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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Urinary Tract Infections; Community-acquired Pneumonia
• Intervention / Treatment: Behavioral: Video-supervised home-based exercise training

• Study Type: Interventional
• Enrollment (Estimated): 460
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Birgitte Lindegaard, MD, PhD; Phone Number: +4548293874; Email: birgitte.lindegaard.madsen@regionh.dk
• Study Contact Backup: Name: Camilla Koch Ryrsø, MSc, PhD; Phone Number: +4548293261; Email: camilla.koch.ryrsoe.01@regionh.dk

Study Locations

• Denmark
  • Hillerød, Denmark, 3400
    • Department of Pulmonary and Infectious Diseases, Copenhagen University Hospital
    • Contact: Birgitte Lindegaard, MD, PhD; Phone Number: +4548293874; Email: birgitte.lindegaard.madsen@regionh.dk
    • Contact: Camilla Koch Ryrsø, MSc, PhD; Phone Number: +4548293261; Email: camilla.koch.ryrsoe.01@regionh.dk
  • Hvidovre, Denmark, 2650
    • Department of Infectious Diseases, Copenhagen University Hospital, Amager-Hvidovre
  • Hvidovre, Denmark, 2650
    • Department of Respiratory Medicine, Copenhagen University Hospital, Amager-Hvidovre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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).	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.
No Intervention: 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Center for Epidemiologic Studies Depression Scale (CES-D)	A self-report rating scale that is designed to measure current symptoms of depression. Lower score is better.	Baseline; 1-month after discharge (secondary endpoint); 3-month after discharge (primary endpoint); 6-month after discharge (secondary endpoint)
Physical activity level	The objectivly measured physical activity level assessed with activity trackers.	Baseline; 1-month after discharge (secondary endpoint); 3-month after discharge (primary endpoint); 6-month after discharge (secondary endpoint)
Blood sample	Concentration of p-phosphate (mmol/l), p-sodium (mmol/l), p-carbamide (mmol/l), and p-potassium (mmol/l).	Baseline; discharge (secondary endpoint); 1-month after discharge (seconary endpoint), 3-month after discharge (primary endpoint), 6-month after discharge (secondary endpoint), and 12-month after discharge (secondary endpoint).
Blood sample	Concentration of pro- and anti-inflammatory cytokines (IL-6, Il-1ra, IL-18, IL-10, TNF-alpha, etc.)	Baseline; discharge (secondary endpoint); 1-month after discharge (seconary endpoint), 3-month after discharge (primary endpoint), 6-month after discharge (secondary endpoint), and 12-month after discharge (secondary endpoint).
Blood sample	Concentration of lipids	Baseline; discharge (secondary endpoint); 1-month after discharge (seconary endpoint), 3-month after discharge (primary endpoint), 6-month after discharge (secondary endpoint), and 12-month after discharge (secondary endpoint).
Blood sample	Concentration of galectin-3 (ng/ml), sST2 (ng/ml), and troponins (ng/ml).	Baseline; discharge (secondary endpoint); 1-month after discharge (seconary endpoint), 3-month after discharge (primary endpoint), 6-month after discharge (secondary endpoint), and 12-month after discharge (secondary endpoint).
Blood sample	Concentration of NT-proBNP (ng/l).	Baseline; discharge (secondary endpoint); 1-month after discharge (seconary endpoint), 3-month after discharge (primary endpoint), 6-month after discharge (secondary endpoint), and 12-month after discharge (secondary endpoint).
Immune function	Complete blood count with differential count. Concentration of immunoglobulin G (IgG), immunoglobulin M (IgM), and immunoglobulin A (IgA), and concentration of subclasses of IgG: IgG1, IgG2, IgG3, and IgG4.	Baseline; discharge (secondary endpoint); 1-month after discharge (seconary endpoint), 3-month after discharge (primary endpoint), 6-month after discharge (secondary endpoint), and 12-month after discharge (secondary endpoint).
Biobank blood sample	Whole blood, plasma, and serum.	Baseline; discharge (secondary endpoint); 1-month after discharge (seconary endpoint), 3-month after discharge (primary endpoint), 6-month after discharge (secondary endpoint), and 12-month after discharge (secondary endpoint).
Glycemic variability	Glucose outcomes from the CGM sensor (Dexcom G6) including time in range (TIR) for blood glucose, time above range (TAR) for blood glucose, time below range (TBR) for blood glucose, average blood glucose, and variance in blood glucose (CV).	Baseline (day 0-10); 3-month after discharge (day 80-90, primary endpoint), and 6-month after discharge (day 170-180, secondary endpoint).
Semi-structured qualitative interviews	Semi-structured qualitative interviews with the patient and a relative. The following themes will be explored: perception of the content in the exercise intervention, barriers and enablers towards physical activity, ideas for improvement of the exercise intervention	1-month after discharge (seconary endpoint), 3-month after discharge (primary endpoint), and 6-month after discharge (secondary endpoint).
Mortality (infection-related and all-cause)	Report of the total number.	30 days after discharge; 90 days after discharge; 180 days after discharge; 360 days after discharge
