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

Primary Purpose

Restless Legs Syndrome, Diabetes

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Aerobic training
strength training
Sponsored by
Riphah International University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Restless Legs Syndrome focused on measuring RLS,, Diabetes,, Aerobic training,, strength training

Eligibility Criteria

40 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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

Exclusion Criteria:

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

Sites / Locations

  • Riphah International University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

aerobic training group

strength training group

Arm Description

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 prescriptions will be in accordance with recommendations of the American College of Sports Medicine.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
March 6, 2020
Last Updated
March 22, 2021
Sponsor
Riphah International University
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1. Study Identification

Unique Protocol Identification Number
NCT04316052
Brief Title
Aerobic And Strength Training Exercises For Restless Leg Syndrome In Patients With Diabetes
Official Title
Comparing the Effect of Aerobic And Strength Training Exercises For Restless Leg Syndrome In Patients With Diabetes
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
February 15, 2020 (Actual)
Primary Completion Date
February 15, 2021 (Actual)
Study Completion Date
February 15, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Riphah International University

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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Restless Legs Syndrome, Diabetes
Keywords
RLS,, Diabetes,, Aerobic training,, strength training

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
aerobic training group
Arm Type
Experimental
Arm Description
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.
Arm Title
strength training group
Arm Type
Experimental
Arm Description
Strength training prescriptions will be in accordance with recommendations of the American College of Sports Medicine.
Intervention Type
Other
Intervention Name(s)
Aerobic training
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
strength training
Intervention Description
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.
Primary Outcome Measure Information:
Title
International Restless Leg Syndrome Study Group Rating Scale: (International tool for finding the severity of RLS)
Description
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
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
The Pittsburgh Sleep Quality Index (PSQI).
Description
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
Time Frame
12 weeks
Other Pre-specified Outcome Measures:
Title
Epworth Sleepiness Scale (ESS)
Description
The Epworth Sleepiness Scale (ESS) is a scale intended to measure daytime sleepiness. The ESS is a self-administered questionnaire with 8 questions. The ESS asks the respondent to rate on a 4-point scale (0-3) their usual chances of having dozed off or fallen asleep while engaged in eight different activities that differ widely. The ESS score is highly correlated (r = 0.82) and the internal consistency as measured by Cronbach's alpha is 0.88. Changes will be assessed from baseline
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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 Exclusion Criteria: Severe Co-morbidities like Cardiac Failure, Stroke etc. Impaired Cognition Communication problems Infectious disease, fracture etc. Serious visual or hearing impairments
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dr.Aruba Saeed, PHD*
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Riphah International University
City
Islamabad
ZIP/Postal Code
44000
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
14742594
Citation
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.
Results Reference
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14744844
Citation
Berger 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.
Results Reference
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PubMed Identifier
14581252
Citation
Nichols 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.
Results Reference
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PubMed Identifier
10905782
Citation
Restless 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. Erratum In: Am Fam Physician 2000 Aug 15;62(4):736.
Results Reference
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PubMed Identifier
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Citation
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Citation
Walters 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.
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Citation
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Aerobic And Strength Training Exercises For Restless Leg Syndrome In Patients With Diabetes

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