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

NCT07109960 | Active Not Recruiting

• 1 other identifier: bahaa198811
• Study Type: interventional
• Target: 136
• Locations: 1 country
• Sites: 1

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

Conditions

Hemodynamic Parameters; Fatigue; Anxiety

Keywords

Isometric Exercise; Hand Reflexology; Acute Myocardial Infarction

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

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.

Other: Isometric exercise and hand reflexology

Routine care

NO INTERVENTION

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

Interventions

Isometric exercise and hand reflexology 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).

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

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).
• 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.

You may not qualify if:

• Severe or ongoing cardiovascular events.
• Heart failure.
• Severe renal or hepatic impairment.
• Active or uncontrolled infections.
• Major surgical intervention.
• Severe musculoskeletal, neurological disorders.
• 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.

Sponsors & Collaborators

• University of Baghdad: lead

Study Sites (1)

Al-Diwaniyah government hospital

Al Qādisīyah, AL-Diwaniya, XXQ7+48J, Iraq

Location

MeSH Terms

Conditions

Fatigue; Anxiety Disorders

Interventions

Exercise

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Bahaa M Skal, PhD

  Qadisiyah University-Faculty of Nursing

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Model Details: 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 Record Dates

• First Submitted: July 23, 2025
• First Posted: August 7, 2025
• Study Start: July 15, 2025
• Primary Completion: November 15, 2025
• Study Completion: January 15, 2026
• Last Updated: August 7, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

IR (1)