Exercise Training in Pediatric-Onset Multiple Sclerosis Patients

NCT04660227 | Completed

• 1 other identifier: IU-C2020-26
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Multiple sclerosis is one of the leading causes of disability in young adults. It is known that patients with pediatric onset multiple sclerosis (POMS) experience their first demyelinating attack before the age of 18. However, studies conducted with individuals with pediatric onset of multiple sclerosis have been reported to be few and have affected parameters such as physical activity, fatigue balance and quality of life. Therefore, this study is planned to consist of two stages. These are the following stages;

1. 1.Assessment of people with pediatric onset multiple sclerosis with the evaluation methods detailed below. After these evaluations, the relationship between the 6-minute walk test performance of the patients and other evaluations will be examined. Within the scope of the project, a publication will be prepared and uploaded with the data obtained from this stage.
2. 2.The patients are divided into two groups, one group is included in the online exercise program, and the other group is included in the exercise program after being put on the waiting list.

Conditions

Pediatric Multiple Sclerosis

Keywords

Physical Activity; Physiotherapy; Degenerative diseases; Exercise

Outcome Measures

Primary Outcomes (2)

• The Leisure-Time Exercise Questionnaire (The change between the initial value and the value after 2 months will be evaluated).

  It is a self-reported questionnaire with two questions that measures the physical activity behavior of the participants. In the first question, the frequencies of mild, moderate and intense physical activity performed for more than 15 minutes in a normal week are questioned. Weekly frequencies of light, moderate, and vigorous physical activities are multiplied by 3, 5 and 9 metabolic equivalents, respectively, and the sum of the results is recorded as total leisure activity. Second question seeks the frequency of activity that causes sweating in a normal week is questioned. Less than 14 scores means insufficiently active/sedentary, 14-23 scores means moderately active and 24 scores or more means active. So higher scores better outcomes.

  Baseline and end of weeks 8.

• One-Week Step Count Measurement with Pedometer for Physical Activity Assessment (The change between the initial value and the value after 2 months will be evaluated).

  It is one of the objective methods used to evaluate physical activity. It is used to record the number of steps taken. The estimated step length is entered into the device and recorded as a step when the vertical oscillation of the body exceeds a certain threshold value. In our study, the number of steps taken by the participants during a week before and after treatment will be calculated and recorded. Higher scores better outcomes.

  Baseline and end of weeks 8.

Secondary Outcomes (8)

• Evaluation of Isokinetic Muscle Strength of Quadriceps and Hamstring Muscles with Biodex Multi-Joint System (The change between the initial value and the value after 2 months will be evaluated).

  Baseline and end of weeks 8.

• Knee Joint Proprioception Assessment with Biodex Multi-Joint System (The change between the initial value and the value after 2 months will be evaluated).

  Baseline and end of weeks 8.

• Static and Dynamic Postural Stability Assessment with Biodex Balance System (The change between the initial value and the value after 2 months will be evaluated).

  Baseline and end of weeks 8.

• 6 Minute Walk Test (The change between the initial value and the value after 2 months will be evaluated).

  Baseline and end of weeks 8.

• Timed 25-Foot Walk (The change between the initial value and the value after 2 months will be evaluated).

  Baseline and end of weeks 8.

Study Arms (2)

Exercise Group

EXPERIMENTAL

Participants in the online exercise program group will be given a treatment protocol consisting of aerobic exercise and strengthening exercises in the presence of a physiotherapist for a total of 8 weeks, 2 days a week for 1 hour.

Procedure: Exercise Trainning

Control Group

OTHER

Participants in the control group will be put on the waiting list after all assessment methods have been applied and will be re-evaluated at the end of 8 weeks.

Other: Control Group

Interventions

Exercise Trainning PROCEDURE

Participants in the online exercise program group will be given a treatment protocol consisting of aerobic exercise and strengthening exercises in the presence of a physiotherapist for a total of 8 weeks, 2 days a week for 1 hour. Before starting the exercise, the risk of possible injury will be minimized by doing warm-up exercises and preparations will be made to start the exercise. Then, the exercise program will be started with aerobic exercise. Strengthening exercises will be planned for large muscle groups, targeting body parts such as hips, knees, shoulders, abdomen and trunk. In exercises, it is planned to do 2 sets of 10-15 repetitions using elastic band, free weights or body weight. The exercise program will be created according to the condition of the people and progression will be provided every 2 weeks. After the exercises are completed, cool down will be done with relaxation and stretching exercises.

