Physical Training During Hospital Admission With Community-Acquired Pneumonia
- Conditions
- Community-acquired Pneumonia
- Interventions
- Behavioral: Exercise bookletBehavioral: In-bed cycling
- Registration Number
- NCT04094636
- Lead Sponsor
- Nordsjaellands Hospital
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 210
- 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.
- 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).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Exercise booklet Exercise booklet Supervised physical training with exercises from exercise booklet In-bed cycling In-bed cycling Supervised in-bed cycling
- Primary Outcome Measures
Name Time Method Length of hospital stay From admission until discharge (an average of 5 days) Number of stays in hospital
- Secondary Outcome Measures
Name Time Method Readmissions Number of readmissions 3-months from discharge Time-to-event within 3-months from discharge
Mortality 6-months from discharge Time-to-event within 6-months from discharge
Changes in total lean mass Day 1, day 5, discharge, 1- and 3-months from discharge Dual-energy x-ray absorptiometry scans
Changes in total fat mass Day 1, day 5, discharge, 1- and 3-months from discharge Dual-energy x-ray absorptiometry scans
Changes in total fat-free mass Day 1, day 5, discharge, 1- and 3-months from discharge Bioelectrical impedance analysis
Health-related quality of life Day 1, discharge, 1-, 3- and 6-months from discharge 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
Activities of daily living Day 1, discharge, 1 month from discharge and 3 months from discharge Scoring from 0 to 100 on the Barthel Index for Activities of Daily Living (ADL) with higher score indicating greater independence.
Muscle strength At day 1, day 5, discharge, 1- and 3-months after discharge Hand grip strength test
Functional ability Day 1, day 5, discharge, 1- and 3-months after discharge 30-sec chair stand test
Systemic inflammation Daily during admission (day 0 to 5), 1- and 3-months after discharge Pro- and anti-inflammatory cytokine concentrations measured in pg/ml (IL-6, IL-8, IL-18, IL-1a, IL-10, TNF-alpha)
Physical activity monitoring During admission (up to 7 days), 7 days from discharge, 7 days from 1- and 3 months follow-up AX3 accelerometers
Trial Locations
- Locations (1)
Department of Pulmonary and Infectious Diseases, Nordsjællands Hospital
🇩🇰Hillerød, Denmark