"Isometric Lower Limbs Exercises Affect on Cardiac Parameters and Headache in Patient After Spinal Anesthesia" (LILE-SPA)

"Effect of Lower Limbs Isometric Muscle Exercise on Cardiac Parameters and Headache in Patients After Spinal Anesthesia"

the Objectives of this clinical trial is :

1. Examine the effect of lower limbs isometric muscle exercises on cardiac parameters in patients after spinal anesthesia.
2. Investigate the effect of lower limbs isometric muscle exercises on headache in patients after spinal anesthesia.
3. Find out the differences in exercise effects based on patient demographics and clinical data.

Study Overview

• Status: Active, not recruiting
• Conditions: Post Dural Puncture Headache
• Intervention / Treatment: Behavioral: Lower Limb Isometric Exercise

Detailed Description

A common technique for lower body anesthesia that has benefits over general anesthesia is spinal anesthesia. Because of its quick onset, predictability, and dependable blockage, spinal anesthesia is the recommended option for lower abdominal and lower extremity surgeries, including orthopedic, urologic, gynecologic, general surgery, and caesarian sections. Additionally, it offers superior postoperative pain management without the dangers of pulmonary aspiration that come with general anesthesia .

Globally, approximately 15 million spinal anesthesia procedures are carried out annually . There were 16,554 patients overall, representing 83 countries. In comparison to other forms of anesthesia, 55,853 (35.4%) of patients underwent spinal anesthesia . An investigation carried out in Zimbabwe demonstrated that using spinal anesthesia to deliver CS constituted 81.0% versus GA's 19.0% .

Bradycardia and hypotension are the most frequent adverse effects of spinal anesthesia. The hypotension brought on by spinal anesthesia is largely caused by a decrease in both cardiac output and systemic vascular resistance (SVR)( .A frequent side effect of spinal anesthesia (SA) that affects 16-33% of patients is hypotension . reported that The incidence of hypotension following spinal anesthesia during cesarean section was 78.1% among the 320 participants . PSPH may start right away. or delayed for a few days, probably due to the rate of leakage of cerebrospinal fluid (CSF) . It can considerably reduce patients' mobility, lengthen hospital stays, and raise medical costs An essential component of advanced strength training and rehabilitation is isometric exercise. It causes sympathetic activation, which raises heart rate, systolic and diastolic blood pressure, and respiratory rate by increasing the metabolic demands on muscles. Higher peripheral resistance causes the diastolic pressure to rise, while increased cardiac output causes the systolic pressure to rise .

At the time isometric training, a continuous intramuscular pressure on the blood vessels was produced, and restricts oxygen delivery, blood flow, and raises peripheral vascular resistance, which means causing the blood pressure .People can easily perform a variety of isometric exercises, like wall squats and handgrip exercises, without the need for costly equipment or a dedicated space, which makes them popular.

The benefits of exercise-induced pain relief are numerous. Initially, athletes might be capable of Use exercises to help them manage their pain right away. before or after an activity. Secondly, physical activity is without the possibility of pharmacological consequences or side effects of prolonged use that are linked to certain interventions. Thirdly, workouts that lessen discomfort are probably more adhered to.

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Iraq
  • Karbala Governorate
    • Karbala, Karbala Governorate, Iraq
      • Obstetric and Gynecology Teaching Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Women aged 18-40 years undergoing cesarean section under spinal anesthesia.
• Able to provide informed consent.
• Hemodynamically stable before surgery. -Willing and able to perform lower limb isometric exercises after surgery. -

Exclusion Criteria:

• History of cardiovascular disease (e.g., hypertension, arrhythmia, heart failure).
• Neuromuscular disorders affecting lower limb function.
• Complications during surgery or spinal anesthesia (e.g., excessive bleeding,).
• Inability or refusal to participate in exercise protocol.
• Postoperative complications preventing mobilization (e.g., severe pain).
• History of migraine or recurrent headaches (to avoid confounding post-spinal headache measurement).

Patients with varicose veins or history of deep vein thrombosis (DVT).

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: intervention-lower limbs isometric exercises; Participants will perform a set of supervised lower limb isometric exercises during the recovery period after spinal anesthesia for cesarean section. Exercises will be standardized and conducted under researcher supervision to assess their effects on cardiac parameters and headache.	Behavioral: Lower Limb Isometric Exercise; Participants will perform a set of supervised lower limb isometric exercises during the recovery period after spinal anesthesia for cesarean section. The exercises include: Ankle plantar and dorsal flexion, Quadriceps muscle isometric contractions Exercises are standardized and conducted under researcher supervision to assess effects on cardiac parameters and headache
No Intervention: control standard care; Participants receive routine postoperative care without additional exercises.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
"Blood Pressure"	"Systolic blood pressure, Diastolic blood pressure are measured; "Unit of Measure is mmHg"	"Baseline(pre exercises )and immediately after exercise (10 seconds post-exercise)"
"Pulse Rate"	"Heart rate measure in one minute" " Unit of Measure: bpm (beats per minute)"	"Baseline(pre exercises )and immediately after exercise (10 seconds post-exercise)"
"Headache"	"Headache severity measured by Visual Analogue Scale Visual Analogue Scale is a line from 0 mm (no pain) to 100 mm (severe pain · Unit of Measure: mm"	"Before exercise, and at 10 minutes, 1 hour, and 2 hours post-exercise"

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
"Body mass index (BMI)"	"(weight in kilograms, height in meters)weight and height will be combined to report BMI in kg/m^2)"	"Baseline only(before exercises)"

Collaborators and Investigators

• Sponsor: Karbala University
• Investigators: Principal Investigator: Mariam A Abbas, MGS, University of Karbala

Study record dates

Study Major Dates

• Study Start (Actual): January 15, 2026
• Primary Completion (Actual): March 15, 2026
• Study Completion (Estimated): May 29, 2026

Study Registration Dates

• First Submitted: March 18, 2026
• First Submitted That Met QC Criteria: April 20, 2026
• First Posted (Actual): April 23, 2026

Study Record Updates

• Last Update Posted (Actual): April 23, 2026
• Last Update Submitted That Met QC Criteria: April 20, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: headache, cardiac parameters, spinal anesthesia ,isometric muscle exercise
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Headache Disorders; Headache Disorders, Secondary; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Headache; Post-Dural Puncture Headache
• Other Study ID Numbers: uok.con.25.0101

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