Physical Training During Hospital Admission With Community-Acquired Pneumonia

Study Overview
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Brief Summary
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The purpose of this study is to assess the effect of standard usual care combined with daily supervised physical training during hospitalization with community-acquired pneumonia (CAP) compared to standard usual care alnone.

Detailed Description
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Community-acuired pneumonia (CAP) is a leading cause of hospitalization worldwide. Despite increased focus on mobilization, hospitalization is associated with bed rest. Bed rest with low levels of physical activity leads to functional deline as well as increased risk of complications. This study is a randomized controlled trial, which investigates the effect of standard usual care combined with daily supervised physical training in patients hospitalized with CAP compared to standard usual care alone.

Official Title
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Physical Training During Hospital Admission With Community-Acquired Pneumonia

Conditions
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Community-acquired Pneumonia

Intervention / Treatment
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* Behavioral: In-bed cycling
* Behavioral: Exercise booklet


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients 18 years of age or older admitted to hospital with CAP defined as a new infiltrate on chest X-ray/CT and minimum one of the following symptoms: temperature <35˚C or ≥38˚C, cough, pleuritic chest pain, dyspnea, or focal chest signs on auscultation. Patients should have an expected admission length of ≥72 hours. Patients should be able to move their legs. Exclusion Criteria: Patients unable to give written consent. Hospital admission within the last 14 days. Severe immunosuppression (cancer chemotherapy ≤28 days, neutropenia ≤1000 cells/μL, ≥20 mg prednisolone-equivalent/day >14 days or other immunosuppressive drugs, HIV infection, former transplant).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: No intervention: Control<br>Control group | |
| Experimental: In-bed cycling<br>Supervised in-bed cycling | Behavioral: In-bed cycling<br>* Patients will daily perform 30 min of supervised in-bed cycling<br>|
| Experimental: Exercise booklet<br>Supervised physical training with exercises from exercise booklet | Behavioral: Exercise booklet<br>* Patients will daily perform 30 min of supervised physical training with exercises from the exercise booklet<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of hospital stay | Number of stays in hospital | From admission until discharge (an average of 5 days) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Readmissions Number of readmissions | Time-to-event within 3-months from discharge | 3-months from discharge | 
| Mortality | Time-to-event within 6-months from discharge | 6-months from discharge | 
| Changes in total lean mass | Dual-energy x-ray absorptiometry scans | Day 1, day 5, discharge, 1- and 3-months from discharge | 
| Changes in total fat mass | Dual-energy x-ray absorptiometry scans | Day 1, day 5, discharge, 1- and 3-months from discharge | 
| Changes in total fat-free mass | Bioelectrical impedance analysis | Day 1, day 5, discharge, 1- and 3-months from discharge | 
| Health-related quality of life | Scoring from -0.624 to 1.000 on the 5-level EQ-5D version (EQ-5D-5L) questionnaire (Danish version), with higher score indicating better health-related quality of life | Day 1, discharge, 1-, 3- and 6-months from discharge | 
| Activities of daily living | Scoring from 0 to 100 on the Barthel Index for Activities of Daily Living (ADL) with higher score indicating greater independence. | Day 1, discharge, 1 month from discharge and 3 months from discharge | 
| Muscle strength | Hand grip strength test | At day 1, day 5, discharge, 1- and 3-months after discharge | 
| Functional ability | 30-sec chair stand test | Day 1, day 5, discharge, 1- and 3-months after discharge | 
| Systemic inflammation | Pro- and anti-inflammatory cytokine concentrations measured in pg/ml (IL-6, IL-8, IL-18, IL-1a, IL-10, TNF-alpha) | Daily during admission (day 0 to 5), 1- and 3-months after discharge | 
| Physical activity monitoring | AX3 accelerometers | During admission (up to 7 days), 7 days from discharge, 7 days from 1- and 3 months follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Physical training