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

NCT06325189 | Completed

• 1 other identifier: Rec-42336
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Artery Disease

Keywords

Angioplasty; Coronary Artery Disease; Fatigue; Recovery of Function; Rehabilitation

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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

Study Arms (2)

Medication alone

NO INTERVENTION

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.

Aerobic Interval Training and medication

EXPERIMENTAL

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

Other: Aerobic Interval Training

Interventions

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.

Aerobic Interval Training and medication

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Riphah International University: lead

Study Sites (1)

Gulab Devi Chest Hospital

Lahore, Punjab Province, 54000, Pakistan

Location

MeSH Terms

Conditions

Coronary Artery Disease; Fatigue

Condition Hierarchy (Ancestors)

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

Study Officials

• Sumera Hamid, MS

  Riphah International University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The study was single-blinded, as assessors of the study were kept blind to the intervention group to which the participant was allocated.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: March 17, 2024
• First Posted: March 22, 2024
• Study Start: July 20, 2023
• Primary Completion: December 1, 2023
• Study Completion: December 10, 2023
• Last Updated: March 22, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)