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Structured Exercise Training in Newly Diagnosed Multiple Sclerosis

Primary Purpose

Multiple Sclerosis

Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Structured exercise training
Sponsored by
Istanbul University - Cerrahpasa (IUC)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Multiple Sclerosis focused on measuring Multiple sclerosis, newly diagnosis, exercise, postural sway, cognition

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Feray GüngörRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

1. Structured exercise group

2. Control group

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.
Postural Stability Test
Anterior-posterior, mediolateral and overall sway will be evaluated with the Postural Stability Test in Biodex Balance System.
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.
Muscle strength
Quadriceps, hamstring, ankle dorsi and plantar flexors muscle strength will be assessed with Hand Held Dynamometer.

Secondary Outcome Measures

2 Minute Walk Test
It will be used to evaluate walking speed.
Timed 25 Foot Walk Test
It will be used to evaluate walking distance.
Brief International Cognitive Assessment for MS (BICAMS)
BICAMS will be used to evaluate cognitive functions.
Curl-up
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.

Full Information

First Posted
June 20, 2023
Last Updated
September 8, 2023
Sponsor
Istanbul University - Cerrahpasa (IUC)
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1. Study Identification

Unique Protocol Identification Number
NCT05957809
Brief Title
Structured Exercise Training in Newly Diagnosed Multiple Sclerosis
Official Title
The Effects of Structured Exercise Training on Disease Course in Newly Diagnosed Multiple Sclerosis
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 20, 2023 (Actual)
Primary Completion Date
February 20, 2025 (Anticipated)
Study Completion Date
June 20, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istanbul University - Cerrahpasa (IUC)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis
Keywords
Multiple sclerosis, newly diagnosis, exercise, postural sway, cognition

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
48 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1. Structured exercise group
Arm Type
Experimental
Arm Description
This group will receive structured exercise training with 60-75 minute sessions per day, 2 days a week, for 8 weeks.
Arm Title
2. Control group
Arm Type
No Intervention
Arm Description
This group will be assessed at the beginning, 8. and 24. weeks.
Intervention Type
Other
Intervention Name(s)
Structured exercise training
Intervention Description
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
Primary Outcome Measure Information:
Title
Clinical Test of Sensory Integration of Balance Test
Description
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.
Time Frame
24 weeks
Title
Postural Stability Test
Description
Anterior-posterior, mediolateral and overall sway will be evaluated with the Postural Stability Test in Biodex Balance System.
Time Frame
24 weeks
Title
Balance Error Scoring System Test
Description
Postural sway in tandem position and feet together position will be evaluated with Balance Error Scoring System in Biodex Balance System.
Time Frame
24 weeks
Title
Muscle strength
Description
Quadriceps, hamstring, ankle dorsi and plantar flexors muscle strength will be assessed with Hand Held Dynamometer.
Time Frame
24 weeks
Secondary Outcome Measure Information:
Title
2 Minute Walk Test
Description
It will be used to evaluate walking speed.
Time Frame
Baseline, 8th and 24th weeks
Title
Timed 25 Foot Walk Test
Description
It will be used to evaluate walking distance.
Time Frame
Baseline, 8th and 24th weeks
Title
Brief International Cognitive Assessment for MS (BICAMS)
Description
BICAMS will be used to evaluate cognitive functions.
Time Frame
Baseline, 8th and 24th weeks
Title
Curl-up
Description
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.
Time Frame
Baseline, 8th and 24th weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Feray Güngör, MSc
Phone
02124141500
Email
feray.gungorr@gmail.com
Facility Information:
Facility Name
Feray Güngör
City
Istanbul
ZIP/Postal Code
34147
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Feray Güngör
Phone
02124141500
Email
feray.gungorr@gmail.com

12. IPD Sharing Statement

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Structured Exercise Training in Newly Diagnosed Multiple Sclerosis

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