search
Back to results

Physical Training During Hospital Admission With Community-Acquired Pneumonia

Primary Purpose

Community-acquired Pneumonia

Status
Recruiting
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
In-bed cycling
Exercise booklet
Sponsored by
Nordsjaellands Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Community-acquired Pneumonia focused on measuring Physical training

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Department of Pulmonary and Infectious Diseases, Nordsjællands HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Experimental

Experimental

Arm Label

No intervention: Control

In-bed cycling

Exercise booklet

Arm Description

Control group

Supervised in-bed cycling

Supervised physical training with exercises from exercise booklet

Outcomes

Primary Outcome Measures

Length of hospital stay
Number of stays in hospital

Secondary Outcome Measures

Readmissions Number of readmissions
Time-to-event within 3-months from discharge
Mortality
Time-to-event within 6-months from discharge
Changes in total lean mass
Dual-energy x-ray absorptiometry scans
Changes in total fat mass
Dual-energy x-ray absorptiometry scans
Changes in total fat-free mass
Bioelectrical impedance analysis
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
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.
Muscle strength
Hand grip strength test
Functional ability
30-sec chair stand test
Systemic inflammation
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
AX3 accelerometers

Full Information

First Posted
September 5, 2019
Last Updated
February 14, 2022
Sponsor
Nordsjaellands Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT04094636
Brief Title
Physical Training During Hospital Admission With Community-Acquired Pneumonia
Official Title
Physical Training During Hospital Admission With Community-Acquired Pneumonia
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 1, 2019 (Actual)
Primary Completion Date
April 1, 2022 (Anticipated)
Study Completion Date
October 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Nordsjaellands Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Community-acquired Pneumonia
Keywords
Physical training

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
210 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
No intervention: Control
Arm Type
No Intervention
Arm Description
Control group
Arm Title
In-bed cycling
Arm Type
Experimental
Arm Description
Supervised in-bed cycling
Arm Title
Exercise booklet
Arm Type
Experimental
Arm Description
Supervised physical training with exercises from exercise booklet
Intervention Type
Behavioral
Intervention Name(s)
In-bed cycling
Intervention Description
Patients will daily perform 30 min of supervised in-bed cycling
Intervention Type
Behavioral
Intervention Name(s)
Exercise booklet
Intervention Description
Patients will daily perform 30 min of supervised physical training with exercises from the exercise booklet
Primary Outcome Measure Information:
Title
Length of hospital stay
Description
Number of stays in hospital
Time Frame
From admission until discharge (an average of 5 days)
Secondary Outcome Measure Information:
Title
Readmissions Number of readmissions
Description
Time-to-event within 3-months from discharge
Time Frame
3-months from discharge
Title
Mortality
Description
Time-to-event within 6-months from discharge
Time Frame
6-months from discharge
Title
Changes in total lean mass
Description
Dual-energy x-ray absorptiometry scans
Time Frame
Day 1, day 5, discharge, 1- and 3-months from discharge
Title
Changes in total fat mass
Description
Dual-energy x-ray absorptiometry scans
Time Frame
Day 1, day 5, discharge, 1- and 3-months from discharge
Title
Changes in total fat-free mass
Description
Bioelectrical impedance analysis
Time Frame
Day 1, day 5, discharge, 1- and 3-months from discharge
Title
Health-related quality of life
Description
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
Title
Activities of daily living
Description
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
Title
Muscle strength
Description
Hand grip strength test
Time Frame
At day 1, day 5, discharge, 1- and 3-months after discharge
Title
Functional ability
Description
30-sec chair stand test
Time Frame
Day 1, day 5, discharge, 1- and 3-months after discharge
Title
Systemic inflammation
Description
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
Title
Physical activity monitoring
Description
AX3 accelerometers
Time Frame
During admission (up to 7 days), 7 days from discharge, 7 days from 1- and 3 months follow-up
Other Pre-specified Outcome Measures:
Title
Self-reported physical activity (PA) level
Description
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
Title
Glucose metabolism
Description
Blood samples drawn during an oral glucose tolerance test
Time Frame
Day 1, 1- and 3-months from discharge
Title
Scoring on the Charlson Comorbidity Index to predict 10-year survival
Description
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
Title
HbA1c
Description
To assess the average blood glucose levels over the previous 3 months
Time Frame
Day 1, 1- and 3-months after discharge

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Camilla Ryrsø, MSc
Phone
+4548293261
Email
camilla.koch.ryrsoe.01@regionh.dk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Birgitte Lindegaard, MD, PhD
Organizational Affiliation
Department of Pulmonary and Infetious Diseases, Nordsjællands Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Department of Pulmonary and Infectious Diseases, Nordsjællands Hospital
City
Hillerød
ZIP/Postal Code
3400
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Camilla Ryrsø, MSc
Phone
+4548293261
Email
camilla.koch.ryrsoe.01@regionh.dk

12. IPD Sharing Statement

Citations:
PubMed Identifier
34454594
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.
Results Reference
derived

Learn more about this trial

Physical Training During Hospital Admission With Community-Acquired Pneumonia

We'll reach out to this number within 24 hrs