Comparison of Open Heart Surgery Patients With Forward Head Posture With and Without Perioperative Therapeutic Exercise

NCT ID: NCT05967780

Last Updated: 2024-02-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-08-17
• Study Completion Date: 2023-12-31

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.

Conditions

Cardiac Rehabilitation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Group A: Patients with FHP receiving standard cardiac rehabilitation

Consenting participants in this group will receive a standard cardiac rehabilitation protocol.

Group Type: ACTIVE_COMPARATOR

Group A: Patients with FHP receiving standard cardiac rehabilitation

Intervention Type: OTHER

Consenting participants in this group will receive a standard cardiac rehabilitation protocol that includes preoperative education and post-operative exercises, chest physiotherapy, functional mobility and care. Phase 1 begins after the patient has been considered clinically compensated due to the optimization of the clinical treatment and/or the use of an interventional procedure. In this phase, a combination of low-intensity physical exercise (that includes range of motion exercises for upper \& lower extremities + progressive mobilization from sitting on bedside to walking short distance and up to stair climbing), incentive spirometry exercise, percussions, breathing exercises and effective coughing exercises.

Group B: Patients with FHP receiving standard cardiac rehabilitation + therapeutic exercises

The participants who give consent will receive standard cardiac rehabilitation protocol (as Group A) with therapeutic exercise in the intervention group.

Group Type: EXPERIMENTAL

Group B: Patients with FHP receiving standard cardiac rehabilitation + therapeutic exercises

Intervention Type: OTHER

The participants who give consent will receive standard cardiac rehabilitation protocol (as Group A) with therapeutic exercise in the intervention group.

Therapeutic exercises will be delivered to the participant by treating physiotherapist in physical, verbal and written formats as individualized sessions on the ward 4 weeks before the surgery and keep him doing exercises under supervision while staying in the ward before surgery. A log will be provided to measure performance to ensure program compliance. After discharge from the hospital, the patient will continue exercises at home as performed and guided physically by the therapist and also in the exercises manual and flyer given to the patient. Patients will be instructed to follow therapeutic exercise for 4 weeks pre-operatively and 4 weeks postoperatively after discharge from the hospital.

Group C: Patients without FHP receiving standard cardiac rehabilitation

The participants without forward head posture will be included in this group and will receive same standard cardiac rehabilitation as the participants in group A.

Group Type: ACTIVE_COMPARATOR

Group C: Patients without FHP receiving standard cardiac rehabilitation

Intervention Type: OTHER

The participants without forward head posture will be included in this group and will receive same standard cardiac rehabilitation as the participants in group A.

Interventions

Group A: Patients with FHP receiving standard cardiac rehabilitation

Consenting participants in this group will receive a standard cardiac rehabilitation protocol that includes preoperative education and post-operative exercises, chest physiotherapy, functional mobility and care. Phase 1 begins after the patient has been considered clinically compensated due to the optimization of the clinical treatment and/or the use of an interventional procedure. In this phase, a combination of low-intensity physical exercise (that includes range of motion exercises for upper \& lower extremities + progressive mobilization from sitting on bedside to walking short distance and up to stair climbing), incentive spirometry exercise, percussions, breathing exercises and effective coughing exercises.

Intervention Type: OTHER

Group B: Patients with FHP receiving standard cardiac rehabilitation + therapeutic exercises

The participants who give consent will receive standard cardiac rehabilitation protocol (as Group A) with therapeutic exercise in the intervention group.

Therapeutic exercises will be delivered to the participant by treating physiotherapist in physical, verbal and written formats as individualized sessions on the ward 4 weeks before the surgery and keep him doing exercises under supervision while staying in the ward before surgery. A log will be provided to measure performance to ensure program compliance. After discharge from the hospital, the patient will continue exercises at home as performed and guided physically by the therapist and also in the exercises manual and flyer given to the patient. Patients will be instructed to follow therapeutic exercise for 4 weeks pre-operatively and 4 weeks postoperatively after discharge from the hospital.

Intervention Type: OTHER

Group C: Patients without FHP receiving standard cardiac rehabilitation

The participants without forward head posture will be included in this group and will receive same standard cardiac rehabilitation as the participants in group A.

Intervention Type: OTHER

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

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Health Education Research Foundation (HERF)

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Aadil Omer, PhD scholar

Role: PRINCIPAL_INVESTIGATOR

Tehran University of Medical Sciences, Iran

Behrouz Attarbashi Moghadam, PhD

Role: STUDY_CHAIR

Tehran University of Medical Sciences, Iran

Azadeh Shadmehr, PhD

Role: STUDY_CHAIR

Tehran University of Medical Sciences, Iran

Locations

Rawalpindi Institute of Cardiology

Rawalpindi, , Pakistan

Countries

Pakistan

Other Identifiers

IR.TUMS.FNM.REC.1402.060

Identifier Type: -

Identifier Source: org_study_id