- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07524790
The Effect of Proprioceptive Neuromuscular Facilitation on Haemodynamic Responses in a Neurological Intensive Care
The Effect of Proprioceptive Neuromuscular Facilitation on the Ankle-Brachial Index and Haemodynamic Responses in Patients in a Neurological Intensive Care Unit: A Randomised Controlled Trial
Although there are studies examining the effect of actively performed PNF exercises on haemodynamic responses in intensive care patients and healthy individuals, there are no studies investigating their effect on circulation and haemodynamic responses in unconscious patients. Therefore, this study was designed to investigate the acute effects of proprioceptive neuromuscular facilitation (PNF) exercises on peripheral circulation and haemodynamic responses in patients admitted to a neurological intensive care unit.
Hypotheses:
H1-1: Passively administered PNF exercises have beneficial effects on peripheral circulation.
H2-1: Passively administered PNF exercises have beneficial effects on haemodynamic responses.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Patients being monitored in the neurology intensive care unit
- Aged 18 years or over
- Haemodynamically stable
- No orthopaedic condition preventing the performance of passive joint movements in the upper and lower limbs
- A signed informed consent form from a patient's next of relative for participation in the study
Exclusion Criteria:
- Presence of haemodynamic instability
- Fractures, contractures or serious orthopaedic conditions in the upper or lower limbs that restrict movement
- Diagnosis or suspicion of deep vein thrombosis
- Severe peripheral arterial disease
- Serious cardiac arrhythmia that may prevent exercise
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: PNF Group
Patients in the PNF group will undergo proprioceptive neuromuscular facilitation (PNF) exercises.
The exercises will be performed with patients in the supine position and the head elevated by 30°.
|
The following PNF patterns will be applied to the upper extremity:
The following PNF patterns will be applied to the lower extremities:
Other Names:
|
|
Sham Comparator: Control Group
Patients in the control group will undergo passive range of motion (PROM) exercises in the same position.
|
Exercises for the upper extremities:
Exercises for the lower extremities:
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Ankle-Brachial İndex
Time Frame: Baseline and five or ten minutes after exercise
|
Systolic blood pressure will be measured at the brachial artery (upper limb) and the posterior tibial or dorsalis pedis artery (lower limb) using a Hadesco ES-101EX Doppler device, with patients in a supine resting position. The cuff will be placed at mid-arm and above the malleolus. It will be inflated until the pulse disappears and deflated slowly; the first reappearance of the pulse will be recorded as systolic pressure. Measurements will be taken in order: same-side arm, same-side leg, opposite leg, and opposite arm. The ankle-brachial index will be calculated as the ratio of the highest lower limb systolic pressure to the highest upper limb systolic pressure. |
Baseline and five or ten minutes after exercise
|
|
Heart Rate
Time Frame: Baseline and five or ten minutes after exercise
|
Heart rate will be recorded as beats per minute and breaths per minute, respectively, based on data obtained from the patient monitor.
Measurement will be taken whilst patients are in the supine position and at rest.
|
Baseline and five or ten minutes after exercise
|
|
Systolic blood pressure and diastolic blood pressure
Time Frame: Baseline and five or ten minutes after exercise
|
Systolic and diastolic blood pressure measurements will be taken from the patient's upper extremity using an appropriately sized cuff and recorded in millimetres of mercury (mmHg).
Measurement will be taken whilst patients are in the supine position and at rest.
|
Baseline and five or ten minutes after exercise
|
|
Respiratory rate
Time Frame: Baseline and five or ten minutes after exercise
|
respiratory rate will be recorded as beats per minute and breaths per minute, respectively, based on data obtained from the patient monitor.
Measurement will be taken whilst patients are in the supine position and at rest.
|
Baseline and five or ten minutes after exercise
|
|
Peripheral oxygen saturation (SpO₂)
Time Frame: Baseline and five or ten minutes after exercise
|
Peripheral oxygen saturation (SpO₂) will be measured using a pulse oximeter.
Measurement will be taken whilst patients are in the supine position and at rest.
|
Baseline and five or ten minutes after exercise
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Rate Pressure Product
Time Frame: Baseline and five or ten minutes after exercise
|
Rate Pressure Product is calculated by dividing the product of heart rate and systolic blood pressure by 1,000
|
Baseline and five or ten minutes after exercise
|
|
Quadriceps circumference measurement
Time Frame: Baseline and five or ten minutes after exercise
|
Measurements will be taken whilst patients are in the supine position or, where appropriate, in a seated position. During the measurement, a non-elastic tape measure will be used to measure the circumference at the widest part of the thigh. The tape measure will be placed parallel to the thigh circumference, and the measurement result will be recorded in centimetres (cm). To enhance the reliability of the measurement, two separate measurements will be taken for each patient, and the average of the obtained values will be used in the analyses. |
Baseline and five or ten minutes after exercise
|
|
Oxford Acute Severity of Illness Score
Time Frame: Baseline and five or ten minutes after exercise
|
Oxford Acute Severity of Illness Score comprises a total of 10 parameters: age, heart rate, mean arterial pressure, respiratory rate, body temperature, Glasgow Coma Scale, urine output, mechanical ventilation status, length of stay in intensive care, and the presence of elective surgery.
Each parameter is assessed according to specific score ranges, and the total score indicates the severity of the illness.
Higher scores indicate a higher risk of mortality.
|
Baseline and five or ten minutes after exercise
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- AIBU-FTR-BS-002
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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