Hemodynamic ParametersNCT07109960
Effect of Isometric Exercise Versus Hand Reflexology on Hemodynamic Parameters Among Patients With AMI
A study testing Isometric exercise and hand reflexology in people with Hemodynamic Parameters and Fatigue, run by University of Baghdad at 1 site in Iraq.
Trial summary
The goal of this clinical trial is to evaluate the comparative effect of isometric exercise versus hand reflexology on primary hemodynamic parameters, fatigue, and anxiety in patients with acute myocardial infarction. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hemodynamic Parameters, Fatigue, Anxiety
- What is being tested?
- Isometric exercise and hand reflexology
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 136 participants
- Where
- 1 siteIraq
- Study dates
- 15 Jul 2025to 15 Jan 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age range: Adults aged 18 to 75 years.
- Confirmed diagnosis of acute myocardial infarction (AMI).
- Time since AMI.
- Stable clinical condition.
- Informed consent.
- No contraindications to interventions (severe musculoskeletal or neurological impairments).
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- No current use of reflexology.
- No recent cardiovascular surgery.
- No uncontrolled co-morbidities such as DM, COPD, or chronic kidney disease.
- Stable medication regimen within the past 24 hours.
- No severe psychological disorders (e.g., major depressive disorder, schizophrenia).
- Ability to complete study protocol.
Who cannot join
- Severe or ongoing cardiovascular events.
- Heart failure.
- Severe renal or hepatic impairment.
- Active or uncontrolled infections.
- Major surgical intervention.
- Severe musculoskeletal, neurological disorders.
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- Severe psychiatric disorders.
- Current participation in other interventional trials.
- Pregnancy or lactation.
- Inability to follow protocol.
- Significant uncontrolled comorbidities (HTN, DM).
- Known allergy to reflexology.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Isometric Exercise Versus Hand Reflexology on Hemodynamic Parameters, Fatigue, and Anxiety Among Patients With Acute Myocardial Infarction: A Randomized Clinical Trial
The goal of this clinical trial is to evaluate the comparative effect of isometric exercise versus hand reflexology on primary hemodynamic parameters, fatigue, and anxiety in patients with acute myocardial infarction.
Researcher will know which one of the interventional procedures (isometric exercise, hand reflexology, or hand reflexology and hand reflexology) was more effective to primary hemodynamic parameters, fatigue, and anxiety.
Read more
Each participant in the isometric exercise group receives included ankle exercises, knee workouts, head exercises, static abdominis exercises, and sustained hand grip exercises. Every contraction lasted for 10 seconds, 10 repetitions, two IE sessions over a period of three days. Each IE session lasted between 25 and 35 minutes.
Each participant in the hand reflexology group underwent two the sessions of hand reflexology. Each session had a duration of 15 minutes, which was then followed by a five-minute period of rest
Read the detailed description
Cardiovascular diseases (CVD) encompass a group of medical conditions including angina pectoris, myocardial infarction, congestive heart failure, irregular rhythms, cardiac valve disease, and aortic atherosclerosis. Clinical CVD is the accumulation of plaque in the arteries that provide blood to the cardiac muscle. Plaque-clogged arteries undergo hardening, resulting in reduced blood flow through them. The specific site of the plaque dictates the type of cardiac defect.
Whenever there is a need to improve patient symptoms or prognosis by obtaining information about the severity through disease of coronary artery, it is recommended to use the invasive coronary angiography (ICA). The femoral artery area commonly experiences various local vascular complications, including minor or major bleeding, hematoma, pseudoaneurysm, and arteriovenous (AV) fistula. These complications arise due to the frequent use of the femoral artery for vascular access procedures.
Cardiac patients typically exhibit a higher prevalence of anxiety compared to people with other medical conditions. Approximately 80% of individuals with cardiac conditions are reported to exhibit and manifest anxiety before to cardiac arrest. The primary factors contributing to patient anxiety include previous encounters, discomfort, emotional strain, unfamiliar environments.
