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

NCT04741035 | Completed

• 1 other identifier: REC00707 Huma Balqias
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiovascular Diseases

Keywords

Sternal precautions; Sternal restrictions; CABG

Outcome Measures

Primary Outcomes (4)

• Short physical performance battery

  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.

  4 Week

• Functional difficulties questionnaire

  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.

  4 week

• Tampa scale of Kinesiophobia (TSK-II)

  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 week

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

  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.

  4 Week

Secondary Outcomes (1)

• Health survey (SF-36)

  4 week

Study Arms (2)

Modified sternal precautions

EXPERIMENTAL

Interventional group (Modified sternal precautions)

Other: Modified sternal precautions

Conventional sternal precautions

ACTIVE COMPARATOR

Control group (Conventional sternal precautions)

Other: Conventional sternal precautions

Interventions

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

Modified sternal precautions

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

Conventional sternal precautions

Eligibility Criteria

• Age: 40 Years - 65 Years
• Gender Eligibility Details: 40 and above
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Open heart surgery patients (CABG and Valve surgeries)

You may not qualify if:

• Unstable vitals
• Patient needing maximum assistance
• Decline consent

Sponsors & Collaborators

• Riphah International University: lead

Study Sites (1)

Rehman medical institute

Peshawar, KPK, 25000, Pakistan

Location

Related Publications (5)

• Epstein AJ, Polsky D, Yang F, Yang L, Groeneveld PW. Coronary revascularization trends in the United States, 2001-2008. JAMA. 2011 May 4;305(17):1769-76. doi: 10.1001/jama.2011.551.

  PMID: 21540420 BACKGROUND

• Deb S, Wijeysundera HC, Ko DT, Tsubota H, Hill S, Fremes SE. Coronary artery bypass graft surgery vs percutaneous interventions in coronary revascularization: a systematic review. JAMA. 2013 Nov 20;310(19):2086-95. doi: 10.1001/jama.2013.281718.

  PMID: 24240936 BACKGROUND

• Hodge T. Fast Facts for the Cardiac Surgery Nurse: Caring for Cardiac Surgery Patients in a Nutshell: Springer Publishing Company; 2015.

  BACKGROUND

• Go AS, Mozaffarian D, Roger VL, Benjamin EJ, Berry JD, Blaha MJ, Dai S, Ford ES, Fox CS, Franco S, Fullerton HJ, Gillespie C, Hailpern SM, Heit JA, Howard VJ, Huffman MD, Judd SE, Kissela BM, Kittner SJ, Lackland DT, Lichtman JH, Lisabeth LD, Mackey RH, Magid DJ, Marcus GM, Marelli A, Matchar DB, McGuire DK, Mohler ER 3rd, Moy CS, Mussolino ME, Neumar RW, Nichol G, Pandey DK, Paynter NP, Reeves MJ, Sorlie PD, Stein J, Towfighi A, Turan TN, Virani SS, Wong ND, Woo D, Turner MB; American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Executive summary: heart disease and stroke statistics--2014 update: a report from the American Heart Association. Circulation. 2014 Jan 21;129(3):399-410. doi: 10.1161/01.cir.0000442015.53336.12. No abstract available.

  PMID: 24446411 BACKGROUND

• Price KJ, Gordon BA, Bird SR, Benson AC. A review of guidelines for cardiac rehabilitation exercise programmes: Is there an international consensus? Eur J Prev Cardiol. 2016 Nov;23(16):1715-1733. doi: 10.1177/2047487316657669. Epub 2016 Jun 27.

  PMID: 27353128 BACKGROUND

MeSH Terms

Conditions

Cardiovascular Diseases

Study Officials

• Sumaiyah Obaid, MS

  Riphah International University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 2, 2021
• First Posted: February 5, 2021
• Study Start: September 19, 2020
• Primary Completion: March 28, 2021
• Study Completion: March 31, 2021
• Last Updated: June 1, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)