NCT06312319

Brief Summary

The aim of this study is to evaluate the effects of a home-based respiratory muscle training on swallowing function in patients with chronic stroke. The patients will be included in a experimental or a control group. The patients in the experimental group will receive a home-based respiratory training using respiratory devices added to standard treatment, while the participants in the control group will only receive the standard treatment.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable stroke

Timeline
Completed

Started Aug 2023

Shorter than P25 for not_applicable stroke

Geographic Reach
1 country

1 active site

Status
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

August 20, 2023

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

January 31, 2024

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 15, 2024

Completed
5 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 20, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 20, 2024

Completed
Last Updated

March 18, 2024

Status Verified

March 1, 2024

Enrollment Period

7 months

First QC Date

January 31, 2024

Last Update Submit

March 14, 2024

Conditions

Stroke

Outcome Measures

Primary Outcomes (3)

  • Gugging Swallowing screen

    Screening test that indicates the need to evaluate the presence of dysphagia. The scores ranges from 0 to 20, with higher scores indicating better performance. Twenty points are the highest score that a patient can attain, and it means normal swallowing ability without aspiration risk.

    Baseline, 6 weeks

  • Swallowing quality of life questionnaire

    Questionnaire evaluating the impact of swallowing deficits on daily living. The scores range from 0 to 100 metric, with a lower score indicating less quality of life.

    Baseline, 6 weeks

  • cough peak flow

    Evaluation of the strength of cough using a peak flow meter

    Baseline, 6 weeks

Secondary Outcomes (4)

  • Forced vital capacity

    Baseline, 6 weeks

  • Forced expiratory volumen in the first second

    Baseline, 6 weeks

  • FEV1/FVC ratio

    Baseline, 6 weeks

  • Respiratory Pressure Meter

    Baseline, 6 weeks

Study Arms (2)

Respiratory training added to orofacial exercises

EXPERIMENTAL

Home-based respiratory training of the inspiratory and expiratory muscles using a device added to standard treatment including orofacial exercises.

Device: Respiratory trainingOther: Orofacial exercises

Orofacial exercises

ACTIVE COMPARATOR

Standard treatment including orofacial exercises.

Other: Orofacial exercises

Interventions

Respiratory trainingDEVICE

Respiratory training using the EMST 150 device to increase inspiratory and expiratory muscle strength.

Respiratory training added to orofacial exercises
Orofacial exercisesOTHER

The exercises will include activities to improve orofacial structures such as mobility, strength and coordination.

Orofacial exercisesRespiratory training added to orofacial exercises

Eligibility Criteria

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

You may qualify if:

  • Clinical diagnosis of stroke
  • years of age or more

You may not qualify if:

  • Cognitive impairment or aphasia that prevents the understanding of instructions.
  • Tracheostomy.
  • Presence of cancer.
  • Patients who present another disease of the central nervous system
  • Absence of neuromotor competence to carry out the respiratory function tests.
  • Central apnea.
  • Hypoventilation-obesity syndrome.
  • Severe cardiorespiratory impairment (hemodynamic instability, pulmonary embolism, recent pneumonothorax, acute hemoptysis, active respiratory infections, recent myocardial infarction, unstable angina, pulmonary hypertension, uncontrolled asthma, or severe chronic obstructive pulmonary disease).
  • Patients with recent otorhinolaryngological, abdominal, or thoracic surgery.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Health Sciences

Granada, 18016, Spain

RECRUITING

MeSH Terms

Conditions

Stroke

Interventions

Breathing Exercises

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsExercise Movement TechniquesPhysical Therapy Modalities

Study Officials

  • Irene Cabrera Martos

    UGR

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Irene Cabrera Martos

CONTACT

958248763irenecm@ugr.es

Irene Cabrera Martos

CONTACT

irenecm@ugr.es

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Profesor titular de Universidad

Study Record Dates

First Submitted

January 31, 2024

First Posted

March 15, 2024

Study Start

August 20, 2023

Primary Completion

March 20, 2024

Study Completion

June 20, 2024

Last Updated

March 18, 2024

Record last verified: 2024-03

Locations

ES(1)