Modified Sternal Precautions Versus Conventional Sternal Precautions in Physical Function After Sternotomy

Not Applicable

Completed

• Conditions: Cardiovascular Diseases
• Interventions: Other: Modified sternal precautions; Other: Conventional sternal precautions

• Registration Number: NCT04741035
• Lead Sponsor: Riphah International University

Brief Summary

This research study Effectiveness of modified sternal precautions versus conventional sternal precautions in improving physical function after sternotomy .After recruitment of the subjects, the intervention group will receive modified sternal precaution while the control group will receive conventional sternal precautions and they will be assess for their physical activity, kinesiophobia, quality of life and post sternotomy pain.

Detailed Description

This study will address the scarcity of research and the variations in recommendations regarding sternal precautions and restrictions of upper limb movement in cardiac patients and will help to evaluate the effect of modified sternal precautions on patients' pain and functional activity. As physical therapists are the ones who have maximum exposure to practice and teaching of sternal precautions, therefore this study will help to formulate the guidelines regarding the use of upper limb during cardiac rehabilitation exercises and making standards for sternal precautions and its management following cardiac surgery.

Study Timeline

• Study Start: 2020-09-19
• Study First Submitted: 2021-02-02
• Study First Submitted QC: 2021-02-04
• Study First Posted: 2021-02-05
• Primary Completion: 2021-03-28
• Study Completion: 2021-03-31
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-31
• Last Update Posted: 2022-06-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 40

Inclusion Criteria

• Open heart surgery patients (CABG and Valve surgeries)

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Exclusion Criteria

• Unstable vitals
• Patient needing maximum assistance
• Decline consent

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Modified sternal precautions	Modified sternal precautions	Interventional group (Modified sternal precautions)
Conventional sternal precautions	Conventional sternal precautions	Control group (Conventional sternal precautions)

Primary Outcome Measures

Name	Time	Method
Tampa scale of Kinesiophobia (TSK-II)	4 week	It is a broadly used tool to measure pain related fear beliefs regarding movement and re-injury. The validly of the questionnaire range between 0.74 to 0.87 and its reliability is 0.747. It is a self-reported questionnaire. It includes 11 questions scale on likert scale ranging from 1 to 4 where 1 means strongly disagree while 4 means strongly agree. The total score ranges between 11 to 44. Higher score indicate high level of kinesiopobhia. A reduction of points equal or more than 3 points accounting for about 10% is considered as relevant change.
Short physical performance battery	4 Week	SPBB is a commonly used tool in clinical setting for measuring the physical performance of patients. It is known for its feasibility and shorter time to conduct. It has been used in different studies for reporting outcome measure post cardiac surgery. This outcome measure is also selected due to its high validity and reliability. The reliability of the test is 0.87. It is divided into three subtests: balance, a short walk at normal pace and lastly standing up from a chair five times repeatedly. These subsets exemplify core tasks being important for independent living.
Functional difficulties questionnaire	4 week	Functional difficulties questionnaire is a functional outcome measures that specially focuses on the thoracic region and upper limb movements in people following cardiac surgery. The validity of the questionnaire is 0.971 while its reliability is 0.918. The questionnaire is divided into 13 questions which consists of functional tasks, causing difficulty following cardiac surgery. Participants are required to mark on an unmarked 10cm VAS the level of difficulty they experienced when completing each of the included tasks, based on the previous time they experience.
Mcgill pain questionnaire - short form version 2 (SF-MPQ-2)	4 Week	It is one of the most widely used questionnaire for the measurement of pain. Its benefit is that it provides valuable information on the sensory, affective and evaluative dimensions of pain experience by an individual. It has a capability of discriminating among different types of pain problems. It has become one of the most commonly used tests for the measurement of pain following cardiac surgery via sternotomy. The reliability of the questionnaire ranges from 0.75 to 0.83.

Secondary Outcome Measures

Name	Time	Method
Health survey (SF-36)	4 week	This questionnaire provides overall measure of quality of recovery of patient according to the patient's perspective. It is a reliable and valid tool used mainly in clinical practices to measure health related quality of life following cardiac surgery. The reliability of scale is 0.65 to 0.96. This tool consists of eight domains comprising of physical functioning, role physical functioning, role emotional functioning, mental health, vitality, social functioning, bodily pain and general health. Responses are recorded on a five-point Likert scale and then transformed onto a 100-point scale. Score higher than 50 shows better health state and less pain experienced

Trial Locations

Locations (1)

Rehman medical institute; 🇵🇰 Peshawar, KPK, Pakistan