitation model following a pneumonia or other infection, nor is there any evidence to support the impact of rehabilitation on the mental and physical health of older and frail individuals following a pneumonia hospitalization or other infection. The aim of the feasibility study is to evaluate a patient-centered and individualized exercise intervention that is kick-started during hospitalization and continued for 3 months after discharge with video-supervised home-based exercise training to patients hospitalized with CAP or UTI compared to standard care with regard to safety, clinical outcomes, patients' perception, functional ability, organizational aspects, and economic aspects.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
460
12 weeks of patient-centered video-supervised home-based exercise training that will be kick-started during hospitalization and continued for 12 weeks after discharge, followed by 12 weeks of self-directed maintenance exercise.
Department of Pulmonary and Infectious Diseases, Copenhagen University Hospital
Hillerød, Denmark
Department of Infectious Diseases, Copenhagen University Hospital, Amager-Hvidovre
Hvidovre, Denmark
Department of Respiratory Medicine, Copenhagen University Hospital, Amager-Hvidovre
Hvidovre, Denmark
Re-hospitalization (infection-related and all-cause)
Report of the total number of re-hospitalized patients, defined as a hospital stay \>12 hours.
Time frame: 90 days after discharge.
Re-hospitalization (infection-related and all-cause)
Report of the total number of re-hospitalized patients, defined as a hospital stay \>12 hours.
Time frame: 30 days after discharge; 180 days after discharge.
Mortality (infection-related and all-cause)
Report of the total number.
Time frame: 30 days after discharge; 90 days after discharge; 180 days after discharge; 360 days after discharge
Handgrip strength
Measure handgrip muscle strength in kilos in the dominant hand using a hand-held dynamometer. The highest number out of three attempts will be recorded.
Time frame: Baseline; 1-month after discharge (secondary endpoint); 3-month after discharge (primary endpoint); and 6-month after discharge (secondary endpoint).
Lower limb muscle strength and power
Assessment of muscle strength and power of the knee extensor muscles with dynamometry.
Time frame: Baseline; 1-month after discharge (secondary endpoint), 3-month after discharge (primary endpoint), and 6-month after discharge (secondary endpoint).
30-second sit to stand
A clinical test where the patient performs as many sit-to-stand actions as possible in 30 seconds. Measures leg muscle strength by counting the number of repetitions.
Time frame: Baseline; 1-month after discharge (secondary endpoint); 3-month after discharge (primary endpoint); and 6-month after discharge (secondary endpoint).
1-minute sit to stand
A clinical test where the patient performs as many sit-to-stand actions as possible in 1 minute. Measures endurance by counting the number of repetitions.
Time frame: Baseline; 1-month after discharge (secondary endpoint); 3-month after discharge (primary endpoint); and 6-month after discharge (secondary endpoint).
6-minute walking test
Measure the distance in meters a person can walk in 6 minutes.
Time frame: Baseline; 1-month after discharge (secondary endpoint); 3-month after discharge (primary endpoint); and 6-month after discharge (secondary endpoint).
Short Physical Performance Battery (SPPB)
An objective measurement instrument combining 3 tests in 1 score. The tests consist of a balance test (measured in seconds), lower extremity strength (measured in seconds), and a walking test measuring functional capacity (measured in seconds).
Time frame: Baseline; 1-month after discharge (secondary endpoint); 3-month after discharge (primary endpoint); and 6-month after discharge (secondary endpoint).
Barthel index
Measure of a persons ability to perform activities of daily living. Scores from 0 to 100. The higher the better.
Time frame: Baseline; 1-month after discharge (secondary endpoint); 3-month after discharge (primary endpoint); and 6-month after discharge (secondary endpoint).
Clinically Frailty Scale
A global clinical measure of the overall frailty of an older person. Scores from 1 to 9. The lower the better.
Time frame: Baseline; 1-month after discharge (secondary endpoint); 3-month after discharge (primary endpoint); and 6-month after discharge (secondary endpoint).
EuroQol-5D-5L (EQ-5D-5L)
Measure health-related quality of life divided into the EQ-5D utility index and EQ-VAS score. The Danish EQ-5D-5L utility scores range from -0.757 for state 55555 to 1.0 for state 11111; the higher the score, the better. The EQ VAS is on a 0-100 scale; the higher the score, the better.
Time frame: Baseline; 1-month after discharge (secondary endpoint); 3-month after discharge (primary endpoint); and 6-month after discharge (secondary endpoint).
36-Item Short Form Survey (SF-36)
Measure health-related quality of life. Total score from 0 to 100; the higher the score, the better.
Time frame: Baseline; 1-month after discharge (secondary endpoint); 3-month after discharge (primary endpoint); and 6-month after discharge (secondary endpoint).
COPD Assessment Test (CAT)
A patient self-administered questionnaire. An 8-item questionnaire designed to assess the impact of disease on a person's life (health status). Range of CAT scores from 0-40. Higher scores implicates a more severe impact of COPD on a patient's life (total score point).
Time frame: Baseline; 1-month after discharge (secondary endpoint); 3-month after discharge (primary endpoint); and 6-month after discharge (secondary endpoint).
