NCT04929990

Brief Summary

Patients with COPD and MCI received either inspiratory muscle training or inspiratory plus expiratory muscle training and compared the therapeutic effects

Trial Health

87
On Track

Trial Health Score

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

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable chronic-obstructive-pulmonary-disease

Timeline
Completed

Started Aug 2018

Typical duration for not_applicable chronic-obstructive-pulmonary-disease

Geographic Reach
1 country

1 active site

Status
completed

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 7, 2018

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 6, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 2, 2021

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

June 3, 2021

Completed
15 days until next milestone

First Posted

Study publicly available on registry

June 18, 2021

Completed
Last Updated

June 18, 2021

Status Verified

June 1, 2021

Enrollment Period

2.7 years

First QC Date

June 3, 2021

Last Update Submit

June 10, 2021

Conditions

Chronic Obstructive Pulmonary DiseaseMild Cognitive Impairment

Outcome Measures

Primary Outcomes (1)

  • MMSE

    Mini-Mental State Examination

    8 weeks

Secondary Outcomes (14)

  • Diaphragmatic thickness fraction

    8 weeks

  • chronic obstructive pulmonary disease assessment test (CAT)

    8 weeks

  • diffusing capacity of the lung for carbon monoxide (DLCO)

    8 weeks

  • dead space fraction (Vd/Vt)

    8 weeks

  • the distance walked in 6 minutes

    8 weeks

  • +9 more secondary outcomes

Study Arms (2)

Inpiratory and expiratory muscle training

EXPERIMENTAL

The initial intensity of training was set on 30% of the MIP and MEP for inspiratory and expiratory muscle training, respectively. The intensity was adjusted to add 5% of resistance each week

Behavioral: Respiratory muscle training

Inspiratory muscle training

ACTIVE COMPARATOR

The initial resistance of the breathing trainer was also set on 30% of MIP, and the following adjustments were also in accordance to the protocol of the experimental group

Behavioral: Respiratory muscle training

Interventions

Respiratory muscle trainingBEHAVIORAL

Inspiratory and expiratory muscle training were performed using a breathing trainer (Dofin DT11/14, Galemed Co. Ltd, Taiwan) for 30 minutes a day with a total of eight weeks. Before the training, the MIP and maximal expiratory pressure (MEP) were documented by the best performance of three trials with a digital pressure gauge (GB60, Jitto International Co. Ltd, Taiwan)

Inpiratory and expiratory muscle trainingInspiratory muscle training

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • \. Having definite diagnosis of COPD, namely the value of the FEV1 divided by forced vital capacity (FVC) 10 to 15 minutes after beta-2 agonist inhalation being less than 0.7.
  • \. The score of Mini-Mental State Examination (MMSE) being between 23 and 27

You may not qualify if:

  • \. Being not able to follow instructions on respiratory muscle training or complete the questionnaires of our study due to cognitive impairment.
  • \. Having difficulty to complete the cardiopulmonary exercise testing or the six minute walking test (6MWT) due to high risk cardiopulmonary diseases or other orthopedic conditions.
  • \. Having the diagnosis of lung cancer or history of receiving thoracoabdominal surgery
  • \. Having Body Mass Index more than 30

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Taichung Veterans General Hospital

Taichung, 407, Taiwan

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic ObstructiveCognitive Dysfunction

Interventions

Breathing Exercises

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsCognition DisordersNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsExercise Movement TechniquesPhysical Therapy Modalities

Study Officials

  • Yuan-Yang Cheng

    Taichung Veterans General Hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 3, 2021

First Posted

June 18, 2021

Study Start

August 7, 2018

Primary Completion

April 6, 2021

Study Completion

June 2, 2021

Last Updated

June 18, 2021

Record last verified: 2021-06

Data Sharing

IPD Sharing
Will not share

Locations

TW(1)