Clinical trial NCT05029700: The Effects of Trunk Stabilization and Aerobic Trainings in Multiple Sclerosis
Official title: The Effect of Trunk Stabilization Training Combined With Aerobic Training on Neuromuscular Parameters and Functional Exercise Capacity in Patients With Multiple Sclerosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Physical Therapy
Keywords: balance
strength
endurance
stability
exercise
Lead sponsor: Ankara Yildirim Beyazıt University
Sponsor class: OTHER
First posted: 2021-08-31
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Balance requires many central nervous system controlled functions, and most or all of these functions can be affected by MS, so balance is very often impaired in patients with MS. Core stability is also decreased in patients with MS. Core stability is among the most important factors that ensure the balance and walking of the participants in different environments and conditions during functional activities. In addition to core muscle activity, lower extremity muscle strength and endurance decrease due to the influence of central nervous system and decrease in physical activity. Functional exercise capacity also decreases due to the influence of the central nervous system and the decrease in physical activity in patients with MS.

Despite all these symptoms and the benefits of exercise training, unfortunately, most MS patients are physically inactive, which can initiate a cycle of deconditioning and worsening of symptoms. In the literature, the combined effects of aerobic training and resistance training have been examined, and it has been stated that combining these two trainings will increase the effectiveness on symptoms. In recent years, trunk stabilization training has started to be included in physiotherapy and rehabilitation programs as an alternative method in patients with MS, based on the knowledge that core stability is effective on many functions and symptoms, as well as aerobic and resistance training. Considering that combined training practices are more effective in reducing symptoms, the investigators think that aerobic training and trunk stabilization training may be more effective in reducing symptoms in patients with MS when applied in combination. In addition, when all these studies were examined, the subtypes of MS patients included in the studies were generally not specified. The effects of these trainings on balance, core stability lower extremity muscle strength and endurance, and functional exercise capacity have not been demonstrated in patients with relapsing remitting MS (RR-MS), the most common type of MS disease. Therefore, the aim of this study is to examine the effects of trunk stabilization training combined with aerobic training on balance, core stability, lower extremity muscle strength and endurance, and functional exercise capacity in patients with RR-MS.

Detailed description: This study was carried out with the purpose of examining the effects of trunk stabilization training combined with aerobic training on balance, core stability, lower extremity muscle strength and endurance, and functional exercise capacity in patients with RR-MS.

A total of 20 patients, 10 in each group, were included in the study. Both the combined exercise group and the control group performed 30 minutes of aerobic training. The combined exercise group also received trunk stabilization training after a 10-minute resting period. Both groups received treatment 2 times a week for 8 weeks (in total 16 sessions). The static and dynamic balance were measured using the posturography (Biodex Balance System SDTM) with Postural Stability Test and Limits of Stability Test. Core stability was assessed by core endurance tests using the McGill protocol. Core endurance tests used are flexion endurance test, extension endurance test, and right and left lateral bridge tests. The lower extremity muscle strength and endurance of the patients were determined by evaluating the strength and endurance of the knee flexor and extensor muscles at angular velocities of 60º/sec and 180º/sec. Evaluations were made using the Biodex System 4 (Biodex Corp, Shirley, NY, USA) isokinetic dynamometer. Functional exercise capacity was assessed using the 6-Minute Walking Test (6-MWT) according to criteria set by the American Thoracic Society.

Eligibility criteria: Inclusion Criteria:

* To be diagnosed with relapsing-remitting multiple sclerosis disease by a specialist physician
* Not having an MS attack in the last 3 months
* Having a disability level between 1 and 5 according to the Expanded Disability Status Scale
* Not being included in the physiotherapy and rehabilitation program in the last 3 months

Exclusion Criteria:

* Using corticosteroids in the past 4 weeks
* Being pregnant
* Spinal deformities, spinal disc herniation or other spinal pathologies, orthopedic problems related to hip, knee, ankle

Primary outcomes:
measure: Static balance
timeFrame: 4 weeks
measure: Static balance
timeFrame: 4 weeks
measure: Static balance
timeFrame: 4 weeks
measure: Dynamic balance
timeFrame: 4 weeks
Secondary outcomes:
measure: Lower extremity muscle strength
timeFrame: 4 weeks
measure: Lower extremity muscle strength
timeFrame: 4 weeks
measure: Lower extremity muscle endurance
timeFrame: 4 weeks
measure: Lower extremity muscle endurance
timeFrame: 4 weeks
Other outcomes:
measure: Core stability
timeFrame: 4 weeks
measure: The flexor endurance test
timeFrame: 4 weeks
measure: The extensor endurance test
timeFrame: 4 weeks
measure: The side bridge test
timeFrame: 4 weeks
measure: Functional exercise capacity
timeFrame: 4 weeks
measure: Heart rate
timeFrame: 4 weeks
measure: Modified Borg scale
timeFrame: 4 weeks
measure: Blood pressure
timeFrame: 4 weeks
Locations:
city: Ankara
country: Turkey
facility: Ankara Yıldırım Beyazıt University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation Etlik, Ankara, Turkey, 06010
Study officials:
affiliation: Ankara Yıldırım Beyazıt University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation
name: Taskin Ozkan, doctorate
role: PRINCIPAL_INVESTIGATOR
References: