Restless Legs SyndromeNCT04316052
Aerobic And Strength Training Exercises For Restless Leg Syndrome In Patients With Diabetes
A study testing Aerobic training and strength training in people with Restless Legs Syndrome and Diabetes, run by Riphah International University at 1 site in Pakistan.
Trial summary
The aim of this research is to find and compare the effect of aerobic exercises and strength training exercise on RLS severity in diabetic patient. Randomized controlled trials done at Physical therapy department of Pakistan Railway general hospital, Rawalpindi. Read more about this study
- Who is it for?
- Ages 40 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Restless Legs Syndrome, Diabetes
- What is being tested?
- Aerobic training and strength training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 sitePakistan
- Study dates
- 15 Feb 2020to 15 Feb 2021
- 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 40 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- The RLS will be diagnosed using the four criteria defined by the International Restless Legs Syndrome Study Group.
- Patient with 5 years old diabetes type II history
- Both genders
- Patients with age limit 40-60 years
- Lower limb MMT 4/5
Who cannot join
- Severe Co-morbidities like Cardiac Failure, Stroke etc.
- Impaired Cognition
- Communication problems
- Infectious disease, fracture etc.
- Serious visual or hearing impairments
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparing the Effect of Aerobic And Strength Training Exercises For Restless Leg Syndrome In Patients With Diabetes
The aim of this research is to find and compare the effect of aerobic exercises and strength training exercise on RLS severity in diabetic patient. Randomized controlled trials done at Physical therapy department of Pakistan Railway general hospital, Rawalpindi. The sample size was 38.The subjects were divided into two groups, 19 subjects in the aerobic physical therapy group and in 19 strength group. Study duration was of 6 months. Sampling technique applied was Simple randomization via computer-generated random numbers. Only 40-60 years individual with restless leg syndrome in 5 years old diabetic history included. Tools used in the study are International Restless Leg Syndrome Study Group Rating Scale: (an International tool for finding the severity of RLS), The Pittsburgh Sleep Quality Index (PSQI) and Epworth Sleepiness Scale (ESS). Data was be analyzed through SPSS 21.
Read the detailed description
Restless legs syndrome (RLS) is a common, underdiagnosed neurological movement disorder of undetermined aetiology. RLS is a collective sensory-motor neural condition that is described by deep restlessness, unpleasant creeping/crawling perceptions profound inside the lower limbs and sleep disturbance, accompanied by a need to move the limb often at bedtime. Usually, the sensory-motor complaints of Restless Leg Syndrome arise or aggravate nocturnally, presenting a day-to-day pattern. These sensations typically occur before sleep onset and cause sleep disturbance in patients. Restless leg syndrome is associated with different conditions including diabetes, diabetic neuropathy, pregnancy, uremia, iron deficiency, hypertension and coronary heart diseases. The Pathophysiology of restless leg syndrome is not clear. Firstly, it was thought to be peripheral nerve disorder, later in last two eras, the authors agreed that origin of Restless Leg Syndrome is in Central Nervous System and there is variation in complex combination between CNS and PNS structures. There is an unusual sensory-motor combination and boosted spinal cord impulsiveness. The positive outcomes of the dopaminergic treatment show that restless leg syndrome may be caused by dopamine dysfunction and iron deficiency in CNS. Prevalence of RLS was found 27%.
