Community-acquired PneumoniaNCT04094636
Physical Training During Hospital Admission With Community-Acquired Pneumonia
A study testing In-bed cycling and Exercise booklet in people with Community-acquired Pneumonia, run by Nordsjaellands Hospital at 1 site in Denmark.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Community-acquired Pneumonia
- What is being tested?
- In-bed cycling and Exercise booklet
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 210 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Apr 2019to 1 Oct 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
Department of Pulmonary and Infectious Diseases, Nordsjællands Hospital
Hillerød, 3400
Camilla Ryrsø, MSc, +4548293261, camilla.koch.ryrsoe.01@regionh.dk
About this study
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.
Read the 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.
- Conditions
- Community-acquired Pneumonia
- Being tested
- In-bed cycling, Exercise booklet
- Keywords
- Physical training
- Medical subject headings
- Community-Acquired Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
In-bed cyclingBehavioural
Patients will daily perform 30 min of supervised in-bed cycling
Exercise bookletBehavioural
Patients will daily perform 30 min of supervised physical training with exercises from the exercise booklet
| Study group | Role | What they receive |
|---|---|---|
| No intervention: Control | No intervention | Control group |
| In-bed cycling | Experimental | Supervised in-bed cycling Receives: Behavioral: In-bed cycling |
| Exercise booklet | Experimental | Supervised physical training with exercises from exercise booklet Receives: Behavioral: Exercise booklet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of hospital stay
Number of stays in hospital
Measured: From admission until discharge (an average of 5 days)
Secondary outcomes (11)
Readmissions Number of readmissions
Time-to-event within 3-months from discharge
Measured: 3-months from discharge
Mortality
Time-to-event within 6-months from discharge
Measured: 6-months from discharge
Changes in total lean mass
Dual-energy x-ray absorptiometry scans
Measured: Day 1, day 5, discharge, 1- and 3-months from discharge
Changes in total fat mass
Dual-energy x-ray absorptiometry scans
Measured: Day 1, day 5, discharge, 1- and 3-months from discharge
Changes in total fat-free mass
Bioelectrical impedance analysis
Measured: 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
Measured: 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.
Measured: Day 1, discharge, 1 month from discharge and 3 months from discharge
Muscle strength
Hand grip strength test
Measured: At day 1, day 5, discharge, 1- and 3-months after discharge
Functional ability
30-sec chair stand test
Measured: 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)
Measured: Daily during admission (day 0 to 5), 1- and 3-months after discharge
Physical activity monitoring
AX3 accelerometers
Measured: During admission (up to 7 days), 7 days from discharge, 7 days from 1- and 3 months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2019
- Study start1 Apr 2019
- Primary completion1 Apr 2022 (estimated)
- Study completion1 Oct 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Community-acquired PneumoniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 210 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nordsjaellands Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Camilla Koch Rysoe, Nordsjaellands Hospital
- Investigators
- Birgitte Lindegaard, MD, PhD, Study director, Department of Pulmonary and Infetious Diseases, Nordsjællands Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04094636
- Sponsor's protocol ID
- CAP-EX
- Status last verified
- Feb 2022
- First submitted
- 5 Sep 2019
- Last updated
- 15 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 38491965Ryrso 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.
PubMed 34454594
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physical Training During Hospital Admission With Community-Acquired Pneumonia
- ClinicalTrials.gov ID
- NCT04094636
- Acronym / sponsor ID
- CAP-EX
- Conditions
- Community-acquired Pneumonia
- Keywords
- Physical training
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 210 participants (estimated)
- Lead sponsor
- Nordsjaellands HospitalUniversity, hospital or other
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- 1 Apr 2022 (estimated)
- Study completion
- 1 Oct 2022 (estimated)
- First posted
- 19 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| No intervention: Control | No intervention | –Control group |
| In-bed cycling | Experimental | Behavioral: In-bed cyclingSupervised in-bed cycling |
| Exercise booklet | Experimental | Behavioral: Exercise bookletSupervised physical training with exercises from exercise booklet |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| In-bed cyclingPatients will daily perform 30 min of supervised in-bed cycling | Behavioural | In-bed cycling |
| Exercise bookletPatients will daily perform 30 min of supervised physical training with exercises from the exercise booklet | Behavioural | Exercise booklet |
Primary outcome
Length of hospital stay
Time frame: From admission until discharge (an average of 5 days)
Number of stays in hospital
11 secondary outcomes
Readmissions Number of readmissions
Time frame: 3-months from discharge
Mortality
Time frame: 6-months from discharge
Changes in total lean mass
Time frame: Day 1, day 5, discharge, 1- and 3-months from discharge
Changes in total fat mass
Time frame: Day 1, day 5, discharge, 1- and 3-months from discharge
Changes in total fat-free mass
Time frame: Day 1, day 5, discharge, 1- and 3-months from discharge
Health-related quality of life
Time frame: Day 1, discharge, 1-, 3- and 6-months from discharge
Activities of daily living
Time frame: Day 1, discharge, 1 month from discharge and 3 months from discharge
Muscle strength
Time frame: At day 1, day 5, discharge, 1- and 3-months after discharge
Functional ability
Time frame: Day 1, day 5, discharge, 1- and 3-months after discharge
Systemic inflammation
Time frame: Daily during admission (day 0 to 5), 1- and 3-months after discharge
Physical activity monitoring
Time frame: During admission (up to 7 days), 7 days from discharge, 7 days from 1- and 3 months follow-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2022.
- Derived from this study: PubMed 38491965Ryrso 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.
- Derived from this study: PubMed 34454594Ryrso 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Birgitte Lindegaard, MD, PhD study director
Department of Pulmonary and Infetious Diseases, Nordsjællands Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing In-bed cycling and Exercise booklet in people with Community-acquired Pneumonia, run by Nordsjaellands Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Camilla Ryrsø, MSc (+4548293261, camilla.koch.ryrsoe.01@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Length of hospital stay (time frame: From admission until discharge (an average of 5 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04094636, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2022.