Clinical trial NCT06325189: Effects of Aerobic Interval Training on Fatigue Level and Functional Performance in Post Angioplasty Patients
Official title: Effects of Aerobic Interval Training on Fatigue Level and Functional Performance in Post Angioplasty Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Artery Disease
Keywords: Angioplasty
Coronary Artery Disease
Fatigue
Recovery of Function
Rehabilitation
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2024-03-22
Enrollment: 47
Sex: ALL
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Fatigue Severity Scale
timeFrame: Baseline and four weeks
measure: Six Minute Walk Test
timeFrame: Baseline and four weeks
measure: 1 minute sit to stand:
timeFrame: Baseline and four weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Gulab Devi Chest Hospital
state: Punjab
Study officials:
affiliation: Riphah International University
name: Sumera Hamid, MS
role: PRINCIPAL_INVESTIGATOR
References: