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

Cardiovascular Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06319651
• Other study ID #: REC/RCR&AHS/23/0360
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2024
• Est. completion date: June 15, 2024

Study information

• Verified date: March 2024
• Source: Riphah International University
• Contact: Imran Amjad, Phd
• Phone: 03324390125
• Email: imran.amjad[@]riphah.edu.pk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 56
• Est. completion date: June 15, 2024
• Est. primary completion date: June 5, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Cardiovascular Diseases

Intervention

Other:
• Lower Limb Resistance Band Exercises
Extending thighs Closing thighs Opening thighs Bending thighs Bending ankles Ankle opening
• Routine Phase 1 cardiac rehabilitation
Routine Phase 1 cardiac rehabilitation only.

Locations

Country	Name	City	State
Pakistan	Rehmatul lil Alameen Institute of cardiology	Lahore	Punjab

Sponsors (1)

Lead Sponsor	Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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