Heart DiseasesNCT05278819
Upper Extremity Elevation and Lungfunction After Open Heart Surgery
A study testing upper extremity elevation and upper extremity elevation with deep breathing in people with Heart Diseases and Heart Diseases, Ischemic, run by Michael Reinhart at 1 site in Sweden.
Trial summary
The purpose of this study is to assess if arm elevation, with or without simultaneous deep breathing, affects oxygen saturation and lung function on patients two to four days after open heart surgery. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Heart Diseases, Heart Diseases, Ischemic, Heart Disease, Valvular
- What is being tested?
- upper extremity elevation and upper extremity elevation with deep breathing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteSweden
- Study dates
- 1 Apr 2022to 6 Jun 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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- open heart surgery at university hospital in Örebro
Who cannot join
- not able to communicate in swedish
- difficulties in cooperating during measurements
- cognitive impairement
- prolonged stay at ICU (still at ICU on the day of investigation)
- ongoing oxygen treatment with more than 5 liter/minut (FiO > 40 %)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Upper Extremity Elevation and Deep Breathing on Oxygen Saturation and Lung Volume Two to Four Days After Open Heart Surgery
The purpose of this study is to assess if arm elevation, with or without simultaneous deep breathing, affects oxygen saturation and lung function on patients two to four days after open heart surgery.
Read the detailed description
This single center, interventional crossover study will involve patients day 2, 3 or 4 after open heart surgery. Patients who meet the eligibility requirements will be informed about the study and potential risks, given a written informed consent they will be included for intervention being held later on the same day. Randomization will be given to the investigator in a sealed envelope and being opened after base line measurements. Data will then be collected for the randomized intervention and after a wash out period (several minutes) again for the crossover intervention.
- Being tested
- upper extremity elevation, upper extremity elevation with deep breathing
- Medical subject headings
- Heart Diseases, Myocardial Ischemia, Heart Valve Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
upper extremity elevationOther
5 repetitions of active upper extremity elevation in a sitting position
upper extremity elevation with deep breathingOther
5 repetitions of active upper extremity elevation with deep breathing in a sitting position
| Study group | Role | What they receive |
|---|---|---|
| upper extremity elevation | Experimental | performing intervention A (5 repetitions of upper extremity elevation), and then crossed over to intervention B (5 repetitions of upper extremity with deep breathing). Receives: Other: upper extremity elevation; Other: upper extremity elevation with deep breathing |
| upper extremity elevation with deep breathing | Experimental | performing intervention B (5 repetitions of upper extremity with deep breathing), and then crossed over to intervention A (5 repetitions of upper extremity elevation). Receives: Other: upper extremity elevation; Other: upper extremity elevation with deep breathing |
What is being measured
The primary outcome is the main question the study is designed to answer.
peripheral oxygen saturation
Measured: 30 minutes
Secondary outcomes (6)
tidal volume
Measured: 30 minutes
heart rate
Measured: 30 minutes
respiratory rate
Measured: 30 minutes
pain - numeric rating scale
Pain (sternal, thorax or overall pain) will be measured before and after intervention, NRS will be used (patient rating of perceived pain with a score from 0 to 10)
Measured: 30 minutes
dyspnea - numeric rating scale
Dyspnea will be measured before and after intervention, NRS will be used (patient rating of perceived dyspnea with a score from 0 to 10)
Measured: 30 minutes
exertion - numeric rating scale
exertion will be measured before and after intervention, NRS will be used (patient rating of perceived exertion with a score from 0 to 10)
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2022
- Study start1 Apr 2022
- Primary completion1 Jun 2022
- Study completion6 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Heart DiseasesStudies 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
- Crossover
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Michael Reinhart
- Sponsor type
- University, hospital or other
- Collaborators
- Region Örebro County, Linkoeping University, Örebro University, Sweden
- Responsible party
- Sponsor-investigator, Michael Reinhart, Region Örebro County
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05278819
- Sponsor's protocol ID
- 278090
- Status last verified
- Nov 2023
- First submitted
- 21 Feb 2022
- Last updated
- 29 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Reinhart M, Jonsson M, Enthoven P, Westerdahl E. Immediate effects of upper limb exercises with and without deep breathing on lung function after cardiac surgery - a randomized crossover trial. J Cardiothorac Surg. 2024 Aug 28;19(1):503. doi: 10.1186/s13019-024-03007-z.
