Home-based Respiratory Training After Stroke

NCT02400138 | Completed

• 1 other identifier: RTS-01
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 2

Brief Summary

Weakness of the respiratory muscles demonstrated by individuals with stroke, may generate important symptoms, such as fatigue and dyspnea. Since adequate strength of the inspiratory and expiratory muscles is required, mainly when performing physical activities, rehabilitation interventions for stroke subjects should include respiratory training. This study will test the hypothesis that home-based combined training of the inspiratory and expiratory muscles is effective in improving strength of the inspiratory and expiratory muscles, endurance of the inspiratory muscles, dyspnea, walking capacity, and ocurrence of respiratory complications after stroke. For this clinical trial, people after stroke will be randomly allocated into either experimental or control/sham groups. The experimental group will undertake training of the inspiratory plus expiratory muscles with the Orygen Dual Valve device, regulated at 50% of the subjects' maximal inspiratory and expíratory pressure values, seven times/week over eight weeks during 40 minutes/day. The control group will undertake the same protocol, but the participants will receive the devices without resistance. At baseline, post intervention, and four weeks after the cessation of the intervention, researchers blinded to group allocations will collect the following outcome measures: maximal inspiratory and expiratory pressures, inspiratory endurance, dyspnea, walking capacity, and ocurrence of respiratory complications.

Conditions

Stroke

Outcome Measures

Primary Outcomes (1)

• Maximal inspiratory pressure

  Changes in maximal inspiratory pressures will be assessed by a digital manovacuometer, following previously described protocols.

  Baseline (week 0), after training (week 8) and one-month follow-up (weeks 12)

Secondary Outcomes (5)

• Maximal expiratory pressure

  Baseline (week 0), after training (week 8) and one-month follow-up (weeks 12)

• Inspiratory endurance

  Baseline (week 0), after training (week 8) and one-month follow-up (weeks 12)

• Dyspnea

  Baseline (week 0), after training (week 8) and one-month follow-up (weeks 12)

• Ocurrence of respiratory complications

  Baseline (week 0), after training (week 8) and one-month follow-up (weeks 12)

• Walking capacity

  Baseline (week 0), after training (week 8) and one-month follow-up (weeks 12)

Study Arms (2)

Respiratory training

EXPERIMENTAL

Respiratory training will include training of the inspiratory and expiratory muscles seven times per week over eight weeks, during 40 minutes per day, divided into two 20-min sessions (morning and afternoon). Each 20-min session comprised 4-min sets of respiratory training, followed by 1-min rest between the sets. The training program will be carried-out with the Orygen Dual Valve device, regulated at 50% of the subjects' maximal inspiratory and expiratory pressure values. Once a week, the treating physiotherapist performed a home visit, measured the current values of inspiratory and expiratory strength, and progressed the load to 50% of the new values.

Other: Respiratory training

Control

SHAM COMPARATOR

The control/sham group will underwent exactly the same protocol and weekly monitoring at home, but the participants will receive the devices without resistance of the spring, which will be also concealed. The control group will also attend the weekly sessions and undergo the same procedures, except for the load adjustments. If the training proves to be effective, the control subjects will be informed and have the choice to receive the training with proper loads.

Other: Control

Interventions

Respiratory training OTHER

Respiratory training will include training of the inspiratory and expiratory muscle seven times per week over eight weeks, during 40 minutes, divided into two 20-min sessions (morning and afternoon). Each 20-min session comprised 4-min sets of respiratory training, followed by 1-min rest between the sets. The training program will be carried-out with the Orygen Dual Valve regulated at 50% of the subjects' maximal inspiratory and expiratory pressure values. Once a week, the treating physiotherapist performed a home visit, measured the current values of inspiratory and expiratory strength, and progressed the load to 50% of the new values.

Respiratory training

Control OTHER

The control/sham group will underwent exactly the same protocol and weekly monitoring at home, but the participants will receive the devices without resistance of the spring.

Control

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Stroke survivors will be eligible if they: were \>3 months and \<5 years after their last episode of stroke; were \>20 years of age; their maximal inspiratory pressure was \<80 cmH2O or maximal expiratory pressure was \<90 cmH2O \[18\]; were not undertaking any respiratory training; and were able to provide informed consent.

You may not qualify if:

• Subjects will be excluded if they had cognitive deficits, facial palsy, associated respiratory diseases, or unstable conditions which might prevent measurement or training; or undergone thoracic or abdominal surgery.

Sponsors & Collaborators

• Federal University of Minas Gerais: lead

Study Sites (2)

Department of Physical Therapy, Universidade Federal de Minas Gerais

Belo Horizonte, Minas Gerais, 31270-901, Brazil

Location

NeuroGroup Laboratory

Belo Horizonte, Minas Gerais, 31270-901, Brazil

Location

Related Publications (3)

• Sutbeyaz ST, Koseoglu F, Inan L, Coskun O. Respiratory muscle training improves cardiopulmonary function and exercise tolerance in subjects with subacute stroke: a randomized controlled trial. Clin Rehabil. 2010 Mar;24(3):240-50. doi: 10.1177/0269215509358932. Epub 2010 Feb 15.

  PMID: 20156979 RESULT

• Britto RR, Rezende NR, Marinho KC, Torres JL, Parreira VF, Teixeira-Salmela LF. Inspiratory muscular training in chronic stroke survivors: a randomized controlled trial. Arch Phys Med Rehabil. 2011 Feb;92(2):184-90. doi: 10.1016/j.apmr.2010.09.029.

  PMID: 21272713 RESULT

• Parreiras de Menezes KK, Nascimento LR, Ada L, Avelino PR, Polese JC, Mota Alvarenga MT, Barbosa MH, Teixeira-Salmela LF. High-Intensity Respiratory Muscle Training Improves Strength and Dyspnea Poststroke: A Double-Blind Randomized Trial. Arch Phys Med Rehabil. 2019 Feb;100(2):205-212. doi: 10.1016/j.apmr.2018.09.115. Epub 2018 Oct 12.

  PMID: 30316960 DERIVED

MeSH Terms

Conditions

Stroke

Interventions

Breathing Exercises

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; 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

• Fatima Rodrigues-de-Paula, Ph.D.

  Federal University of Minas Gerais

  STUDY DIRECTOR

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: Titular professor

Study Record Dates

• First Submitted: March 23, 2015
• First Posted: March 26, 2015
• Study Start: February 1, 2016
• Primary Completion: June 30, 2017
• Study Completion: July 15, 2017
• Last Updated: October 26, 2017

Record last verified: 2017-10

Data Sharing

• IPD Sharing: Will not share

Locations

BR (2)