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Completed

NCT Number: NCT06325189

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

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.

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Key information

Conditions

Coronary Artery Disease Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Disease Fatigue Heart Diseases Myocardial Ischemia Pathological Conditions, Signs and Symptoms Signs and Symptoms Vascular Diseases

Age range

40 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Gulab Devi Chest Hospital

Lahore, Punjab Province, 54000, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Aerobic interval training

Other

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.

Primary outcomes

  1. Fatigue Severity Scale

    Time frame: 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.

  2. Six Minute Walk Test

    Time frame: 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.

  3. 1 minute sit to stand:

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Riphah International University

Other

Registry information

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Mar 22, 2024
Registry last updated
Mar 22, 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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