Adverse events	Numbers of severe adverse events and adverse events	At 1-month after discharge, 3-month after discharge (primary endpoint), and 6-month after discharge.
Re-hospitalization (infection-related and all-cause)	Report of the total number of re-hospitalized patients, defined as a hospital stay >12 hours.	30 days after discharge; 180 days after discharge.
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.	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	Assessment of muscle strength and power of the knee extensor muscles with dynamometry.	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	A clinical test where the patient performs as many sit-to-stand actions as possible in 30 seconds. Measures leg muscle strength by counting the number of repetitions.	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	A clinical test where the patient performs as many sit-to-stand actions as possible in 1 minute. Measures endurance by counting the number of repetitions.	Baseline; 1-month after discharge (secondary endpoint); 3-month after discharge (primary endpoint); and 6-month after discharge (secondary endpoint).
6-minute walking test	Measure the distance in meters a person can walk in 6 minutes.	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)	An objective measurement instrument combining 3 tests in 1 score. The tests consist of a balance test (measured in seconds), lower extremity strength (measured in seconds), and a walking test measuring functional capacity (measured in seconds).	Baseline; 1-month after discharge (secondary endpoint); 3-month after discharge (primary endpoint); and 6-month after discharge (secondary endpoint).
Barthel index	Measure of a persons ability to perform activities of daily living. Scores from 0 to 100. The higher the better.	Baseline; 1-month after discharge (secondary endpoint); 3-month after discharge (primary endpoint); and 6-month after discharge (secondary endpoint).
Clinically Frailty Scale	A global clinical measure of the overall frailty of an older person. Scores from 1 to 9. The lower the better.	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)	Measure health-related quality of life divided into the EQ-5D utility index and EQ-VAS score. The Danish EQ-5D-5L utility scores range from -0.757 for state 55555 to 1.0 for state 11111; the higher the score, the better. The EQ VAS is on a 0-100 scale; the higher the score, the better.	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)	Measure health-related quality of life. Total score from 0 to 100; the higher the score, the better.	Baseline; 1-month after discharge (secondary endpoint); 3-month after discharge (primary endpoint); and 6-month after discharge (secondary endpoint).
COPD Assessment Test (CAT)	A patient self-administered questionnaire. An 8-item questionnaire designed to assess the impact of disease on a person's life (health status). Range of CAT scores from 0-40. Higher scores implicates a more severe impact of COPD on a patient's life (total score point).	Baseline; 1-month after discharge (secondary endpoint); 3-month after discharge (primary endpoint); and 6-month after discharge (secondary endpoint).
Montreal Cognitive Assessment (MoCA)	Measure of mild cognitive impairment. MoCa scores range from 0 to 30. Scores of 26 or over are considered to be normal.	Baseline; 1-month after discharge (secondary endpoint); 3-month after discharge (primary endpoint); and 6-month after discharge (secondary endpoint).
Family Reported Outcome Measure (FROM-16)	Measure of the impact on the quality of life of an adult family member or partner resulting from having a person (of any age) in a family with any disease or condition, across all of medicine.	1-month after discharge (secondary endpoint); 3-month after discharge (primary endpoint); 6-month after discharge (secondary endpoint)
Blood sample	Concentration of HbA1c.	Baseline; discharge (secondary endpoint); 1-month after discharge (seconary endpoint), 3-month after discharge (primary endpoint), 6-month after discharge (secondary endpoint), and 12-month after discharge (secondary endpoint).
Blood sample	Concentration of c-peptide (pmol/L).	Baseline; 1-month after discharge (secondary endpoint); 3-month after discharge (primary endpoint); 6-month after discharge (secondary endpoint); and 12-month after discharge (secondary endpoint).
Blood sample	Concentration p-glucose (mmol/L).	Baseline; 1-month after discharge (secondary endpoint); 3-month after discharge (primary endpoint); 6-month after discharge (secondary endpoint); and 12-month after discharge (secondary endpoint).
Blood sample	Concentration of p-insulin (pmol/L).	Baseline; 1-month after discharge (secondary endpoint); 3-month after discharge (primary endpoint); 6-month after discharge (secondary endpoint); and 12-month after discharge (secondary endpoint).
Insulin resistance	The Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) will be used to measure severity of insulin resistance. Normal reference levels for HOMA-IR is 0.7 to 2.0, with values >2.0 representing clinically significant insulin resistance.	Baseline; 1-month after discharge (secondary endpoint); 3-month after discharge (primary endpoint), and 6-month after discharge (secondary endpoint).
P-glucose during an oral glucose tolerance test (OGTT)	P-glucose (mmol/L) measured during an OGTT.	Baseline; 3-month after discharge (primary endpoint), and 6-month after discharge (secondary endpoint).
P-insulin during an oral glucose tolerance test (OGTT)	P-insulin (pmol/L) measured during an OGTT.	Baseline; 3-month after discharge (primary endpoint), and 6-month after discharge (secondary endpoint).
C-peptide during an oral glucose tolerance test (OGTT)	C-peptide (pmol/L) measured during an OGTT.	Baseline; 3-month after discharge (primary endpoint), and 6-month after discharge (secondary endpoint).
Insulin sensitivity	Insulin sensitivity using Matsuda index. The index is calculated based on p-glucose and p-insulin in fasting state and during an OGTT.	Baseline; 3 month after discharge (primary endpoint); 6 months after discharge (secondary endpoint).
Glucose-lowering medication	Changes in glucose-lowering medication in patients with diabetes	Baseline; 3 months after discharge (primary endpoint); 6 months after discharge (secondary endpoint)
Total and appendicular lean and fat mass	DXA-scan	Baseline; 1-month after discharge (secondary endpoint); 3-month after discharge (primary endpoint); and 6-month after discharge (secondary endpoint).
Muslce quality and density	Midt-thigh CT-scan	Baseline; 3-month after discharge (primary endpoint); and 6-month after discharge (secondary endpoint).
Fat mass index and fat-free mass index	Bioelectrical impedance analysis	Baseline; 1-month after discharge (secondary endpoint); 3-month after discharge (primary endpoint); and 6-month after discharge (secondary endpoint).
Muscle oxidative stress and inflammation	Muscle biopsies from the m. vastus lateralis of the quadriceps muscle	Baseline; 3-month after discharge (primary endpoint); and 6-month after discharge (secondary endpoint).
Muscle protein synthesis and proteolysis	Muscle biopsies from the m. vastus lateralis of the quadriceps muscle	Baseline; 3-month after discharge (primary endpoint); and 6-month after discharge (secondary endpoint).
Muscle insulin sensitivity	Muscle biopsies from the m. vastus lateralis of the quadriceps muscle	Baseline; 3-month after discharge (primary endpoint); and 6-month after discharge (secondary endpoint).
Skeletal muscle cell growth, development, and function	Skeletal muscle cell cultures of muscle tissue from m. vastus lateralis of the quadriceps muscle.	Baseline; 3-month after discharge (primary endpoint); and 6-month after discharge (secondary endpoint)
Insulin sensitivity and signaling of adipose tissue	Adipose tissue biopsy	Baseline; 3-month after discharge (primary endpoint); and 6-month after discharge (secondary endpoint)
Adipose tissue inflammation	Adipose tissue biopsy	Baseline; 3-month after discharge (primary endpoint); and 6-month after discharge (seconary endpoint)
Adipose tissue immune cell infiltration	Adipose tissue biopsy	Baseline; 3-month after discharg (primary endpoint); and 6-month after discharge (secondary endpoint)
Pulmonary medication	Changes in pulmonary medication (tablets and inhalation)	Baseline; 3 months after discharge (primary endpoint); 6 months after discharge (secondary endpoint)
Lung function	Spirometry in patients with COPD	Baseline; 3 months after discharge (primary endpoint); 6 months after discharge (secondary endpoint)
Lung function	Body plethysmography in patients with COPD	Baseline; 3 months after discharge (primary endpoint); 6 months after discharge (secondary endpoint)
Lung function	Single-breath carbon monoxide uptake in patients with COPD	Baseline, 3 months after discharge (primary endpoint); 6 months after discharge (seconary endpoint)
Acute exacerbations of COPD	Notification of acute exacerbations of COPD through patient files	Baseline; 3 months after discharge (primary endpoint); 6 months after discharge (secondary endpoint)
Health economics	Health costs, the cost per quality-adjusted life years (QALYs), and the lifetime estimated cost per QALY gained will be calculated.	From baseline to 360 days after discharge.

Collaborators and Investigators

• Sponsor: Nordsjaellands Hospital
• Investigators: Principal Investigator: Birgitte Lindegaard, MD, PhD, Department of Pulmonary and Infectious Diseases, Copenhagen University Hospital - North Zealand

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2026
• Primary Completion (Estimated): March 31, 2029
• Study Completion (Estimated): December 31, 2029

Study Registration Dates

• First Submitted: November 12, 2024
• First Submitted That Met QC Criteria: November 12, 2024
• First Posted (Actual): November 14, 2024

Study Record Updates

• Last Update Posted (Actual): December 2, 2025
• Last Update Submitted That Met QC Criteria: November 26, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: CAP; UTI
• Additional Relevant MeSH Terms: Urogenital Diseases; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Respiratory Tract Infections; Infections; Respiratory Tract Diseases; Pneumonia; Community-Acquired Infections; Urinary Tract Infections; Community-Acquired Pneumonia
• Other Study ID Numbers: REHAB-CAI (H-24047753)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No