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

Primary Purpose

Restless Legs Syndrome, Anxiety, Sleep

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Aerobic exercise
Stretchin exercise
Sponsored by
Gulhane School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Restless Legs Syndrome

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Gulhane Health Science Faculty

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Experimental

Experimental

Arm Label

Control group

Aerobic exercise group

Stretching exercise group

Arm Description

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.

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

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

Outcomes

Primary Outcome Measures

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.
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.
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
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.

Secondary Outcome Measures

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.
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.
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.
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.
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.

Full Information

First Posted
January 11, 2021
Last Updated
December 15, 2022
Sponsor
Gulhane School of Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT04711993
Brief Title
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

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
February 17, 2021 (Actual)
Primary Completion Date
August 17, 2022 (Actual)
Study Completion Date
September 17, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Gulhane School of Medicine

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Restless Legs Syndrome, Anxiety, Sleep

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
18 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control group
Arm Type
No Intervention
Arm Description
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.
Arm Title
Aerobic exercise group
Arm Type
Experimental
Arm Description
Patients in the aerobic exercise group will exercise under the supervision of the therapist.
Arm Title
Stretching exercise group
Arm Type
Experimental
Arm Description
Patients in the stretching-mobility exercise group will do stretching exercises under the supervision of the therapist
Intervention Type
Other
Intervention Name(s)
Aerobic exercise
Intervention Description
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
Intervention Name(s)
Stretchin exercise
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Symptoms
Description
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.
Time Frame
Before treatment, after treatment (end of 8 weeks)
Title
Change in Sleep
Description
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.
Time Frame
Before treatment, after treatment (end of 8 weeks)
Title
Change in Sleepiness
Description
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
Time Frame
Before treatment, after treatment (end of 8 weeks)
Title
Change in Sleep Quality
Description
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.
Time Frame
Before treatment, after treatment (end of 8 weeks)
Secondary Outcome Measure Information:
Title
Change in Psychological status
Description
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.
Time Frame
Before treatment, after treatment (end of 8 weeks)
Title
Change in Quality of life in RLS
Description
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.
Time Frame
Before treatment, after treatment (end of 8 weeks)
Title
Change in Fatigue
Description
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.
Time Frame
Before treatment, after treatment (end of 8 weeks)
Title
Change in Gastrointestinal symptoms
Description
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.
Time Frame
Before treatment, after treatment (end of 8 weeks)
Title
Change in Cognitive function
Description
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.
Time Frame
Before treatment, after treatment (end of 8 weeks)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Gulhane Health Science Faculty
City
Ankara
ZIP/Postal Code
06018
Country
Turkey

12. IPD Sharing Statement

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

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