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

July 22, 2024 updated by: Riphah International University

Effects of Lower Limb Resistance Band Exercises in Phase 1 Cardiac Rehabilitation on Functional Recovery Among Post Coronary Artery Bypass Grafting Patients

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study will be randomized controlled trial with non-probability purposive sampling. Study conducted among post CABG patients. Descriptive analysis will be applied. Data will be collected from Rehmatul lil Alameen Institute of cardiology Lahore. Sample size will be 56, 28 in each group. In addition to the routine Phase 1 cardiac rehabilitation for experimental group the exercise protocol consisted of 10 minutes of warm up, elastic band strength exercise protocol (30 minutes) and cool down (5 minutes) so that an exercise session lasted about 45-50 minutes, exercise will performed circularly 2 sets, 10 repetition with a 2 minute rest after each cycle and monitored the performance of exercise for 6 days. Resisted band exercise are Extending thighs, Closing thighs, Opening thighs, Bending thighs, Dorsiflexion, Plantarflexion. For control group routine Phase 1 cardiac rehabilitation only. Outcome will be measured by using 6 minute walk test, Spirometry (FVC, FEV1/FVC and PEF), Functional Independence Measure.

Study Type

Interventional

Enrollment (Actual)

56

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Punjab
      • Lahore, Punjab, Pakistan, 42000
        • Rehmatul lil Alameen Institute of cardiology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental Group

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
  • Extending thighs
  • Closing thighs
  • Opening thighs
  • Bending thighs
  • Bending ankles
  • Ankle opening
Other: Routine Phase 1 cardiac rehabilitation
Routine Phase 1 cardiac rehabilitation only.
Active Comparator: Routine Phase 1 cardiac rehabilitation
Routine Phase 1 cardiac rehabilitation only.
Other: Routine Phase 1 cardiac rehabilitation
Routine Phase 1 cardiac rehabilitation only.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Functional Independence Measure
Time Frame: 6 Days

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
Time Frame: 6 Days
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)
Time Frame: 6 Days
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)
Time Frame: 6 Days
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
Time Frame: 6 Days
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Riphah International University

Investigators

  • Principal Investigator: Muhammad Faizan Hamid, MS-CPPT, Riphah International University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2024

Primary Completion (Actual)

June 5, 2024

Study Completion (Actual)

June 15, 2024

Study Registration Dates

First Submitted

March 4, 2024

First Submitted That Met QC Criteria

March 12, 2024

First Posted (Actual)

March 20, 2024

Study Record Updates

Last Update Posted (Actual)

July 23, 2024

Last Update Submitted That Met QC Criteria

July 22, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REC/RCR&AHS/23/0360

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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