Effect of Isometric Exercise Versus Hand Reflexology on Hemodynamic Parameters Among Patients With AMI

NCT ID: NCT07109960

Last Updated: 2025-08-07

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 136 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-07-15
• Study Completion Date: 2026-01-15

Brief 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.

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.

Conditions

Hemodynamic Parameters; Fatigue; Anxiety

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Isometric exercise, hand reflexology, isometric exercise-hand reflexology, and control groups

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.

Group Type: EXPERIMENTAL

Isometric exercise and hand reflexology

Intervention Type: OTHER

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).

Routine care

no interventions were done for the control group (received routine care only).

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Isometric exercise and hand reflexology

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).

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. Age range: Adults aged 18 to 75 years.

2. Confirmed diagnosis of acute myocardial infarction (AMI).

3. Time since AMI.

4. Stable clinical condition.

5. Informed consent.

6. No contraindications to interventions (severe musculoskeletal or neurological impairments).

7. No current use of reflexology.

8. No recent cardiovascular surgery.

9. No uncontrolled co-morbidities such as DM, COPD, or chronic kidney disease.

10. Stable medication regimen within the past 24 hours.

11. No severe psychological disorders (e.g., major depressive disorder, schizophrenia).

12. Ability to complete study protocol.

Exclusion Criteria

1. Severe or ongoing cardiovascular events.

2. Heart failure.

3. Severe renal or hepatic impairment.

4. Active or uncontrolled infections.

5. Major surgical intervention.

6. Severe musculoskeletal, neurological disorders.

7. Severe psychiatric disorders.

8. Current participation in other interventional trials.

9. Pregnancy or lactation.

10. Inability to follow protocol.

11. Significant uncontrolled comorbidities (HTN, DM).

12. Known allergy to reflexology.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Baghdad

OTHER

Sponsor Role: lead

Responsible Party

Bahaa Mirza Skal

Lecturer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Bahaa M Skal, PhD

Role: PRINCIPAL_INVESTIGATOR

Qadisiyah University-Faculty of Nursing

Locations

Al-Diwaniyah government hospital

Al-Qadisiyah, Muḩāfaz̧at al Qādisīyah, Iraq

Countries

Iraq

Other Identifiers

bahaa198811

Identifier Type: -

Identifier Source: org_study_id