An acute myocardial infarction (AMI) occurs due to decreased blood flow inside the coronary arteries. Ischemia and myocardial damage may an elevating or descending ST segment on the Electrocardiogram (ECG). Among the consequences of AMI include arrhythmia and alterations in physiological parameters including hypertension, hypotension, tachypnea, and fever.
Isometric exercise occurs a feature pressor rase in blood flow which may significant in keep provide of muscle through continuous contraction. the response is middle by joint central and peripheral occur input to the medullary of cardiovascular the centers. In the normal persons the rise in blood flow is middle through a increase in output of heart with no change in resistance of systemic vascular.
- Conditions
- Hemodynamic Parameters, Fatigue, Anxiety
- Being tested
- Isometric exercise and hand reflexology
- Keywords
- Isometric Exercise, Hand Reflexology, Acute Myocardial Infarction
- Medical subject headings
- Fatigue, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Isometric exercise and hand reflexologyOther
Each participant in the isometric exercise group receives included ankle exercises, knee workouts, head exercises, static abdominis exercises, and sustained hand grip exercises. Every contraction lasted for 10 seconds, 10 repetitions, two IE sessions over a period of three days. Each IE session lasted between 25 and 35 minutes.
Each participant in the hand reflexology group underwent two the sessions of hand reflexology. Each session had a duration of 15 minutes, which was then followed by a five-minute period of rest.
While isometric exercise- hand reflexology experimental group was given for the participant, the same intervention of isometric exercise and hand reflexology groups Furthermore, no interventions were done for the control group (received routine care only).
| Study group | Role | What they receive |
|---|---|---|
| Isometric exercise, hand reflexology, isometric exercise-hand reflexology, and control groups | Experimental | Each participant in the isometric exercise group receives included ankle exercises, knee workouts, head exercises, static abdominis exercises, and sustained hand grip exercises. Every contraction lasted for 10 seconds, 10 repetitions, two IE sessions over a period of three days. Each IE session lasted between 25 and 35 minutes. Each participant in the hand reflexology group underwent two the sessions of hand reflexology. Each session had a duration of 15 minutes, which was then followed by a five-minute period of rest. While isometric exercise- hand reflexology experimental group was given for the participant, the same intervention of isometric exercise and hand reflexology groups. Receives: Other: Isometric exercise and hand reflexology |
| Routine care | No intervention | no interventions were done for the control group (received routine care only). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood pressure
Blood pressure (right hand lying on the back) was measured through digital blood pressure monitor (RossMax MG150f, made in Tiwan).
Measured: Patients' blood pressure were measured and recorded 15 minutes before intervention by researcher, and 15 minutes after the completion of intervention
Fatigue
Fatigue visual analogue scale (VAS) was used to measure fatigue. VAS is a self-administered visual scale that includes a 10 cm horizontal line graded from 0 to 10. Zero indicates no fatigue, 1-3 indicates mild fatigue, 4-7 indicates moderate fatigue, and 8-10 indicates severe fatigue.
Measured: Patients' fatigue were measured and recorded 15 minutes before intervention by patient, and 15 minutes after the completion of intervention
Anxiety
State- Trait Anxiety Inventory (STAI) is a reliable and valid instrument that was developed by Spielberger in 1983 with a range of internal consistency coefficients from 0.86- 0.95.
Measured: Patients' fatigue were measured and recorded 15 minutes before intervention by patient, and 15 minutes after the completion of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2025
- Study start15 Jul 2025
- Primary completion15 Nov 2025 (estimated)
- Study completion15 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemodynamic ParametersStudies of the same condition, open and under way.
- More trials run by University of BaghdadThe 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
- Each participant in the isometric exercise group receives included ankle exercises, knee workouts, head exercises, static abdominis exercises, and sustained hand grip exercises. Every contraction lasted for 10 seconds, 10 repetitions, two IE sessions over a period of three days. Each IE session lasted between 25 and 35 minutes. Each participant in the hand reflexology group underwent two the sessions of hand reflexology. Each session had a duration of 15 minutes, which was then followed by a five-minute period of rest. While isometric exercise- hand reflexology experimental group was given for the participant, the same intervention of isometric exercise and hand reflexology groups Furthermore, no interventions were done for the control group (received routine care only).
