An interventional study of In-bed cycling and Exercise booklet in Community-acquired Pneumonia, sponsored by Nordsjaellands Hospital. Status unknown at 1 site in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-02-15.
Sponsored by Nordsjaellands Hospital · Not applicable, Interventional, and Treatment
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.
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.
2,044 studies on the registry are indexed under Pneumonia; 283 are open to participants now.
This study's planned enrollment of 210 is above the median of 106 across 1,247 interventional studies indexed under Pneumonia.
Browse Pneumonia studies →Nordsjaellands Hospital is the lead sponsor of 88 studies on the registry; 21 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Control group
Supervised in-bed cycling
Behavioral: In-bed cycling
Supervised physical training with exercises from exercise booklet
Behavioral: Exercise booklet
Patients will daily perform 30 min of supervised in-bed cycling
Patients will daily perform 30 min of supervised physical training with exercises from the exercise booklet
Length of hospital stay
Number of stays in hospital
Time frame: From admission until discharge (an average of 5 days)
Readmissions Number of readmissions
Time-to-event within 3-months from discharge
Time frame: 3-months from discharge
Mortality
Time-to-event within 6-months from discharge
Time frame: 6-months from discharge
Changes in total lean mass
Dual-energy x-ray absorptiometry scans
Time frame: Day 1, day 5, discharge, 1- and 3-months from discharge
Changes in total fat mass
Dual-energy x-ray absorptiometry scans
Time frame: Day 1, day 5, discharge, 1- and 3-months from discharge
Changes in total fat-free mass
Bioelectrical impedance analysis
Time frame: 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
Time frame: 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.
Time frame: Day 1, discharge, 1 month from discharge and 3 months from discharge
Muscle strength
Hand grip strength test
Time frame: At day 1, day 5, discharge, 1- and 3-months after discharge
Functional ability
30-sec chair stand test
Time frame: 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)
Time frame: Daily during admission (day 0 to 5), 1- and 3-months after discharge
Physical activity monitoring
AX3 accelerometers
Time frame: During admission (up to 7 days), 7 days from discharge, 7 days from 1- and 3 months follow-up
Self-reported physical activity (PA) level
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.
Time frame: Answered on day 1, 1-, 3- and 6 months after discharge
Glucose metabolism
Blood samples drawn during an oral glucose tolerance test
Time frame: Day 1, 1- and 3-months from discharge
Scoring on the Charlson Comorbidity Index to predict 10-year survival
Scale ranges from 0 to 33 points to predict he 10-year mortality for patients with a range of comorbid conditions
Time frame: Day 1
HbA1c
To assess the average blood glucose levels over the previous 3 months
Time frame: Day 1, 1- and 3-months after discharge
This study is status unknown, as verified in Feb 2022. You cannot join it, but the record below documents what was studied.
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Nordsjaellands Hospital