Effects of Aerobic Interval Training on Fatigue Level and Functional Performance in Post Angioplasty Patients

Not Applicable

Completed

• Conditions: Coronary Artery Disease
• Interventions: Other: Aerobic Interval Training

• Registration Number: NCT06325189
• Lead Sponsor: Riphah International University

Brief Summary

The goal of this randomized controlled trial is to determine the effects of aerobic interval training on levels of tiredness and functional performance in post-angioplasty patients. The main question it aims to answer is:

Does aerobic interval training reduce fatigue and improve functional performance compared to medication alone in post-angioplasty patients?

Participants will:

Be randomly assigned to either the control group (medication) or the experimental group (medication + aerobic interval training) Perform aerobic interval training for 30 minutes, three times a week, for six weeks (experimental group only) Complete pre and post-intervention assessments using the fatigue severity scale, the 6-minute walk test, and the one minute sit to stand test Researchers will compare the two groups to see if aerobic interval training leads to significant improvements in fatigue levels and functional performance.

Detailed Description

The study is a randomized controlled trial that aims to evaluate the effects of aerobic interval training (AIT) on fatigue level and functional performance in post-angioplasty patients.

The study involves 47 participants who have undergone percutaneous coronary intervention (PCI) for coronary artery disease (CAD) and have completed phase 1 of cardiac rehabilitation.

The participants are divided into two groups: Group A receives medication only, and Group B receives medication plus AIT. The AIT consists of four sessions per week for four weeks, with each session lasting 40 minutes and alternating between high and low-intensity intervals.

The study hypothesizes that AIT will have a positive effect on fatigue level and functional performance in post-angioplasty patients, compared to medication alone.

The study uses descriptive statistics, paired t-tests, and independent t-tests to analyze the data and test the hypotheses.

Study Timeline

• Study Start: 2023-07-20
• Primary Completion: 2023-12-01
• Study Completion: 2023-12-10
• Status Verified: 2024-03
• Study First Submitted: 2024-03-17
• Study First Submitted QC: 2024-03-21
• Last Update Submitted: 2024-03-21
• Study First Posted: 2024-03-22
• Last Update Posted: 2024-03-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 47

Inclusion Criteria

• Patient with post angioplasty (having 1 or 2 stents)
• Patient who completed phase 1 cardiac rehabilitation
• Post coronary angioplasty patients 2 weeks of hospital discharge.

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Exclusion Criteria

• Patients with neurological disorders
• Patients with valvular and obstructive airway diseases.
• Patients with acute infections, malignancy
• Angioplasty complications such as arrhythmias, blood clots in-stent, and atrial fibrillations
• Patients with uncontrolled hypertension.
• Patients with uncontrolled diabetes.
• Presence of fracture.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Aerobic Interval Training and medication	Aerobic Interval Training	In this arm, participants will receive the intervention. The intervention consists of aerobic interval training in addition to medication.

Primary Outcome Measures

Name	Time	Method
Fatigue Severity Scale	Baseline and four weeks	This is a self-report measure that consists of nine items related to the level of fatigue and how it affects different tasks. The measure uses a seven-point scale, where 1 means strongly disagree and 7 means strongly agree. The lowest score that can be obtained is nine and the highest is 63. A higher score indicates a higher degree of fatigue and a greater impact on the person's activity. The measure is simple to comprehend and takes about eight minutes to complete.
Six Minute Walk Test	Baseline and four weeks	Six Minute Walk Test is a measure of functional ability that is valid and reliable for the Phase II/III CR population. The 6-minute walk involves three walks, and a learning effect of six percent was observed. It is not known if this effect will persist in the long term. This test can be very useful for smaller CR centers that want to track functional progress but do not have the resources for conventional treadmill testing.
1 minute sit to stand:	Baseline and four weeks	The 1-minute sit to stand test is a simple and quick fitness test that requires minimal equipment and space. It involves repeatedly standing up and sitting down on a chair for one minute and counting the number of repetitions. The test is reliable in measuring the functional capacity of cardiac patients, as it reflects their aerobic endurance and lower limb strength. The test can also help monitor the progress and response to cardiac rehabilitation programs.

Trial Locations

Locations (1)

Gulab Devi Chest Hospital; 🇵🇰 Lahore, Punjab, Pakistan