Clinical trial NCT06689280: Physical Rehabilitation of Older Persons Following a Community-Acquired Infection Hospitalization: a Feasibility Study
Official title: Physical Rehabilitation of Older Persons Following a Community-Acquired Infection Hospitalization: a Feasibility Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Community-acquired Pneumonia
Urinary Tract Infections
Keywords: CAP
UTI
Lead sponsor: Nordsjaellands Hospital
Sponsor class: OTHER
First posted: 2024-11-14
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Eligibility
timeFrame: Assesment before enrollment
measure: Adherence
timeFrame: Baseline; 12-weeks from discharge (primary endpoint); 24-weeks from discharge (secondary endpoint)
measure: Acceptability
timeFrame: Acceptance when enrolling the project
Secondary outcomes:
measure: Handgrip strength
timeFrame: Baseline; 1-month after discharge (secondary endpoint); 3-month after discharge (primary endpoint); 6-month after discharge (secondary endpoint)
measure: Lower limb muscle strength and power
timeFrame: Baseline; 1-month after discharge (secondary endpoint), 3-month after discharge (primary endpoint), and 6-month after discharge (secondary endpoint).
measure: 30-second sit to stand
timeFrame: Baseline; 1-month after discharge (secondary endpoint); 3-month after discharge (primary endpoint); 6-month after discharge (secondary endpoint)
measure: 1-minute sit to stand
timeFrame: Baseline; 1-month after discharge (secondary endpoint); 3-month after discharge (primary endpoint); 6-month after discharge (secondary endpoint)
measure: 6-minute walking test
timeFrame: Baseline; 1-month after discharge (secondary endpoint); 3-month after discharge (primary endpoint); 6-month after discharge (secondary endpoint)
measure: Short Physical Performance Battery and (SPPB)
timeFrame: Baseline; 1-month after discharge (secondary endpoint); 3-month after discharge (primary endpoint); 6-month after discharge (secondary endpoint)
measure: Barthel index
timeFrame: Baseline; 1-month after discharge (secondary endpoint); 3-month after discharge (primary endpoint); 6-month after discharge (secondary endpoint)
measure: Clinically Frailty Scale
timeFrame: Baseline; 1-month after discharge (secondary endpoint); 3-month after discharge (primary endpoint); 6-month after discharge (secondary endpoint)
measure: FRAIL Scale
timeFrame: Baseline; 1-month after discharge (secondary endpoint), 3-month after discharge (primary endpoint), and 6-month after discharge (secondary endpoint).
measure: EuroQol-5D-5L (EQ-5D-5L)
timeFrame: Baseline; 1-month after discharge (secondary endpoint); 3-month after discharge (primary endpoint); 6-month after discharge (secondary endpoint)
measure: 36-Item Short Form Survey (SF-36)
timeFrame: Baseline; 1-month after discharge (secondary endpoint); 3-month after discharge (primary endpoint); 6-month after discharge (secondary endpoint)
measure: COPD Assessment Test (CAT)
timeFrame: Baseline; 1-month after discharge (secondary endpoint); 3-month after discharge (primary endpoint); 6-month after discharge (secondary endpoint)
measure: Montreal Cognitive Assessment (MoCA)
timeFrame: Baseline; 1-month after discharge (secondary endpoint); 3-month after discharge (primary endpoint); 6-month after discharge (secondary endpoint)
measure: Center for Epidemiologic Studies Depression Scale (CES-D)
timeFrame: Baseline; 1-month after discharge (secondary endpoint); 3-month after discharge (primary endpoint); 6-month after discharge (secondary endpoint)
measure: Family Reported Outcome Measure (FROM-16)
timeFrame: Baseline; 1-month after discharge (secondary endpoint); 3-month after discharge (primary endpoint); 6-month after discharge (secondary endpoint)
measure: Physical activity level
timeFrame: Baseline; 1-month after discharge (secondary endpoint); 3-month after discharge (primary endpoint); 6-month after discharge (secondary endpoint)
measure: Blood sample
timeFrame: 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).
measure: Blood sample
timeFrame: 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).
measure: Blood sample
timeFrame: 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).
measure: Blood sample
timeFrame: 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).
measure: Blood sample
timeFrame: 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).
measure: Immune function
timeFrame: 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).
measure: Blood sample
timeFrame: 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).
measure: Biobank blood sample
timeFrame: 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).
measure: Insulin resistance
timeFrame: Baseline; 1-month after discharge (secondary endpoint); 3-month after discharge (primary endpoint), and 6-month after discharge (secondary endpoint).
measure: Glycemic variability
timeFrame: Baseline (day 0-10); 3-month after discharge (day 80-90, primary endpoint), and 6-month after discharge (day 170-180, secondary endpoint).
measure: Oral glucose tolerance test (OGTT)
timeFrame: Baseline; 3-month after discharge (primary endpoint), and 6-month after discharge (secondary endpoint).
measure: Semi-structured qualitative interviews
timeFrame: 1-month after discharge (seconary endpoint), 3-month after discharge (primary endpoint), and 6-month after discharge (secondary endpoint).
measure: Re-hospitalization (infection-related and all-cause)
timeFrame: 30 days after discharge; 90 days after discharge; 180 days after discharge.
measure: Mortality (infection-related and all-cause)
timeFrame: 30 days after discharge; 90 days after discharge; 180 days after discharge; 360 days after discharge
measure: Adverse events
timeFrame: At 1-month after discharge, 3-month after discharge (primary endpoint), and 6-month after discharge.
Other outcomes:
Locations:
city: Hillerød
country: Denmark
facility: Department of Pulmonary and Infectious Diseases, Copenhagen University Hospital
city: Hvidovre
country: Denmark
facility: Department of Infectious Diseases, Copenhagen University Hospital, Amager-Hvidovre
city: Hvidovre
country: Denmark
facility: Department of Respiratory Medicine, Copenhagen University Hospital, Amager-Hvidovre
Study officials:
affiliation: Department of Pulmonary and Infectious Diseases, Copenhagen University Hospital - North Zealand
name: Birgitte Lindegaard, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: