Physical TherapyNCT05029700
The Effects of Trunk Stabilization and Aerobic Trainings in Multiple Sclerosis
A study testing Combined exercise training and Aerobic training in people with Physical Therapy, run by Ankara Yildirim Beyazıt University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Physical Therapy
- What is being tested?
- Combined exercise training and Aerobic training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2019to 1 Feb 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ankara Yıldırım Beyazıt University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation Etlik, Ankara, Turkey, 06010
Ankara
About this study
Official title: The Effect of Trunk Stabilization Training Combined With Aerobic Training on Neuromuscular Parameters and Functional Exercise Capacity in Patients With Multiple Sclerosis
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.
Read the 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
- Being tested
- Combined exercise training, Aerobic training
- Keywords
- balance, strength, endurance, stability, exercise
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combined exercise trainingOther
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 trainingOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Combined exercise group | Experimental | Combined training consists of trunk stabilization training and aerobic training. Receives: Other: Combined exercise training; Other: Aerobic training |
| Control group | Active comparator | Aerobic training was given to the control group. Receives: Other: Aerobic training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 4 weeks
Secondary outcomes (4)
Lower extremity muscle strength
The lower extremity muscle strength of the participants were determined by evaluating the strength of the knee flexor and extensor muscles at angular velocities of 60º/second and 180º/second. Evaluations were made using the Biodex System 4 (Biodex Corp, Shirley, NY, USA) isokinetic instrument. The tests were repeated on both the dominant and nondominant sides. As a result of the evaluations, peak torque value was obtained at angular velocities of 60º/second and 180º/second.
Measured: 4 weeks
Lower extremity muscle strength
The lower extremity muscle strength of the participants were determined by evaluating the strength of the knee flexor and extensor muscles at angular velocities of 60º/second and 180º/second. Evaluations were made using the Biodex System 4 (Biodex Corp, Shirley, NY, USA) isokinetic instrument. The tests were repeated on both the dominant and nondominant sides. As a result of the evaluations, peak torque/body weight value was obtained at angular velocities of 60º/second and 180º/second.
Measured: 4 weeks
Lower extremity muscle endurance
The lower extremity muscle endurance of the participants were determined by evaluating the endurance of the knee flexor and extensor muscles at angular velocities of 60º/second and 180º/second. Evaluations were made using the Biodex System 4 (Biodex Corp, Shirley, NY, USA) isokinetic instrument. The tests were repeated on both the dominant and nondominant sides. As a result of the evaluations, peak torque value was obtained at angular velocities of 60º/second and 180º/second.
Measured: 4 weeks
Lower extremity muscle endurance
The lower extremity muscle endurance of the participants were determined by evaluating the endurance of the knee flexor and extensor muscles at angular velocities of 60º/second and 180º/second. Evaluations were made using the Biodex System 4 (Biodex Corp, Shirley, NY, USA) isokinetic instrument. The tests were repeated on both the dominant and nondominant sides. As a result of the evaluations, peak torque/body weight value was obtained at angular velocities of 60º/second and 180º/second.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2021
- Study start1 Jun 2019
- Primary completion1 Dec 2020
- Study completion1 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Physical TherapyStudies of the same condition, open and under way.
- More trials run by Ankara Yildirim Beyazıt UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara Yildirim Beyazıt University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Taskin Ozkan, doctorate, Principal investigator, Ankara Yıldırım Beyazıt University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05029700
- Sponsor's protocol ID
- 2021-02-09
- Status last verified
- Aug 2021
- First submitted
- 8 Jul 2021
- Last updated
- 31 Aug 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Trunk Stabilization Training Combined With Aerobic Training on Neuromuscular Parameters and Functional Exercise Capacity in Patients With Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT05029700
- Acronym / sponsor ID
- 2021-02-09
- Conditions
- Physical Therapy
- Keywords
- balance, strength, endurance, stability, exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Ankara Yildirim Beyazıt UniversityUniversity, hospital or other
- Study start
- 1 Jun 2019 (actual)
- Primary completion
- 1 Dec 2020 (actual)
- Study completion
- 1 Feb 2021 (actual)
- First posted
- 31 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Combined exercise group | Experimental | Other: Combined exercise training, Other: Aerobic trainingCombined training consists of trunk stabilization training and aerobic training. |
| Control group | Active comparator | Other: Aerobic trainingAerobic training was given to the control group. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Combined exercise trainingCombined 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. | Other | Combined exercise group |
| Aerobic trainingControl 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. | Other | Combined exercise group, Control group |
Primary outcome
Static balance
Time frame: 4 weeks
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.
Static balance
Time frame: 4 weeks
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.
Static balance
Time frame: 4 weeks
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.
Dynamic balance
Time frame: 4 weeks
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 secondary outcomes
Lower extremity muscle strength
Time frame: 4 weeks
Lower extremity muscle strength
Time frame: 4 weeks
Lower extremity muscle endurance
Time frame: 4 weeks
Lower extremity muscle endurance
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2021.
- Individual participant dataSharing planned: Undecided
Related trials for Physical Therapy
Not yet recruiting
Feasibility of a Robot-Guided Active Play Intervention for Children With Cerebral Palsy
Cerebral Palsy
Enrolling by invitation
Online Exercise Program for Transplant Patients: A Pilot Study
Kidney Transplantation, Physical Function
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8
Not yet recruitingPhase 2
Alberta Cancer Exercise Dose in Colorectal Cancer
Cancer, Colorectal Cancer
Recruiting
Sensory Integration Therapy vs Conventional Physical Therapy in Children With Mixed Cerebral Palsy
Cerebral Palsy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Taskin Ozkan, doctorate principal investigator
Ankara Yıldırım Beyazıt University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Combined exercise training and Aerobic training in people with Physical Therapy, run by Ankara Yildirim Beyazıt University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Static balance (time frame: 4 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2021.