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Upper Extremity Exercises With and Without Deep Breathing After Cardiac Surgery (ROM-DB)

30. maj 2026 opdateret af: MUSTAFA CANIKOGLU, Kocaeli University

Evaluation of the Effects of Upper Extremity Range of Motion Exercises Performed With and Without Deep Breathing on Respiratory Parameters After Cardiac Surgery: A Randomized Trials

This randomized 2×2 crossover trial aims to evaluate the effects of upper extremity range of motion exercises performed with and without deep breathing on respiratory parameters in patients after open cardiac surgery. The study will include adult patients who underwent elective open cardiac surgery and are receiving postoperative care in the cardiovascular surgery intensive care unit. Each participant will perform both exercise protocols: upper extremity range of motion exercises alone and upper extremity range of motion exercises combined with deep breathing. The order of the two interventions will be randomized. Respiratory and clinical outcomes, including oxygen saturation, tidal volume, respiratory rate, heart rate, pain, perceived exertion, and dyspnea, will be assessed before and after each intervention.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Postoperative pulmonary complications are common after cardiac surgery and may include atelectasis, pulmonary edema, hypoxemia, reduced lung volumes, impaired thoracic mobility, and respiratory muscle dysfunction. Median sternotomy, postoperative pain, fear of movement, prolonged immobilization, and changes in respiratory mechanics may contribute to impaired pulmonary function during the early postoperative period.

Postoperative physiotherapy, early mobilization, breathing exercises, and range of motion exercises are commonly included in standard postoperative care after cardiac surgery. Deep breathing exercises are recommended to support lung expansion and improve pulmonary function, while upper extremity range of motion exercises may contribute to thoracic mobility, postural drainage, secretion clearance, and functional recovery. However, evidence regarding the immediate effects of standardized upper extremity exercises on respiratory parameters after open cardiac surgery remains limited.

Previous studies have examined respiratory physiotherapy, mobilization, and exercise-based interventions after cardiac surgery, and some evidence suggests potential benefits on lung function and inspiratory capacity. Nevertheless, the specific contribution of upper extremity range of motion exercises performed with versus without deep breathing has not been sufficiently clarified. This study is designed to compare the immediate effects of these two standardized exercise protocols on oxygen saturation, tidal volume, respiratory rate, heart rate, pain, perceived exertion, and dyspnea in patients after cardiac surgery.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

90

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ja

Beskrivelse

Inclusion Criteria:

  • underwent elective open-heart surgery,
  • stayed in the cardiovascular ICU for at least 2 nights post-operatively,
  • had FiO2 below 40% (Spo2 will be kept above 92),
  • were conscious,
  • could speak Turkish,
  • were willing to participate in the study.

Exclusion Criteria:

underwent another thoracic surgery or repeat surgery simultaneously,

  • had any limb loss,
  • underwent prolonged immobilization and intubation,
  • developed serious complications such as infection or respiratory failure after surgery,
  • had problems such as paresthesia, plegia, etc. after stroke, or had diseases such as Parkinson's that affect the level of relaxa

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Andet
  • Tildeling: Randomiseret
  • Interventionel model: Crossover opgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Deep Breathing followed by ROM with Deep Breathing
Participants will first perform deep breathing exercises alone, followed by upper extremity range of motion exercises combined with deep breathing.
Adfærdsmæssigt: Deep Breathing Exercise
Participants will perform slow and deep breathing exercises in a sitting position. Measurements will be recorded before and immediately after the intervention.
Adfærdsmæssigt: Upper Extremity ROM Exercise Combined with Deep Breathing
Participants will perform bilateral upper extremity range of motion exercises while taking a slow deep breath during arm elevation and exhaling during arm lowering. The exercise will be repeated five times in a sitting position. Measurements will be recorded before and immediately after the intervention.
Aktiv komparator: ROM with Deep Breathing followed by Deep Breathing
Participants will first perform upper extremity range of motion exercises combined with deep breathing, followed by deep breathing exercises alone.
Adfærdsmæssigt: Deep Breathing Exercise
Participants will perform slow and deep breathing exercises in a sitting position. Measurements will be recorded before and immediately after the intervention.
Adfærdsmæssigt: Upper Extremity ROM Exercise Combined with Deep Breathing
Participants will perform bilateral upper extremity range of motion exercises while taking a slow deep breath during arm elevation and exhaling during arm lowering. The exercise will be repeated five times in a sitting position. Measurements will be recorded before and immediately after the intervention.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in Oxygen Saturation SpO₂
Tidsramme: Baseline and immediately after each intervention.
Oxygen saturation will be measured using a bedside clinical monitor or pulse oximeter. SpO₂ represents the percentage of hemoglobin saturated with oxygen in the blood and will be recorded as a percentage. Higher values indicate better oxygenation.
Baseline and immediately after each intervention.

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in Respiratory Rate
Tidsramme: Baseline and immediately after each intervention.
Respiratory rate will be assessed as the number of breaths taken per minute and recorded as breaths per minute
Baseline and immediately after each intervention.
Change in Heart Rate
Tidsramme: Baseline and immediately after each intervention.
Heart rate will be measured using a bedside clinical monitor and recorded as beats per minute.
Baseline and immediately after each intervention.
Change in Pain Intensity Assessed by the Numeric Rating Scale
Tidsramme: Baseline and immediately after each intervention.
Pain intensity will be assessed using the Numeric Rating Scale, ranging from 0 to 10. Higher scores indicate greater pain intensity.
Baseline and immediately after each intervention.

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Kocaeli University

Efterforskere

  • Ledende efterforsker: MUSTAFA CANİKOĞLU, Assist. Prof, Kocaeli University
  • Studiestol: Yasemin Özhanlı, Assist. Prof, Kocaeli University

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. september 2025

Primær færdiggørelse (Faktiske)

2. september 2025

Studieafslutning (Anslået)

30. september 2026

Datoer for studieregistrering

Først indsendt

30. maj 2026

Først indsendt, der opfyldte QC-kriterier

30. maj 2026

Først opslået (Faktiske)

4. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

4. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

30. maj 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Andre undersøgelses-id-numre

  • KOU-CVS-ROM-DB-2026

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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