Physical Rehabilitation of Older Persons Following a Community-Acquired Infection Hospitalization: a Feasibility Study
- Conditions
- Community-acquired PneumoniaUrinary Tract Infections
- Registration Number
- NCT06689280
- Lead Sponsor
- Nordsjaellands Hospital
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 50
- Patients aged ≥65 years or ≤65 years if the presence of at least one chronic disease (e.g., diabetes, COPD, heart failure, etc.)
- Suspicious of a lower respiratory tract infection AND
- Presence of one or more symptoms of a lower respiratory tract infection such as fever ≥38.3°C, hypothermia <35.0°C, new onset of cough, pleuritic chest pain, dyspnea, or altered breath sounds on auscultation.
- Positive urine nitrate test and/or leukocyturia as depicted by positive esterase test or microscopy AND
- Presence of one or more symptoms of urinary tract infection such as dysuria, urgent or frequent urination, perineal or suprapubic pain, costo-vertebral tenderness or flank pain, fever (ear or rectal temperature of ≥38.2°C or axillary temperature of ≥38.0°C), or history of feeling feverish with shivering or rigors in the past 24 hours.
- Functionally independent before hospitalization and expected to be discharged to their own homes.
- Signed informed consent.
- Hospitalization within the past 14 days.
- Inability to participate in the study due to dementia, paralysis, or other disorders.
- Severe aortic valve stenosis or terminal illness.
- Unstable cardiac arrhythmic disease.
- High risk for non-adherence as determined by screening evaluation.
- Already participating in regular exercise training.
- Unable to understand Danish.
- Unwilling or unable to give informed consent.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Eligibility Assesment before enrollment Number of eligible patients for randomisation (Absolute number)
Adherence Baseline; 12-weeks from discharge (primary endpoint); 24-weeks from discharge (secondary endpoint) Number of participants adherent (Participant completion of 70% or more of the planned sessions) (Absolute number)
Acceptability Acceptance when enrolling the project Number of patients accepting to participate (Absolute number)
- Secondary Outcome Measures
Name Time Method Handgrip strength Baseline; 1-month after discharge (secondary endpoint); 3-month after discharge (primary endpoint); 6-month after discharge (secondary endpoint) Measure hangrip muscle strengt in kilo in the dominant hand using a hand-held dynamometer. The highest number out of three attempts will be recorded.
Lower limb muscle strength and power Baseline; 1-month after discharge (secondary endpoint), 3-month after discharge (primary endpoint), and 6-month after discharge (secondary endpoint). Assessment of muscle strength and power of the knee extensor muscles with a dynamometry.
30-second sit to stand Baseline; 1-month after discharge (secondary endpoint); 3-month after discharge (primary endpoint); 6-month after discharge (secondary endpoint) A clinical test where the patient performes as many sit to stand actions as possible in 30 seconds. Measures leg muscle strength by counting the number of repetitions.
1-minute sit to stand Baseline; 1-month after discharge (secondary endpoint); 3-month after discharge (primary endpoint); 6-month after discharge (secondary endpoint) A clinical test where the patient performes as many sit to stand actions as possible in 1 minute. Measures endurance by counting the number of repetitions
6-minute walking test Baseline; 1-month after discharge (secondary endpoint); 3-month after discharge (primary endpoint); 6-month after discharge (secondary endpoint) Measure the distance in meters a person can walk during 6 minutes.
Short Physical Performance Battery and (SPPB) Baseline; 1-month after discharge (secondary endpoint); 3-month after discharge (primary endpoint); 6-month after discharge (secondary endpoint) An objective measurement instrument combining 3 test in 1 score. The tests consist of a balance test (measured in seconds), lower extremity strength (measured in seconds), and a walkning test measuring functional capacity (measured in seconds).
Barthel index Baseline; 1-month after discharge (secondary endpoint); 3-month after discharge (primary endpoint); 6-month after discharge (secondary endpoint) Measure of a persons ability to perform activities of daily living. Scores from 0 to 100. The higher the better.
Clinically Frailty Scale Baseline; 1-month after discharge (secondary endpoint); 3-month after discharge (primary endpoint); 6-month after discharge (secondary endpoint) A global clinical measure of the overall frailty of an older person.
FRAIL Scale Baseline; 1-month after discharge (secondary endpoint), 3-month after discharge (primary endpoint), and 6-month after discharge (secondary endpoint). A global clinical measure of the overall frailty of an older person.
EuroQol-5D-5L (EQ-5D-5L) Baseline; 1-month after discharge (secondary endpoint); 3-month after discharge (primary endpoint); 6-month after discharge (secondary endpoint) Patient completed questionaires that assess quality of life.
36-Item Short Form Survey (SF-36) Baseline; 1-month after discharge (secondary endpoint); 3-month after discharge (primary endpoint); 6-month after discharge (secondary endpoint) Patient completed questionaires that assess quality of life.
COPD Assessment Test (CAT) Baseline; 1-month after discharge (secondary endpoint); 3-month after discharge (primary endpoint); 6-month after discharge (secondary endpoint) A patient self administered questionaire. 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).
Montreal Cognitive Assessment (MoCA) Baseline; 1-month after discharge (secondary endpoint); 3-month after discharge (primary endpoint); 6-month after discharge (secondary endpoint) Measure of mild cognitive impairment.
Center for Epidemiologic Studies Depression Scale (CES-D) Baseline; 1-month after discharge (secondary endpoint); 3-month after discharge (primary endpoint); 6-month after discharge (secondary endpoint) A self-report rating scale that is designed to measure current symptoms of depression. Lower score is better.
Family Reported Outcome Measure (FROM-16) Baseline; 1-month after discharge (secondary endpoint); 3-month after discharge (primary endpoint); 6-month after discharge (secondary endpoint) 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.
Physical activity level Baseline; 1-month after discharge (secondary endpoint); 3-month after discharge (primary endpoint); 6-month after discharge (secondary endpoint) The objectivly measured physical activity level assessed with activity trackers.
Blood sample 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). Concentration of HbA1c, p-glucose, p-insulin, and c-peptide.
Immune function 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). 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.
Biobank blood sample 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). Whole blood, plasma, and serum.
Insulin resistance Baseline; 1-month after discharge (secondary endpoint); 3-month after discharge (primary endpoint), and 6-month after discharge (secondary endpoint). Fasting p-glucose and p-insulin for calculation of insulin resistance by HOMA-IR.
Glycemic variability Baseline (day 0-10); 3-month after discharge (day 80-90, primary endpoint), and 6-month after discharge (day 170-180, secondary endpoint). 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).
Oral glucose tolerance test (OGTT) Baseline; 3-month after discharge (primary endpoint), and 6-month after discharge (secondary endpoint). P-glucose, p-insulin, and c-peptide measured during an OGTT.
Semi-structured qualitative interviews 1-month after discharge (seconary endpoint), 3-month after discharge (primary endpoint), and 6-month after discharge (secondary endpoint). 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
Re-hospitalization (infection-related and all-cause) 30 days after discharge; 90 days after discharge; 180 days after discharge. Report of the total number of re-hospitalized patients, defined as a hospital stay \>12 hours.
Mortality (infection-related and all-cause) 30 days after discharge; 90 days after discharge; 180 days after discharge; 360 days after discharge Report of the total number.
Adverse events At 1-month after discharge, 3-month after discharge (primary endpoint), and 6-month after discharge. Numbers of severe adverse events and adverse events
Trial Locations
- Locations (3)
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