Physical Training During Hospital Admission With Community-Acquired Pneumonia

Community-acquired Pneumonia Clinical Trial

Official title:

Physical Training During Hospital Admission With Community-Acquired Pneumonia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04094636
• Other study ID #: CAP-EX
• Status: Recruiting
• Phase: N/A
• Start date: April 1, 2019
• Est. completion date: October 1, 2022

Study information

• Verified date: February 2022
• Source: Nordsjaellands Hospital
• Contact: Camilla Ryrsø, MSc
• Phone: +4548293261
• Email: camilla.koch.ryrsoe.01[@]regionh.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 210
• Est. completion date: October 1, 2022
• Est. primary completion date: April 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Community-acquired Pneumonia
• Pneumonia

Intervention

Behavioral:
• In-bed cycling
Patients will daily perform 30 min of supervised in-bed cycling
• Exercise booklet
Patients will daily perform 30 min of supervised physical training with exercises from the exercise booklet

Locations

Country	Name	City	State
Denmark	Department of Pulmonary and Infectious Diseases, Nordsjællands Hospital	Hillerød

Sponsors (1)

Lead Sponsor	Collaborator
Nordsjaellands Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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.	Answered on day 1, 1-, 3- and 6 months after discharge
Other	Glucose metabolism	Blood samples drawn during an oral glucose tolerance test	Day 1, 1- and 3-months from discharge
Other	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	Day 1
Other	HbA1c	To assess the average blood glucose levels over the previous 3 months	Day 1, 1- and 3-months after discharge
Primary	Length of hospital stay	Number of stays in hospital	From admission until discharge (an average of 5 days)
Secondary	Readmissions Number of readmissions	Time-to-event within 3-months from discharge	3-months from discharge
Secondary	Mortality	Time-to-event within 6-months from discharge	6-months from discharge
Secondary	Changes in total lean mass	Dual-energy x-ray absorptiometry scans	Day 1, day 5, discharge, 1- and 3-months from discharge
Secondary	Changes in total fat mass	Dual-energy x-ray absorptiometry scans	Day 1, day 5, discharge, 1- and 3-months from discharge
Secondary	Changes in total fat-free mass	Bioelectrical impedance analysis	Day 1, day 5, discharge, 1- and 3-months from discharge
Secondary	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
Secondary	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
Secondary	Muscle strength	Hand grip strength test	At day 1, day 5, discharge, 1- and 3-months after discharge
Secondary	Functional ability	30-sec chair stand test	Day 1, day 5, discharge, 1- and 3-months after discharge
Secondary	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
Secondary	Physical activity monitoring	AX3 accelerometers	During admission (up to 7 days), 7 days from discharge, 7 days from 1- and 3 months follow-up