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

NCT06689280 | Not Yet Recruiting

• 1 other identifier: REHAB-CAI (H-24047753)
• Study Type: interventional
• Target: 460
• Locations: 1 country
• Sites: 3

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.

Conditions

Community-acquired Pneumonia; Urinary Tract Infections

Keywords

CAP; UTI

Outcome Measures

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.

  90 days after discharge.

Secondary Outcomes (53)

• Re-hospitalization (infection-related and all-cause)

  30 days after discharge; 180 days after discharge.

• Mortality (infection-related and all-cause)

  30 days after discharge; 90 days after discharge; 180 days after discharge; 360 days after discharge

• Handgrip strength

  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

  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

  Baseline; 1-month after discharge (secondary endpoint); 3-month after discharge (primary endpoint); and 6-month after discharge (secondary endpoint).

Study Arms (2)

Video-supervised home-based exercise training

EXPERIMENTAL

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).

Behavioral: Video-supervised home-based exercise training

Standard care

NO INTERVENTION

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).

Interventions

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.

Video-supervised home-based exercise training

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nordsjaellands Hospital: lead

Study Sites (3)

Department of Pulmonary and Infectious Diseases, Copenhagen University Hospital

Hillerød, 3400, Denmark

Location

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

Hvidovre, 2650, Denmark

Location

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

Hvidovre, 2650, Denmark

Location

MeSH Terms

Conditions

Community-Acquired Pneumonia; Urinary Tract Infections

Condition Hierarchy (Ancestors)

Community-Acquired Infections; Infections; Pneumonia; Respiratory Tract Infections; Respiratory Tract Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Birgitte Lindegaard, MD, PhD

  Department of Pulmonary and Infectious Diseases, Copenhagen University Hospital - North Zealand

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Birgitte Lindegaard, MD, PhD

CONTACT

+4548293874; birgitte.lindegaard.madsen@regionh.dk

Camilla Koch Ryrsø, MSc, PhD

CONTACT

+4548293261; camilla.koch.ryrsoe.01@regionh.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor, research responsible chief physician, PhD

Study Record Dates

• First Submitted: November 12, 2024
• First Posted: November 14, 2024
• Study Start: January 1, 2026
• Primary Completion (Estimated): March 31, 2029
• Study Completion (Estimated): December 31, 2029
• Last Updated: December 2, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

DK (3)