Effects of a 12-Week Respiratory Muscle Training Program (RMTP) on Respiratory and Peripheral Muscle Strength in Patients with Multiple Sclerosis (PwMS): a multicenter, prospective, double-blind, randomized controlled clinical trial

niversity of MÃ¡laga, Spain0 sites42 target enrollmentSeptember 30, 2016

Overview

No summary available.

Registry

who.int

Start Date

September 30, 2016

End Date

March 2, 2016

Last Updated

last year

Study Type

Interventional

Sex

All

Sponsor

niversity of MÃ¡laga, Spain

•Inclusion criteria were people with a diagnosis of RR\-MS, clinically definite MS according to Lublin criteria18 and revised McDonaldâ€™s criteria19, and according to a neurologist criteria, aged 18 years or over, people with mild to moderate disability and the ability to understand and accept the trial procedures and to sign an informed consent. Neurologic disability was assessed by the Expanded Disability Status Scale (EDSS),20 (score between 1 \[no disability, minimal signs in one FS] and 6 \[requires a walking aid \- cane, crutch, etc \- to walk about 100m with or without resting ])20 and by the Hauser Ambulation Index (AI),21 (score between 1 \[walks normally, but reports fatigue that interferes with athletic or other demanding activities] and 4 \[requires unilateral support (cane or single crutch) to walk; walks 25 feet in 20 seconds or less]). The AI is a rating scale developed by Hauser et al (1983\) to assess mobility by evaluating the time and degree of assistance required to walk 25 feet.21 It has been used in several studies focusing on patients suffering from MS. It has 10 grades ranging from 0 â€ 9; a grade of 0 means â€˜â€˜no gait impairmentâ€™â€™, a grade of 10 means â€˜â€˜Restricted to wheelchairâ€™â€™.22

•Exclusion criteria included individuals with relapse of MS within the last 4 weeks, new corticosteroid or medication which is known to affect walking within the last 4 weeks, respiratory infections within the last 4 weeks, concomitant chronic respiratory disease, musculoskeletal conditions unrelated to MS affecting performance, overt symptoms or signs of depression or cognitive/language dysfunction that could interfere with the outcome measures self\-administered test and any other significant medical conditions screened and addressed by their neurologists that could interfere with the trial procedures. A relapse or medication change during the intervention period led to exclusion of the participant.