Exergaming in Persons With Multiple Sclerosis With Restless Legs Syndrome

• ClinicalTrials.gov Identifier: NCT03878810
• Recruitment Status: Unknown
• First Posted: March 18, 2019
• Last Update Posted: October 8, 2019
• Sponsor: Dokuz Eylul University
• Information provided by (Responsible Party): Turhan Kahraman, Izmir Katip Celebi University

Study Description

Brief Summary:

In this studly, the effects of an 8-week videogame-based physical activity training in persons with multiple sclerosis will be investigated.

Condition or disease	Intervention/treatment	Phase
Multiple Sclerosis	Behavioral: Exergaming	Not Applicable

Detailed Description:

Multiple sclerosis is a chronic, progressive, and demyelinating disease of the central nervous system that affects more than 2.5 million people worldwide and is more common in young adults. The most common clinical signs and symptoms include fatigue, spasticity, cognitive impairment, chronic pain, depression, decreased quality of life, and bladder and bowel dysfunction.

Sleep disturbance is affecting more than 50% of persons with multiple sclerosis. Restless legs syndrome is one of the factors causing sleep disturbance in persons with multiple sclerosis. Studies have showed that the incidence of restless legs syndrome in persons with multiple sclerosis is about five times more than the general population.

In order to increase and maintain the quality of life of persons with multiple sclerosis, the disease-related progressive symptoms need to be managed. Therefore, persons with multiple sclerosis need long-term rehabilitation. This situation reduces the motivation of the people over time and makes the continuity of treatment difficult. Developments in rehabilitation technology aim to contribute to the treatment process as well as to increase the active participation of individuals with chronic diseases.

Current literature has shown that video-based physical activity training as non-pharmacological therapy may be an effective method for symptoms such as balance, walking, fatigue, cognitive functions in persons with multiple sclerosis, but the effects on restless legs syndrome are not known.

The main aim of the study is to investigate the effects of 8-week video game-based physical activity training in persons with multiple sclerosis with restless legs syndrome.

Persons who followed by the outpatient Multiple Sclerosis Clinic of Dokuz Eylül University Hospital will participate in the study. A total of 68 participants will randomly be divided into 4 groups as exergaming group and control group with restless legs syndrome, exergaming group and control group without restless legs syndrome.

A video game-based physical activity training will apply to exergaming groups by a physiotherapist for 2 days/week. The control groups will continue their routine treatment during the study. After the study, the treatment options will be offered to the participants. Assessments will done at baseline, after 8 weeks (post-treatment) and at 8 weeks (follow-up). Assessments will be done by assessors who are blinded to the group allocation.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 68 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Effects of Video Game-based Physical Activity Training in Persons With Multiple Sclerosis With Restless Legs Syndrome
• Actual Study Start Date: March 29, 2019
• Estimated Primary Completion Date: September 2020
• Estimated Study Completion Date: October 2020

Arms and Interventions

Arm	Intervention/treatment
Experimental: Exergaming, restless legs syndrome (+); A video game-based physical activity training will be applied under a physiotherapist supervision for 2 days/week for 8 weeks.	Behavioral: Exergaming; A video game-based physical activity training applied using a commercial game console.
Experimental: Exergaming, restless legs syndrome (-); A video game-based physical activity training will be applied under a physiotherapist supervision for 2 days/week for 8 weeks.	Behavioral: Exergaming; A video game-based physical activity training applied using a commercial game console.
No Intervention: Control, restless legs syndrome (+); No specific intervention.
No Intervention: Control, restless legs syndrome (-); No specific intervention.

Outcome Measures

Primary Outcome Measures :

1. International Restless Legs Syndrome Study Group rating scale for restless legs syndrome [ Time Frame: Change from Baseline at 8 and 16 weeks ]
   The International Restless Legs Syndrome Study Group rating scale for restless legs syndrome is used to assess severity of the restless legs syndrome symptoms. It consists of 10 items scored by 0 to 4. Possible scores range from 0 to 40. Higher scores indicate higher severity.

Secondary Outcome Measures :

1. Timed 25-Foot Walk [ Time Frame: Change from Baseline at 8 and 16 weeks ]
   The Timed 25-Foot Walk is a quantitative mobility and leg function performance test based on a timed 25-walk. he patient is directed to one end of a clearly marked 25-foot course and is instructed to walk 25 feet as quickly as possible, but safely. The time is calculated from the initiation of the instruction to start and ends when the patient has reached the 25-foot mark. The task is immediately administered again by having the patient walk back the same distance. Patients may use assistive devices when doing this task. The score is the average of the two completed trials. Higher time represents slower walking speed and more walking impairment.
2. 12-Item Multiple sclerosis walking scale [ Time Frame: Change from Baseline at 8 and 16 weeks ]
   The 12-Item Multiple sclerosis walking scale is a self-assessment scale which measures the impact of multiple sclerosis on walking. It consists of 12 questions with Likert-type choose options concerning the limitations to walking due to multiple sclerosis during the past 2 weeks. Total score ranges 0 from 100. Higher scores indicate more impact of multiple sclerosis on walking.
3. Modified Fatigue Impact Scale [ Time Frame: Change from Baseline at 8 and 16 weeks ]
   The Modified Fatigue Impact Scale provides an assessment of the effects of fatigue in terms of physical, cognitive, and psychosocial functioning. The scale consists of 21 items with a Likert-type choose options. The total score for the scale is the sum of the scores for the 21 items. Individual subscale scores for physical, cognitive, and psychosocial functioning can also be generated by calculating the sum of specific sets of items. The total score ranges from 0 to 84. Higher score indicates higher level of fatigue.
4. Timed Up and Go test [ Time Frame: Change from Baseline at 8 and 16 weeks ]
   The Timed Up and Go test is a simple test used to assess a person's mobility and requires both static and dynamic balance. It uses the time that a person takes to rise from a chair, walk three meters, turn around, walk back to the chair, and sit down. During the test, the person is expected to wear their regular footwear and use any mobility aids that they would normally require. The time is calculated from the initiation of the instruction to start and ends when the patient has sit down. Higher time represents more static and dynamic balance and mobility impairment.
5. 6-Minute Walk Test [ Time Frame: Change from Baseline at 8 and 16 weeks ]
   The 6-Minute Walk Test is a submaximal exercise test that entails measurement of distance walked over a span of 6 minutes. The goal is for the individual to walk as far and fast as possible in 6 minutes. The total distance is recorded. Higher distance represents a better submaximal exercise capacity.
6. Epworth Sleepiness Scale [ Time Frame: Change from Baseline at 8 and 16 weeks ]
   The Epworth Sleepiness Scale is a self-administered questionnaire with 8 questions. Respondents are asked to rate, on a 4-point scale (0-3), their usual chances of dozing off or falling asleep while engaged in eight different activities. The score (the sum of 8 item scores, 0-3) can range from 0 to 24. The higher the score, the higher that person's average sleep propensity in daily life, or their 'daytime sleepiness'.
7. Godin Leisure Time Exercise Questionnaire [ Time Frame: Change from Baseline at 8 and 16 weeks ]
   The Godin Leisure Time Exercise Questionnaire is a commonly used questionnaire to measure of usual physical activity in persons with multiple sclerosis. It contains three items that measure the frequency of strenuous, moderate, and mild physical activities for periods of more than 15 minutes during one's free time within a typical week. Weekly frequencies of strenuous, moderate and mild physical activity were multiplied by 9, 5 and 3 metabolic equivalents, respectively, and were summed to form a measure of the total leisure physical activity. Higher scores indicate higher level of physical activity.
8. Hospital Anxiety And Depression Scale - Anxiety [ Time Frame: Change from Baseline at 8 and 16 weeks ]
   The scale aims to measure symptoms of generalized anxiety disorder and consists of 7 items, seven items. Each item is scored on a response-scale with four alternatives ranging between 0 and 3. Higher scores indicate higher symptoms.
9. Hospital Anxiety And Depression Scale - Depression [ Time Frame: Change from Baseline at 8 and 16 weeks ]
   The scale aims to measure symptoms of depression and consists of 7 items, seven items. Each item is scored on a response-scale with four alternatives ranging between 0 and 3. Higher scores indicate higher symptoms.
10. Multiple Sclerosis International Quality of Life questionnaire [ Time Frame: Change from Baseline at 8 and 16 weeks ]
    The Multiple Sclerosis International Quality of Life questionnaire is a disease-specific, self-administered, multidimensional questionnaire, was co-developed and initially validated in 15 countries including Turkey. The questionnaire comprises 31 questions in 9 subscales: activities of daily living, psychological well-being, symptoms, relationships with friends, relationships with family, sentimental and sexual life, coping, rejection, and relationships with healthcare system. All 9 dimensions and the index score were linearly transformed and standardized on a 0-100 scale, where 0 indicates the worst possible level of quality of life and 100 indicates the best level.
11. Multiple Sclerosis-Related Symptom Checklist [ Time Frame: Change from Baseline at 8 and 16 weeks ]
    Multiple Sclerosis-Related Symptom Checklist has 26 items that consist 5 subsections and 2 independent items. Sub-sections evaluate motor (7 items), brainstem (4 items), sensory (4 items), neuropsychiatric problems (3 items) and excretory problems (6 items). Independent items are related with fatigue and sleep difficulty. Responses are in the form of a 6-point Likert scale (None: 0, almost no: 1, sometimes: 2, usually: 3, almost always: 4, always: 5). The minimum score that can be taken from the scale is 0, the maximum score is 130, and the high score shows an increased symptom load.

Other Outcome Measures:

1. Restless Legs Syndrome Diagnostic Criteria [ Time Frame: At Baseline ]
   Diagnostic Criteria for Restless Legs Syndrome was developed by the Restless Legs Syndrome Working Group in 1995 and revised in 2003 and 2014. These criteria include; the need to move the legs due to uncomfortable or unpleasant sensations in the legs, the need for movement or disturbing sensations start or worsen at rest, the need for movement or disturbing sensations can be partially or totally relieved by movements such as walking or stretching, the need for movement or disturbing sensations may worsen at night or only occur in the evening or night, The aforementioned features cannot be considered only in relation to primary symptoms or other medical or behavioral conditions (e.g., myalgia, venous stasis, leg edema, leg cramps, habitual foot swing). Patients meeting all of the criteria are diagnosed with restless legs syndrome. The restless legs syndrome diagnosis will be confirmed by a neurologist.
2. Expanded Disability Status Scale [ Time Frame: At Baseline ]
   The Expanded Disability Status Scale is a method of quantifying disability in multiple sclerosis. The scale is based on a neurological examination by a clinician. It has steps from 0 to 10. The higher scores indicate higher neurological disability.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 65 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• A relapsing-remitting or secondary progressive type of multiple sclerosis,
• Being able to walk at least 100 meters without resting,
• Being able to stably stand for half an hour,
• To be willing to participate in the study.

Exclusion Criteria:

• Another neurological disorder,
• Relapse during the study period,
• Orthopedic surgery history including the ankle-foot, knee, hip, or spine, affecting balance,
• Diagnosed severe cognitive and/or psychiatric impairment

Contacts and Locations

Contacts

Contact: Turhan Kahraman, PhD; +905557219849; turhan.kahraman@yahoo.com

Locations

Turkey

MS Outpatient Clinic, Dokuz Eylul University Hospital; Recruiting

Izmir, Turkey, 35430

Contact: Serkan Ozakbas, MD +902324124064 ext 4064 serkan.ozakbas@deu.edu.tr

Sub-Investigator: Asiye Tuba Ozdogar, MSc

Sub-Investigator: Ozge Ertekin, PhD

Sub-Investigator: Zuhal Abasiyanik, MSc

Sponsors and Collaborators

Dokuz Eylul University

Investigators

• Study Director: Serkan Ozakbas, MD; Izmir Katip Celebi University

More Information

• Responsible Party: Turhan Kahraman, Principal Investigator, Izmir Katip Celebi University
• ClinicalTrials.gov Identifier: NCT03878810
• Other Study ID Numbers: 2019/01-138
• First Posted: March 18, 2019
• Last Update Posted: October 8, 2019
• Last Verified: October 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Multiple Sclerosis; Restless Legs Syndrome; Sclerosis; Pathologic Processes; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Parasomnias; Mental Disorders