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Effects of Early Mobility Protocols in Cardiac ICU

Primary Purpose

CABG

Status
Recruiting
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Mobility out of Bed
Ergometry in Bed
Sponsored by
Riphah International University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for CABG focused on measuring Early mobility, Physical activity, Kinesiophobia, Functional capacity

Eligibility Criteria

40 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Rehman Medical InstituteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Mobility out of Bed

Ergometry in Bed

Arm Description

Outcomes

Primary Outcome Measures

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.
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.
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.
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

Secondary Outcome Measures

STERNAL INSTABILITY SCALE:
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
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
Total number of days stay in hospital average of days in both group.

Full Information

First Posted
December 6, 2022
Last Updated
September 12, 2023
Sponsor
Riphah International University
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1. Study Identification

Unique Protocol Identification Number
NCT06029556
Brief Title
Effects of Early Mobility Protocols in Cardiac ICU
Official Title
Effects of Early Mobilization on Functional Capacity, Physical Activity and Kinesiophobia in Post Coronary Artery Bypass Grafting
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 1, 2022 (Actual)
Primary Completion Date
September 30, 2023 (Anticipated)
Study Completion Date
October 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Riphah International University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
CABG
Keywords
Early mobility, Physical activity, Kinesiophobia, Functional capacity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Mobility out of Bed
Arm Type
Active Comparator
Arm Title
Ergometry in Bed
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Mobility out of Bed
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Ergometry in Bed
Intervention Description
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)
Primary Outcome Measure Information:
Title
Functional Status score Questionnaire
Description
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.
Time Frame
Pre Operative (Baseline), 1st Assessment (0 Week) and 2nd Assessment (4 week)
Title
BAECK PHYSICAL ACTIVITY QUESTIONNAIRE
Description
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.
Time Frame
Pre Operative (Baseline), 1st Assessment (0 Week) and 2nd Assessment (4 week)
Title
6 minute walk Test
Description
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.
Time Frame
Pre Operative (Baseline), 1st Assessment (0 Week) and 2nd Assessment (4 week)
Title
Tampa Scale of Kinesiophobia
Description
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
Time Frame
Pre Operative (Baseline), 1st Assessment (0 Week) and 2nd Assessment (4 week)
Secondary Outcome Measure Information:
Title
STERNAL INSTABILITY SCALE:
Description
The sternal instability scale (SIS) is a non-invasive manual assessment tool used to detect early bony non-union or instability.
Time Frame
Pre Operative (Baseline), 1st Assessment (0 Week) and 2nd Assessment (4 week)
Title
BORG RATING OF PERCEIVED EXERTION
Description
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.
Time Frame
Pre Operative (Baseline), 1st Assessment (0 Week) and 2nd Assessment (4 week)
Title
Length of Hospital stay
Description
Total number of days stay in hospital average of days in both group.
Time Frame
Pre Operative (Baseline), 1st Assessment (0 Week) and 2nd Assessment (4 week)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sumaiyah Obaid, MS
Phone
+923212683462
Email
sumaiyah.obaid@riphah.edu.pk
First Name & Middle Initial & Last Name or Official Title & Degree
Sarmad Khattak, DPT
Phone
+923428578356
Email
sarmadkhattak007@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sumaiyah Obaid, MS
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rehman Medical Institute
City
Peshawar
State/Province
KPK
ZIP/Postal Code
25000
Country
Pakistan
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No

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Effects of Early Mobility Protocols in Cardiac ICU

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