Clinical trial NCT04548206: Effect of Pilates Training in Patients With Multiple Sclerosis
Official title: Effect of Pilates Training on Sensory, Muscle Strength, Balance, and Gait in Patients With Multiple Sclerosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Sclerosis
Keywords: Multiple Sclerosis
sensation
gait
Pilates
Lead sponsor: Gazi University
Sponsor class: OTHER
First posted: 2020-09-14
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: prospective randomize controlled study
Primary purpose: TREATMENT

Brief summary: Knee flexor and extensor muscle weakness in MS patients causes a decrease in walking distance and is an important determinant of walking capacity. Exercise training has beneficial effects on muscle strength, balance, and walking in MS patients. Although the effects of aerobic and resistant exercise training in MS patients are often emphasized, today the effect of different exercise types is also wondered. Pilates is a core stability-based exercise method that improves endurance, flexibility, movement, posture, and respiratory control. The aim of this study is to examine the effect of Pilates training on sensation, muscle strength, balance, and walking in MS patients.

Detailed description: Patients with MS between 0-5,5 score according to the Extended Disability Status Scale (EDSS) will be included in the study. The balance, gait, position sense, and muscle strength will be evaluated. The study was designed as a prospective, randomized controlled study. The patients will be randomly assigned to two groups, the "Pilates training" group, and the control group. Pilates training will be performed by the Pilates training group 2 times for 8 weeks under supervision in the outpatient clinic. The control group will be taught relaxation exercises and will be asked to perform the exercises 2 times for 8 weeks at home. Statistical analyses will be performed using the SPSS software version 15 (SPSS Inc. Chicago, IL, USA). The pre-training and post-training measurements of groups will be compared with the paired sample t-test.

Eligibility criteria: Inclusion Criteria:

* 18-65 years of age
* Having a diagnosis of "Multiple Sclerosis"
* Relapse free in the last 3 mounts
* Having an ambulatory status (Expanded Disability Status Scale score ≤ 6 )
* No diagnosis of depression

Exclusion Criteria:

* Any cardiovascular, orthopedic, visual, hearing and perception problems that may affect the results of the research.

Primary outcomes:
measure: Gait
timeFrame: 5 minutes
measure: Balance
timeFrame: 10 minutes
measure: Light touch-pressure sensation
timeFrame: 10 minutes
measure: Vibration sensation
timeFrame: 10 minutes
measure: Two-point discrimination
timeFrame: 10 minutes
measure: Position sensation of knee joint
timeFrame: 5 minutes
measure: Knee proprioception
timeFrame: 10 minutes
measure: Position sensation of trunk
timeFrame: 10 minutes
measure: Knee strength
timeFrame: 20 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Gazi University
Study officials:
affiliation: Gazi University
name: Cagla Ozkul, Phd
role: PRINCIPAL_INVESTIGATOR
References:
citation: Citaker S, Gunduz AG, Guclu MB, Nazliel B, Irkec C, Kaya D. Relationship between foot sensation and standing balance in patients with multiple sclerosis. Gait Posture. 2011 Jun;34(2):275-8. doi: 10.1016/j.gaitpost.2011.05.015. Epub 2011 Jun 16.
citation: Bulguroglu I, Guclu-Gunduz A, Yazici G, Ozkul C, Irkec C, Nazliel B, Batur-Caglayan HZ. The effects of Mat Pilates and Reformer Pilates in patients with Multiple Sclerosis: A randomized controlled study. NeuroRehabilitation. 2017;41(2):413-422. doi: 10.3233/NRE-162121.