Physical Rehabilitation of Older Persons Following a Community-Acquired Infection Hospitalization - A Randomised-Controlled Trial
NCT ID: NCT06689280
Last Updated: 2025-12-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
460 participants
INTERVENTIONAL
2026-01-01
2029-12-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Video-supervised home-based exercise training
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).
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.
Standard care
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).
No interventions assigned to this group
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Nordsjaellands Hospital
OTHER
Responsible Party
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Birgitte Lindegaard Madsen
Associate professor, research responsible chief physician, PhD
Principal Investigators
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Birgitte Lindegaard, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Department of Pulmonary and Infectious Diseases, Copenhagen University Hospital - North Zealand
Locations
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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
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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REHAB-CAI (H-24047753)
Identifier Type: -
Identifier Source: org_study_id
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