Aerobic And Strength Training Exercises For Restless Leg Syndrome In Patients With Diabetes

Not Applicable

Completed

• Conditions: Restless Legs Syndrome; Diabetes
• Interventions: Other: Aerobic training; Other: strength training

• Registration Number: NCT04316052
• Lead Sponsor: Riphah International University

Brief 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. 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 Timeline

• Study Start: 2020-02-15
• Study First Submitted: 2020-03-06
• Study First Submitted QC: 2020-03-18
• Study First Posted: 2020-03-20
• Primary Completion: 2021-02-15
• Study Completion: 2021-02-15
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-22
• Last Update Posted: 2021-03-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• 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

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Exclusion Criteria

• Severe Co-morbidities like Cardiac Failure, Stroke etc.
• Impaired Cognition
• Communication problems
• Infectious disease, fracture etc.
• Serious visual or hearing impairments

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
aerobic training group	Aerobic training	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.
strength training group	strength training	Strength training prescriptions will be in accordance with recommendations of the American College of Sports Medicine.

Primary Outcome Measures

Name	Time	Method
International Restless Leg Syndrome Study Group Rating Scale: (International tool for finding the severity of RLS)	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

Secondary Outcome Measures

Name	Time	Method
The Pittsburgh Sleep Quality Index (PSQI).	12 weeks	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

Trial Locations

Locations (1)

Riphah International University; 🇵🇰 Islamabad, Pakistan