The Outcome of Respiratory Muscle Training in Stroke Patients

NCT03491111 | Completed DMC

• 1 other identifier: CMRPG8E0911
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief Summary

Stroke survivors commonly have respiratory muscle weakness, swallowing disturbance, general weakness, reduced the daily living activities and short of motivation for rehabilitation. Respiratory muscle training (RMT) has been reported to improve the pulmonary function, respiratory muscle strength, exercise capacity, sensation of dyspnea and quality of life in several diseases, but rare in stroke patients. Reviewing previous reports, the protocol, intensity and duration of respiratory muscle training is still variable. Purpose: To investigate the feasibility and efficacy of respiratory muscle training on cardio-pulmonary function, swallowing function, cough function and reduction of incidence of pneumonia in post-stroke patients. Methods: A prospective, single blinded, randomized study. Consecutive patients with diagnosis of stroke will be proved by magnetic resonance image or computerized tomography. Stroke patients, aged 35-80 years old, with inspiratory muscle weakness or swallowing disturbance will be enrolled and randomly divided into control group (usual rehabilitation alone) and experimental group \[inspiratory muscle training (IMT) group for patients with inspiratory muscle weakness and expiratory muscle strengthening training (EMT) for patients with swallowing disturbance\]. Each patients will receive usual rehabilitation. The investigator expect that RMT will be practical for the restoration of respiratory muscle, swallowing function, cough function and voice quality, thereby reduction of the incidence of pneumonia.

Conditions

Cerebrovascular Disorders

Keywords

Cerebrovascular disease; respiratory muscle training; spirometry; peak flow; maximal inspiratory pressure, maximal expiratory pressure

Outcome Measures

Primary Outcomes (2)

• MIP (maximal inspiratory pressure)

  MIP(cm H20) is measured after maximal expiration while patients sitting and wearing a nose-clip. For MIP, more negative pressure is better.

  At the beginning and the end of program respectively, up to 6 weeks.

• MEP (maximal expiratory pressure)

  MEP(cm H20) is measured after maximal inspiration while patients sitting and wearing a nose-clip. For MEP, more positive is better.

  At the beginning and the end of program respectively, up to 6 weeks.

Secondary Outcomes (10)

• Forced vital capacity, FVC(liter)

  At the beginning and the end of program respectively, up to 6 weeks.

• Forced vital capacity, FVC(%pred)(liter)

  At the beginning and the end of program respectively, up to 6 weeks.

• Forced expiratory volume 1/Forced vital capacity, FEV1/FVC(%)

  At the beginning and the end of program respectively, up to 6 weeks.

• Maximal mid-expiratory flow, MMEF(%)

  At the beginning and the end of program respectively, up to 6 weeks.

• Peak cough flow(liter/min)

  At the beginning and the end of program respectively, up to 6 weeks.

Study Arms (3)

IMT & EMT

EXPERIMENTAL

Interventions: Respiratory muscle training for EMT+IMT. Respiratory muscle training for IMT (Inspiratory muscle training)+EMT (Expiratory muscle training). Respiratory muscle breathing training for patients with inspiratory muscle weakness and swallowing disturbance (MIP less than 70% of normal range).

Other: Respiratory muscle training for EMT+IMT; Other: Regular Rehabilitation

Control group

ACTIVE COMPARATOR

Intervention: Non-training group, receive regular rehabilitation. All participants will receive usual rehabilitation care including body positioning instruction, postural correction, breathing control, cough maneuver, respiratory muscle stretch, chest wall mobility exercise and ventilation, fatigue management.

Other: Regular Rehabilitation

EMT group

EXPERIMENTAL

Intervention: Respiratory muscle training for EMT. Respiratory muscle breathing training for swallowing disturbance. EMT for patients with swallowing disturbance will commence from 15% to 75% of threshold load of an individual's MEP.

Other: Regular Rehabilitation; Other: Respiratory muscle training for EMT

Interventions

Respiratory muscle training for EMT+IMT OTHER

2 times per day and 5 day per week, 6 weeks, training with breathing trainer.

IMT & EMT

Regular Rehabilitation OTHER

Regular Rehabilitation: 2-3 times a week, 6 weeks.

Control group; EMT group; IMT & EMT

Respiratory muscle training for EMT OTHER

5 sets, 5 repetition with one or two minute of rest between sets, twice per day, 5 days per week, training with breathing trainer.

EMT group

Eligibility Criteria

• Age: 35 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients identified as stroke and capable of performing voluntary respiratory maneuvers.

You may not qualify if:

• Increased intracranial pressure
• Uncontrolled hypertension
• Complicated arrhythmia
• Decompensated heart failure
• Unstable angina
• Myocardial infarction in the preceding 3 months
• Pneumothorax, bullae/blebs or infection.

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Study Sites (1)

Department of Physical Medicine and Rehabilitation, Kaohsiung Chang Gung Memorial Hospital.

Kaohsiung City, 83305, Taiwan

Location

Related Publications (1)

• Liaw MY, Hsu CH, Leong CP, Liao CY, Wang LY, Lu CH, Lin MC. Respiratory muscle training in stroke patients with respiratory muscle weakness, dysphagia, and dysarthria - a prospective randomized trial. Medicine (Baltimore). 2020 Mar;99(10):e19337. doi: 10.1097/MD.0000000000019337.

  PMID: 32150072 DERIVED

MeSH Terms

Conditions

Cerebrovascular Disorders

Interventions

Breathing Exercises

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Exercise Movement Techniques; Physical Therapy Modalities

Study Officials

• Liaw Mei-Yun, MD

  Department of Physical Medicine and Rehabilitation, Kaohsiung Chang Gung Memorial Hospital.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical doctor in Department of Physical Medicine and Rehabilitation

Study Record Dates

• First Submitted: January 30, 2018
• First Posted: April 9, 2018
• Study Start: April 1, 2016
• Primary Completion: July 18, 2018
• Study Completion: July 31, 2018
• Last Updated: December 1, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)