Post Dural Puncture HeadacheLILE-SPANCT07547150
"Isometric Lower Limbs Exercises Affect on Cardiac Parameters and Headache in Patient After Spinal Anesthesia"
A study testing Lower Limb Isometric Exercise in people with Post Dural Puncture Headache, run by Karbala University at 1 site in Iraq.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Post Dural Puncture Headache
- What is being tested?
- Lower Limb Isometric Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteIraq
- Study dates
- 15 Jan 2026to 29 May 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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. -
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
Iraq1 site
Obstetric and Gynecology Teaching Hospital
Karbala, Karbala Governorate
About this study
Official title: "Effect of Lower Limbs Isometric Muscle Exercise on Cardiac Parameters and Headache in Patients After Spinal Anesthesia"
the Objectives of this clinical trial is :
- Examine the effect of lower limbs isometric muscle exercises on cardiac parameters in patients after spinal anesthesia.
- Investigate the effect of lower limbs isometric muscle exercises on headache in patients after spinal anesthesia.
- Find out the differences in exercise effects based on patient demographics and clinical data.
Read the 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.
- Conditions
- Post Dural Puncture Headache
- Being tested
- Lower Limb Isometric Exercise
- Keywords
- headache, cardiac parameters, spinal anesthesia ,isometric muscle exercise
- Medical subject headings
- Post-Dural Puncture Headache, Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lower Limb Isometric ExerciseBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Lower Limb Isometric Exercise |
| control standard care | No intervention | Participants receive routine postoperative care without additional exercises. |
What is being measured
The primary outcome is the main question the study is designed to answer.
"Blood Pressure"
- "Systolic blood pressure, Diastolic blood pressure are measured
- "Unit of Measure is mmHg"
Measured: "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)"
Measured: "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"
Measured: "Before exercise, and at 10 minutes, 1 hour, and 2 hours post-exercise"
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2026
- Study start15 Jan 2026
- Primary completion15 Mar 2026
- Study completion29 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Dural Puncture HeadacheStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karbala University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maryam Awad Abbas, Karbala University
- Investigators
- Mariam A Abbas, MGS, Principal investigator, University of Karbala
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07547150
- Sponsor's protocol ID
- uok.con.25.0101
- Acronym
- LILE-SPA
- Status last verified
- Apr 2026
- First submitted
- 18 Mar 2026
- Last updated
- 23 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Effect of Lower Limbs Isometric Muscle Exercise on Cardiac Parameters and Headache in Patients After Spinal Anesthesia"
- ClinicalTrials.gov ID
- NCT07547150
- Acronym / sponsor ID
- LILE-SPA / uok.con.25.0101
- Conditions
- Post Dural Puncture Headache
- Keywords
- headache, cardiac parameters, spinal anesthesia ,isometric muscle exercise
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Karbala UniversityUniversity, hospital or other
- Study start
- 15 Jan 2026 (actual)
- Primary completion
- 15 Mar 2026 (actual)
- Study completion
- 29 May 2026 (estimated)
- First posted
- 23 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
the Objectives of this clinical trial is :
- Examine the effect of lower limbs isometric muscle exercises on cardiac parameters in patients after spinal anesthesia.
- Investigate the effect of lower limbs isometric muscle exercises on headache in patients after spinal anesthesia.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| intervention-lower limbs isometric exercises | Experimental | Behavioral: Lower Limb Isometric ExerciseParticipants 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. |
| control standard care | No intervention | –Participants receive routine postoperative care without additional exercises. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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. -
Key exclusion criteria (7 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lower Limb Isometric ExerciseParticipants 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 | Behavioural | intervention-lower limbs isometric exercises |
Primary outcome
"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"
"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)"
"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"
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2026.
- Individual participant dataSharing planned: No
Related trials for Post Dural Puncture Headache
Not yet recruiting
Dural Puncture Epidural With 27G vs 26G Needles Versus Standard Epidural for Elective Cesarean Delivery
Cesarean Section, Anesthesia, Obstetrical
Not yet recruiting
Comparing Spinal, Epidural, and Dural Puncture Epidural Anesthesia for Cesarean Delivery: Hemodynamics and Block Quality
Hypotension After Neuraxial Anesthesia, Cesarean Section
Not yet recruitingPhase 4
Effect of Intravenous Oxytocin on Post Dural Puncture Headache After Caesarean Sections
Post Dural Puncture Headache
RecruitingObservational study
Effect of Altitude on Postdural Puncture Headache After Caesarean Delivery
Post-Dural Puncture Headache
Enrolling by invitation
Ultrasound-assisted vs Palpation-guided Lumbar Punctures
Lumbar Puncture
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mariam A Abbas, MGS principal investigator
University of Karbala
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lower Limb Isometric Exercise in people with Post Dural Puncture Headache, run by Karbala University at 1 site in Iraq.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 23 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iraq. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
"Blood Pressure" (time frame: "Baseline(pre exercises )and immediately after exercise (10 seconds post-exercise)"). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2026.