Effects of Early Mobility Protocols in Cardiac ICU

Sponsor
Riphah International University (Other)
Overall Status
Recruiting
CT.gov ID
NCT06029556
Collaborator
(none)
70
1
2
10
7

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Mobility out of Bed
  • Other: Ergometry in Bed
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
70 participants
Allocation:
Randomized
Intervention Model:
Sequential Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Effects of Early Mobilization on Functional Capacity, Physical Activity and Kinesiophobia in Post Coronary Artery Bypass Grafting
Actual Study Start Date :
Dec 1, 2022
Anticipated Primary Completion Date :
Sep 30, 2023
Anticipated Study Completion Date :
Oct 1, 2023

Arms and Interventions

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)

Outcome Measures

Primary Outcome Measures

  1. 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.

  2. 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.

  3. 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.

  4. 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

  1. 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.

  2. 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.

  3. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
40 Years to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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)

Contacts and Locations

Locations

Site City State Country Postal Code
1 Rehman Medical Institute Peshawar KPK Pakistan 25000

Sponsors and Collaborators

  • Riphah International University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Riphah International University
ClinicalTrials.gov Identifier:
NCT06029556
Other Study ID Numbers:
  • REC/01373 Sarmad
First Posted:
Sep 8, 2023
Last Update Posted:
Sep 14, 2023
Last Verified:
Sep 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Riphah International University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 14, 2023