"Isometric Lower Limbs Exercises Affect on Cardiac Parameters and Headache in Patient After Spinal Anesthesia"

NCT07547150 | Active Not Recruiting DMC

• 1 other identifier: uok.con.25.0101
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

the Objectives of this clinical trial is :

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

Conditions

Post Dural Puncture Headache

Keywords

headache, cardiac parameters, spinal anesthesia ,isometric muscle exercise

Outcome Measures

Primary Outcomes (3)

• "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 Outcomes (1)

• "Body mass index (BMI)"

  "Baseline only(before exercises)"

Study Arms (2)

intervention-lower limbs isometric exercises

EXPERIMENTAL

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

control standard care

NO INTERVENTION

Participants receive routine postoperative care without additional exercises.

Interventions

Lower Limb Isometric Exercise BEHAVIORAL

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

intervention-lower limbs isometric exercises

Eligibility Criteria

• Age: 18 Years - 40 Years
• Gender Eligibility Details: only individuals who identify as female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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. -

You may not qualify if:

• 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).

Sponsors & Collaborators

• Karbala University: lead

Study Sites (1)

Obstetric and Gynecology Teaching Hospital

Karbala, Karbala Governorate, Iraq

Location

MeSH Terms

Conditions

Post-Dural Puncture Headache; Headache

Condition Hierarchy (Ancestors)

Headache Disorders, Secondary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Mariam A Abbas, MGS

  University of Karbala

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Master's graduate student

Model Details: Parallel Assignment Essential data were collected, including socio-demographic characteristics, clinical data, type of surgery, and baseline headache intensity and cardiac parameters. Standardized assessment tools were used. This process required approximately 15-20 minutes. . Patients were instructed to rest for 5 minutes before initiating the exercise program, Participants in the intervention group performed a structured isometric exercise program consisting of two main exercises. Each exercise was performed for 2 minutes, under direct supervision of the researcher. Ankle Plantar and Dorsal Flexion and Quadriceps Isometric Exercise. Pré and Post-Exercise Cardiac Parameters assessment measured: After 10 seconds of completion of exercises.Headache Intensity Assessment,Headache intensity was evaluated using the 100 mm Visual Analog Scale (VAS)Measurements were recorded at:Before intervention (baseline),After 10 minutes,After 1 hour and After 2 hours post-intervention.

Study Record Dates

• First Submitted: March 18, 2026
• First Posted: April 23, 2026
• Study Start: January 15, 2026
• Primary Completion: March 15, 2026
• Study Completion (Estimated): May 29, 2026
• Last Updated: April 23, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

IR (1)