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Restless Legs SyndromeNCT04711993

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

A study testing Aerobic exercise and Stretchin exercise in people with Restless Legs Syndrome and Anxiety, run by Gulhane School of Medicine at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Restless Legs Syndrome, Anxiety, Sleep
What is being tested?
Aerobic exercise and Stretchin exercise
Could I receive a placebo?
No, everyone receives an active treatment
How many people
18 participants
Where
1 siteTurkey (Türkiye)
Study dates
17 Feb 2021to 17 Sep 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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
Show all 10Show fewer
  • Diagnosis of gastrointestinal disease (irritable bowel syndrome, Crohn's disease, ulcerative colitis etc.)
  • Pregnancy
  • History of psychiatric, psychoactive, antidepressant medication use
  • History of malignancy

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

  • Gulhane Health Science Faculty

    Ankara, 06018

Other trials in Turkey (Türkiye)

About this study

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.

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.

Being tested
Aerobic exercise, Stretchin exercise
Medical subject headings
Restless Legs Syndrome, Anxiety Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Aerobic exerciseOther

    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".

  • Stretchin exerciseOther

    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.

Study groups in NCT04711993
Study groupRoleWhat they receive
Control groupNo interventionNo 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 groupExperimentalPatients in the aerobic exercise group will exercise under the supervision of the therapist.
Receives: Other: Aerobic exercise
Stretching exercise groupExperimentalPatients in the stretching-mobility exercise group will do stretching exercises under the supervision of the therapist
Receives: Other: Stretchin exercise

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Before treatment, after treatment (end of 8 weeks)

  2. 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.

    Measured: Before treatment, after treatment (end of 8 weeks)

  3. 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

    Measured: Before treatment, after treatment (end of 8 weeks)

  4. 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.

    Measured: Before treatment, after treatment (end of 8 weeks)

Secondary outcomes (5)

  1. Change in Psychological status

    Psychological status of the patients will be evaluated with the Hospital Anxiety and Depression Scale. The scale has 14 items, 7 of which with odd numbers represent anxiety while the other 7 with even numbers represent depression. The scores range from 0 to 3 for each item and the maximum score in each sub-scale is 2. Higher scores means worse psychological status.

    Measured: Before treatment, after treatment (end of 8 weeks)

  2. Change in Quality of life in RLS

    Quality of life of the patients will be evaluated with the John Hopkins Restless Leg Syndrome Life Quality Questionnaire. It has 18 items. Ten of the items contribute to a single summary score, the overall life impact score. The remaining eight items concern employment (one question), sexual interest (two questions) and work (five questions).13 are scored on a 5-point scale which can be transformed to a 0-100 score, lower scores indicating worse quality of life. The remainder items are recorded as either a numerical value or a dichotomous response.

    Measured: Before treatment, after treatment (end of 8 weeks)

  3. Change in Fatigue

    Fatigue of the patients will be evaluated with the the Fatigue Severity Scale.The items are scored on a 7 point scale with 1 = strongly disagree and 7= strongly agree. The minimum score = 9 and maximum score possible = 63. Higher the score = greater fatigue severity.

    Measured: Before treatment, after treatment (end of 8 weeks)

  4. Change in Gastrointestinal symptoms

    Gastrointestinal symptoms of the patients will be evaluated with the Gastrointestinal Symptom Rating Scale.The GSRS is a 15-item 7-point Likert-type scale that evaluates how the individual feels in terms of GIS symptoms. It consists of five subcategories: abdominal pain, reflux, diarrhea, indigestion, and contipation. The 1st, 4th and 5th questions of the scale are about abdominal pain; 2. and 3. questions are about reflux; questions 11, 12 and 14 are about diarrhea; Questions 6, 7, 8, and 9 areabout indigestion; 10th, 13th and 15th questions are about constipation. Each item in the scale is valued between the statements of "no discomfort" and "very severe annoyance" and higher scores indicate that the symptoms are more severe.

    Measured: Before treatment, after treatment (end of 8 weeks)

  5. Change in Cognitive function

    Cognitive disfunction of the patients will be evaluated with the Cognitive Montreal Assessment Scale. Scores on the MoCA range from zero to 30, with a score of 26 and higher generally considered normal.

    Measured: Before treatment, after treatment (end of 8 weeks)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Jan 2021
  2. Study start17 Feb 2021
  3. Primary completion17 Aug 2022
  4. Study completion17 Sep 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Investigator
Enrolment
18 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04711993
Sponsor's protocol ID
2020-422.
Status last verified
Dec 2022
First submitted
11 Jan 2021
Last updated
19 Dec 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Aerobic exercise and Stretchin exercise in people with Restless Legs Syndrome and Anxiety, run by Gulhane School of Medicine at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Symptoms (time frame: Before treatment, after treatment (end of 8 weeks)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04711993.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2022; AzTrials last refreshed its copy on 7 Nov 2026.

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