Clinical trial NCT06210581: The Effects of Internet-Based and Supervised Exercise Programs in People With Multiple Sclerosis
Official title: Comparison of the Effects of Internet-Based and Supervised Exercise Programs in People With Multiple Sclerosis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Multiple Sclerosis
Keywords: Balance
Multiple Sclerosis
Exercise
Lead sponsor: Istanbul University - Cerrahpasa
Sponsor class: OTHER
First posted: 2024-01-18
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: 2 Minutes Walk Test (2MWT) (The change between the initial value and the value after 2 months will be evaluated).
timeFrame: Baseline and end of weeks 8.
Secondary outcomes:
measure: Fatigue Severity Scale (FSS) (The change between the initial value and the value after 2 months will be evaluated).
timeFrame: Baseline and end of weeks 8.
measure: 12 Item MS Walking Scale (MSWS- 12) (The change between the initial value and the value after 2 months will be evaluated).
timeFrame: Baseline and end of weeks 8.
measure: Modified Falls Efficacy Scale (MFES) (The change between the initial value and the value after 2 months will be evaluated).
timeFrame: Baseline and end of weeks 8.
measure: Canadian Occupational Performance Measure (COPM) (The change between the initial value and the value after 2 months will be evaluated).
timeFrame: Baseline and end of weeks 8.
measure: Multiple Sclerosis International Quality of Life Questionnaire (MusiQoL) (The change between the initial value and the value after 2 months will be evaluated).
timeFrame: Baseline and end of weeks 8.
measure: The Multiple Sclerosis Impact Scale (MSIS- 29) (The change between the initial value and the value after 2 months will be evaluated).
timeFrame: Baseline and end of weeks 8.
measure: Berg Balance Scale (BBS) (The change between the initial value and the value after 2 months will be evaluated).
timeFrame: Baseline and end of weeks 8.
measure: 5 Times Sit to Stand Test (5TSTS) (The change between the initial value and the value after 2 months will be evaluated).
timeFrame: Baseline and end of weeks 8.
measure: Timed 25- Foot Walk (T25- FW) (The change between the initial value and the value after 2 months will be evaluated).
timeFrame: Baseline and end of weeks 8.
measure: Timed Get up and Go Test (TUG) (The change between the initial value and the value after 2 months will be evaluated).
timeFrame: Baseline and end of weeks 8.
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul University- Cerrahpasa
Study officials:
affiliation: Istanbul University-Cerrahpasa Faculty of Health Science
name: Yonca ZENGINLER YAZGAN
role: STUDY_CHAIR
affiliation: Istanbul University Faculty of Medicine Department of Neurology
name: Murat KURTUNCU
role: STUDY_CHAIR
References: