Aerobic And Strength Training Exercises For Restless Leg Syndrome In Patients With Diabetes
Condition: Restless Legs Syndrome; Diabetes
MeSH terms: Psychomotor Agitation; Restless Legs Syndrome; Diabetes Mellitus; Syndrome
Study type: Interventional

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.
    

Intervention name(s): Aerobic training; strength training
Intervention type(s): Other; Other
Intervention description(s): 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; 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: RLS,; Diabetes,; Aerobic training,; strength training