NCT03153345

The Efficacy of Bedside Respiratory Muscle Training in Stroke Patients

Completed NA Last updated 15 May 2017

What this trial tests

NA trial testing bedside respiratory muscle training in Stroke in 40 participants. Completed in 31 December 2016.

Timeline

1 March 2015

Primary endpoint
31 October 2016

31 December 2016

Quick facts

Lead sponsor	Korea University Anam Hospital
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	40
Start date	1 March 2015
Primary completion	31 October 2016
Estimated completion	31 December 2016

Drugs / interventions tested

• bedside respiratory muscle training
• conventional stroke rehabilitation program

Conditions studied

• Stroke — all drugs for Stroke →
• Rehabilitation — all drugs for Rehabilitation →
• Breathing Exercise — all drugs for Breathing Exercise →
• Pneumonia — all drugs for Pneumonia →

Sponsor

Korea University Anam Hospital

Who can join

18 and older, any sex, with Stroke or Rehabilitation. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.