Structured Exercise Training in Newly Diagnosed Multiple Sclerosis

Sponsor

Istanbul University - Cerrahpasa (IUC) (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05957809

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

2.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Multiple Sclerosis	Other: Structured exercise training	N/A

Detailed Description

According to the data of the World Multiple Sclerosis (MS) atlas, the incidence of MS in our country is 51-100/100.000 and it is estimated that there are over 70.000 individuals with MS. MS continues to be the most common cause of non-traumatic neurological disability in young adults with its increasing prevalence in our country as well as all over the world. The most common problems seen in MS are deterioration of balance and postural control, decrease in muscle strength, gait problems, and cognitive and emotional functions. These effects become more visible in the later stages of the disease, but a limited number of studies reveal that there is an insidious progression from the early period. The topographical model of MS suggests that the burden of disease below the threshold is compensated by functional reserve, presents no physical problems, and symptoms become evident once the clinical threshold is crossed. Furthermore, the evidence suggests that disease activity may be continued even during the relapse-remitting phase of the disease course, highlighting the need for the use of sensitive outcome measures that can detect early disorders. Therefore, the involvement in individuals with newly diagnosed MS is ignored because it is not reflected in activities of daily living, is compensated by functional reserve because it is below the threshold value, and cannot be detected in the non-objective clinical neurological examination. Rehabilitation approaches for individuals with newly diagnosed MS are needed in order to benefit from the protective effects of exercise and to prevent the effects from progressing. Therefore, within the scope of our proposed project, 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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

48 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Health Services Research

Official Title:

The Effects of Structured Exercise Training on Disease Course in Newly Diagnosed Multiple Sclerosis

Anticipated Study Start Date :

Jul 20, 2023

Anticipated Primary Completion Date :

Feb 20, 2025

Anticipated Study Completion Date :

Jun 20, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1. Structured exercise group 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 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 minutes Aerobic exercise - 25 minutes Cool-down program - 10 minutes
No Intervention: 2. Control group This group will be assessed at the beginning, 8. and 24. weeks.

Arm

Intervention/Treatment

Experimental: 1. Structured exercise group

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

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 minutes Aerobic exercise - 25 minutes Cool-down program - 10 minutes

No Intervention: 2. Control group

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

Outcome Measures

Primary Outcome Measures

Clinical Test of Sensory Integration of Balance Test [24 weeks]
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.
Postural Stability Test [24 weeks]
Anterior-posterior, mediolateral and overall sway will be evaluated with the Postural Stability Test in Biodex Balance System.
Balance Error Scoring System Test [24 weeks]
Postural sway in tandem position and feet together position will be evaluated with Balance Error Scoring System in Biodex Balance System.
Muscle strength [24 weeks]
Quadriceps, hamstring, ankle dorsi and plantar flexors muscle strength will be assessed with Hand Held Dynamometer.

Secondary Outcome Measures

2 Minute Walk Test [Baseline, 8th and 24th weeks]
It will be used to evaluate walking speed.
Timed 25 Foot Walk Test [Baseline, 8th and 24th weeks]
It will be used to evaluate walking distance.
Brief International Cognitive Assessment for MS (BICAMS) [Baseline, 8th and 24th weeks]
BICAMS will be used to evaluate cognitive functions.
Curl-up [Baseline, 8th and 24th weeks]
It will be used to evaluate trunk flexor muscle strength. While the hips and knees are in 90º flexion position and the feet are fixed by the therapist, the individuals will be asked to flex their trunk and the number of repetitions done for 30 seconds will be recorded.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 45 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

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

Exclusion Criteria:

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