Montreal Cognitive Assessment (MoCA)
Measure of mild cognitive impairment. MoCa scores range from 0 to 30. Scores of 26 or over are considered to be normal.
Time frame: Baseline; 1-month after discharge (secondary endpoint); 3-month after discharge (primary endpoint); and 6-month after discharge (secondary endpoint).
Center for Epidemiologic Studies Depression Scale (CES-D)
A self-report rating scale that is designed to measure current symptoms of depression. Lower score is better.
Time frame: Baseline; 1-month after discharge (secondary endpoint); 3-month after discharge (primary endpoint); 6-month after discharge (secondary endpoint)
Family Reported Outcome Measure (FROM-16)
Measure of the impact on the quality of life of an adult family member or partner resulting from having a person (of any age) in a family with any disease or condition, across all of medicine.
Time frame: 1-month after discharge (secondary endpoint); 3-month after discharge (primary endpoint); 6-month after discharge (secondary endpoint)
Physical activity level
The objectivly measured physical activity level assessed with activity trackers.
Time frame: Baseline; 1-month after discharge (secondary endpoint); 3-month after discharge (primary endpoint); 6-month after discharge (secondary endpoint)
Blood sample
Concentration of p-phosphate (mmol/l), p-sodium (mmol/l), p-carbamide (mmol/l), and p-potassium (mmol/l).
Time frame: Baseline; discharge (secondary endpoint); 1-month after discharge (seconary endpoint), 3-month after discharge (primary endpoint), 6-month after discharge (secondary endpoint), and 12-month after discharge (secondary endpoint).
Blood sample
Concentration of pro- and anti-inflammatory cytokines (IL-6, Il-1ra, IL-18, IL-10, TNF-alpha, etc.)
Time frame: Baseline; discharge (secondary endpoint); 1-month after discharge (seconary endpoint), 3-month after discharge (primary endpoint), 6-month after discharge (secondary endpoint), and 12-month after discharge (secondary endpoint).
Blood sample
Concentration of lipids
Time frame: Baseline; discharge (secondary endpoint); 1-month after discharge (seconary endpoint), 3-month after discharge (primary endpoint), 6-month after discharge (secondary endpoint), and 12-month after discharge (secondary endpoint).
Blood sample
Concentration of galectin-3 (ng/ml), sST2 (ng/ml), and troponins (ng/ml).
Time frame: Baseline; discharge (secondary endpoint); 1-month after discharge (seconary endpoint), 3-month after discharge (primary endpoint), 6-month after discharge (secondary endpoint), and 12-month after discharge (secondary endpoint).
Blood sample
Concentration of NT-proBNP (ng/l).
Time frame: Baseline; discharge (secondary endpoint); 1-month after discharge (seconary endpoint), 3-month after discharge (primary endpoint), 6-month after discharge (secondary endpoint), and 12-month after discharge (secondary endpoint).
Immune function
Complete blood count with differential count. Concentration of immunoglobulin G (IgG), immunoglobulin M (IgM), and immunoglobulin A (IgA), and concentration of subclasses of IgG: IgG1, IgG2, IgG3, and IgG4.
Time frame: Baseline; discharge (secondary endpoint); 1-month after discharge (seconary endpoint), 3-month after discharge (primary endpoint), 6-month after discharge (secondary endpoint), and 12-month after discharge (secondary endpoint).
Blood sample
Concentration of HbA1c.
Time frame: Baseline; discharge (secondary endpoint); 1-month after discharge (seconary endpoint), 3-month after discharge (primary endpoint), 6-month after discharge (secondary endpoint), and 12-month after discharge (secondary endpoint).
Blood sample
Concentration of c-peptide (pmol/L).
Time frame: Baseline; 1-month after discharge (secondary endpoint); 3-month after discharge (primary endpoint); 6-month after discharge (secondary endpoint); and 12-month after discharge (secondary endpoint).
Blood sample
Concentration p-glucose (mmol/L).
Time frame: Baseline; 1-month after discharge (secondary endpoint); 3-month after discharge (primary endpoint); 6-month after discharge (secondary endpoint); and 12-month after discharge (secondary endpoint).
Blood sample
Concentration of p-insulin (pmol/L).
Time frame: Baseline; 1-month after discharge (secondary endpoint); 3-month after discharge (primary endpoint); 6-month after discharge (secondary endpoint); and 12-month after discharge (secondary endpoint).
Biobank blood sample
Whole blood, plasma, and serum.
Time frame: Baseline; discharge (secondary endpoint); 1-month after discharge (seconary endpoint), 3-month after discharge (primary endpoint), 6-month after discharge (secondary endpoint), and 12-month after discharge (secondary endpoint).
Insulin resistance
The Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) will be used to measure severity of insulin resistance. Normal reference levels for HOMA-IR is 0.7 to 2.0, with values \>2.0 representing clinically significant insulin resistance.
Time frame: Baseline; 1-month after discharge (secondary endpoint); 3-month after discharge (primary endpoint), and 6-month after discharge (secondary endpoint).
