NCT07627009

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
3mo left

Started Sep 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress73%
Sep 2025Sep 2026

Study Start

First participant enrolled

September 1, 2025

Completed
1 day until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 2, 2025

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

May 30, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 4, 2026

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2026

Expected
Last Updated

June 4, 2026

Status Verified

May 1, 2026

Enrollment Period

1 day

First QC Date

May 30, 2026

Last Update Submit

May 30, 2026

Conditions

Keywords

Cardiac surgeryRange of motion exerciseDeep breathing exercisePostoperative respiratory function

Outcome Measures

Primary Outcomes (1)

  • Change in Oxygen Saturation SpO₂

    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.

Secondary Outcomes (3)

  • Change in Respiratory Rate

    Baseline and immediately after each intervention.

  • Change in Heart Rate

    Baseline and immediately after each intervention.

  • Change in Pain Intensity Assessed by the Numeric Rating Scale

    Baseline and immediately after each intervention.

Study Arms (2)

Deep Breathing followed by ROM with Deep Breathing

EXPERIMENTAL

Participants will first perform deep breathing exercises alone, followed by upper extremity range of motion exercises combined with deep breathing.

Behavioral: Deep Breathing ExerciseBehavioral: Upper Extremity ROM Exercise Combined with Deep Breathing

ROM with Deep Breathing followed by Deep Breathing

ACTIVE COMPARATOR

Participants will first perform upper extremity range of motion exercises combined with deep breathing, followed by deep breathing exercises alone.

Behavioral: Deep Breathing ExerciseBehavioral: Upper Extremity ROM Exercise Combined with Deep Breathing

Interventions

Participants will perform slow and deep breathing exercises in a sitting position. Measurements will be recorded before and immediately after the intervention.

Deep Breathing followed by ROM with Deep BreathingROM with Deep Breathing followed by 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.

Deep Breathing followed by ROM with Deep BreathingROM with Deep Breathing followed by Deep Breathing

Eligibility Criteria

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

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kocaeli University

İzmit, Kocaeli, 41100, Turkey (Türkiye)

RECRUITING

Related Publications (1)

  • Amin R, Alaparthi GK, Samuel SR, Bairapareddy KC, Raghavan H, Vaishali K. Effects of three pulmonary ventilation regimes in patients undergoing coronary artery bypass graft surgery: a randomized clinical trial. Sci Rep. 2021 Mar 24;11(1):6730. doi: 10.1038/s41598-021-86281-4.

Study Officials

  • MUSTAFA CANİKOĞLU, Assist. Prof

    Kocaeli University

    PRINCIPAL INVESTIGATOR
  • Yasemin Özhanlı, Assist. Prof

    Kocaeli University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
Due to the nature of the exercise interventions, blinding of participants and intervention providers will not be feasible. Outcome measurements will be obtained using standard clinical monitoring devices and patient-reported scales.
Purpose
OTHER
Intervention Model
CROSSOVER
Model Details: Participants will be randomized to one of two sequences. Each participant will receive both upper extremity exercise protocols, with and without deep breathing, in a 2×2 crossover design.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assist.Prof.

Study Record Dates

First Submitted

May 30, 2026

First Posted

June 4, 2026

Study Start

September 1, 2025

Primary Completion

September 2, 2025

Study Completion (Estimated)

September 30, 2026

Last Updated

June 4, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Locations