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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)

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)???. A prospective, multicenter, double blinded randomized controlled trial.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
TCTR
Registry ID
TCTR20161113002
Enrollment
Unknown
Registered
2016-11-13
Start date
2014-10-14
Completion date
Unknown
Last updated
2026-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple Sclerosis Weakness respiratory Fatigue Quality of life multiple sclerosis

Interventions

Intervention protocol: experimental group (EG) completed a combined progressive resistance RMT for 12 weeks&#44
according to previous studies (1)(3)(28) and it was conducted 3d/w under supervision of a physiotherapist in small groups (4 or 5 people).. The applied intervention was inspirations and expirations th
and 20 minutes of specific muscle group strengthening (1 set of 6 to 8 repetitions) (45) and aerobic exercises (walking or cycling on a stationary bike). Strengthening included calf raises and squats.
twice/day. During the training and/or control period&#44
participants were asked to maintain their normal level of physical activity. Treatment adherence was recorded in their exercise logs by the physiotherapist after each sesión according to Treatme
Experimental Device,Active Comparator Device
Respiratory Muscle Training Program (RMTP) group,Sham RMTP group

Sponsors

University of Málaga, Spain
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria: 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.

Design outcomes

Primary

MeasureTime frame
Respiratory Muscle Strenght Three months Maximal inspiratory and expiratory pressures (MIP amd MEP)

Secondary

MeasureTime frame
Fatigue, quality of life and respiratory function Three months Modified Fatigue Impact Scsle (MFIS),Multiple Sclerosis Quality of Life (MSQoL-54) and PDI

Contacts

Public ContactPATRICIA GÓMEZ

University of Málaga, Spain

patriadra2@hotmail.com+34 657 834 413

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Apr 4, 2026