One of the most important risk factors of RLS is diabetes. According to a study by in 2019 stated Diabetes type 2 prevalence is 80.0%. Various Studies on Restless Leg Syndrome in diabetes is conducted showing a significant association between RLS and type 2 diabetes. A study was done in Saudi Arabia reported that RLS can affect diabetic patients and it is important to treat RLS, for even better diabetes control. Prevalence of RLS in diabetic patient is 28.6%. Mostly RLS is mixed with other sleep disorder known as a periodic limb movement disorder. Restless leg syndrome also causes strong sleep disturbances (e.g., chronic insomnia, sleep apnea) which have a major impact on health and quality of life, its adverse impact can usually be reversed by on-time diagnosis and treatment. The primary treatments for restless legs syndrome are pharmacological but recently non-pharmacological treatment is being used. A single-blinded RCT was done in 2013 on the physical therapy management of restless leg syndrome in hemodialysis patients stated progressive exercise training program appears to be a safe and effective approach in reducing RLS symptom severity in HD patients. It seems that exercise-induced adaptations to the whole body are mostly responsible for the reduction in RLS severity score. Another study in 2016 was done in which it was reported that muscle stretching exercise seems to be very effective and can reduce RLS symptoms. A 12-week trial in restless leg syndrome patient. The exercise group was prescribed a conditioning program of the aerobic and control group was prescribed lower-body resistance training, both groups had a positive effect on decreasing severity but the exercise group had a significant improvement in symptoms compared with the control group. Diabetes is one of the most prevalent risk factors of "Restless leg syndrome" but unluckily there were limited studies done here in Pakistan for severity control. Our study differs from other literature in sense of its an RCT investigator is trying to find out better treatment option by comparing two treatments (aerobic training and strengthening exercise) for diabetic patients suffering from restless leg syndrome.
- Conditions
- Restless Legs Syndrome, Diabetes
- Being tested
- Aerobic training, strength training
- Keywords
- RLS,, Diabetes,, Aerobic training,, strength training
- Medical subject headings
- Restless Legs Syndrome, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aerobic trainingOther
After the baseline assessment, Following randomization into the exercise group, participants will undergo an exercise program orientation, which will be conducted individually.At the visit, participants will be first instructed in the use of the treadmill, which included heart rate assessment capability. Walking intensity and duration prescriptions will be accordance with recommendations of the American College of Sports Medicine. Participants will be instructed to walk for 45 minutes, including a 5-minute warm-up and 5 min cool-down, at 50% to 80% of their age-predicted maximum heart rate.Over the course of 4 months, each patient will complete 48 sessions. The morning after the 24th and 48nd sessions of aerobic physical exercise, each participant will be assessed completely
strength trainingOther
After the baseline assessment, participants will undergo exercise program orientation, which will be conducted individually. Participants will be instructed to perform 45 min session, two sets of 8 to 12 repetitions of each exercise (2 second hold each up and down hold) for the first 2 weeks to provide an introductory period. In the first session, muscular strength will be assessed using a standardized 10-repetition maximum approach, from which one repetition maximum (1-RM) will be estimated. The exercise prescription for strength training will be made at approximately 50% of the estimated 1-RM.The strength training activities included horizontal leg press, leg extension, leg curl, hip adduction, hip abduction, and seated rotary calf press.
| Study group | Role | What they receive |
|---|---|---|
| aerobic training group | Experimental | At the visit, participants will be first instructed in the use of the treadmill, which included heart rate assessment capability. Walking intensity and duration prescriptions will be accordance with recommendations of the American College of Sports Medicine. Receives: Other: Aerobic training |
| strength training group | Experimental | Strength training prescriptions will be in accordance with recommendations of the American College of Sports Medicine. Receives: Other: strength training |
What is being measured
The primary outcome is the main question the study is designed to answer.
International Restless Leg Syndrome Study Group Rating Scale: (International tool for finding the severity of RLS)
This validated 10-item questionnaire was designed to assess symptom severity, frequency, and impact on daily life. RLS symptom severity score will be determined by summing the questionnaire answers. The maximum score is 40, and a higher score indicates more severe RLS. The total score on the RLS Rating Scale questionnaire will be used as the primary outcome measure of RLS severity. Validity of this scale is 0.84. Internal consistency Cronbach alpha measures is 0.93, Inter-examiner reliability is 0.95 and Test-retest reliability is 0.87. Changes will be assessed from baseline
Measured: 12 weeks
Secondary outcomes (1)
The Pittsburgh Sleep Quality Index (PSQI).
Sleep quality can be evaluated by the Pittsburgh Sleep Quality Index (PSQI). This scale has seven components, each one dealing with a major aspect of sleep: 1) subjective quality of sleep, 2) sleep onset latency, 3) sleep duration, 4) sleep efficiency, 5) the presence of sleep disturbances, 6) the use of hypnotic or sedative medication, and 7) the presence of daytime disturbances, as an indication of daytime alertness. Individuals with a PSQI score of six or more are considered poor sleepers. The PSQI global score correlation coefficient for test - retest reliability is.87. Validity analyses showed high correlations between PSQI and sleep log data. A PSQI global score > 5 resulted in a sensitivity of 91.55.Changes will be assessed from baseline
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2020
- Study start15 Feb 2020
- Primary completion15 Feb 2021
- Study completion15 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Restless Legs SyndromeStudies of the same condition, open and under way.
