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

Coronary Artery Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06325189
• Other study ID #: Rec-42336
• Status: Completed
• Phase: N/A
• Start date: July 20, 2023
• Est. completion date: December 10, 2023

Study information

• Verified date: March 2024
• Source: Riphah International University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 47
• Est. completion date: December 10, 2023
• Est. primary completion date: December 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 65 Years

Eligibility

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.

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.

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Fatigue
• Myocardial Ischemia

Intervention

Other:
• Aerobic Interval Training
Aerobic interval training is a cardiovascular exercise that involves short bursts of high-intensity activity followed by a brief rest or low-intensity exercise. It improves cardiovascular fitness, increases lung capacity, and enhances cardiovascular endurance. It also leads to higher calorie expenditure and time efficiency, allowing for faster fitness goals.

Locations

Country	Name	City	State
Pakistan	Gulab Devi Chest Hospital	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	Fatigue Severity Scale	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.	Baseline and four weeks
Primary	Six Minute Walk Test	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.	Baseline and four weeks
Primary	1 minute sit to stand:	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.	Baseline and four weeks