COMPARISON OF BREATHING AND SUBOCCIPITAL RELEASE IN STROKE

Official title

COMPARISON OF THE EFFECTS OF DEEP AND SLOW BREATHING EXERCISES AND SUBOCCIPITAL RELEASE, ADDED TO ROUTINE PHYSIOTHERAPY AND REHABILITATION, ON AUTONOMIC, MOTOR, AND COGNITIVE FUNCTIONS AND EMOTIONAL STATUS IN STROKE PATIENTS

Overview

The aim of this study is to investigate the positive effects of deep, slow breathing exercises and suboccipital relaxation, when added to a routine physiotherapy and rehabilitation program, on autonomic, motor, cognitive, and emotional status functions in individuals who have experienced a stroke, and to examine their superiority compared to routine physiotherapy and rehabilitation alone.

Detailed description

Deep, slow breathing exercises have been reported in the literature to positively affect lung function, balance, and gait. Studies have also shown that slow and deep breathing can improve cognitive function. Current evidence indicates that these exercises significantly enhance baroreflex function, heart rate variability (HRV), and blood pressure regulation, as well as improve sleep quality and emotional conditions such as stress, anxiety, and depression.

Suboccipital relaxation has been identified as a beneficial therapeutic approach for improving balance and gait ability in individuals with chronic stroke. Additionally, cervical mobilization has been suggested as a supportive intervention in stroke rehabilitation. Suboccipital relaxation is noteworthy due to its potential to influence the parasympathetic nervous system, which plays a key role in regulating various bodily functions, including heart rate, digestion, and stress responses. Furthermore, the combined use of cervical joint mobilization and diaphragmatic breathing in individuals with chronic stroke has been reported to improve lung function and craniovertebral angle.

Although the literature reports positive effects of deep, slow breathing exercises and suboccipital relaxation individually, these methods have primarily been studied separately. To date, no study has evaluated their combined or comparative effects in stroke rehabilitation. In this respect, the present study is both clinically and methodologically novel. It aims to generate scientific evidence for multidimensional recovery processes after stroke, provide a theoretical and practical foundation for the development of comprehensive rehabilitation protocols, and ultimately contribute to reducing the global burden of stroke.

Interventions

• Other Breathing Exercise
  Individuals assigned to Group 1 will receive deep breathing exercises in addition to the hospital's routine physiotherapy and rehabilitation program, for a duration of 6 weeks, 3 days per week, with each session lasting 20 minutes. During the application of the breathing exercises, stroke patients will be positioned in a supine position, and the procedure will be conducted according to previously described protocols. The total 20-minute session will consist of breathing cycles with 4 seconds of
• Other Suboccipital Release
  Individuals assigned to Group 2 will receive the hospital's routine physiotherapy and rehabilitation program. In addition, suboccipital release will be applied for 6 weeks, 3 days per week, with each session lasting 20 minutes. Before initiating the suboccipital release procedure, the patient will be positioned in a supine position, and the practitioner will be seated on a stool at the head of the bed. The bed will be adjusted so that the patient's head is at the level of the practitioner's abdo
• Other Standard treatment
  Individuals assigned to Group 3 will receive only the hospital's routine physiotherapy and rehabilitation program. All participants will be included in this standard program, which consists of gait training, balance training, and upper extremity rehabilitation commonly applied to stroke patients. Under the supervision of a physiotherapist, patients will perform normal range of motion exercises in bed, upper extremity exercises in a sitting position, and functional activities such as walking, sta

Primary outcome measures

• Heart Rate Variability (HRV) [Time frame: Baseline and after 6 weeks of intervention]

Secondary outcome measures (5)

• Berg Balance Scale (BBS) [Time frame: Baseline and after 6 weeks of intervention]
• Motor Activity Log-28 (MAL-28) [Time frame: Baseline and after 6 weeks of intervention]
• Fugl-Meyer Assessment - Upper Extremity (FMA-UE): [Time frame: Baseline and after 6 weeks of intervention]
• Montreal Cognitive Assessment (MoCA): [Time frame: Baseline and after 6 weeks of intervention]
• Beck Depression Inventory (BDI): [Time frame: Baseline and after 6 weeks of intervention]

Eligibility criteria

Inclusion criteria

• First-time diagnosis of stroke
• Presence of unilateral hemiplegia due to ischemic or hemorrhagic stroke etiology
• Presence of hemiparesis
• At least 3 months post-stroke
• Having signed the informed consent form
• Aged between 18 and 84 years

Exclusion criteria

• Presence of active or chronic respiratory disease
• Low heart rate (<60 bpm)
• Known cardiac conduction disorder
• Symptomatic carotid or vertebrobasilar stenosis
• Severe carotid or vertebrobasilar stenosis
• Advanced liver, kidney, heart, or lung disease
• Diagnosed depression
• Pregnancy
• Severe aphasia or cognitive impairment that may interfere with the informed consent process or study procedures
• Malignant tumors or infectious diseases
• Presence of a pacemaker or other implanted electrical device
• Spasticity of grade 4 or higher according to the Modified Ashworth Scale in the upper and lower extremities
• Brunnstrom Motor Staging below stage 3 in the upper and lower extremities
• Failure to meet the inclusion criteria

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

Turkey (Türkiye) · 1 center

• Afyonkarahisar Health Sciences University Health Practice and Research Center — Afyonkarahisar

Identifiers

NCT: NCT07725471 · AYBU-FTR-ZA-01

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