- More trials run by Riphah International 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
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dr.Aruba Saeed, PHD*, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04316052
- Sponsor's protocol ID
- REC/00660 Fizah Mahnoor
- Status last verified
- Mar 2021
- First submitted
- 6 Mar 2020
- Last updated
- 24 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sevim S, Dogu O, Kaleagasi H, Aral M, Metin O, Camdeviren H. Correlation of anxiety and depression symptoms in patients with restless legs syndrome: a population based survey. J Neurol Neurosurg Psychiatry. 2004 Feb;75(2):226-30.
PubMed 14742594Berger K, Luedemann J, Trenkwalder C, John U, Kessler C. Sex and the risk of restless legs syndrome in the general population. Arch Intern Med. 2004 Jan 26;164(2):196-202. doi: 10.1001/archinte.164.2.196.
PubMed 14744844Nichols DA, Allen RP, Grauke JH, Brown JB, Rice ML, Hyde PR, Dement WC, Kushida CA. Restless legs syndrome symptoms in primary care: a prevalence study. Arch Intern Med. 2003 Oct 27;163(19):2323-9. doi: 10.1001/archinte.163.19.2323.
PubMed 14581252Restless legs syndrome: detection and management in primary care. National Heart, Lung, and Blood Institute Working Group on Restless Legs Syndrome. Am Fam Physician. 2000 Jul 1;62(1):108-14.
PubMed 10905782Hening W, Walters AS, Allen RP, Montplaisir J, Myers A, Ferini-Strambi L. Impact, diagnosis and treatment of restless legs syndrome (RLS) in a primary care population: the REST (RLS epidemiology, symptoms, and treatment) primary care study. Sleep Med. 2004 May;5(3):237-46. doi: 10.1016/j.sleep.2004.03.006.
PubMed 15165529Walters AS. Toward a better definition of the restless legs syndrome. The International Restless Legs Syndrome Study Group. Mov Disord. 1995 Sep;10(5):634-42. doi: 10.1002/mds.870100517.
PubMed 8552117De Mello MT, Esteves AM, Tufik S. Comparison between dopaminergic agents and physical exercise as treatment for periodic limb movements in patients with spinal cord injury. Spinal Cord. 2004 Apr;42(4):218-21. doi: 10.1038/sj.sc.3101575.
PubMed 15060518Abetz L, Allen R, Follet A, Washburn T, Earley C, Kirsch J, Knight H. Evaluating the quality of life of patients with restless legs syndrome. Clin Ther. 2004 Jun;26(6):925-35. doi: 10.1016/s0149-2918(04)90136-1.
PubMed 15262463Lopes LA, Lins Cde M, Adeodato VG, Quental DP, de Bruin PF, Montenegro RM Jr, de Bruin VM. Restless legs syndrome and quality of sleep in type 2 diabetes. Diabetes Care. 2005 Nov;28(11):2633-6. doi: 10.2337/diacare.28.11.2633.
PubMed 16249531Omar SM, Musa IR, ElSouli A, Adam I. Prevalence, risk factors, and glycaemic control of type 2 diabetes mellitus in eastern Sudan: a community-based study. Ther Adv Endocrinol Metab. 2019 Jun 27;10:2042018819860071. doi: 10.1177/2042018819860071. eCollection 2019.
PubMed 31275546Merlino G, Fratticci L, Valente M, Del Giudice A, Noacco C, Dolso P, Cancelli I, Scalise A, Gigli GL. Association of restless legs syndrome in type 2 diabetes: a case-control study. Sleep. 2007 Jul;30(7):866-71. doi: 10.1093/sleep/30.7.866.
PubMed 17682657Zobeiri M, Shokoohi A. Restless leg syndrome in diabetics compared with normal controls. Sleep Disord. 2014;2014:871751. doi: 10.1155/2014/871751. Epub 2014 May 7.
