Clinical trial NCT04711993: Investigation of the Effects of Different Exercise Programs in Patients With Restless Legs Syndrome.
Official title: Investigation of the Effects of Different Exercise Programs on Symptoms, Sleep, Cognitive Functions, Fatigue, Quality of Life, and Psychological Status in Patients With Restless Legs Syndrome.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Restless Legs Syndrome
Anxiety
Sleep
Lead sponsor: Gulhane School of Medicine
Sponsor class: OTHER
First posted: 2021-01-15
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Restless leg syndrome (RLS) is a very common neurological condition characterized by an uncontrollable desire to move the legs. Due to the traumatic effect of RLS on morbidity, the patient is negatively affected in many different directions. The duration and quality of sleep of the patients decrease, and their cognitive functions change. The prevalence or risk of anxiety and depression increases in this population. At the same time, the quality of life of patients is significantly reduced. Among the different pharmacological agents used in RLS, dopamine agonists are the most widely used. However, the reporting of serious and common side effects related to this treatment has led to non-pharmacological approaches in the treatment of RLS and the effectiveness of many different approaches has been investigated. The exercise approach, which is determined to be effective in the treatment of the disease, is a subject that has been little studied. The type, duration and frequency of optimal exercise could not be standardized. In addition, the effect of exercise on RLS patients has been investigated in limited subjects. For this reason, the aim of our study is to examine the effect of different exercise programs on symptoms, sleep, cognitive functions, quality of life, psychological status and fatigue in patients with RLS.


Eligibility criteria: Inclusion Criteria:

* Having been diagnosed with RLS according to the International Restless Legs Syndrome Study Group 2014 criteria
* Being over the age of 18
* Being literate
* Not having received any treatment for RLS, discontinuing treatment, or continuing symptoms despite current treatment.

Exclusion Criteria:

* Having any of musculoskeletal disorders that prevent physical activity
* History of ischemic heart disease (recent myocardial infarction or unstable angina, uncontrolled hypertension)
* Liver dysfunction
* Kidney dysfunction
* Anemia
* Diagnosis of another sleep disorder
* Diagnosis of gastrointestinal disease (irritable bowel syndrome, Crohn's disease, ulcerative colitis etc.)
* Pregnancy
* History of psychiatric, psychoactive, antidepressant medication use
* History of malignancy

Primary outcomes:
measure: Change in Symptoms
timeFrame: Before treatment, after treatment (end of 8 weeks)
measure: Change in Sleep
timeFrame: Before treatment, after treatment (end of 8 weeks)
measure: Change in Sleepiness
timeFrame: Before treatment, after treatment (end of 8 weeks)
measure: Change in Sleep Quality
timeFrame: Before treatment, after treatment (end of 8 weeks)
Secondary outcomes:
measure: Change in Psychological status
timeFrame: Before treatment, after treatment (end of 8 weeks)
measure: Change in Quality of life in RLS
timeFrame: Before treatment, after treatment (end of 8 weeks)
measure: Change in Fatigue
timeFrame: Before treatment, after treatment (end of 8 weeks)
measure: Change in Gastrointestinal symptoms
timeFrame: Before treatment, after treatment (end of 8 weeks)
measure: Change in Cognitive function
timeFrame: Before treatment, after treatment (end of 8 weeks)
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Gulhane Health Science Faculty
Study officials:
References: