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

30. mai 2026 oppdatert av: 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.

Studieoversikt

Detaljert 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.

Studietype

Intervensjonell

Registrering (Antatt)

90

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske 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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Annen
  • Tildeling: Randomisert
  • Intervensjonsmodell: Crossover-oppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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.
Participants will perform slow and deep breathing exercises in a sitting position. Measurements will be recorded before and immediately after the intervention.
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.
Participants will perform slow and deep breathing exercises in a sitting position. Measurements will be recorded before and immediately after the intervention.
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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
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
Tiltaksbeskrivelse
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.

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Etterforskere

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

Publikasjoner og nyttige lenker

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Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

1. september 2025

Primær fullføring (Faktiske)

2. september 2025

Studiet fullført (Antatt)

30. september 2026

Datoer for studieregistrering

Først innsendt

30. mai 2026

Først innsendt som oppfylte QC-kriteriene

30. mai 2026

Først lagt ut (Faktiske)

4. juni 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

4. juni 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

30. mai 2026

Sist bekreftet

1. mai 2026

Mer informasjon

Begreper knyttet til denne studien

Andre studie-ID-numre

  • KOU-CVS-ROM-DB-2026

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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