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

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.

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

Study Overview

• Status: Active, not recruiting
• Conditions: Fatigue; Anxiety; Hemodynamic Parameters
• Intervention / Treatment: Other: Isometric exercise and hand reflexology

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 Type: Interventional
• Enrollment (Actual): 136
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Iraq
  • AL-Diwaniya
    • Al-Qadisiyah, AL-Diwaniya, Iraq, XXQ7+48J
      • Al-Diwaniyah government hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Other: 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).
No Intervention: Routine care; no interventions were done for the control group (received routine care only).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood pressure	Blood pressure (right hand lying on the back) was measured through digital blood pressure monitor (RossMax MG150f, made in Tiwan).	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.	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.	Patients' fatigue were measured and recorded 15 minutes before intervention by patient, and 15 minutes after the completion of intervention

Collaborators and Investigators

• Sponsor: University of Baghdad
• Investigators: Principal Investigator: Bahaa M Skal, PhD, Qadisiyah University-Faculty of Nursing

Study record dates

Study Major Dates

• Study Start (Actual): July 15, 2025
• Primary Completion (Estimated): November 15, 2025
• Study Completion (Estimated): January 15, 2026

Study Registration Dates

• First Submitted: July 23, 2025
• First Submitted That Met QC Criteria: July 30, 2025
• First Posted (Actual): August 7, 2025

Study Record Updates

• Last Update Posted (Actual): August 7, 2025
• Last Update Submitted That Met QC Criteria: July 30, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: Acute Myocardial Infarction; Isometric Exercise; Hand Reflexology
• Additional Relevant MeSH Terms: Fatigue
• Other Study ID Numbers: bahaa198811

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No