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临床试验/NCT06325189
NCT06325189已完成不适用

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

Riphah International University2 个研究点 分布在 1 个国家目标入组 47 人开始时间: 2023年7月20日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
47
试验地点
2
主要终点
Fatigue Severity Scale

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

盲法说明

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

入排标准

年龄范围
40 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

研究组 & 干预措施

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.

干预措施: Aerobic Interval Training (Other)

结局指标

主要结局

Fatigue Severity Scale

时间窗: 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.

Six Minute Walk Test

时间窗: 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.

1 minute sit to stand:

时间窗: 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.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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