Restless Legs SyndromeNCT06156007
Effect of Progressive Muscle Relaxation Exercises in Menopausal Women Experiencing RLS.
A study testing progressive muscle relaxation exercises in people with Restless Legs Syndrome, run by Gazi University at 1 site in Turkey (Türkiye).
Trial summary
Restless legs syndrome is a symptom that can be seen in all stages of a woman's life, but its frequency and severity increases with menopause. Restless legs syndrome is a neurological problem that occurs usually at night with an irresistible urge to move the legs. It is a progressive muscle relaxation exercise. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Restless Legs Syndrome
- What is being tested?
- progressive muscle relaxation exercises
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 25 Dec 2023to 30 May 2024
- 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 Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Having entered natural menopause
- At least 1 year has passed since the last menstrual period
- Not having any psychiatric disease
- Not having any communication problems (mental, auditory, visual, etc.)
Who cannot join
- Women not performing post-test applications
- Not doing progressive muscle relaxation exercises twice in a row.
- Wants to quit the research.
- The woman is hospitalized
- Inability to reach women during follow-ups
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Karabük Training and Research Hospital
Karabük, Karabük Province, 78050
About this study
Official title: Effect of Progressive Muscle Relaxation Exercise on RLS Severity, Quality of Life and Sleep Quality in Menopausal Women with Restless Legs Syndrome (RLS): a Randomized Controlled Study
Restless legs syndrome is a symptom that can be seen in all stages of a woman's life, but its frequency and severity increases with menopause. Restless legs syndrome is a neurological problem that occurs usually at night with an irresistible urge to move the legs. It is a progressive muscle relaxation exercise. Progressive muscle relaxation exercise is a systematic practice aimed at providing deep relaxation by exercising large muscle groups in the body along with breathing techniques. This study aims to evaluate the effect of progressive muscle relaxation exercise on the severity of restless legs syndrome, quality of life and sleep quality related to restless legs syndrome in menopausal women with restless legs syndrome.
Read the detailed description
Menopause, which is a natural part of women's life; It is a condition that occurs between the ages of 45-52 on average and is characterized by hormonal changes and cessation of the menstrual cycle. Many symptoms are observed during menopause, such as hot flashes, sleep problems, mood disorders, sexual dysfunction, weight gain, and decline in cognitive functioning. Restless legs syndrome is another symptom that can be seen in all periods of a woman's life, but its frequency and severity increases with menopause. Restless legs syndrome is a neurological problem that occurs usually at night with an irresistible urge to move the legs. There are studies reporting that sleep problems, which are a common problem during the menopausal period, worsen with the addition of restless legs syndrome. Restless legs syndrome and sleep problems are two important factors that negatively affect the quality of life of women in the menopausal period. Alternative and complementary therapies are frequently used among the methods used to cope with menopausal symptoms and symptoms triggered by menopause. These methods include hypnosis, body-mind techniques, cognitive behavioral therapies, aromatherapies, and herbal supplements. It is stated that these techniques reduce the stress of women in the menopausal period and are effective in improving their quality of life. One of these methods is progressive muscle relaxation exercise. Progressive muscle relaxation exercise is a systematic practice that aims to provide deep relaxation by exercising large muscle groups in the body along with breathing techniques. There are studies reporting that PCGE is used effectively in coping with menopausal symptoms. This study aims to evaluate the effect of progressive muscle relaxation exercise on the severity of restless legs syndrome, quality of life and sleep quality related to restless legs syndrome in menopausal women with restless legs syndrome.
- Conditions
- Restless Legs Syndrome
- Being tested
- progressive muscle relaxation exercises
- Keywords
- restless legs syndrome, menopause, progressive muscle relaxation exercises
- Medical subject headings
- Restless Legs Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
progressive muscle relaxation exercisesBehavioural
Progressive muscle relaxation exercises (PKGE); 16 large muscles (right hand and forearm, right upper arm, left hand and forearm of left arm, left upper arm, forehead, upper cheek and nose, chin, neck, abdomen, upper right arm, which people can do on their own after learning) leg, right calf, right foot, left upper leg, left thigh and left foot), followed by the contraction and then relaxation and accompanied by deep breathing, is a preferred method for reducing pain, anxiety and depression in individuals.The relaxation will be required to take 10-20 before stretching the next muscle group. In this way, the muscle groups in the hands, arms, neck, shoulder, chest, abdomen, hips, feet and fingers, face and the whole body will be voluntarily stretched and relaxed, and pregnant women will be relieved.