- Masking
- None (open label)
- Enrolment
- 136 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Baghdad
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bahaa Mirza Skal, University of Baghdad
- Investigators
- Bahaa M Skal, PhD, Principal investigator, Qadisiyah University-Faculty of Nursing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07109960
- Sponsor's protocol ID
- bahaa198811
- Status last verified
- Jul 2025
- First submitted
- 23 Jul 2025
- Last updated
- 7 Aug 2025
- 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 7 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Isometric Exercise Versus Hand Reflexology on Hemodynamic Parameters, Fatigue, and Anxiety Among Patients With Acute Myocardial Infarction: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07109960
- Acronym / sponsor ID
- bahaa198811
- Conditions
- Hemodynamic Parameters, Fatigue, Anxiety
- Keywords
- Isometric Exercise, Hand Reflexology, Acute Myocardial Infarction
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 136 participants (actual)
- Lead sponsor
- University of BaghdadUniversity, hospital or other
- Study start
- 15 Jul 2025 (actual)
- Primary completion
- 15 Nov 2025 (estimated)
- Study completion
- 15 Jan 2026 (estimated)
- First posted
- 7 Aug 2025 (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 clinical trial is to evaluate the comparative effect of isometric exercise versus hand reflexology on primary hemodynamic parameters, fatigue, and anxiety in patients with acute myocardial infarction.
Researcher will know which one of the interventional procedures (isometric exercise, hand reflexology, or hand reflexology and hand reflexology) was more effective to primary hemodynamic parameters, fatigue, and anxiety.
Each participant in the isometric exercise group receives included ankle exercises, knee workouts, head exercises, static abdominis exercises, and sustained hand grip exercises. Every contraction lasted for 10 seconds, 10 repetitions, two IE sessions over a period of three days. Each IE session lasted between 25 and 35 minutes.
Each participant in the hand reflexology group underwent two the sessions of hand reflexology. Each session had a duration of 15 minutes, which was then followed by a five-minute period of rest
Detailed description
Cardiovascular diseases (CVD) encompass a group of medical conditions including angina pectoris, myocardial infarction, congestive heart failure, irregular rhythms, cardiac valve disease, and aortic atherosclerosis. Clinical CVD is the accumulation of plaque in the arteries that provide blood to the cardiac muscle. Plaque-clogged arteries undergo hardening, resulting in reduced blood flow through them. The specific site of the plaque dictates the type of cardiac defect.
Whenever there is a need to improve patient symptoms or prognosis by obtaining information about the severity through disease of coronary artery, it is recommended to use the invasive coronary angiography (ICA). The femoral artery area commonly experiences various local vascular complications, including minor or major bleeding, hematoma, pseudoaneurysm, and arteriovenous (AV) fistula. These complications arise due to the frequent use of the femoral artery for vascular access procedures.
Cardiac patients typically exhibit a higher prevalence of anxiety compared to people with other medical conditions. Approximately 80% of individuals with cardiac conditions are reported to exhibit and manifest anxiety before to cardiac arrest. The primary factors contributing to patient anxiety include previous encounters, discomfort, emotional strain, unfamiliar environments.
An acute myocardial infarction (AMI) occurs due to decreased blood flow inside the coronary arteries. Ischemia and myocardial damage may an elevating or descending ST segment on the Electrocardiogram (ECG). Among the consequences of AMI include arrhythmia and alterations in physiological parameters including hypertension, hypotension, tachypnea, and fever.
