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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorNordsjaellands Hospital

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Video-supervised home-based exercise training

    Behavioral

    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.

Treatment groups

460 Participants
are divided into 2 treatment groups
Group A: Video-supervised home-based exercise trainingExperimental treatment 1 intervention
Group B: Standard careNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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.

Secondary outcomes

1

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.
2

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
3

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).
4

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).

Other outcomes

Sponsors and contacts

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