Physical Training During Hospital Admission With Community-Acquired Pneumonia

Overview

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 Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: April 1, 2022

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.

Interventions

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

Arms, Groups and Cohorts

  • No Intervention: No intervention: Control
    • Control group
  • Experimental: In-bed cycling
    • Supervised in-bed cycling
  • Experimental: Exercise booklet
    • Supervised physical training with exercises from exercise booklet

Clinical Trial Outcome Measures

Primary Measures

  • Length of hospital stay
    • Time Frame: From admission until discharge (an average of 5 days)
    • Number of stays in hospital

Secondary Measures

  • Readmissions Number of readmissions
    • Time Frame: 3-months from discharge
    • Time-to-event within 3-months from discharge
  • Mortality
    • Time Frame: 6-months from discharge
    • Time-to-event within 6-months from discharge
  • Changes in total lean mass
    • Time Frame: Day 1, day 5, discharge, 1- and 3-months from discharge
    • Dual-energy x-ray absorptiometry scans
  • Changes in total fat mass
    • Time Frame: Day 1, day 5, discharge, 1- and 3-months from discharge
    • Dual-energy x-ray absorptiometry scans
  • Changes in total fat-free mass
    • Time Frame: Day 1, day 5, discharge, 1- and 3-months from discharge
    • Bioelectrical impedance analysis
  • Health-related quality of life
    • Time Frame: 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
    • Time Frame: 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
    • Time Frame: At day 1, day 5, discharge, 1- and 3-months after discharge
    • Hand grip strength test
  • Functional ability
    • Time Frame: Day 1, day 5, discharge, 1- and 3-months after discharge
    • 30-sec chair stand test
  • Systemic inflammation
    • Time Frame: 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
    • Time Frame: During admission (up to 7 days), 7 days from discharge, 7 days from 1- and 3 months follow-up
    • AX3 accelerometers

Participating in This Clinical Trial

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).

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Nordsjaellands Hospital
  • Provider of Information About this Clinical Study
    • Principal Investigator: Camilla Koch Rysoe, Principal investigator, MSc – Nordsjaellands Hospital
  • Overall Official(s)
    • Birgitte Lindegaard, MD, PhD, Study Director, Department of Pulmonary and Infetious Diseases, Nordsjællands Hospital
  • Overall Contact(s)
    • Camilla Ryrsø, MSc, +4548293261, camilla.koch.ryrsoe.01@regionh.dk

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