NCT07524790

Brief Summary

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.

Trial Health

65
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
11mo left

Started May 2026

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress9%
May 2026May 2027

First Submitted

Initial submission to the registry

April 3, 2026

Completed
10 days until next milestone

First Posted

Study publicly available on registry

April 13, 2026

Completed
1 month until next milestone

Study Start

First participant enrolled

May 15, 2026

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2027

Expected
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 15, 2027

Last Updated

April 13, 2026

Status Verified

April 1, 2026

Enrollment Period

8 months

First QC Date

April 3, 2026

Last Update Submit

April 9, 2026

Conditions

Keywords

Proprioceptive Neuromusculer FacilitationNeurological Intensive CareHaemodynamic Responses

Outcome Measures

Primary Outcomes (5)

  • Ankle-Brachial İndex

    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

    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

    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

    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)

    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 Outcomes (3)

  • 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

Study Arms (2)

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°.

Other: Proprioceptive Neuromuscular Facilitation Exercises

Control Group

SHAM COMPARATOR

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

Other: Passive Range of Motion Exercises

Interventions

The following PNF patterns will be applied to the upper extremity: * flexion - abduction - external rotation → extension - adduction - internal rotation * extension - abduction - internal rotation → flexion - adduction - external rotation The following PNF patterns will be applied to the lower extremities: * flexion - adduction - external rotation (with the knee extended) → extension - abduction - internal rotation * extension - adduction - external rotation (with the knee extended) → flexion - abduction - internal rotation All exercises will be performed passively by the physiotherapist. Each movement will be performed in sets of 10-12 repetitions, with a 30-second rest period between sets.

Also known as: PNF
PNF Group

Exercises for the upper extremities: * shoulder flexion - extension * shoulder abduction - adduction * shoulder internal - external rotation * elbow flexion - extension * wrist flexion - extension * finger flexion - extension Exercises for the lower extremities: * hip flexion - extension * hip abduction - adduction * hip internal - external rotation * knee flexion - extension * ankle dorsiflexion - plantar flexion All exercises will be performed passively by the physiotherapist. Each movement will be performed in sets of 10-12 repetitions, with a 30-second rest period between sets.

Also known as: PROM
Control Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Nervous System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
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.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: two groups with a conventional therapy control group.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

April 3, 2026

First Posted

April 13, 2026

Study Start

May 15, 2026

Primary Completion (Estimated)

January 15, 2027

Study Completion (Estimated)

May 15, 2027

Last Updated

April 13, 2026

Record last verified: 2026-04