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NCT Number: NCT06319651

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

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.

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Key information

Conditions

Cardiovascular Diseases

Age range

35 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rehmatul lil Alameen Institute of cardiology

Lahore, Punjab Province, 42000, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lower Limb Resistance Band Exercises

Other
  • Extending thighs
  • Closing thighs
  • Opening thighs
  • Bending thighs
  • Bending ankles
  • Ankle opening

Routine Phase 1 cardiac rehabilitation

Other

Routine Phase 1 cardiac rehabilitation only.

Primary outcomes

  1. 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.

  2. 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

  3. 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

  4. 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

  5. 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

Sponsors and collaborators

Lead sponsor

Riphah International University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Mar 20, 2024
Registry last updated
Jul 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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