Respiratory Muscle Training in Subacute Stroke Patients

NCT02125760 | Completed

• 2 other identifiers: PSM/RHB/NR/14RETORNUS
• Study Type: interventional
• Target: 129
• Locations: 1 country
• Sites: 1

Brief Summary

This study is divided for development in two complementary work packages justified by the need to incorporate new strategies to optimize rehabilitation outcomes in stroke patients. The general objectives are: 1) to determine the prevalence of respiratory muscle dysfunction in stroke patients; 2) to identify the existence of a potential amino acid marker of increased risk of muscle dysfunction after suffering a stroke; 3) to evaluate the effectiveness of incorporating the respiratory muscle training as an innovative adjuvant therapy in stroke rehabilitation program that may decrease the incidence of morbidity and mortality in the medium and long term; and 4) to quantify the potential impact of respiratory muscle training on the costs of care for stroke patients.

Conditions

Muscle Weakness

Keywords

Respiratory muscle training; stroke; rehabilitation

Outcome Measures

Primary Outcomes (1)

• Respiratory muscle strength

  Respiratory muscle strength is assessed through maximal inspiratory and expiratory pressures (MIP and MEP, respectively) using a pressure transducer connected to a digital register system. The MIP is measured at mouth during a maximum effort from residual volume against occluded airway. To determine the MEP, the patients will perform a maximum expiratory effort from total lung capacity (TLC) in the face of the occluded airway. A specific and validated respiratory pressures manometer will be used (Micro RPM, Cardinalhealth, Kent, UK). For the purposes of the study, 'responders' will include the group of patients with an increase of 25% or more in respiratory muscle strength (MIP and MEP). Measures will be done once every week

  3 weeks

Secondary Outcomes (4)

• Handgrip strength assessment

  3 weeks

• Lower limb strength measurement

  3 weeks

• Serum aminoacids analysis

  Up to 3 weeks

• Adverse events as a measure of safety and tolerability

  18 months after discharge

Study Arms (2)

Inspiratory Muscle Training (IMT)

SHAM COMPARATOR

Patients with subacute stroke in a neurorehabilitation setting.

Other: Inspiratory Muscle Training (IMT)

High-intensity IMT

EXPERIMENTAL

Patients with subacute stroke in a neurorehabilitation setting.

Other: High-intensity IMT

Interventions

Inspiratory Muscle Training (IMT) OTHER

Sham IMT at a fixed workload of 10 cmH2O. 5 sets of 10 repetitions, twice a day, 7 days per week, for 4 weeks.

Also known as: No applicable

Inspiratory Muscle Training (IMT)

High-intensity IMT OTHER

High Intensity IMT. The training load is the maximum inspiratory load defined according to patient tolerance. This load will be equivalent to 10 maximal repetitions (RM) as 10 consecutive inspirations (x 5 sessions), twice a day.

Also known as: Short duration respiratory muscle training

High-intensity IMT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Hemiplegia secondary to first ischemic stroke in the subacute phase, and
• informed consent signed by the candidates of the study, after receiving full information on objectives, techniques and possible consequences.

You may not qualify if:

• Serious cardiovascular, neuromuscular or metabolic conditions that could interfere with the results and/or interfere with the measurements,
• significant alcohol abuse (\> 80 g/day) or severe malnutrition, and
• treatment with drugs with potential effect on muscle structure and function (steroids, anabolic steroids, thyroid hormones and immunosuppressants).

Sponsors & Collaborators

• Parc de Salut Mar: lead

Study Sites (1)

Physical Medicine and Rehabilitation Dpt. Parc de Salut Mar, Hospital del Mar

Barcelona, Barcelona, 08003, Spain

Location

Related Publications (26)

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MeSH Terms

Conditions

Muscle Weakness; Stroke

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Esther Duarte, MD, PhD

  Institut Hospital del Mar d'Investigacions Mèdiques. Universitat Autònoma de Barcelona.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: April 23, 2014
• First Posted: April 29, 2014
• Study Start: March 1, 2011
• Primary Completion: December 1, 2013
• Study Completion: September 1, 2014
• Last Updated: February 17, 2016

Record last verified: 2016-02

Locations

ES (1)