Clinical trial NCT06319651: Effects of Lower Limb Resistance Band Exercises in Phase 1 Cardiac Rehabilitation
Official title: Effects of Lower Limb Resistance Band Exercises in Phase 1 Cardiac Rehabilitation on Functional Recovery Among Post Coronary Artery Bypass Grafting Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Diseases
Keywords: Coronary artery bypass grafting
Cardiac rehabilitation
Resistance band exercise
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2024-03-20
Enrollment: 56
Sex: ALL
Minimum age (years): 35
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial (RCT). Pre \& Post data collection
Primary purpose: OTHER

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Functional Independence Measure
timeFrame: 6 Days
measure: 6 Minute Walk Test
timeFrame: 6 Days
measure: Forced expiratory volume (FEV1)
timeFrame: 6 Days
measure: Forced vital capacity (FVC)
timeFrame: 6 Days
measure: FEV1/FVC ratio
timeFrame: 6 Days
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Rehmatul lil Alameen Institute of cardiology
state: Punjab
Study officials:
affiliation: Riphah International University
name: Muhammad Faizan Hamid, Ms-CPPT
role: PRINCIPAL_INVESTIGATOR
References: