Effects of Early Mobility Protocols in Cardiac ICU

NCT06029556 | Unknown DMC

• 1 other identifier: REC/01373 Sarmad
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

CABG

Keywords

Early mobility; Physical activity; Kinesiophobia; Functional capacity

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (3)

• STERNAL INSTABILITY SCALE:

  Pre Operative (Baseline), 1st Assessment (0 Week) and 2nd Assessment (4 week)

• BORG RATING OF PERCEIVED EXERTION

  Pre Operative (Baseline), 1st Assessment (0 Week) and 2nd Assessment (4 week)

• Length of Hospital stay

  Pre Operative (Baseline), 1st Assessment (0 Week) and 2nd Assessment (4 week)

Study Arms (2)

Mobility out of Bed

ACTIVE COMPARATOR

Other: Mobility out of Bed; Other: Ergometry in Bed

Ergometry in Bed

EXPERIMENTAL

Other: Mobility out of Bed; Other: Ergometry in Bed

Interventions

Mobility out of Bed OTHER

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; Mobility out of Bed

Ergometry in Bed OTHER

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)

Ergometry in Bed; Mobility out of Bed

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 40-70 years
• Both Genders
• Extubated patients with no Complication
• Post CABG (Elective)
• Vitally stable
• st CABG
• Selective CABG surgeries

You may not qualify if:

• Post anesthesia Psychosis
• Corrective surgeries
• Post CABG Stroke
• Infectious wound
• Participants with a physical disability
• Intra-aortic balloon pump (IABP)

Sponsors & Collaborators

• Riphah International University: lead

Study Sites (1)

Rehman Medical Institute

Peshawar, KPK, 25000, Pakistan

RECRUITING

MeSH Terms

Conditions

Motor Activity; Kinesiophobia

Interventions

Ergometry; Beds

Condition Hierarchy (Ancestors)

Behavior; Phobic Disorders; Anxiety Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Investigative Techniques; Equipment and Supplies, Hospital; Equipment and Supplies

Study Officials

• Sumaiyah Obaid, MS

  Riphah International University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sumaiyah Obaid, MS

CONTACT

+923212683462; sumaiyah.obaid@riphah.edu.pk

Sarmad Khattak, DPT

CONTACT

+923428578356; sarmadkhattak007@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 6, 2022
• First Posted: September 8, 2023
• Study Start: December 1, 2022
• Primary Completion: September 30, 2023
• Study Completion: October 1, 2023
• Last Updated: September 14, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)