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

Results pending

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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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

460 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-01-01

Study Completion Date

2029-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Community-acquired Pneumonia Urinary Tract Infections

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

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).

Group Type EXPERIMENTAL

Video-supervised home-based exercise training

Intervention Type 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.

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).

Group Type NO_INTERVENTION

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Nordsjaellands Hospital

OTHER

Sponsor Role lead

Responsible Party

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Birgitte Lindegaard Madsen

Associate professor, research responsible chief physician, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

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

Site Status

Department of Infectious Diseases, Copenhagen University Hospital, Amager-Hvidovre

Hvidovre, , Denmark

Site Status

Department of Respiratory Medicine, Copenhagen University Hospital, Amager-Hvidovre

Hvidovre, , Denmark

Site Status

Countries

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Denmark

Central Contacts

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Birgitte Lindegaard, MD, PhD

Role: CONTACT

+4548293874

Camilla Koch Ryrsø, MSc, PhD

Role: CONTACT

+4548293261

Facility Contacts

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Birgitte Lindegaard, MD, PhD

Role: primary

+4548293874

Camilla Koch Ryrsø, MSc, PhD

Role: backup

+4548293261

Other Identifiers

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REHAB-CAI (H-24047753)

Identifier Type: -

Identifier Source: org_study_id

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