NCT05278819

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

February 21, 2022

Completed
21 days until next milestone

First Posted

Study publicly available on registry

March 14, 2022

Completed
18 days until next milestone

Study Start

First participant enrolled

April 1, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2022

Completed
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 6, 2022

Completed
Last Updated

November 29, 2023

Status Verified

November 1, 2023

Enrollment Period

2 months

First QC Date

February 21, 2022

Last Update Submit

November 23, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • peripheral oxygen saturation

    30 minutes

Secondary Outcomes (6)

  • tidal volume

    30 minutes

  • heart rate

    30 minutes

  • respiratory rate

    30 minutes

  • pain - numeric rating scale

    30 minutes

  • dyspnea - numeric rating scale

    30 minutes

  • +1 more secondary outcomes

Study Arms (2)

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).

Other: upper extremity elevationOther: 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).

Other: upper extremity elevationOther: upper extremity elevation with deep breathing

Interventions

5 repetitions of active upper extremity elevation in a sitting position

upper extremity elevationupper extremity elevation with deep breathing

5 repetitions of active upper extremity elevation with deep breathing in a sitting position

upper extremity elevationupper extremity elevation with deep breathing

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • open heart surgery at university hospital in Örebro

You may not qualify if:

  • 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 %)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital

Örebro, 70186, Sweden

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Heart DiseasesMyocardial IschemiaHeart Valve Diseases

Condition Hierarchy (Ancestors)

Cardiovascular DiseasesVascular Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Physical therapist

Study Record Dates

First Submitted

February 21, 2022

First Posted

March 14, 2022

Study Start

April 1, 2022

Primary Completion

June 1, 2022

Study Completion

June 6, 2022

Last Updated

November 29, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations