Structured Exercise Training in Newly Diagnosed Multiple Sclerosis

NCT05957809 | Completed

• 1 other identifier: 2023/68
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

Brief Summary

the effectiveness of structured exercise training will be investigated for individuals with MS who are newly diagnosed and have no clinical problems. Individuals with MS included in the study will be randomly divided into two groups a Structured Exercise Group (SEG) and a Control Group (CG). In order to compare baseline and follow-up data, the Healthy Group (HG) will be taken and all three groups will be evaluated initially, 8. weeks and 24. weeks with primary and secondary outcome measurements. SEG, CG, and HG will be evaluated initially for postural sway, muscle strength, mobility, dexterity, cognitive function, trunk strength-endurance, and fatigue. Afterward, SEG will receive structured exercise training consisting of clinically supervised aerobic exercise and resistance training on unstable surfaces for 8 weeks, 2 days a week, with a minimum session duration of 60 minutes. Stretching and mobility exercises will be added to warm up and cool down before and after the program. CG will be on the waiting list during this process. At the end of 8 weeks, both groups will be reassessed with their initial assessment. After the 8-week program, the SEG physical activity recommendation will be given and the KG group will continue on the waiting list, and a follow-up evaluation will be made in the 24th week. This study will allow the comparison of newly diagnosed individuals with MS who do not have any physical or cognitive effects on neurological examination and healthy controls with objective and detailed evaluations, and will also reveal the evidence on the effects of planned structured exercises specific to individuals with newly diagnosed MS. During the 24-week follow-up period, the change in the clinical status of individuals with MS who received or did not receive any exercise training can be interpreted.

Conditions

Multiple Sclerosis

Keywords

Multiple sclerosis; newly diagnosis; exercise; postural sway; cognition

Outcome Measures

Primary Outcomes (4)

• Clinical Test of Sensory Integration of Balance Test

  Postural sway in "open eyes-firm surface, closed eyes-firm surface, open eyes-foam surface, closed eyes-foam surface" conditions will be evaluated with the Clinical Test of Sensory Integration of Balance.

  24 weeks

• Postural Stability Test

  Anterior-posterior, mediolateral and overall sway will be evaluated with the Postural Stability Test in Biodex Balance System.

  24 weeks

• Balance Error Scoring System Test

  Postural sway in tandem position and feet together position will be evaluated with Balance Error Scoring System in Biodex Balance System.

  24 weeks

• Muscle strength

  Quadriceps, hamstring, ankle dorsi and plantar flexors muscle strength will be assessed with Hand Held Dynamometer.

  24 weeks

Secondary Outcomes (4)

• 2 Minute Walk Test

  Baseline, 8th and 24th weeks

• Timed 25 Foot Walk Test

  Baseline, 8th and 24th weeks

• Brief International Cognitive Assessment for MS (BICAMS)

  Baseline, 8th and 24th weeks

• Curl-up

  Baseline, 8th and 24th weeks

Study Arms (2)

1. Structured exercise group

EXPERIMENTAL

This group will receive structured exercise training with 60-75 minute sessions per day, 2 days a week, for 8 weeks.

Other: Structured exercise training

2. Control group

NO INTERVENTION

This group will be assessed at the beginning, 8. and 24. weeks.

Interventions

Structured exercise training OTHER

This group will receive structured exercise training with 60-75 minute sessions per day, 2 days a week, for 8 weeks. • Warm-up program - 10 minutes * Strength training on unstable surfaces - 25-30 minutes * High repetition muscular endurance training - 25-30 minutes * Cool-down program - 10 minutes

1. Structured exercise group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Being diagnosed with MS according to McDonald diagnostic criteria
• EDSS below 2.5
• Diagnosis period less than 1 year
• Being between the ages of 18-45
• Volunteering to participate in the study

You may not qualify if:

• Apart from the MS diagnosis, orthopedic, neurological, psychological, etc., which will affect the evaluation results. have diseases
• Regular exercise and doing sports
• Being involved in another rehabilitation program
• Being pregnant

Sponsors & Collaborators

• Istanbul University - Cerrahpasa: lead

Study Sites (1)

Feray Güngör

Istanbul, 34147, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Multiple Sclerosis; Motor Activity

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Behavior

Study Design

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

Study Record Dates

• First Submitted: June 20, 2023
• First Posted: July 24, 2023
• Study Start: July 20, 2023
• Primary Completion: March 20, 2025
• Study Completion: May 20, 2025
• Last Updated: May 25, 2025

Record last verified: 2025-05

Locations

TU (1)