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

NCT ID: NCT04741035

Last Updated: 2022-06-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-19

Study Completion Date

2021-03-31

Brief Summary

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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

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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.

Conditions

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Cardiovascular Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Modified sternal precautions

Interventional group (Modified sternal precautions)

Group Type EXPERIMENTAL

Modified sternal precautions

Intervention Type 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

Control group (Conventional sternal precautions)

Group Type ACTIVE_COMPARATOR

Conventional sternal precautions

Intervention Type 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

Interventions

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Modified sternal precautions

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

Intervention Type OTHER

Conventional sternal precautions

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

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Open heart surgery patients (CABG and Valve surgeries)

Exclusion Criteria

* Unstable vitals
* Patient needing maximum assistance
* Decline consent
Minimum Eligible Age

40 Years

Maximum Eligible Age

65 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Riphah International University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sumaiyah Obaid, MS

Role: PRINCIPAL_INVESTIGATOR

Riphah International University

Locations

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Rehman medical institute

Peshawar, KPK, Pakistan

Site Status

Countries

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Pakistan

References

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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.

Reference Type BACKGROUND
PMID: 21540420 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24240936 (View on PubMed)

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

Reference Type 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.

Reference Type BACKGROUND
PMID: 24446411 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27353128 (View on PubMed)

Other Identifiers

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REC00707 Huma Balqias

Identifier Type: -

Identifier Source: org_study_id

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