Effects of Early Mobility Protocols in Cardiac ICU

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

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.

Study Overview

• Status: Recruiting
• Conditions: CABG
• Intervention / Treatment: Other: Mobility out of Bed; Other: Ergometry in Bed

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 70
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sumaiyah Obaid, MS; Phone Number: +923212683462; Email: sumaiyah.obaid@riphah.edu.pk
• Study Contact Backup: Name: Sarmad Khattak, DPT; Phone Number: +923428578356; Email: sarmadkhattak007@gmail.com

Study Locations

• Pakistan
  • KPK
    • Peshawar, KPK, Pakistan, 25000
      • Recruiting
      • Rehman Medical Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Mobility out of Bed	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; Other: 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)
Experimental: Ergometry in Bed	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; Other: 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)
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)
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)
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)

Collaborators and Investigators

• Sponsor: Riphah International University
• Investigators: Principal Investigator: Sumaiyah Obaid, MS, Riphah International University

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2022
• Primary Completion (Estimated): September 30, 2023
• Study Completion (Estimated): October 1, 2023

Study Registration Dates

• First Submitted: December 6, 2022
• First Submitted That Met QC Criteria: August 31, 2023
• First Posted (Actual): September 8, 2023

Study Record Updates

• Last Update Posted (Actual): September 14, 2023
• Last Update Submitted That Met QC Criteria: September 12, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: Physical activity; Kinesiophobia; Functional capacity; Early mobility
• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders; Phobic Disorders; Kinesiophobia
• Other Study ID Numbers: REC/01373 Sarmad

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No