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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07547150
Acronym
LILE-SPA
Enrollment
120
Registered
2026-04-23
Start date
2026-01-15
Completion date
2026-05-29
Last updated
2026-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Post Dural Puncture Headache

Keywords

headache, cardiac parameters, spinal anesthesia ,isometric muscle exercise

Brief summary

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.

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.

Interventions

BEHAVIORALLower 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

Sponsors

Karbala University
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

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.

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
Yes

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).

Design outcomes

Primary

MeasureTime frameDescription
"Blood Pressure""Baseline(pre exercises )and immediately after exercise (10 seconds post-exercise)"* "Systolic blood pressure, Diastolic blood pressure are measured * "Unit of Measure is mmHg"
"Pulse Rate""Baseline(pre exercises )and immediately after exercise (10 seconds post-exercise)""Heart rate measure in one minute" " Unit of Measure: bpm (beats per minute)"
"Headache""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"

Countries

Iraq

Contacts

PRINCIPAL_INVESTIGATORMariam A Abbas, MGS

University of Karbala

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 24, 2026