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

NCT ID: NCT04711993

Last Updated: 2022-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-02-17

Study Completion Date

2022-09-17

Brief Summary

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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.

Detailed Description

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Conditions

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Restless Legs Syndrome Anxiety Sleep

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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Control group

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Aerobic exercise group

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

Group Type EXPERIMENTAL

Aerobic exercise

Intervention Type 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".

Stretching exercise group

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

Group Type EXPERIMENTAL

Stretchin exercise

Intervention Type 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.

Interventions

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Aerobic exercise

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".

Intervention Type OTHER

Stretchin exercise

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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Gulhane School of Medicine

OTHER

Sponsor Role lead

Responsible Party

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Özge Çoban

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.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Gulhane Health Science Faculty

Ankara, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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2020-422.

Identifier Type: -

Identifier Source: org_study_id