Effects of Lower Limb Resistance Band Exercises in Phase 1 Cardiac Rehabilitation

NCT06319651 | Completed DMC

• 1 other identifier: REC/RCR&AHS/23/0360
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief Summary

This study will be randomized controlled trial with non-probability purposive sampling. Study conducted among post CABG patients. Sample size will be 56, 28 in each group. Outcome will be measured by using 6 minute walk test, Spirometry (FVC, FEV1/FVC and PEF), Functional Independence Measure.

Conditions

Cardiovascular Diseases

Keywords

Coronary artery bypass grafting; Cardiac rehabilitation; Resistance band exercise

Outcome Measures

Primary Outcomes (5)

• Functional Independence Measure

  The Functional Independence Measure (FIM) is an instrument that was developed as a measure of disability for a variety of populations and is not specific to any diagnosis. The FIM instrument Includes measures of independence for self-care, including sphincter control, transfers, locomotion, communication, and social cognition. Is an 18-item, seven-level, ordinal scale intended to be sensitive to changes over the course of a comprehensive inpatient medical rehabilitation program. Uses the level of assistance an individual needs to grade functional status from total independence to total assistance). The tool is used to assess a patient's level of disability as well as a change in patient status in response to rehabilitation or medical intervention. FIM 3 levels.

  6 Days

• 6 Minute Walk Test

  The 6 Minute Walk Test is a sub-maximal exercise test used to assess aerobic capacity and endurance. The distance covered over a time of 6 minutes is used as the outcome by which to compare changes in performance capacity

  6 Days

• Forced expiratory volume (FEV1)

  Forced expiratory volume (FEV1) calculates the amount of air that a person can force out of their lungs in 1 second. It's measured by spirometry

  6 Days

• Forced vital capacity (FVC)

  Forced vital capacity (FVC) is the amount of air that can be forcibly exhaled from your lungs after taking the deepest breath possible. It's measured by spirometry

  6 Days

• FEV1/FVC ratio

  The FEV1/FVC ratio is the ratio of the forced expiratory volume in the first one second to the forced vital capacity of the lungs. The normal value for this ratio is above 0.75-85. It's measured by spirometry

  6 Days

Study Arms (2)

Experimental Group

EXPERIMENTAL

In addition to the routine Phase 1 cardiac rehabilitation, Resistance Exercises * Extending thighs * Closing thighs * Opening thighs * Bending thighs * Bending ankles * Ankle opening

Other: Lower Limb Resistance Band Exercises; Other: Routine Phase 1 cardiac rehabilitation

Routine Phase 1 cardiac rehabilitation

ACTIVE COMPARATOR

Routine Phase 1 cardiac rehabilitation only.

Other: Routine Phase 1 cardiac rehabilitation

Interventions

Lower Limb Resistance Band Exercises OTHER

* Extending thighs * Closing thighs * Opening thighs * Bending thighs * Bending ankles * Ankle opening

Experimental Group

Routine Phase 1 cardiac rehabilitation OTHER

Routine Phase 1 cardiac rehabilitation only.

Experimental Group; Routine Phase 1 cardiac rehabilitation

Eligibility Criteria

• Age: 35 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age 35 to 60
• Female and Male both
• Hemodynamic stable patients
• Arrhythmias or angina not present
• Post elective sternotomy surgery
• Post extubating

You may not qualify if:

• Chronic obstructive pulmonary disease
• Neurological Sequelae
• Neuromuscular disease
• Emergency or off pump surgery
• Surgical re-intervention
• Patient who remained on mechanical ventilation longer than 24 hours
• Patient who had a baseline partial pressure of oxygen (PaO2) less than 75 mmHg and partial pressure of carbon dioxide (PCO2) 45 mmHg
• Patients who had history of respiratory tract infection within a period of three months

Sponsors & Collaborators

• Riphah International University: lead

Study Sites (1)

Rehmatul lil Alameen Institute of cardiology

Lahore, Punjab Province, 42000, Pakistan

Location

MeSH Terms

Conditions

Cardiovascular Diseases

Study Officials

• Muhammad Faizan Hamid, Ms-CPPT

  Riphah International University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized controlled trial (RCT). Pre \& Post data collection

Study Record Dates

• First Submitted: March 4, 2024
• First Posted: March 20, 2024
• Study Start: March 1, 2024
• Primary Completion: June 5, 2024
• Study Completion: June 15, 2024
• Last Updated: July 23, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)