Clinical trial NCT05967780: Comparison of Open Heart Surgery Patients With Forward Head Posture With and Without Perioperative Therapeutic Exercise
Official title: Comparison of Open Heart Surgery Patients With Forward Head Posture With and Without Perioperative Therapeutic Exercise on Craniovertebral Angle, Pulmonary Function, Balance and Quality of Life
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiac Rehabilitation
Keywords: Balance
Craniovertebral angle
Forward head posture
Open heart surgery
Pulmonary function
Quality of life
Strengthening
Stretching
Lead sponsor: Health Education Research Foundation (HERF)
Sponsor class: OTHER
First posted: 2023-08-01
Enrollment: 48
Sex: MALE
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Comparison of open heart surgery patients with forward head posture with and without perioperative therapeutic exercise on craniovertebral angle, pulmonary function, balance and quality of life

Detailed description: Open heart surgery is at high risk of postoperative complications including pulmonary disorders, balance dysfunction and affects quality of life. These complications contribute to morbidity and mortality and increase hospitalization stay and its associated costs. The high prevalence of forward head posture (FHP) in the community is also associated with stated complications like pulmonary disorders, balance dysfunction and affecting quality of life. This close association of these complications in a person with forward head posture undergoing open heart surgery may further heighten the risks. The aim of this study is to evaluate the effects of therapeutic exercises on craniovertebral angle, pulmonary disorders, static and dynamic balance and quality of life in open heart surgery patient having forward head posture. This study will be a prospective, parallel-group, allocation concealment, randomized control, patient and assessor blind trial. Patients (n=53) who undergo open heart surgery via median sternotomy with forward head posture will be recruited from a cardiac hospital. Participants will be divided into three groups. Participants with FHP will be randomized into two groups; 1) patients with FHP will receive standard cardiac rehab protocol, 2) patients with FHP will receive standard cardiac rehab protocol with therapeutic exercise for forward head posture, and 3) participants without FHP will receive standard cardiac rehabilitation. The intervention group will receive a combination of stretching and strengthening exercises (including sternocleidomastoid stretch, pectoralis stretch, the supine chin tuck, and scapular retraction) for forward head posture with standard cardiac rehabilitation. The outcome measures will be craniovertebral angle, pulmonary parameters, neck disability index, functional difficulties questionnaire, single-leg stance test, forward reach test, health-related quality of life (SF-36), and Tampa scale for kinesiophobia. Repeated measures analysis of variance will be taken to test the hypothesis and to evaluate the change from baseline (4 weeks before surgery) to one day before surgery, after surgery before discharge and 4 weeks after discharge from the hospital in the intervention group compared with the standard-care group.

Eligibility criteria: Inclusion Criteria:

* Craniovertebral angle \< 50 degrees (included in Group A \& B), Craniovertebral angle ≥ 50 degree (included in Group C)
* First elective coronary artery bypass graft surgery, valve replacement, or both through a median sternotomy
* Extubated within 6 hours after surgery

Exclusion Criteria:

* Subjects with a history of surgery or any diagnosed pathology or clinical deformity or any musculoskeletal injury within the last six months to the spine or thorax or shoulder or lower extremity
* Any comorbid lung disease
* Patients having angina pectoris while doing therapeutic exercises
* Neurological dis¬orders, neuromuscular disorders, psychiatric, dizziness and blurred vision
* Inability to stand or walk independently
* Leg length discrepancy
* Have been reoperated on/ History of previous cardiac surgery
* Postoperative cardiac dysfunction, hemodynamically unstable, ventilator dependent
* Emergency cardiac surgery
* A length of stay in the intensive care unit for 5 days or more due to medical reasons after cardiac surgery
* Postoperative wound infections or sternal instability as diagnosed by medical staff

Primary outcomes:
measure: Craniovertebral angle
timeFrame: Baseline to nine weeks
measure: Forced Vital Capacity (FVC)
timeFrame: Baseline to nine weeks
measure: Forced Expired Volume in one second (FEV1)
timeFrame: Baseline to nine weeks
measure: Forced Expired Volume in one second/Forced Vital Capacity (FEV1/FVC) ratio
timeFrame: Baseline to nine weeks
measure: Peak expiratory flow (PEF)
timeFrame: Baseline to nine weeks
measure: 25% of the Force Expiratory Flow (FEF25)
timeFrame: Baseline to nine weeks
measure: 75% of the Force Expiratory Flow (FEF75)
timeFrame: Baseline to nine weeks
measure: Average flow between 25% and 75% of the Force Expiratory Flow (FEF25-75)
timeFrame: Baseline to nine weeks
measure: Standing balance
timeFrame: Baseline to nine weeks
measure: Dynamic balance
timeFrame: Baseline to nine weeks
measure: Disability
timeFrame: Baseline to nine weeks
measure: Functional status
timeFrame: Baseline to nine weeks
measure: Health related Quality of life
timeFrame: Baseline to nine weeks
measure: Pain-related fear beliefs
timeFrame: Baseline to nine weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Rawalpindi
country: Pakistan
facility: Rawalpindi Institute of Cardiology
Study officials:
affiliation: Tehran University of Medical Sciences, Iran
name: Aadil Omer, PhD scholar
role: PRINCIPAL_INVESTIGATOR
affiliation: Tehran University of Medical Sciences, Iran
name: Behrouz Attarbashi Moghadam, PhD
role: STUDY_CHAIR
affiliation: Tehran University of Medical Sciences, Iran
name: Azadeh Shadmehr, PhD
role: STUDY_CHAIR
References: