Effects of a 12-Week Respiratory Muscle Training Program (RMTP) on Respiratory Muscle Strength, fatigue and quality of life in Patients with Multiple Sclerosis (PwMS)
- Conditions
- quality of lifefatiguerespiratory muscle training.Multiple SclerosisWeakness respiratoryFatigueQuality of lifemultiple sclerosisrespiratory muscle strengthmaximal inspiratory pressure (MIP)maximal expiratory pressure (MEP)
- Registration Number
- TCTR20161113002
- Lead Sponsor
- niversity of Málaga, Spain
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 42
Inclusion criteria were people with a diagnosis of RR-MS, clinically definite MS according to Lublin criteria (29) and revised McDonald’s criteria (30), and according to a neurologist criteria, aged 18 years or over, people with mild to moderate MS and the ability to understand and accept the trial procedures and to sign an informed consent. Neurologic disability was assessed by the EDSS (31) (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 ]) (31) and by the Hauser Ambulation Index (AI) (32). (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. (32) It has been used in several studies focusing on patients suffering from MS. It has 10 grades ranging from 0 †9; a grade of 0 means ‘‘no gait impairment’’, a grade of 10 means ‘‘Restricted to wheelchair’’. (33)
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Respiratory Muscle Strenght Three months Maximal inspiratory and expiratory pressures (MIP amd MEP)
- Secondary Outcome Measures
Name Time Method Fatigue, quality of life and respiratory function Three months Modified Fatigue Impact Scsle (MFIS),Multiple Sclerosis Quality of Life (MSQoL-54) and PDI