Glycemic variability
Glucose outcomes from the CGM sensor (Dexcom G6) including time in range (TIR) for blood glucose, time above range (TAR) for blood glucose, time below range (TBR) for blood glucose, average blood glucose, and variance in blood glucose (CV).
Time frame: Baseline (day 0-10); 3-month after discharge (day 80-90, primary endpoint), and 6-month after discharge (day 170-180, secondary endpoint).
P-glucose during an oral glucose tolerance test (OGTT)
P-glucose (mmol/L) measured during an OGTT.
Time frame: Baseline; 3-month after discharge (primary endpoint), and 6-month after discharge (secondary endpoint).
P-insulin during an oral glucose tolerance test (OGTT)
P-insulin (pmol/L) measured during an OGTT.
Time frame: Baseline; 3-month after discharge (primary endpoint), and 6-month after discharge (secondary endpoint).
C-peptide during an oral glucose tolerance test (OGTT)
C-peptide (pmol/L) measured during an OGTT.
Time frame: Baseline; 3-month after discharge (primary endpoint), and 6-month after discharge (secondary endpoint).
Insulin sensitivity
Insulin sensitivity using Matsuda index. The index is calculated based on p-glucose and p-insulin in fasting state and during an OGTT.
Time frame: Baseline; 3 month after discharge (primary endpoint); 6 months after discharge (secondary endpoint).
Glucose-lowering medication
Changes in glucose-lowering medication in patients with diabetes
Time frame: Baseline; 3 months after discharge (primary endpoint); 6 months after discharge (secondary endpoint)
Semi-structured qualitative interviews
Semi-structured qualitative interviews with the patient and a relative. The following themes will be explored: perception of the content in the exercise intervention, barriers and enablers towards physical activity, ideas for improvement of the exercise intervention
Time frame: 1-month after discharge (seconary endpoint), 3-month after discharge (primary endpoint), and 6-month after discharge (secondary endpoint).
Adverse events
Numbers of severe adverse events and adverse events
Time frame: At 1-month after discharge, 3-month after discharge (primary endpoint), and 6-month after discharge.
Total and appendicular lean and fat mass
DXA-scan
Time frame: Baseline; 1-month after discharge (secondary endpoint); 3-month after discharge (primary endpoint); and 6-month after discharge (secondary endpoint).
Muslce quality and density
Midt-thigh CT-scan
Time frame: Baseline; 3-month after discharge (primary endpoint); and 6-month after discharge (secondary endpoint).
Fat mass index and fat-free mass index
Bioelectrical impedance analysis
Time frame: Baseline; 1-month after discharge (secondary endpoint); 3-month after discharge (primary endpoint); and 6-month after discharge (secondary endpoint).
Muscle oxidative stress and inflammation
Muscle biopsies from the m. vastus lateralis of the quadriceps muscle
Time frame: Baseline; 3-month after discharge (primary endpoint); and 6-month after discharge (secondary endpoint).
Muscle protein synthesis and proteolysis
Muscle biopsies from the m. vastus lateralis of the quadriceps muscle
Time frame: Baseline; 3-month after discharge (primary endpoint); and 6-month after discharge (secondary endpoint).
Muscle insulin sensitivity
Muscle biopsies from the m. vastus lateralis of the quadriceps muscle
Time frame: Baseline; 3-month after discharge (primary endpoint); and 6-month after discharge (secondary endpoint).
Skeletal muscle cell growth, development, and function
Skeletal muscle cell cultures of muscle tissue from m. vastus lateralis of the quadriceps muscle.
Time frame: Baseline; 3-month after discharge (primary endpoint); and 6-month after discharge (secondary endpoint)
Insulin sensitivity and signaling of adipose tissue
Adipose tissue biopsy
Time frame: Baseline; 3-month after discharge (primary endpoint); and 6-month after discharge (secondary endpoint)
Adipose tissue inflammation
Adipose tissue biopsy
Time frame: Baseline; 3-month after discharge (primary endpoint); and 6-month after discharge (seconary endpoint)
Adipose tissue immune cell infiltration
Adipose tissue biopsy
Time frame: Baseline; 3-month after discharg (primary endpoint); and 6-month after discharge (secondary endpoint)
Pulmonary medication
Changes in pulmonary medication (tablets and inhalation)
Time frame: Baseline; 3 months after discharge (primary endpoint); 6 months after discharge (secondary endpoint)
Lung function
Spirometry in patients with COPD
Time frame: Baseline; 3 months after discharge (primary endpoint); 6 months after discharge (secondary endpoint)
Lung function
Body plethysmography in patients with COPD
Time frame: Baseline; 3 months after discharge (primary endpoint); 6 months after discharge (secondary endpoint)
Lung function
Single-breath carbon monoxide uptake in patients with COPD
Time frame: Baseline, 3 months after discharge (primary endpoint); 6 months after discharge (seconary endpoint)
Acute exacerbations of COPD
Notification of acute exacerbations of COPD through patient files
Time frame: Baseline; 3 months after discharge (primary endpoint); 6 months after discharge (secondary endpoint)
Health economics
Health costs, the cost per quality-adjusted life years (QALYs), and the lifetime estimated cost per QALY gained will be calculated.
Time frame: From baseline to 360 days after discharge.
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