Community-acquired PneumoniaREHAB-CAINCT06689280
Physical Rehabilitation of Older Persons Following a Community-Acquired Infection Hospitalization - A Randomised-Controlled Trial
A study testing Video-supervised home-based exercise training in people with Community-acquired Pneumonia and Urinary Tract Infections, run by Nordsjaellands Hospital at 3 sites in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Community-acquired Pneumonia, Urinary Tract Infections
- What is being tested?
- Video-supervised home-based exercise training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 460 participants
- Where
- 3 sitesDenmark
- Study dates
- 1 Jan 2026to 31 Dec 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged ≥65 years or 18-64 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.
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark3 sites
Department of Pulmonary and Infectious Diseases, Copenhagen University Hospital
Hillerød, 3400
Birgitte Lindegaard, MD, PhD, +4548293874, birgitte.lindegaard.madsen@regionh.dk
Camilla Koch Ryrsø, MSc, PhD, +4548293261, camilla.koch.ryrsoe.01@regionh.dk
Department of Infectious Diseases, Copenhagen University Hospital, Amager-Hvidovre
Hvidovre, 2650
Department of Respiratory Medicine, Copenhagen University Hospital, Amager-Hvidovre
Hvidovre, 2650
About this study
Official title: Physical Rehabilitation of Older Persons Following a Community-Acquired Infection Hospitalization: A Feasibility Study
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.
- Being tested
- Video-supervised home-based exercise training
- Keywords
- CAP, UTI
- Medical subject headings
- Community-Acquired Pneumonia, Urinary Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Video-supervised home-based exercise trainingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Video-supervised home-based exercise training | Experimental | In-hospital exercise training: 30 min of daily one-on-one supervised exercise training using exercises from the exercise booklet "Sick but Healthy and Active".
Patient-centred video-supervised home-based exercise intervention phase (weeks 0-12): 3 weekly exercise sessions (3 supervised sessions/week) over 12 weeks. Each session will last 45-50 min, consisting of 10-15 min of endurance, 20-30 min of resistance, and 5 min of balance exercises. The exercise intensity will progressively increase during the 12 weeks and be based on a target training intensity of 4-7 points on the Borg CR-10 scale. The exercise training is supplemented with weekly, individualised step-count goals that progressively increase (+5%) if previous step goals are achieved.
Self-directed maintenance exercise phase (weeks 13-24): unsupervised self-directed exercise training 3 times per week for 12 weeks with phone calls, but with less frequency (see standard care below). Receives: Behavioral: Video-supervised home-based exercise training |
| Standard care | No intervention | In-hospital: Patients will receive standard of care as recommended by their healthcare personnel. Control phase (weeks 0-12): Patients are contacted biweekly by phone calls after discharge up to 12 weeks after discharge. The patients will not receive any specific recommendations regarding physical activity. Control phase (week 13-24): The patients will continuously receive phone calls, but with less frequency (i.e., 3 calls per week in week 13-16, 1 call per week in week 17-20, and 0 call per week in week 21-24). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Re-hospitalization (infection-related and all-cause)
Report of the total number of re-hospitalized patients, defined as a hospital stay >12 hours.
Measured: 90 days after discharge.
Secondary outcomes (53)
Re-hospitalization (infection-related and all-cause)
Report of the total number of re-hospitalized patients, defined as a hospital stay >12 hours.
Measured: 30 days after discharge; 180 days after discharge.
Mortality (infection-related and all-cause)
Report of the total number.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.)
Measured: 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
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: Baseline; 3-month after discharge (primary endpoint); and 6-month after discharge (secondary endpoint)
Insulin sensitivity and signaling of adipose tissue
Adipose tissue biopsy
Measured: Baseline; 3-month after discharge (primary endpoint); and 6-month after discharge (secondary endpoint)
Adipose tissue inflammation
Adipose tissue biopsy
Measured: Baseline; 3-month after discharge (primary endpoint); and 6-month after discharge (seconary endpoint)
Adipose tissue immune cell infiltration
Adipose tissue biopsy
Measured: Baseline; 3-month after discharg (primary endpoint); and 6-month after discharge (secondary endpoint)
Pulmonary medication
Changes in pulmonary medication (tablets and inhalation)
Measured: Baseline; 3 months after discharge (primary endpoint); 6 months after discharge (secondary endpoint)
Lung function
Spirometry in patients with COPD
Measured: Baseline; 3 months after discharge (primary endpoint); 6 months after discharge (secondary endpoint)
Lung function
Body plethysmography in patients with COPD
Measured: Baseline; 3 months after discharge (primary endpoint); 6 months after discharge (secondary endpoint)
Lung function
Single-breath carbon monoxide uptake in patients with COPD
Measured: 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
Measured: 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.
