NCT04094636

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
210

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2019

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

September 5, 2019

Completed
14 days until next milestone

First Posted

Study publicly available on registry

September 19, 2019

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2022

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2022

Completed
Last Updated

February 15, 2022

Status Verified

February 1, 2022

Enrollment Period

3 years

First QC Date

September 5, 2019

Last Update Submit

February 14, 2022

Conditions

Community-acquired Pneumonia

Keywords

Physical training

Outcome Measures

Primary Outcomes (1)

  • Length of hospital stay

    Number of stays in hospital

    From admission until discharge (an average of 5 days)

Secondary Outcomes (11)

  • Readmissions Number of readmissions

    3-months from discharge

  • Mortality

    6-months from discharge

  • Changes in total lean mass

    Day 1, day 5, discharge, 1- and 3-months from discharge

  • Changes in total fat mass

    Day 1, day 5, discharge, 1- and 3-months from discharge

  • Changes in total fat-free mass

    Day 1, day 5, discharge, 1- and 3-months from discharge

  • +6 more secondary outcomes

Other Outcomes (4)

  • Self-reported physical activity (PA) level

    Answered on day 1, 1-, 3- and 6 months after discharge

  • Glucose metabolism

    Day 1, 1- and 3-months from discharge

  • Scoring on the Charlson Comorbidity Index to predict 10-year survival

    Day 1

  • +1 more other outcomes

Study Arms (3)

No intervention: Control

NO INTERVENTION

Control group

In-bed cycling

EXPERIMENTAL

Supervised in-bed cycling

Behavioral: In-bed cycling

Exercise booklet

EXPERIMENTAL

Supervised physical training with exercises from exercise booklet

Behavioral: Exercise booklet

Interventions

In-bed cyclingBEHAVIORAL

Patients will daily perform 30 min of supervised in-bed cycling

In-bed cycling
Exercise bookletBEHAVIORAL

Patients will daily perform 30 min of supervised physical training with exercises from the exercise booklet

Exercise booklet

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Pulmonary and Infectious Diseases, Nordsjællands Hospital

Hillerød, 3400, Denmark

RECRUITING

Related Publications (2)

  • Ryrso CK, Faurholt-Jepsen D, Ritz C, Hegelund MH, Dungu AM, Pedersen BK, Krogh-Madsen R, Lindegaard B. Effect of Exercise Training on Prognosis in Community-acquired Pneumonia: A Randomized Controlled Trial. Clin Infect Dis. 2024 Jun 14;78(6):1718-1726. doi: 10.1093/cid/ciae147.

    PMID: 38491965DERIVED

  • 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.

    PMID: 34454594DERIVED

MeSH Terms

Conditions

Community-Acquired Pneumonia

Condition Hierarchy (Ancestors)

Community-Acquired InfectionsInfectionsPneumoniaRespiratory Tract InfectionsRespiratory Tract Diseases

Study Officials

  • Birgitte Lindegaard, MD, PhD

    Department of Pulmonary and Infetious Diseases, Nordsjællands Hospital

    STUDY DIRECTOR

Central Study Contacts

Camilla Ryrsø, MSc

CONTACT

+4548293261camilla.koch.ryrsoe.01@regionh.dk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator, MSc

Study Record Dates

First Submitted

September 5, 2019

First Posted

September 19, 2019

Study Start

April 1, 2019

Primary Completion

April 1, 2022

Study Completion

October 1, 2022

Last Updated

February 15, 2022

Record last verified: 2022-02

Locations

DK(1)