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Effects of a 12-Week Respiratory Muscle Training Program (RMTP) on Respiratory and Peripheral Muscle Strength in Patients with Multiple Sclerosis (PwMS)

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
TCTR
Registry ID
TCTR20160930001
Enrollment
Unknown
Registered
2016-09-30
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 (MS) Multiple sclerosis Respiratory muscle strength maximal expiratory pressure maximal inspiratory pressure respiratory muscle training functional mobility pulmonary function

Interventions

Intervention protocol: experimental participants completed a combined progressive resistance RMT for 12 weeks&#44
according to previous studies 4&#44
41 and it was conducted three days a week under supervision of a physiotherapist in small groups (4 or 5 people). The applied intervention was inspirations and expirations through the trainers (Orygen
and 20 minutes of specific muscle group strengthening (1 set of 6 to 8 repetitions)42 and aerobic exercises (walking or cycling on a stationary bike). Strengthening included calf raises and squats. Al
twice a day,Control group received sham&#45
RMT&#44
with the same exercise program&#44
although at a workload of 10 cmH2O in the RMT throughout the study period&#44
along with health education. The control group was offered the RMT intervention at the end of the study.
Experimental Device,Sham Comparator Device
RMTP group,Sham RMTP

Sponsors

University of Málaga, Spain
Lead Sponsor
University of Málaga&#44
Collaborator
Spain
Collaborator

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 criteria18 and revised McDonald’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 – 9; a grade of 0 means ‘‘no gait impairment’’, a grade of 10 means ‘‘Restricted to wheelchair’’.22

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 and MEP)

Secondary

MeasureTime frame
Peripheral muscle strength, Functional Mobility Measures, pulmonary function three months Hand grip strenght, squats, T25-FW, MSWS12, forced vital capacity (FVC), forced expiratory volume in

Countries

Spain

Contacts

Public ContactROCÍO VALERO

University of Málaga, Spain

rovalemas@gmail.com+34 657 834 413

Outcome results

None listed

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