Measured: From baseline to 360 days after discharge.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2024
- Study start1 Jan 2026 (estimated)
- Primary completion31 Mar 2029 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Community-acquired PneumoniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 460 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nordsjaellands Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Birgitte Lindegaard Madsen, Nordsjaellands Hospital
- Investigators
- Birgitte Lindegaard, MD, PhD, Principal investigator, Department of Pulmonary and Infectious Diseases, Copenhagen University Hospital - North Zealand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06689280
- Sponsor's protocol ID
- REHAB-CAI (H-24047753)
- Acronym
- REHAB-CAI
- Status last verified
- Nov 2025
- First submitted
- 12 Nov 2024
- Last updated
- 2 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physical Rehabilitation of Older Persons Following a Community-Acquired Infection Hospitalization: A Feasibility Study
- ClinicalTrials.gov ID
- NCT06689280
- Acronym / sponsor ID
- REHAB-CAI / REHAB-CAI (H-24047753)
- Keywords
- CAP, UTI
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 460 participants (estimated)
- Lead sponsor
- Nordsjaellands HospitalUniversity, hospital or other
- Study start
- 1 Jan 2026 (estimated)
- Primary completion
- 31 Mar 2029 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 14 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Video-supervised home-based exercise training | Experimental | Behavioral: Video-supervised home-based exercise trainingIn-hospital exercise training: 30 min of daily one-on-one supervised exercise training using exercises from the exercise booklet "Sick but Healthy and Active". Patient-centred video-supervised home-based exercise intervention phase (weeks 0-12): 3 weekly exercise sessions (3 supervised sessions/week) over 12 weeks. Each session will last 45-50 min, consisting of 10-15 min of endurance, 20-30 min of resistance, and 5 min of balance exercises. The exercise intensity will progressively increase during the 12 weeks and be based on a target training intensity of 4-7 points on the Borg CR-10 scale. The exercise training is supplemented with weekly, individualised step-count goals that progressively increase (+5%) if previous step goals are achieved. Self-directed maintenance exercise phase (weeks 13-24): unsupervised self-directed exercise training 3 times per week for 12 weeks with phone calls, but with less frequency (see standard care below). |
| Standard care | No intervention | –In-hospital: Patients will receive standard of care as recommended by their healthcare personnel. Control phase (weeks 0-12): Patients are contacted biweekly by phone calls after discharge up to 12 weeks after discharge. The patients will not receive any specific recommendations regarding physical activity. Control phase (week 13-24): The patients will continuously receive phone calls, but with less frequency (i.e., 3 calls per week in week 13-16, 1 call per week in week 17-20, and 0 call per week in week 21-24). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients aged ≥65 years or 18-64 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Video-supervised home-based exercise training12 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. | Behavioural | Video-supervised home-based exercise training |
Primary outcome
Re-hospitalization (infection-related and all-cause)
Time frame: 90 days after discharge.
Report of the total number of re-hospitalized patients, defined as a hospital stay >12 hours.
53 secondary outcomes
Re-hospitalization (infection-related and all-cause)
Time frame: 30 days after discharge; 180 days after discharge.
Mortality (infection-related and all-cause)
Time frame: 30 days after discharge; 90 days after discharge; 180 days after discharge; 360 days after discharge
Handgrip strength
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
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
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
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
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)
Time frame: Baseline; 1-month after discharge (secondary endpoint); 3-month after discharge (primary endpoint); and 6-month after discharge (secondary endpoint).
Barthel index
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
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)
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)
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)
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)
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)
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)
Time frame: 1-month after discharge (secondary endpoint); 3-month after discharge (primary endpoint); 6-month after discharge (secondary endpoint)
Physical activity level
Time frame: Baseline; 1-month after discharge (secondary endpoint); 3-month after discharge (primary endpoint); 6-month after discharge (secondary endpoint)
Blood sample
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
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
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
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
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
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
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
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
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
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
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
Time frame: Baseline; 1-month after discharge (secondary endpoint); 3-month after discharge (primary endpoint), and 6-month after discharge (secondary endpoint).
Glycemic variability
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)
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)
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)
Time frame: Baseline; 3-month after discharge (primary endpoint), and 6-month after discharge (secondary endpoint).
Insulin sensitivity
Time frame: Baseline; 3 month after discharge (primary endpoint); 6 months after discharge (secondary endpoint).
Glucose-lowering medication
Time frame: Baseline; 3 months after discharge (primary endpoint); 6 months after discharge (secondary endpoint)
Semi-structured qualitative interviews
Time frame: 1-month after discharge (seconary endpoint), 3-month after discharge (primary endpoint), and 6-month after discharge (secondary endpoint).
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
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
Time frame: Baseline; 3-month after discharge (primary endpoint); and 6-month after discharge (secondary endpoint).
Fat mass index and fat-free mass index
Time frame: Baseline; 1-month after discharge (secondary endpoint); 3-month after discharge (primary endpoint); and 6-month after discharge (secondary endpoint).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Birgitte Lindegaard, MD, PhD principal investigator
Department of Pulmonary and Infectious Diseases, Copenhagen University Hospital - North Zealand
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Video-supervised home-based exercise training in people with Community-acquired Pneumonia and Urinary Tract Infections, run by Nordsjaellands Hospital at 3 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 2 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Birgitte Lindegaard, MD, PhD (+4548293874, birgitte.lindegaard.madsen@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Re-hospitalization (infection-related and all-cause) (time frame: 90 days after discharge.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2025; AzTrials last refreshed its copy on 8 Nov 2026.