Effects of Early Mobility Protocols in Cardiac ICU

CABG Clinical Trial

Official title:

Effects of Early Mobilization on Functional Capacity, Physical Activity and Kinesiophobia in Post Coronary Artery Bypass Grafting

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06029556
• Other study ID #: REC/01373 Sarmad
• Status: Recruiting
• Phase: N/A
• Start date: December 1, 2022
• Est. completion date: October 1, 2023

Study information

• Verified date: September 2023
• Source: Riphah International University
• Contact: Sumaiyah Obaid, MS
• Phone: +923212683462
• Email: sumaiyah.obaid[@]riphah.edu.pk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

In this study the investigator aim to find the effects of early mobility on different physical activity protocols in post CABG patients. Physical activity, functional status, functional capacity, Kinesiophobia, ICU mortality, heart rate, blood pressure, oxygen saturation, length of hospital stay and sternal instability. To compare the physical activity protocol used by physical therapist.

Description:

Current study will compare two different early mobility protocols and will help in assessing best protocol to be use in cardiac ICU for better outcomes of patients.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: October 1, 2023
• Est. primary completion date: September 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 70 Years

Eligibility

Inclusion Criteria:

• Age 40-70 years

• Both Genders

• Extubated patients with no Complication

• Post CABG (Elective)

• Vitally stable

• 1st CABG

• Selective CABG surgeries

Exclusion Criteria:

• Post anesthesia Psychosis

• Corrective surgeries

• Post CABG Stroke

• Infectious wound

• Participants with a physical disability

• Intra-aortic balloon pump (IABP)

Related Conditions & MeSH terms

• CABG
• Kinesiophobia

Intervention

Other:
• Mobility out of Bed
Active upper limb exercises will be conducted (flexion-extension and adduction-abduction) of large joints (shoulder, elbow and wrist) Associated with upper limb exercises, patients will undergo a series of exercises ergometer with lower limb (LL). The mobilization will be conduct on a cycle ergometer in an active, lasting 20 minutes, divided into three steps: heat 5 minutes; 10 minutes of low-intensity exercise, with a speed of 30 revolutions per minute (rpm); and 5 minutes recovery. The patient remains in the supine position with the head of the bed elevated to 45 degrees, while the lower limbs will remain planned
• Ergometry in Bed
Ankle pumps (5*2), knee extension (5*2), breathing exercises with elbow flexion and extension(5*2), spirometry and progressive early ambulation (from bed to wheelchair and wheelchair to standing and from standing to few steps), and conventional chest physical activity (5 minutes on precursor)

Locations

Country	Name	City	State
Pakistan	Rehman Medical Institute	Peshawar	KPK

Sponsors (1)

Lead Sponsor	Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Functional Status score Questionnaire	Five item scale measures the physical performance of patients in ICU.The Functional Status Score for the Intensive Care Unit (FSS-ICU) is a 5-item performance-based measure that utilizes an 8 point, ordinal scale to measure physical function for patients in the intensive care unit setting.	Pre Operative (Baseline), 1st Assessment (0 Week) and 2nd Assessment (4 week)
Primary	BAECK PHYSICAL ACTIVITY QUESTIONNAIRE	Evaluates the physical activity over the past 12 months. The MBPAQ (BHPAQ) evaluates habitual physical activities in individuals. Activities are scored on a scale of 1-5. A score of 5 indicates the most activity and 1 indicates the least activity for each index.	Pre Operative (Baseline), 1st Assessment (0 Week) and 2nd Assessment (4 week)
Primary	6 minute walk Test	Sub-maximal test evaluates the aerobic endurance. The 6-minute walk test (6MWT) assesses distance walked over 6 minutes as a sub-maximal test of aerobic capacity/endurance.	Pre Operative (Baseline), 1st Assessment (0 Week) and 2nd Assessment (4 week)
Primary	Tampa Scale of Kinesiophobia	Evaluate the fear of movement during activity ,17 items a self-reporting questionnaire based on evaluation of fear of movement, fear of physical activity, and fear avoidance. Individual item scores range from 1-4, with the negatively worded items (4,8,12,16) having a reverse scoring (4-1). The 17 item TSK total scores range from 17 to 68 where the lowest 17 means no or negligible kinesiophobia, and the higher scores indicate an increasing degree of kinesiophobia. Changes will be measured at baseline and at completion of 4th week	Pre Operative (Baseline), 1st Assessment (0 Week) and 2nd Assessment (4 week)
Secondary	STERNAL INSTABILITY SCALE:	The sternal instability scale (SIS) is a non-invasive manual assessment tool used to detect early bony non-union or instability.	Pre Operative (Baseline), 1st Assessment (0 Week) and 2nd Assessment (4 week)
Secondary	BORG RATING OF PERCEIVED EXERTION	The Borg RPE Scale is a 15-point scale (6 to 20) used to rate subjective experiences during physical exertion. This subjective load scale can help estimate load symptoms, such as the degree of exertion, the degree of load and fatigue.	Pre Operative (Baseline), 1st Assessment (0 Week) and 2nd Assessment (4 week)
Secondary	Length of Hospital stay	Total number of days stay in hospital average of days in both group.	Pre Operative (Baseline), 1st Assessment (0 Week) and 2nd Assessment (4 week)