Physical Training During Hospital Admission With Community-Acquired Pneumonia
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| No Intervention: No intervention: Control Control group |
|
| Experimental: In-bed cycling Supervised in-bed cycling |
Behavioral: In-bed cycling
Patients will daily perform 30 min of supervised in-bed cycling
|
| Experimental: Exercise booklet Supervised physical training with exercises from exercise booklet |
Behavioral: Exercise booklet
Patients will daily perform 30 min of supervised physical training with exercises from the exercise booklet
|
Outcome Measures
Primary Outcome Measures
- Length of hospital stay [From admission until discharge (an average of 5 days)]
Number of stays in hospital
Secondary Outcome Measures
- 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
Other Outcome Measures
- Self-reported physical activity (PA) level [Answered on day 1, 1-, 3- and 6 months after discharge]
3 groups of PA level (high, medium, low) are established based on the scoring of the international physical activity questionnaire (IPAQ). High PA level: Vigorous-intensity activity on at least 3 days and accumulating a minimum of 1500 MET-minutes/week OR 7 or more days of any combination of walking, moderate-intensity or vigorous intensity activities achieving a minimum of 3000 MET-minutes/week Medium PA level: 3 or more days of vigorous-activity of at least 20 minutes/day OR 5 or more days of moderate-intensity activity or walking of at least 30 minutes/day OR 5 or more days of any combination of walking, moderate-intensity or vigorous-intensity activities achieving a minimum of 600 MET-min/week. Low PA Level: No activity is reported OR some activity is reported but not enough to meet criteria for high or medium PA level group.
- Glucose metabolism [Day 1, 1- and 3-months from discharge]
Blood samples drawn during an oral glucose tolerance test
- Scoring on the Charlson Comorbidity Index to predict 10-year survival [Day 1]
Scale ranges from 0 to 33 points to predict he 10-year mortality for patients with a range of comorbid conditions
- HbA1c [Day 1, 1- and 3-months after discharge]
To assess the average blood glucose levels over the previous 3 months
Eligibility Criteria
Criteria
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.
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Patients should have an expected admission length of ≥72 hours.
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Patients should be able to move their legs.
Exclusion Criteria:
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Patients unable to give written consent.
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Hospital admission within the last 14 days.
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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).
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Department of Pulmonary and Infectious Diseases, Nordsjællands Hospital | Hillerød | Denmark | 3400 |
Sponsors and Collaborators
- Nordsjaellands Hospital
Investigators
- Study Director: Birgitte Lindegaard, MD, PhD, Department of Pulmonary and Infetious Diseases, Nordsjællands Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CAP-EX