Isometric exercise occurs a feature pressor rase in blood flow which may significant in keep provide of muscle through continuous contraction. the response is middle by joint central and peripheral occur input to the medullary of cardiovascular the centers. In the normal persons the rise in blood flow is middle through a increase in output of heart with no change in resistance of systemic vascular.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Each participant in the isometric exercise group receives included ankle exercises, knee workouts, head exercises, static abdominis exercises, and sustained hand grip exercises. Every contraction lasted for 10 seconds, 10 repetitions, two IE sessions over a period of three days. Each IE session lasted between 25 and 35 minutes. Each participant in the hand reflexology group underwent two the sessions of hand reflexology. Each session had a duration of 15 minutes, which was then followed by a five-minute period of rest. While isometric exercise- hand reflexology experimental group was given for the participant, the same intervention of isometric exercise and hand reflexology groups Furthermore, no interventions were done for the control group (received routine care only).
| Arm | Type | Receives |
|---|---|---|
| Isometric exercise, hand reflexology, isometric exercise-hand reflexology, and control groups | Experimental | Other: Isometric exercise and hand reflexologyEach participant in the isometric exercise group receives included ankle exercises, knee workouts, head exercises, static abdominis exercises, and sustained hand grip exercises. Every contraction lasted for 10 seconds, 10 repetitions, two IE sessions over a period of three days. Each IE session lasted between 25 and 35 minutes. Each participant in the hand reflexology group underwent two the sessions of hand reflexology. Each session had a duration of 15 minutes, which was then followed by a five-minute period of rest. While isometric exercise- hand reflexology experimental group was given for the participant, the same intervention of isometric exercise and hand reflexology groups. |
| Routine care | No intervention | –no interventions were done for the control group (received routine care only). |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Age range: Adults aged 18 to 75 years.
- Confirmed diagnosis of acute myocardial infarction (AMI).
- Time since AMI.
- Stable clinical condition.
- Informed consent.
Key exclusion criteria (12 listed)
- Severe or ongoing cardiovascular events.
- Heart failure.
- Severe renal or hepatic impairment.
- Active or uncontrolled infections.
- Major surgical intervention.
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 |
|---|---|---|
| Isometric exercise and hand reflexologyEach participant in the isometric exercise group receives included ankle exercises, knee workouts, head exercises, static abdominis exercises, and sustained hand grip exercises. Every contraction lasted for 10 seconds, 10 repetitions, two IE sessions over a period of three days. Each IE session lasted between 25 and 35 minutes. Each participant in the hand reflexology group underwent two the sessions of hand reflexology. Each session had a duration of 15 minutes, which was then followed by a five-minute period of rest. While isometric exercise- hand reflexology experimental group was given for the participant, the same intervention of isometric exercise and hand reflexology groups Furthermore, no interventions were done for the control group (received routine care only). | Other | Isometric exercise, hand reflexology, isometric exercise-hand reflexology, and control groups |
Primary outcome
Blood pressure
Time frame: Patients' blood pressure were measured and recorded 15 minutes before intervention by researcher, and 15 minutes after the completion of intervention
Blood pressure (right hand lying on the back) was measured through digital blood pressure monitor (RossMax MG150f, made in Tiwan).
Fatigue
Time frame: Patients' fatigue were measured and recorded 15 minutes before intervention by patient, and 15 minutes after the completion of intervention
Fatigue visual analogue scale (VAS) was used to measure fatigue. VAS is a self-administered visual scale that includes a 10 cm horizontal line graded from 0 to 10. Zero indicates no fatigue, 1-3 indicates mild fatigue, 4-7 indicates moderate fatigue, and 8-10 indicates severe fatigue.
Anxiety
Time frame: Patients' fatigue were measured and recorded 15 minutes before intervention by patient, and 15 minutes after the completion of intervention
State- Trait Anxiety Inventory (STAI) is a reliable and valid instrument that was developed by Spielberger in 1983 with a range of internal consistency coefficients from 0.86- 0.95.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2025.
- 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.
Bahaa M Skal, PhD principal investigator
Qadisiyah University-Faculty of Nursing
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Isometric exercise and hand reflexology in people with Hemodynamic Parameters and Fatigue, run by University of Baghdad at 1 site in Iraq.
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 12 inclusion and 12 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: under way, not looking for participants, as of the sponsor's last update on 7 Aug 2025. 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 Iraq. 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?
This study is still under way. Results are not available in the source record yet.
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?
Blood pressure (time frame: Patients' blood pressure were measured and recorded 15 minutes before intervention by researcher, and 15 minutes after the completion of intervention). 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 7 Aug 2025.