Exercise Group

Control Group OTHER

Participants in the control group will be put on the waiting list after all assessment methods have been applied and will be re-evaluated at the end of 8 weeks. After the final evaluations, they will be directed to the exercise group.

Control Group

Eligibility Criteria

• Age: 15 Years - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Being diagnosed with pediatric onset multiple sclerosis
• EDSS \<6
• Having internet access

You may not qualify if:

• Having an orthopedic problem affecting its mobility
• Blurred vision problem
• Having another diagnosis in addition to the diagnosis of pediatric onset multiple sclerosis
• Having had an attack or received corticosteroid treatment 3 months before participating in the study

Sponsors & Collaborators

• Istanbul University - Cerrahpasa: lead

Study Sites (1)

Istanbul University-Cerrahpasa

Bakırköy, Istanbul, 34100, Turkey (Türkiye)

Location

Related Publications (19)

• Grover SA, Aubert-Broche B, Fetco D, Collins DL, Arnold DL, Finlayson M, Banwell BL, Motl RW, Yeh EA. Lower physical activity is associated with higher disease burden in pediatric multiple sclerosis. Neurology. 2015 Nov 10;85(19):1663-9. doi: 10.1212/WNL.0000000000001939. Epub 2015 Aug 12.

  PMID: 26268901 BACKGROUND

• Grover SA, Sawicki CP, Kinnett-Hopkins D, Finlayson M, Schneiderman JE, Banwell B, Till C, Motl RW, Yeh EA. Physical Activity and Its Correlates in Youth with Multiple Sclerosis. J Pediatr. 2016 Dec;179:197-203.e2. doi: 10.1016/j.jpeds.2016.08.104. Epub 2016 Oct 4.

  PMID: 27717498 BACKGROUND

• Sikes EM, Richardson EV, Motl RW. A Qualitative Study of Exercise and Physical Activity in Adolescents with Pediatric-Onset Multiple Sclerosis. Int J MS Care. 2019 Mar-Apr;21(2):81-91. doi: 10.7224/1537-2073.2018-033.

  PMID: 31049039 BACKGROUND

• Storm Van's Gravesande K, Blaschek A, Calabrese P, Rostasy K, Huppke P, Kessler J J, Kalbe E, Mall V; MUSICADO Study group. Fatigue and depression predict health-related quality of life in patients with pediatric-onset multiple sclerosis. Mult Scler Relat Disord. 2019 Nov;36:101368. doi: 10.1016/j.msard.2019.08.010. Epub 2019 Aug 9.

  PMID: 31557681 BACKGROUND

• Hebert D, Geisthardt C, Hoffman H. Insights and Recommendations From Parents Receiving a Diagnosis of Pediatric Multiple Sclerosis for Their Child. J Child Neurol. 2019 Jul;34(8):464-471. doi: 10.1177/0883073819842420. Epub 2019 Apr 23.

  PMID: 31012369 BACKGROUND

• Weikert M, Motl RW, Suh Y, McAuley E, Wynn D. Accelerometry in persons with multiple sclerosis: measurement of physical activity or walking mobility? J Neurol Sci. 2010 Mar 15;290(1-2):6-11. doi: 10.1016/j.jns.2009.12.021. Epub 2010 Jan 8.

  PMID: 20060544 BACKGROUND

• Warren JM, Ekelund U, Besson H, Mezzani A, Geladas N, Vanhees L; Experts Panel. Assessment of physical activity - a review of methodologies with reference to epidemiological research: a report of the exercise physiology section of the European Association of Cardiovascular Prevention and Rehabilitation. Eur J Cardiovasc Prev Rehabil. 2010 Apr;17(2):127-39. doi: 10.1097/HJR.0b013e32832ed875.

  PMID: 20215971 BACKGROUND

• Moghadasi A, Ghasemi G, Sadeghi-Demneh E, Etemadifar M. The Effect of Total Body Resistance Exercise on Mobility, Proprioception, and Muscle Strength of the Knee in People With Multiple Sclerosis. J Sport Rehabil. 2020 Feb 1;29(2):192-199. doi: 10.1123/jsr.2018-0303.

  PMID: 30676232 BACKGROUND

• Abdin MMN, Abdelazeim F, Elshennawy S. Immediate effect of induced fatigue of the unaffected limb on standing balance, proprioception and vestibular symptoms in children with hemiplegia. J Pediatr Rehabil Med. 2020;13(2):119-125. doi: 10.3233/PRM-180587.

