Investigation of the Effects of Different Exercise Programs in Patients With Restless Legs Syndrome.

NCT04711993 | Completed

• 1 other identifier: 2020-422.
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Restless Legs Syndrome; Anxiety; Sleep

Outcome Measures

Primary Outcomes (4)

• Change in Symptoms

  The severity of the symptoms of the patients will be evaluated with the International Restless Legs Syndrome Study Group Rating Scale. It is a 10-item questionnaire developed through expert evaluation of potential items. Scoring varies between 0-40. The higher the score indicates higher symptoms.

  Before treatment, after treatment (end of 8 weeks)

• Change in Sleep

  the patient will be asked to sleep by wearing watches that detect movement (movement watch) for 3 nights, one of which is fixed on the metatarsal and the other is fixed on the wrist. While the objective test of sleep is performed with the software compatible with the wrist watch, periodic extremity movements will be recorded with the software compatible with the other watch.

  Before treatment, after treatment (end of 8 weeks)

• Change in Sleepiness

  Epworth Sleepiness Scale(ESS) will be used. Its score (the sum of 8 item scores, 0-3) can range from 0 to 24. The higher the ESS score, the higher that person's average sleep propensity in daily life (ASP), or their 'daytime

  Before treatment, after treatment (end of 8 weeks)

• Change in Sleep Quality

  Pittsburgh Sleep Quality Index will be used.Pittsburgh Sleep Quality Index scale has seven sub-scales that portray various domains of sleep: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleep medication, and daytime dysfunction. Responses for each subscale are scored as 0-3. Having a global score of 5 or higher indicates bad sleep quality. sleepiness.

  Before treatment, after treatment (end of 8 weeks)

Secondary Outcomes (5)

• Change in Psychological status

  Before treatment, after treatment (end of 8 weeks)

• Change in Quality of life in RLS

  Before treatment, after treatment (end of 8 weeks)

• Change in Fatigue

  Before treatment, after treatment (end of 8 weeks)

• Change in Gastrointestinal symptoms

  Before treatment, after treatment (end of 8 weeks)

• Change in Cognitive function

  Before treatment, after treatment (end of 8 weeks)

Study Arms (3)

Control group

NO INTERVENTION

No application will be made to the control group. However, these patients will be included in the exercise program they want after the 8-week treatment period is completed.

Aerobic exercise group

EXPERIMENTAL

Patients in the aerobic exercise group will exercise under the supervision of the therapist.

Other: Aerobic exercise

Stretching exercise group

EXPERIMENTAL

Patients in the stretching-mobility exercise group will do stretching exercises under the supervision of the therapist

Other: Stretchin exercise

Interventions

Aerobic exercise OTHER

Patients will do aerobic exercise three days a week for 40 minutes during 8 weeks. Aerobic exercise protocol will consist of warm up, loading and cooling periods. . Exercise prescription will be prepared in line with the recommendations of "The American College of Sports Medicine".

Aerobic exercise group

Stretchin exercise OTHER

Patients will do stretching exercise three days a week for 40 minutes during 8 weeks. Stretching exercises will start with active warm-up activities. Static stretching method will be used.

Stretching exercise group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Gulhane School of Medicine: lead

Study Sites (1)

Gulhane Health Science Faculty

Ankara, 06018, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Restless Legs Syndrome; Anxiety Disorders

Interventions

Exercise

Condition Hierarchy (Ancestors)

Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Parasomnias; Mental Disorders

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI 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 Record Dates

• First Submitted: January 11, 2021
• First Posted: January 15, 2021
• Study Start: February 17, 2021
• Primary Completion: August 17, 2022
• Study Completion: September 17, 2022
• Last Updated: December 19, 2022

Record last verified: 2022-12

Locations

TU (1)