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临床试验/NCT07524790
NCT07524790尚未招募不适用

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

Abant Izzet Baysal University0 个研究点目标入组 24 人开始时间: 2026年5月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
24
主要终点
Ankle-Brachial İndex

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

盲法说明

The researcher conducting the measurements will not know which group the patients have been assigned to; this will ensure that the study is as blinded as possible. However, due to the nature of the exercises being performed, it will not be possible for the physiotherapist administering the treatment or the patients themselves to be blinded to the group allocation.

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

研究组 & 干预措施

PNF Group

Experimental

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°.

干预措施: Proprioceptive Neuromuscular Facilitation Exercises (Other)

Control Group

Sham Comparator

Patients in the control group will undergo passive range of motion (PROM) exercises in the same position.

干预措施: Passive Range of Motion Exercises (Other)

结局指标

主要结局

Ankle-Brachial İndex

时间窗: 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.

Heart Rate

时间窗: 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.

Systolic blood pressure and diastolic blood pressure

时间窗: 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.

Respiratory rate

时间窗: 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.

Peripheral oxygen saturation (SpO₂)

时间窗: 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.

次要结局

  • Rate Pressure Product(Baseline and five or ten minutes after exercise)
  • Quadriceps circumference measurement(Baseline and five or ten minutes after exercise)
  • Oxford Acute Severity of Illness Score(Baseline and five or ten minutes after exercise)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Alp Ozel

Assistant Professor

Abant Izzet Baysal University

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