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Active, Not Recruiting

NCT Number: NCT07547150

"Isometric Lower Limbs Exercises Affect on Cardiac Parameters and Headache in Patient 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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Obstetric and Gynecology Teaching Hospital

Karbala, Karbala Governorate, Iraq

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

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

Primary outcomes

  1. "Blood Pressure"

    Time frame: "Baseline(pre exercises )and immediately after exercise (10 seconds post-exercise)"

    • "Systolic blood pressure, Diastolic blood pressure are measured
    • "Unit of Measure is mmHg"
  2. "Pulse Rate"

    Time frame: "Baseline(pre exercises )and immediately after exercise (10 seconds post-exercise)"

    "Heart rate measure in one minute" " Unit of Measure: bpm (beats per minute)"

  3. "Headache"

    Time frame: "Before exercise, and at 10 minutes, 1 hour, and 2 hours post-exercise"

    "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"

Other outcomes

  1. "Body mass index (BMI)"

    Time frame: "Baseline only(before exercises)"

    "(weight in kilograms, height in meters)weight and height will be combined to report BMI in kg/m^2)"

Sponsors and collaborators

Lead sponsor

Karbala University

Other

Registry information

Official study title

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

Acronym: LILE-SPA

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Apr 23, 2026
Registry last updated
Apr 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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