Physical Training During Hospital Admission With Community-Acquired Pneumonia

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.

Study Overview

• Status: Recruiting
• Conditions: Community-acquired Pneumonia
• Intervention / Treatment: Behavioral: In-bed cycling; Behavioral: Exercise booklet

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 Type: Interventional
• Enrollment (Anticipated): 210
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Camilla Ryrsø, MSc; Phone Number: +4548293261; Email: camilla.koch.ryrsoe.01@regionh.dk

Study Locations

• Denmark
  • Hillerød, Denmark, 3400
    • Recruiting
    • Department of Pulmonary and Infectious Diseases, Nordsjællands Hospital
    • Contact: Camilla Ryrsø, MSc; Phone Number: +4548293261; Email: camilla.koch.ryrsoe.01@regionh.dk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

3

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Length of hospital stay	Number of stays in hospital	From admission until discharge (an average of 5 days)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Readmissions Number of readmissions	Time-to-event within 3-months from discharge	3-months from discharge
Mortality	Time-to-event within 6-months from discharge	6-months from discharge
Changes in total lean mass	Dual-energy x-ray absorptiometry scans	Day 1, day 5, discharge, 1- and 3-months from discharge
Changes in total fat mass	Dual-energy x-ray absorptiometry scans	Day 1, day 5, discharge, 1- and 3-months from discharge
Changes in total fat-free mass	Bioelectrical impedance analysis	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	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.	Day 1, discharge, 1 month from discharge and 3 months from discharge
Muscle strength	Hand grip strength test	At day 1, day 5, discharge, 1- and 3-months after discharge
Functional ability	30-sec chair stand test	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)	Daily during admission (day 0 to 5), 1- and 3-months after discharge
Physical activity monitoring	AX3 accelerometers	During admission (up to 7 days), 7 days from discharge, 7 days from 1- and 3 months follow-up

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Glucose metabolism	Blood samples drawn during an oral glucose tolerance test	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	Day 1
HbA1c	To assess the average blood glucose levels over the previous 3 months	Day 1, 1- and 3-months after discharge

Collaborators and Investigators

• Sponsor: Nordsjaellands Hospital
• Investigators: Study Director: Birgitte Lindegaard, MD, PhD, Department of Pulmonary and Infetious Diseases, Nordsjællands Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 1, 2019
• Primary Completion (ANTICIPATED): April 1, 2022
• Study Completion (ANTICIPATED): October 1, 2022

Study Registration Dates

• First Submitted: September 5, 2019
• First Submitted That Met QC Criteria: September 18, 2019
• First Posted (ACTUAL): September 19, 2019

Study Record Updates

• Last Update Posted (ACTUAL): February 15, 2022
• Last Update Submitted That Met QC Criteria: February 14, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Keywords: Physical training
• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Lung Diseases; Pneumonia
• Other Study ID Numbers: CAP-EX

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No