The Effects of Trunk Stabilization and Aerobic Trainings in Multiple Sclerosis

NCT05029700 | Completed

• 1 other identifier: 2021-02-09
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Physical Therapy

Keywords

balance; strength; endurance; stability; exercise

Outcome Measures

Primary Outcomes (4)

• Static balance

  Static balance was evaluated by Biodex Balance System SD™ (Biodex Medical Systems, Shirley, New York, USA). Postural Stability Test (PST) was used for static balance assessment of the participants. PST is assessed, while participants stand on both feet on the firm surface and with eyes open. In the start position, a dot is defined as a symbolic presentation of participants' center of feet pressure positioned in the center of the coordinate axes on the monitor screen. The participants targets on holding the dot at the center. PST provides overall postural stability index score. Lower scores indicated better performance.

  4 weeks

• Static balance

  Static balance was evaluated by Biodex Balance System SD™ (Biodex Medical Systems, Shirley, New York, USA). Postural Stability Test (PST) was used for static balance assessment of the participants. PST is assessed, while participants stand on both feet on the firm surface and with eyes open. In the start position, a dot is defined as a symbolic presentation of participants' center of feet pressure positioned in the center of the coordinate axes on the monitor screen. The participants targets on holding the dot at the center. PST provides anterior-posterior postural stability index score. Lower scores indicated better performance.

  4 weeks

• Static balance

  Static balance was evaluated by Biodex Balance System SD™ (Biodex Medical Systems, Shirley, New York, USA). Postural Stability Test (PST) was used for static balance assessment of the participants. PST is assessed, while participants stand on both feet on the firm surface and with eyes open. In the start position, a dot is defined as a symbolic presentation of participants' center of feet pressure positioned in the center of the coordinate axes on the monitor screen. The participants targets on holding the dot at the center. PST provides medial-lateral postural stability index scores. Lower scores indicated better performance.

  4 weeks

• Dynamic balance

  Dynamic balance was evaluated by Biodex Balance System SD™ (Biodex Medical Systems, Shirley, New York, USA). Limits of Stability (LOS) Test was used for dynamic balance assessment of the participants. LOS Test consists of standing on the platform and leaning in eight directions to make a cursor displayed on the system's screen hit a target. LOS Test provides overall direction control score. Higher scores indicated better performance

  4 weeks

Secondary Outcomes (4)

• Lower extremity muscle strength

  4 weeks

• Lower extremity muscle strength

  4 weeks

• Lower extremity muscle endurance

  4 weeks

• Lower extremity muscle endurance

  4 weeks

Other Outcomes (8)

• Core stability

  4 weeks

• The flexor endurance test

  4 weeks

• The extensor endurance test

  4 weeks

Study Arms (2)

Combined exercise group

EXPERIMENTAL

Combined training consists of trunk stabilization training and aerobic training.

Other: Combined exercise training; Other: Aerobic training

Control group

ACTIVE COMPARATOR

Aerobic training was given to the control group.

Other: Aerobic training

Interventions

Combined exercise training OTHER

Combined exercise group (CEG) performed 30 minutes of aerobic training and also received trunk stabilization training in about 30 minutes after a 10-minute resting period. CEG received treatment 2 times a week for 8 weeks. During trunk stabilization training, the participants were taught how to contract the transversus abdominis and multifidus muscles. Due to the progression protocol, endurance levels of trunk muscles were increased by holding each posture for longer periods. The training was started with theraband resistance, which could be repeated between 10-12 repetitions, and the repetition time was increased up to 20. Aerobic training (AT) was given using a treadmill. A heart rate monitor (Polar V800™, Finland) was used by each patient to follow heart rates during the AT. During AT, the target heart rate was calculated as 60-80% of maximum heart rates (MHR). Each exercise session consisted of a 5-minutes warm-up, 20 minutes of walking, and 5 minutes cool down on the treadmill.

Combined exercise group

Aerobic training OTHER

Control group (CG) performed 30 minutes of aerobic training.CG received treatment 2 times a week for 8 weeks. Aerobic training (AT) was given using a treadmill. A heart rate monitor (Polar V800™, Finland) was used by each patient to follow their heart rates during the AT. During AT, the target heart rate was calculated as 60-80% of maximum heart rates (MHR). Each exercise session consisted of a 5-minutes warm-up, 20 minutes of walking, and 5 minutes cool down on the treadmill.

Combined exercise group; Control group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ankara Yildirim Beyazıt University: lead

Study Sites (1)

Ankara Yıldırım Beyazıt University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation Etlik, Ankara, Turkey, 06010

Ankara, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Taskin Ozkan, doctorate

  Ankara Yıldırım Beyazıt University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2021
• First Posted: August 31, 2021
• Study Start: June 1, 2019
• Primary Completion: December 1, 2020
• Study Completion: February 1, 2021
• Last Updated: August 31, 2021

Record last verified: 2021-08

Locations

TU (1)