PubMed 24895540
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing the Effect of Aerobic And Strength Training Exercises For Restless Leg Syndrome In Patients With Diabetes
- ClinicalTrials.gov ID
- NCT04316052
- Acronym / sponsor ID
- REC/00660 Fizah Mahnoor
- Conditions
- Restless Legs Syndrome, Diabetes
- Keywords
- RLS,, Diabetes,, Aerobic training,, strength training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 15 Feb 2020 (actual)
- Primary completion
- 15 Feb 2021 (actual)
- Study completion
- 15 Feb 2021 (actual)
- First posted
- 20 Mar 2020 (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.
The aim of this research is to find and compare the effect of aerobic exercises and strength training exercise on RLS severity in diabetic patient. Randomized controlled trials done at Physical therapy department of Pakistan Railway general hospital, Rawalpindi. The sample size was 38.The subjects were divided into two groups, 19 subjects in the aerobic physical therapy group and in 19 strength group. Study duration was of 6 months. Sampling technique applied was Simple randomization via computer-generated random numbers. Only 40-60 years individual with restless leg syndrome in 5 years old diabetic history included. Tools used in the study are International Restless Leg Syndrome Study Group Rating Scale: (an International tool for finding the severity of RLS), The Pittsburgh Sleep Quality Index (PSQI) and Epworth Sleepiness Scale (ESS). Data was be analyzed through SPSS 21.
Detailed description
Restless legs syndrome (RLS) is a common, underdiagnosed neurological movement disorder of undetermined aetiology. RLS is a collective sensory-motor neural condition that is described by deep restlessness, unpleasant creeping/crawling perceptions profound inside the lower limbs and sleep disturbance, accompanied by a need to move the limb often at bedtime. Usually, the sensory-motor complaints of Restless Leg Syndrome arise or aggravate nocturnally, presenting a day-to-day pattern. These sensations typically occur before sleep onset and cause sleep disturbance in patients. Restless leg syndrome is associated with different conditions including diabetes, diabetic neuropathy, pregnancy, uremia, iron deficiency, hypertension and coronary heart diseases. The Pathophysiology of restless leg syndrome is not clear. Firstly, it was thought to be peripheral nerve disorder, later in last two eras, the authors agreed that origin of Restless Leg Syndrome is in Central Nervous System and there is variation in complex combination between CNS and PNS structures. There is an unusual sensory-motor combination and boosted spinal cord impulsiveness. The positive outcomes of the dopaminergic treatment show that restless leg syndrome may be caused by dopamine dysfunction and iron deficiency in CNS. Prevalence of RLS was found 27%.
One of the most important risk factors of RLS is diabetes. According to a study by in 2019 stated Diabetes type 2 prevalence is 80.0%. Various Studies on Restless Leg Syndrome in diabetes is conducted showing a significant association between RLS and type 2 diabetes. A study was done in Saudi Arabia reported that RLS can affect diabetic patients and it is important to treat RLS, for even better diabetes control. Prevalence of RLS in diabetic patient is 28.6%. Mostly RLS is mixed with other sleep disorder known as a periodic limb movement disorder. Restless leg syndrome also causes strong sleep disturbances (e.g., chronic insomnia, sleep apnea) which have a major impact on health and quality of life, its adverse impact can usually be reversed by on-time diagnosis and treatment. The primary treatments for restless legs syndrome are pharmacological but recently non-pharmacological treatment is being used. A single-blinded RCT was done in 2013 on the physical therapy management of restless leg syndrome in hemodialysis patients stated progressive exercise training program appears to be a safe and effective approach in reducing RLS symptom severity in HD patients. It seems that exercise-induced adaptations to the whole body are mostly responsible for the reduction in RLS severity score. Another study in 2016 was done in which it was reported that muscle stretching exercise seems to be very effective and can reduce RLS symptoms. A 12-week trial in restless leg syndrome patient. The exercise group was prescribed a conditioning program of the aerobic and control group was prescribed lower-body resistance training, both groups had a positive effect on decreasing severity but the exercise group had a significant improvement in symptoms compared with the control group. Diabetes is one of the most prevalent risk factors of "Restless leg syndrome" but unluckily there were limited studies done here in Pakistan for severity control. Our study differs from other literature in sense of its an RCT investigator is trying to find out better treatment option by comparing two treatments (aerobic training and strengthening exercise) for diabetic patients suffering from restless leg syndrome.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| aerobic training group | Experimental | Other: Aerobic trainingAt the visit, participants will be first instructed in the use of the treadmill, which included heart rate assessment capability. Walking intensity and duration prescriptions will be accordance with recommendations of the American College of Sports Medicine. |
| strength training group | Experimental | Other: strength trainingStrength training prescriptions will be in accordance with recommendations of the American College of Sports Medicine. |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- The RLS will be diagnosed using the four criteria defined by the International Restless Legs Syndrome Study Group.
- Patient with 5 years old diabetes type II history
- Both genders
- Patients with age limit 40-60 years
- Lower limb MMT 4/5
Key exclusion criteria (5 listed)
- Severe Co-morbidities like Cardiac Failure, Stroke etc.
- Impaired Cognition
- Communication problems
- Infectious disease, fracture etc.
- Serious visual or hearing impairments
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 |
|---|---|---|
| Aerobic trainingAfter the baseline assessment, Following randomization into the exercise group, participants will undergo an exercise program orientation, which will be conducted individually.At the visit, participants will be first instructed in the use of the treadmill, which included heart rate assessment capability. Walking intensity and duration prescriptions will be accordance with recommendations of the American College of Sports Medicine. Participants will be instructed to walk for 45 minutes, including a 5-minute warm-up and 5 min cool-down, at 50% to 80% of their age-predicted maximum heart rate.Over the course of 4 months, each patient will complete 48 sessions. The morning after the 24th and 48nd sessions of aerobic physical exercise, each participant will be assessed completely | Other | aerobic training group |
| strength trainingAfter the baseline assessment, participants will undergo exercise program orientation, which will be conducted individually. Participants will be instructed to perform 45 min session, two sets of 8 to 12 repetitions of each exercise (2 second hold each up and down hold) for the first 2 weeks to provide an introductory period. In the first session, muscular strength will be assessed using a standardized 10-repetition maximum approach, from which one repetition maximum (1-RM) will be estimated. The exercise prescription for strength training will be made at approximately 50% of the estimated 1-RM.The strength training activities included horizontal leg press, leg extension, leg curl, hip adduction, hip abduction, and seated rotary calf press. | Other | strength training group |
Primary outcome
International Restless Leg Syndrome Study Group Rating Scale: (International tool for finding the severity of RLS)
Time frame: 12 weeks
This validated 10-item questionnaire was designed to assess symptom severity, frequency, and impact on daily life. RLS symptom severity score will be determined by summing the questionnaire answers. The maximum score is 40, and a higher score indicates more severe RLS. The total score on the RLS Rating Scale questionnaire will be used as the primary outcome measure of RLS severity. Validity of this scale is 0.84. Internal consistency Cronbach alpha measures is 0.93, Inter-examiner reliability is 0.95 and Test-retest reliability is 0.87. Changes will be assessed from baseline
1 secondary outcome
The Pittsburgh Sleep Quality Index (PSQI).
Time frame: 12 weeks
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 24 Mar 2021.
- Background: PubMed 14742594Sevim S, Dogu O, Kaleagasi H, Aral M, Metin O, Camdeviren H. Correlation of anxiety and depression symptoms in patients with restless legs syndrome: a population based survey. J Neurol Neurosurg Psychiatry. 2004 Feb;75(2):226-30.
- Background: PubMed 14744844Berger K, Luedemann J, Trenkwalder C, John U, Kessler C. Sex and the risk of restless legs syndrome in the general population. Arch Intern Med. 2004 Jan 26;164(2):196-202. doi: 10.1001/archinte.164.2.196.
- Background: PubMed 14581252Nichols DA, Allen RP, Grauke JH, Brown JB, Rice ML, Hyde PR, Dement WC, Kushida CA. Restless legs syndrome symptoms in primary care: a prevalence study. Arch Intern Med. 2003 Oct 27;163(19):2323-9. doi: 10.1001/archinte.163.19.2323.
- Background: PubMed 10905782Restless legs syndrome: detection and management in primary care. National Heart, Lung, and Blood Institute Working Group on Restless Legs Syndrome. Am Fam Physician. 2000 Jul 1;62(1):108-14.
- Background: PubMed 15165529Hening W, Walters AS, Allen RP, Montplaisir J, Myers A, Ferini-Strambi L. Impact, diagnosis and treatment of restless legs syndrome (RLS) in a primary care population: the REST (RLS epidemiology, symptoms, and treatment) primary care study. Sleep Med. 2004 May;5(3):237-46. doi: 10.1016/j.sleep.2004.03.006.
- Background: PubMed 8552117Walters AS. Toward a better definition of the restless legs syndrome. The International Restless Legs Syndrome Study Group. Mov Disord. 1995 Sep;10(5):634-42. doi: 10.1002/mds.870100517.
- Background: PubMed 15060518De Mello MT, Esteves AM, Tufik S. Comparison between dopaminergic agents and physical exercise as treatment for periodic limb movements in patients with spinal cord injury. Spinal Cord. 2004 Apr;42(4):218-21. doi: 10.1038/sj.sc.3101575.
- Background: PubMed 15262463Abetz L, Allen R, Follet A, Washburn T, Earley C, Kirsch J, Knight H. Evaluating the quality of life of patients with restless legs syndrome. Clin Ther. 2004 Jun;26(6):925-35. doi: 10.1016/s0149-2918(04)90136-1.
- Background: PubMed 16249531Lopes LA, Lins Cde M, Adeodato VG, Quental DP, de Bruin PF, Montenegro RM Jr, de Bruin VM. Restless legs syndrome and quality of sleep in type 2 diabetes. Diabetes Care. 2005 Nov;28(11):2633-6. doi: 10.2337/diacare.28.11.2633.
- Background: PubMed 31275546Omar SM, Musa IR, ElSouli A, Adam I. Prevalence, risk factors, and glycaemic control of type 2 diabetes mellitus in eastern Sudan: a community-based study. Ther Adv Endocrinol Metab. 2019 Jun 27;10:2042018819860071. doi: 10.1177/2042018819860071. eCollection 2019.
- Background: PubMed 17682657Merlino G, Fratticci L, Valente M, Del Giudice A, Noacco C, Dolso P, Cancelli I, Scalise A, Gigli GL. Association of restless legs syndrome in type 2 diabetes: a case-control study. Sleep. 2007 Jul;30(7):866-71. doi: 10.1093/sleep/30.7.866.
- Background: PubMed 24895540Zobeiri M, Shokoohi A. Restless leg syndrome in diabetics compared with normal controls. Sleep Disord. 2014;2014:871751. doi: 10.1155/2014/871751. Epub 2014 May 7.
- Individual participant dataSharing planned: No
Related trials for Restless Legs Syndrome
RecruitingObservational study
Lemborexant vs Clonidine vs Sedatives to Treat Insomnia in Chronic Pain Patients
Chronic Insomnia, Chronic Pain
Not yet recruiting
Neuromodulation to Overcome Severe Restless Legs Syndrome
Restless Leg Syndrome (RLS), Spinal Cord Stimulation (SCS)
Not yet recruitingPhase 2
Tolerability and Efficacy of CBD Extract for RLS Treatment
Restless Leg Syndrome
Recruiting
Functional Connectivity of the Interoceptive Network in RLS
Restless Legs Syndrome
Not yet recruitingPhase 2
Intravenous Iron in the Management of Drug-resistant Restless Legs syndromeI
Restless Legs Syndrome (RLS)
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.
Dr.Aruba Saeed, PHD* principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aerobic training and strength training in people with Restless Legs Syndrome and Diabetes, run by Riphah International University at 1 site in Pakistan.
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 5 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 24 Mar 2021. 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 Pakistan. 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?
International Restless Leg Syndrome Study Group Rating Scale: (International tool for finding the severity of RLS) (time frame: 12 weeks). 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 NCT04316052, which also lists 12 linked publications.
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 24 Mar 2021.