The Effects of Trunk Stabilization and Aerobic Trainings in Multiple Sclerosis

NCT ID: NCT05029700

Last Updated: 2021-08-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-06-01
• Study Completion Date: 2021-02-01

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.

Conditions

Physical Therapy

Keywords

balance; strength; endurance; stability; exercise

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Combined exercise group

Combined training consists of trunk stabilization training and aerobic training.

Group Type: EXPERIMENTAL

Combined exercise training

Intervention Type: 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.

Aerobic training

Intervention Type: 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.

Control group

Aerobic training was given to the control group.

Group Type: ACTIVE_COMPARATOR

Aerobic training

Intervention Type: 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.

Interventions

Combined exercise training

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.

Intervention Type: OTHER

Aerobic training

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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ankara Yildirim Beyazıt University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Taskin Ozkan, doctorate

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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

Ankara, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

2021-02-09

Identifier Type: -

Identifier Source: org_study_id