PubMed 39198875
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Upper Extremity Elevation and Deep Breathing on Oxygen Saturation and Lung Volume Two to Four Days After Open Heart Surgery
- ClinicalTrials.gov ID
- NCT05278819
- Acronym / sponsor ID
- 278090
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Michael ReinhartUniversity, hospital or other
- Collaborators
- Region Örebro County, Linkoeping University, Örebro University, Sweden
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 1 Jun 2022 (actual)
- Study completion
- 6 Jun 2022 (actual)
- First posted
- 14 Mar 2022 (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 if arm elevation, with or without simultaneous deep breathing, affects oxygen saturation and lung function on patients two to four days after open heart surgery.
Detailed description
This single center, interventional crossover study will involve patients day 2, 3 or 4 after open heart surgery. Patients who meet the eligibility requirements will be informed about the study and potential risks, given a written informed consent they will be included for intervention being held later on the same day. Randomization will be given to the investigator in a sealed envelope and being opened after base line measurements. Data will then be collected for the randomized intervention and after a wash out period (several minutes) again for the crossover intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| upper extremity elevation | Experimental | Other: upper extremity elevation, Other: upper extremity elevation with deep breathingperforming intervention A (5 repetitions of upper extremity elevation), and then crossed over to intervention B (5 repetitions of upper extremity with deep breathing). |
| upper extremity elevation with deep breathing | Experimental | Other: upper extremity elevation, Other: upper extremity elevation with deep breathingperforming intervention B (5 repetitions of upper extremity with deep breathing), and then crossed over to intervention A (5 repetitions of upper extremity elevation). |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- open heart surgery at university hospital in Örebro
Key exclusion criteria (5 listed)
- not able to communicate in swedish
- difficulties in cooperating during measurements
- cognitive impairement
- prolonged stay at ICU (still at ICU on the day of investigation)
- ongoing oxygen treatment with more than 5 liter/minut (FiO > 40 %)
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 |
|---|---|---|
| upper extremity elevation5 repetitions of active upper extremity elevation in a sitting position | Other | upper extremity elevation, upper extremity elevation with deep breathing |
| upper extremity elevation with deep breathing5 repetitions of active upper extremity elevation with deep breathing in a sitting position | Other | upper extremity elevation, upper extremity elevation with deep breathing |
Primary outcome
peripheral oxygen saturation
Time frame: 30 minutes
6 secondary outcomes
tidal volume
Time frame: 30 minutes
heart rate
Time frame: 30 minutes
respiratory rate
Time frame: 30 minutes
pain - numeric rating scale
Time frame: 30 minutes
dyspnea - numeric rating scale
Time frame: 30 minutes
exertion - numeric rating scale
Time frame: 30 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2023.
- Derived from this study: PubMed 39198875Reinhart M, Jonsson M, Enthoven P, Westerdahl E. Immediate effects of upper limb exercises with and without deep breathing on lung function after cardiac surgery - a randomized crossover trial. J Cardiothorac Surg. 2024 Aug 28;19(1):503. doi: 10.1186/s13019-024-03007-z.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing upper extremity elevation and upper extremity elevation with deep breathing in people with Heart Diseases and Heart Diseases, Ischemic, run by Michael Reinhart at 1 site in Sweden.
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 1 inclusion and 5 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: finished, as of the sponsor's last update on 29 Nov 2023. 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 Sweden. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
peripheral oxygen saturation (time frame: 30 minutes). 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 NCT05278819, which also lists 1 linked publication.
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 29 Nov 2023.