Effects of Early Mobility Protocols in Cardiac ICU

Not Applicable

Recruiting

• Conditions: CABG
• Interventions: Other: Mobility out of Bed; Other: Ergometry in Bed

• Registration Number: NCT06029556
• Lead Sponsor: Riphah International University

Brief 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.

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 Timeline

• Study Start: 2022-12-01
• Study First Submitted: 2022-12-06
• Study First Submitted QC: 2023-08-31
• Status Verified: 2023-09
• Study First Posted: 2023-09-08
• Last Update Submitted: 2023-09-12
• Last Update Posted: 2023-09-14
• Primary Completion: 2023-09-30
• Study Completion: 2023-10-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 70

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Mobility out of Bed	Ergometry in Bed	-
Ergometry in Bed	Mobility out of Bed	-
Mobility out of Bed	Mobility out of Bed	-
Ergometry in Bed	Ergometry in Bed	-

Primary Outcome Measures

Name	Time	Method
BAECK PHYSICAL ACTIVITY QUESTIONNAIRE	Pre Operative (Baseline), 1st Assessment (0 Week) and 2nd Assessment (4 week)	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.
Functional Status score Questionnaire	Pre Operative (Baseline), 1st Assessment (0 Week) and 2nd Assessment (4 week)	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.
6 minute walk Test	Pre Operative (Baseline), 1st Assessment (0 Week) and 2nd Assessment (4 week)	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.
Tampa Scale of Kinesiophobia	Pre Operative (Baseline), 1st Assessment (0 Week) and 2nd Assessment (4 week)	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

Secondary Outcome Measures

Name	Time	Method
STERNAL INSTABILITY SCALE:	Pre Operative (Baseline), 1st Assessment (0 Week) and 2nd Assessment (4 week)	The sternal instability scale (SIS) is a non-invasive manual assessment tool used to detect early bony non-union or instability.
BORG RATING OF PERCEIVED EXERTION	Pre Operative (Baseline), 1st Assessment (0 Week) and 2nd Assessment (4 week)	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.
Length of Hospital stay	Pre Operative (Baseline), 1st Assessment (0 Week) and 2nd Assessment (4 week)	Total number of days stay in hospital average of days in both group.

Trial Locations

Locations (1)

Rehman Medical Institute; 🇵🇰 Peshawar, KPK, Pakistan