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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03153345
Other study ID # KoreaUAnamHRehab
Secondary ID
Status Completed
Phase N/A
First received May 8, 2017
Last updated May 12, 2017
Start date March 1, 2015
Est. completion date December 31, 2016

Study information

Verified date May 2017
Source Korea University Anam Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Objectives: To investigate the efficacy of bedside respiratory muscle training on pulmonary function and stroke-related disabilities in stroke patients.

Design: Prospective randomized controlled trial

Setting: A single physical medicine and rehabilitation department at a university hospital

Participants: Stroke patients in a rehabilitation unit were recruited and randomly assigned to either the intervention group or the control group.

Intervention: Both groups participated in a conventional stroke rehabilitation program. During the study period, the intervention group received bedside respiratory muscle training twice a day for three weeks. The respiratory muscle training consisted of (1) a breath stacking exercise, (2) inspiratory muscle training and (3) expiratory muscle training. The participants were evaluated at baseline and again at the end of the study (3 weeks later).

Main Outcome Measures: The primary outcomes were measures of pulmonary function: functional vital capacity (FVC), forced expiratory volume in one second (FEV1) and peak flow.

Secondary outcomes were stroke-related disabilities assessed by the following: National Institutes of Health Stroke Scale, Modified Barthel Index, Berg Balance Scale, Fugl-Meyer Assessment, the Korean Mini-Mental State Examination, and the incidence of pneumonia.


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date December 31, 2016
Est. primary completion date October 31, 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

1. older than 18 years of age,

2. first episode of stroke within three months,

3. moderate to severe stroke impairment, defined as a NIHSS score from 5-36, and

4. the ability to follow instructions and engage in the study program.

Exclusion Criteria:

1. a medical history of persistent cardiopulmonary disease,

2. other coexisting brain disorders, such as brain tumor,

3. poorly controlled hypertension, which was defined as a blood pressure higher than 180/100 mmHg during the preceding 24 hours,

4. severe facial palsy or other oropharyngeal structural abnormality,

5. severe oral apraxia, and (6) having a tracheostomy.

Study Design


Intervention

Device:
bedside respiratory muscle training
The program consisted of three sessions: (1) 10 minutes of breath stacking exercise, followed by (2) 10 minutes of inspiratory muscle training using a flow-oriented incentive spirometer and (3) 10 minutes of expiratory muscle training using Acapella vibratory PEP device.
Behavioral:
conventional stroke rehabilitation program
The program consisted of joint range of motion exercises, muscle strengthening, gait training, fine motor exercises, and activity of daily living training.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Korea University Anam Hospital

Outcome

Type Measure Description Time frame Safety issue
Primary functional vital capacity functional vital capacity in percent (%) 21 days
Primary Forced expiratory volume Forced expiratory volume in one second in percent (%) 21 days
Primary Peak flow Peak flow in milliliter 21 days
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