| Study group | Role | What they receive |
|---|---|---|
| progressive muscle relaxation exercises | Experimental | Women will be given one-time progressive muscle relaxation exercise training prepared by the researcher. In the training, the exercise will be demonstrated through demonstration method. Following training, women will be asked to perform progressive relaxation exercise at least 3 times a week (every other day). Women will be followed for 8 weeks with a progressive muscle relaxation exercise daily follow-up chart prepared by the researcher, and weekly reminders will be made (via WhatsApp® or text message). The final test will be administered to women online at the end of 8 weeks. RLS Severity Rating Scale form, Johns Hopkins Restless Legs Syndrome Quality of Life Scale and Pittsburg Sleep Quality Index will be used in the pre-test and post-test applications. Receives: Behavioral: progressive muscle relaxation exercises |
| no intervention | No intervention | No intervention will be applied to women. Posttest application to women; It will be conducted online 8 weeks after the pre-test application. RLS Severity Rating Scale form, Johns Hopkins Restless Legs Syndrome Quality of Life Scale and Pittsburg Sleep Quality Index will be used in the pre-test and post-test applications. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Restless Legs Syndrome Severity
Measurements will be made using the RLS Severity Rating Scale. A total score is obtained, with the entire score range varying between 0 and 40; A score between 1-10 indicates mild disease, a score between 11-20 indicates moderate disease, a score between 21-30 indicates severe disease, and a score between 31-40 indicates very severe disease.
Measured: Change from Baseline RLS Severity at 8 weeks
Quality of life associated with restless legs syndrome
Measurements will be made using the Johns Hopkins Restless Leg Syndrome Quality of Life Scale. The lowest score from the scale is 0 and the highest score is 100. As the score obtained from the scale decreases, it indicates that the quality of life associated with restless legs syndrome is poor.
Measured: Change from Baseline Quality of Life at 8 weeks
Quality of sleep associated with restless legs syndrome
Measurements will be made using the Pittsburg Sleep Quality Index.A high total score indicates poor sleep quality. Total score is between 0-21. The index does not indicate the presence or frequency of sleep disturbances. However, a PSQI total score of 5 or above indicates poor sleep quality. The cut-off score indicating poor sleep quality is accepted as 5.
Measured: Change from Baseline Quality of Life at 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2023
- Study start25 Dec 2023
- Primary completion30 May 2024
- Study completion30 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Restless Legs SyndromeStudies of the same condition, open and under way.
- More trials run by Gazi UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Model description
- The research was planned as a single-center, parallel randomized controlled experimental study with stratified randomization (mild-moderate, severe-very severe) and pretest-posttest control group.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gazi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pinar Akbas, Gazi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06156007
- Sponsor's protocol ID
- menopause
- Status last verified
- Sep 2024
- First submitted
- 26 Nov 2023
- Last updated
- 26 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Progressive Muscle Relaxation Exercise on RLS Severity, Quality of Life and Sleep Quality in Menopausal Women with Restless Legs Syndrome (RLS): a Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06156007
- Acronym / sponsor ID
- menopause
- Conditions
- Restless Legs Syndrome
- Keywords
- restless legs syndrome, menopause, progressive muscle relaxation exercises
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Gazi UniversityUniversity, hospital or other
- Study start
- 25 Dec 2023 (actual)
- Primary completion
- 30 May 2024 (actual)
- Study completion
- 30 May 2024 (actual)
- First posted
- 5 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Restless legs syndrome is a symptom that can be seen in all stages of a woman's life, but its frequency and severity increases with menopause. Restless legs syndrome is a neurological problem that occurs usually at night with an irresistible urge to move the legs. It is a progressive muscle relaxation exercise. Progressive muscle relaxation exercise is a systematic practice aimed at providing deep relaxation by exercising large muscle groups in the body along with breathing techniques. This study aims to evaluate the effect of progressive muscle relaxation exercise on the severity of restless legs syndrome, quality of life and sleep quality related to restless legs syndrome in menopausal women with restless legs syndrome.
