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

NCT ID: NCT06325189

Last Updated: 2024-03-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

47 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-07-20

Study Completion Date

2023-12-10

Brief Summary

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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

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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.

Conditions

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Coronary Artery Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

In this parallel-group randomized controlled trial (RCT), post-angioplasty patients will be assigned to either the control group (receiving standard medication) or the experimental group (receiving medication along with aerobic interval training). The study aims to evaluate the impact of aerobic interval training on fatigue levels and functional performance in these patients.
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
The study was single-blinded, as assessors of the study were kept blind to the intervention group to which the participant was allocated.

Study Groups

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Medication alone

Participants in this arm will not receive any specific intervention. They will only receive standard care medications after angioplasty. No additional treatments or therapies will be administered.

Group Type NO_INTERVENTION

No interventions assigned to this group

Aerobic Interval Training and medication

In this arm, participants will receive the intervention. The intervention consists of aerobic interval training in addition to medication.

Group Type EXPERIMENTAL

Aerobic Interval Training

Intervention Type 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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

40 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Riphah International University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sumera Hamid, MS

Role: PRINCIPAL_INVESTIGATOR

Riphah International University

Locations

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Gulab Devi Chest Hospital

Lahore, Punjab Province, Pakistan

Site Status

Countries

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Pakistan

Other Identifiers

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Rec-42336

Identifier Type: -

Identifier Source: org_study_id

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