Clinical trial NCT04094636: Physical Training During Hospital Admission With Community-Acquired Pneumonia
Official title: Physical Training During Hospital Admission With Community-Acquired Pneumonia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Community-acquired Pneumonia
Keywords: Physical training
Lead sponsor: Nordsjaellands Hospital
Sponsor class: OTHER
First posted: 2019-09-19
Enrollment: 210
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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.
* 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).

Primary outcomes:
measure: Length of hospital stay
timeFrame: From admission until discharge (an average of 5 days)
Secondary outcomes:
measure: Readmissions Number of readmissions
timeFrame: 3-months from discharge
measure: Mortality
timeFrame: 6-months from discharge
measure: Changes in total lean mass
timeFrame: Day 1, day 5, discharge, 1- and 3-months from discharge
measure: Changes in total fat mass
timeFrame: Day 1, day 5, discharge, 1- and 3-months from discharge
measure: Changes in total fat-free mass
timeFrame: Day 1, day 5, discharge, 1- and 3-months from discharge
measure: Health-related quality of life
timeFrame: Day 1, discharge, 1-, 3- and 6-months from discharge
measure: Activities of daily living
timeFrame: Day 1, discharge, 1 month from discharge and 3 months from discharge
measure: Muscle strength
timeFrame: At day 1, day 5, discharge, 1- and 3-months after discharge
measure: Functional ability
timeFrame: Day 1, day 5, discharge, 1- and 3-months after discharge
measure: Systemic inflammation
timeFrame: Daily during admission (day 0 to 5), 1- and 3-months after discharge
measure: Physical activity monitoring
timeFrame: During admission (up to 7 days), 7 days from discharge, 7 days from 1- and 3 months follow-up
Other outcomes:
measure: Self-reported physical activity (PA) level
timeFrame: Answered on day 1, 1-, 3- and 6 months after discharge
measure: Glucose metabolism
timeFrame: Day 1, 1- and 3-months from discharge
measure: Scoring on the Charlson Comorbidity Index to predict 10-year survival
timeFrame: Day 1
measure: HbA1c
timeFrame: Day 1, 1- and 3-months after discharge
Locations:
city: Hillerød
country: Denmark
facility: Department of Pulmonary and Infectious Diseases, Nordsjællands Hospital
Study officials:
affiliation: Department of Pulmonary and Infetious Diseases, Nordsjællands Hospital
name: Birgitte Lindegaard, MD, PhD
role: STUDY_DIRECTOR
References:
citation: Ryrso CK, Faurholt-Jepsen D, Ritz C, Pedersen BK, Hegelund MH, Dungu AM, Sejdic A, Lindegaard B, Krogh-Madsen R. The impact of physical training on length of hospital stay and physical function in patients hospitalized with community-acquired pneumonia: protocol for a randomized controlled trial. Trials. 2021 Aug 28;22(1):571. doi: 10.1186/s13063-021-05503-2.