Detailed description
Menopause, which is a natural part of women's life; It is a condition that occurs between the ages of 45-52 on average and is characterized by hormonal changes and cessation of the menstrual cycle. Many symptoms are observed during menopause, such as hot flashes, sleep problems, mood disorders, sexual dysfunction, weight gain, and decline in cognitive functioning. Restless legs syndrome is another symptom that can be seen in all periods of a woman's life, but its frequency and severity increases with menopause. Restless legs syndrome is a neurological problem that occurs usually at night with an irresistible urge to move the legs. There are studies reporting that sleep problems, which are a common problem during the menopausal period, worsen with the addition of restless legs syndrome. Restless legs syndrome and sleep problems are two important factors that negatively affect the quality of life of women in the menopausal period. Alternative and complementary therapies are frequently used among the methods used to cope with menopausal symptoms and symptoms triggered by menopause. These methods include hypnosis, body-mind techniques, cognitive behavioral therapies, aromatherapies, and herbal supplements. It is stated that these techniques reduce the stress of women in the menopausal period and are effective in improving their quality of life. One of these methods is progressive muscle relaxation exercise. Progressive muscle relaxation exercise is a systematic practice that aims to provide deep relaxation by exercising large muscle groups in the body along with breathing techniques. There are studies reporting that PCGE is used effectively in coping with menopausal symptoms. This study aims to evaluate the effect of progressive muscle relaxation exercise on the severity of restless legs syndrome, quality of life and sleep quality related to restless legs syndrome in menopausal women with restless legs syndrome.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- The research was planned as a single-center, parallel randomized controlled experimental study with stratified randomization (mild-moderate, severe-very severe) and pretest-posttest control group.
| Arm | Type | Receives |
|---|---|---|
| progressive muscle relaxation exercises | Experimental | Behavioral: progressive muscle relaxation exercisesWomen will be given one-time progressive muscle relaxation exercise training prepared by the researcher. In the training, the exercise will be demonstrated through demonstration method. Following training, women will be asked to perform progressive relaxation exercise at least 3 times a week (every other day). Women will be followed for 8 weeks with a progressive muscle relaxation exercise daily follow-up chart prepared by the researcher, and weekly reminders will be made (via WhatsApp® or text message). The final test will be administered to women online at the end of 8 weeks. RLS Severity Rating Scale form, Johns Hopkins Restless Legs Syndrome Quality of Life Scale and Pittsburg Sleep Quality Index will be used in the pre-test and post-test applications. |
| no intervention | No intervention | –No intervention will be applied to women. Posttest application to women; It will be conducted online 8 weeks after the pre-test application. RLS Severity Rating Scale form, Johns Hopkins Restless Legs Syndrome Quality of Life Scale and Pittsburg Sleep Quality Index will be used in the pre-test and post-test applications. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Having entered natural menopause
- At least 1 year has passed since the last menstrual period
- Not having any psychiatric disease
- Not having any communication problems (mental, auditory, visual, etc.)
Key exclusion criteria (5 listed)
- Women not performing post-test applications
- Not doing progressive muscle relaxation exercises twice in a row.
- Wants to quit the research.
- The woman is hospitalized
- Inability to reach women during follow-ups
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| progressive muscle relaxation exercisesProgressive muscle relaxation exercises (PKGE); 16 large muscles (right hand and forearm, right upper arm, left hand and forearm of left arm, left upper arm, forehead, upper cheek and nose, chin, neck, abdomen, upper right arm, which people can do on their own after learning) leg, right calf, right foot, left upper leg, left thigh and left foot), followed by the contraction and then relaxation and accompanied by deep breathing, is a preferred method for reducing pain, anxiety and depression in individuals.The relaxation will be required to take 10-20 before stretching the next muscle group. In this way, the muscle groups in the hands, arms, neck, shoulder, chest, abdomen, hips, feet and fingers, face and the whole body will be voluntarily stretched and relaxed, and pregnant women will be relieved. | Behavioural | progressive muscle relaxation exercises |
Primary outcome
Restless Legs Syndrome Severity
Time frame: Change from Baseline RLS Severity at 8 weeks
Measurements will be made using the RLS Severity Rating Scale. A total score is obtained, with the entire score range varying between 0 and 40; A score between 1-10 indicates mild disease, a score between 11-20 indicates moderate disease, a score between 21-30 indicates severe disease, and a score between 31-40 indicates very severe disease.
Quality of life associated with restless legs syndrome
Time frame: Change from Baseline Quality of Life at 8 weeks
Measurements will be made using the Johns Hopkins Restless Leg Syndrome Quality of Life Scale. The lowest score from the scale is 0 and the highest score is 100. As the score obtained from the scale decreases, it indicates that the quality of life associated with restless legs syndrome is poor.
Quality of sleep associated with restless legs syndrome
Time frame: Change from Baseline Quality of Life at 8 weeks
Measurements will be made using the Pittsburg Sleep Quality Index.A high total score indicates poor sleep quality. Total score is between 0-21. The index does not indicate the presence or frequency of sleep disturbances. However, a PSQI total score of 5 or above indicates poor sleep quality. The cut-off score indicating poor sleep quality is accepted as 5.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2024.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing progressive muscle relaxation exercises in people with Restless Legs Syndrome, run by Gazi University 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 5 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 26 Sep 2024. 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?
Restless Legs Syndrome Severity (time frame: Change from Baseline RLS Severity at 8 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Sep 2024.