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Clinical Trials/NCT06210581
NCT06210581CompletedNot Applicable

Comparison of the Effects of Internet-Based and Supervised Exercise Programs in People With Multiple Sclerosis

Istanbul University - Cerrahpasa3 sites in 2 countries34 target enrollmentStarted: May 29, 2023Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
34
Locations
3
Primary Endpoint
2 Minutes Walk Test (2MWT) (The change between the initial value and the value after 2 months will be evaluated).

Study Overview

Brief Summary

The main aim of this study is resarch and compare the effects of supervised exercise programs and internet-based exercise programs, which have started to benefit from their effects in recent years, known for not requiring conditions such as transportation distance, cost and time, on motor disorders and quality of life in people with multiple sclerosis (MS). This study conducting for develop a new perspective on conventional physiotherapy and rehabilitation practices. Our study will be performed in people with MS with a high EDSS score, is seen as an important contribution for the literature.

Detailed Description

The groups were included in exercise programs of 16 sessions in total, twice a week for 8 weeks. Exercise programs will consist of warm-up, aerobic exercises, strengthening exercises, balance exercises, breathing exercises, cooling and relaxation exercises. Exercise programs will be created by the physiotherapist and arranged every 2 weeks according to the patients' conditions. Patients who do not participate in the program 2 times in a row will be excluded from the study.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None (Participant)

Masking Description

Statistical analyses were performed by a statistician blinded to group allocation.

Eligibility Criteria

Ages
18 Years to 65 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Diagnosed with MS by a neurologist
  • Being between ages of 18-65
  • Not having had an attack in the last 3 months
  • The score of Expanded Disability Status Scale (EDSS) is 5.5- 7.5
  • Not participating in a another physiotherapy and rehabilitation program
  • Having internet access

Exclusion Criteria

  • Pregnancy
  • Severe cognitive impairment that effects participating to rehabilitation
  • The cardiopulmonary disease that will prevent aerobic exercise
  • Having a major hearing and/or vision problem
  • Having a major speech disorder

Arms & Interventions

Group II

Other

Patients who are in the internet-based exercise program group will register cite ''https://www.telenororehab.com /'' which is web- based physiotherapy program for exercises.

Intervention: Internet Based Exercise Program Group (Other)

Group I

Experimental

The treatment sessions will be terminated by performing relaxation exercises combined with stretching and breathing exercises.

Intervention: Supervised Exercise Program Group (Other)

Outcomes

Primary Outcomes

2 Minutes Walk Test (2MWT) (The change between the initial value and the value after 2 months will be evaluated).

Time Frame: Baseline and end of weeks 8.

This test is performed for the assessment of walking endurance. The patient is informed about the test before starting the test. The distance that a person walks along a 25-meter corridor in 2 minutes is calculated in meters. During the test, patients who have tiredness and shortness of breath can have a rest.

Secondary Outcomes

  • Timed 25- Foot Walk (T25- FW) (The change between the initial value and the value after 2 months will be evaluated).(Baseline and end of weeks 8.)
  • Timed Get up and Go Test (TUG) (The change between the initial value and the value after 2 months will be evaluated).(Baseline and end of weeks 8.)
  • Modified Falls Efficacy Scale (MFES) (The change between the initial value and the value after 2 months will be evaluated).(Baseline and end of weeks 8.)
  • Multiple Sclerosis International Quality of Life Questionnaire (MusiQoL) (The change between the initial value and the value after 2 months will be evaluated).(Baseline and end of weeks 8.)
  • The Multiple Sclerosis Impact Scale (MSIS- 29) (The change between the initial value and the value after 2 months will be evaluated).(Baseline and end of weeks 8.)
  • 5 Times Sit to Stand Test (5TSTS) (The change between the initial value and the value after 2 months will be evaluated).(Baseline and end of weeks 8.)
  • Fatigue Severity Scale (FSS) (The change between the initial value and the value after 2 months will be evaluated).(Baseline and end of weeks 8.)
  • 12 Item MS Walking Scale (MSWS- 12) (The change between the initial value and the value after 2 months will be evaluated).(Baseline and end of weeks 8.)
  • Canadian Occupational Performance Measure (COPM) (The change between the initial value and the value after 2 months will be evaluated).(Baseline and end of weeks 8.)
  • Berg Balance Scale (BBS) (The change between the initial value and the value after 2 months will be evaluated).(Baseline and end of weeks 8.)

Investigators

Sponsor
Istanbul University - Cerrahpasa
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Tahire Basak Demir

Principal Investigator

Istanbul University - Cerrahpasa

Study Sites (3)

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