Physical Rehabilitation of Older Persons Following a Community-Acquired Infection Hospitalization - A Randomised-Controlled Trial

Official title

Physical Rehabilitation of Older Persons Following a Community-Acquired Infection Hospitalization: A Feasibility Study

Overview

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.

Interventions

• Behavioral Video-supervised home-based exercise training
  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.

Primary outcome measures

• Re-hospitalization (infection-related and all-cause) [Time frame: 90 days after discharge.]

Secondary outcome measures (12)

• 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).]

Eligibility criteria

Inclusion criteria

• 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.

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

Denmark · 3 centers

• Department of Pulmonary and Infectious Diseases, Copenhagen University Hospital — Hillerød
• Department of Infectious Diseases, Copenhagen University Hospital, Amager-Hvidovre — Hvidovre
• Department of Respiratory Medicine, Copenhagen University Hospital, Amager-Hvidovre — Hvidovre

Identifiers

NCT: NCT06689280 · REHAB-CAI (H-24047753)

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