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NCT Number: NCT04741035

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

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.

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Key information

Age range

40 year–65 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Rehman medical institute

Peshawar, KPK, 25000, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Open heart surgery patients (CABG and Valve surgeries)

Exclusion criteria

  • Unstable vitals
  • Patient needing maximum assistance
  • Decline consent

Treatment and study plan

Modified sternal precautions

Other

Use pain and discomfort to guide the safe use of the arms Avoid pushing or pulling with one arm Use both arms close to the body during lifting Use of arms is possible, but keep them close to the body Avoid stretching one or both arms backwards at the same time Use a cushion or perform sternal preservation technique (crossing the arms in a 'self-hugging 'posture) when coughing.

When transferring, roll onto the side, ease the legs over the edge of the bed and carefully use the arms to sit up from a lying position

Conventional sternal precautions

Other

Avoid pushing or pulling through the arms Avoid one-arm (unilateral) activity Limit the elevation of the arms to 90 degrees Avoid lifting objects heavier than 2 kg Use a cushion or perform sternal preservation technique (crossing the arms in a 'self-hugging' posture) when coughing Limit the use of the arms when transferring from sitting to standing and getting out of bed Avoid placing the arms behind the back

Primary outcomes

  1. Short physical performance battery

    Time frame: 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.

  2. Functional difficulties questionnaire

    Time frame: 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.

  3. Tampa scale of Kinesiophobia (TSK-II)

    Time frame: 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.

  4. Mcgill pain questionnaire - short form version 2 (SF-MPQ-2)

    Time frame: 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 outcomes

  1. Health survey (SF-36)

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Riphah International University

Other

Registry information

Official study title

Effectiveness of Modified Sternal Precautions Versus Conventional Sternal Precautions in Improving Physical Function After Sternotomy

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Feb 5, 2021
Registry last updated
Jun 1, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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