  PMID: 32444572 BACKGROUND

• Greve JM, Cug M, Dulgeroglu D, Brech GC, Alonso AC. Relationship between anthropometric factors, gender, and balance under unstable conditions in young adults. Biomed Res Int. 2013;2013:850424. doi: 10.1155/2013/850424. Epub 2013 Jan 16.

  PMID: 23509788 BACKGROUND

• Soysal Tomruk M, Uz MZ, Kara B, Idiman E. Effects of Pilates exercises on sensory interaction, postural control and fatigue in patients with multiple sclerosis. Mult Scler Relat Disord. 2016 May;7:70-3. doi: 10.1016/j.msard.2016.03.008. Epub 2016 Mar 22.

  PMID: 27237762 BACKGROUND

• Paltamaa J, West H, Sarasoja T, Wikstrom J, Malkia E. Reliability of physical functioning measures in ambulatory subjects with MS. Physiother Res Int. 2005;10(2):93-109. doi: 10.1002/pri.30.

  PMID: 16146327 BACKGROUND

• Marrie RA, Goldman M. Validity of performance scales for disability assessment in multiple sclerosis. Mult Scler. 2007 Nov;13(9):1176-82. doi: 10.1177/1352458507078388. Epub 2007 Jul 10.

  PMID: 17623733 BACKGROUND

• Rampello A, Franceschini M, Piepoli M, Antenucci R, Lenti G, Olivieri D, Chetta A. Effect of aerobic training on walking capacity and maximal exercise tolerance in patients with multiple sclerosis: a randomized crossover controlled study. Phys Ther. 2007 May;87(5):545-55. doi: 10.2522/ptj.20060085. Epub 2007 Apr 3.

  PMID: 17405806 BACKGROUND

• Savci S, Inal-Ince D, Arikan H, Guclu-Gunduz A, Cetisli-Korkmaz N, Armutlu K, Karabudak R. Six-minute walk distance as a measure of functional exercise capacity in multiple sclerosis. Disabil Rehabil. 2005 Nov 30;27(22):1365-71. doi: 10.1080/09638280500164479.

  PMID: 16372431 BACKGROUND

• ATS Committee on Proficiency Standards for Clinical Pulmonary Function Laboratories. ATS statement: guidelines for the six-minute walk test. Am J Respir Crit Care Med. 2002 Jul 1;166(1):111-7. doi: 10.1164/ajrccm.166.1.at1102. No abstract available.

  PMID: 12091180 BACKGROUND

• Motl RW, Cohen JA, Benedict R, Phillips G, LaRocca N, Hudson LD, Rudick R; Multiple Sclerosis Outcome Assessments Consortium. Validity of the timed 25-foot walk as an ambulatory performance outcome measure for multiple sclerosis. Mult Scler. 2017 Apr;23(5):704-710. doi: 10.1177/1352458517690823. Epub 2017 Feb 16.

  PMID: 28206828 BACKGROUND

• Sönmez, S., & Başbakkal, Z. (2007). Türk Çocuklarının Pediatrik Yaşam Kalitesi 4. Envanterinin (PedsQL 4.) Geçerlilik ve Güvenilirlik Çalışması. Türkiye Klinikleri Pediatri Dergisi, 16(4), 229-237.

  BACKGROUND

• Krupp LB, LaRocca NG, Muir-Nash J, Steinberg AD. The fatigue severity scale. Application to patients with multiple sclerosis and systemic lupus erythematosus. Arch Neurol. 1989 Oct;46(10):1121-3. doi: 10.1001/archneur.1989.00520460115022.

  PMID: 2803071 BACKGROUND

MeSH Terms

Conditions

Motor Activity

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Pelin Vural

  Istanbul University-Cerrahpasa Institute of Postgraduate Education

  PRINCIPAL INVESTIGATOR

• Yonca Zenginler Yazgan, PhD

  Istanbul University-Cerrahpasa Faculty of Health Science

  STUDY CHAIR

• Sema Saltık, Prof. Dr.

  Istanbul University-Cerrahpasa Cerrahpasa Faculty of Medicine, Department of Pediatric Neurology

  STUDY CHAIR

• Serhat Güler, Assoc. Prof.

  Istanbul University-Cerrahpasa Cerrahpasa Faculty of Medicine Department of Pediatric Neurology

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 25, 2020
• First Posted: December 9, 2020
• Study Start: November 23, 2020
• Primary Completion: November 25, 2021
• Study Completion: January 1, 2022
• Last Updated: May 19, 2023

Record last verified: 2023-05

Locations

TU (1)