NCT06328803

Brief Summary

The goal of this clinical trial is to explore The Effect of Active Breathing Exercises in Stroke Patients With Respiratory Rhythm Disorder. Patients will be randomly divided into an observation group and a control group, all receiving routine rehabilitation treatment. On this basis, the observation group will be given Active Breathing Exercises. Researchers will compare dysphagia of two groups.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for not_applicable stroke

Timeline
Completed

Started Mar 2024

Shorter than P25 for not_applicable stroke

Status
not yet recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2024

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

March 10, 2024

Completed
15 days until next milestone

First Posted

Study publicly available on registry

March 25, 2024

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

March 25, 2024

Status Verified

March 1, 2024

Enrollment Period

9 months

First QC Date

March 10, 2024

Last Update Submit

March 18, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Penetration-Aspiration Scale

    The Penetration-Aspiration Scale is used to assess the severity of airway invasion during swallowing. The score ranges from 1 to 8, with higher scores indicating more severe penetration or aspiration events. A lower score indicates better swallowing function and less risk of airway invasion, while a higher score suggests more significant impairment and increased risk of aspiration.

    day 1 and day 15

Secondary Outcomes (5)

  • Functional Oral Intake Scale

    day 1 and day 15

  • Yale Pharyngeal Residue Severity Rating Scale

    day 1 and day 15

  • Fiberoptic Endoscopic Dysphagia Severity Scale

    day 1 and day 15

  • Murray Secretion Scale

    day 1 and day 15

  • Swallowing Quality of Life

    day 1 and day 15

Study Arms (2)

Rehabilitation training+Active Breathing Exercises

EXPERIMENTAL

Assigned by the random number table. During the treatment, all patients were provided with comprehensive rehabilitation therapy as follows: Basic treatment, including corresponding control of risk factors and education on healthy lifestyles. Swallowing training, including lemon ice stimulation, mendelson maneuver, empty swallowing training, and pronunciation training. Based on this, this group was given Active Breathing Exercises

Behavioral: Rehabilitation trainingBehavioral: Active Breathing Exercises

Rehabilitation training

ACTIVE COMPARATOR

Assigned by the random number table. During the treatment, all patients were provided with comprehensive rehabilitation therapy as follows: Basic treatment, including corresponding control of risk factors and education on healthy lifestyles. Swallowing training, including lemon ice stimulation, mendelson maneuver, empty swallowing training, and pronunciation training.

Behavioral: Rehabilitation training

Interventions

Including 1) Basic treatment, including corresponding control of risk factors and education on healthy lifestyles. 2)Swallowing training, including lemon ice stimulation, mendelson maneuver, empty swallowing training, and pronunciation training.

Rehabilitation trainingRehabilitation training+Active Breathing Exercises

Active breathing exercises aim to enhance the strength and flexibility of respiratory muscles through a series of exercises, improving breathing patterns and increasing respiratory efficiency. The following are common components of active breathing exercises: 1) Deep Breathing. 2) Chest Expansion. 3) Diaphragmatic Breathing. 4) Coughing Techniques. 5) Expiratory Resistance Training. 6) Gradual Increase in Activity.

Rehabilitation training+Active Breathing Exercises

Eligibility Criteria

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

You may qualify if:

  • diagnosed with Respiratory Rhythm Disorder
  • age ≥ 18 years;
  • meeting the diagnostic criteria of stroke;
  • any degree of dysphagia at admission;
  • steady vital signs, without severe cognitive impairment or sensory aphasia, able to cooperate with the assessment.
  • transferred out within three weeks of hospitalization in the neurology department.

You may not qualify if:

  • complicated with other neurological diseases;
  • tracheostomy tube plugged;
  • unfeasible to the support of parenteral nutrition;
  • simultaneously suffering from liver, kidney failure, tumors, or hematological diseases.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Nieto Luis, Master

    Site Coordinator of United Medical Group

    STUDY CHAIR

Central Study Contacts

Lavie Ce, Master

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR INVESTIGATOR
PI Title
The Research Director

Study Record Dates

First Submitted

March 10, 2024

First Posted

March 25, 2024

Study Start

March 1, 2024

Primary Completion

December 1, 2024

Study Completion

December 1, 2024

Last Updated

March 25, 2024

Record last verified: 2024-03