Coronary Artery DiseaseNCT06325189
Effects of Aerobic Interval Training on Fatigue Level and Functional Performance in Post Angioplasty Patients
A study testing Aerobic Interval Training in people with Coronary Artery Disease, run by Riphah International University at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 65 years
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Aerobic Interval Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 1 sitePakistan
- Study dates
- 20 Jul 2023to 10 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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?
Read more
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.
Read the 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.
- Conditions
- Coronary Artery Disease
- Being tested
- Aerobic Interval Training
- Keywords
- Angioplasty, Coronary Artery Disease, Fatigue, Recovery of Function, Rehabilitation
- Medical subject headings
- Coronary Artery Disease, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aerobic Interval TrainingOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Aerobic Interval Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Baseline and four weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2024
- Study start20 Jul 2023
- Primary completion1 Dec 2023
- Study completion10 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sumera Hamid, MS, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06325189
- Sponsor's protocol ID
- Rec-42336
- Status last verified
- Mar 2024
- First submitted
- 17 Mar 2024
- Last updated
- 22 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Aerobic Interval Training on Fatigue Level and Functional Performance in Post Angioplasty Patients
- ClinicalTrials.gov ID
- NCT06325189
- Acronym / sponsor ID
- Rec-42336
- Conditions
- Coronary Artery Disease
- Keywords
- Angioplasty, Coronary Artery Disease, Fatigue, Recovery of Function, Rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 20 Jul 2023 (actual)
- Primary completion
- 1 Dec 2023 (actual)
- Study completion
- 10 Dec 2023 (actual)
- First posted
- 22 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| 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 | Other: Aerobic Interval TrainingIn this arm, participants will receive the intervention. The intervention consists of aerobic interval training in addition to medication. |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aerobic Interval TrainingAerobic 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. | Other | Aerobic Interval Training and medication |
Primary outcome
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sumera Hamid, MS principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aerobic Interval Training in people with Coronary Artery Disease, run by Riphah International University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fatigue Severity Scale (time frame: Baseline and four weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2024.