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

NCT04316052 | Completed

• 1 other identifier: REC/00660 Fizah Mahnoor
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Restless Legs Syndrome; Diabetes

Keywords

RLS,; Diabetes,; Aerobic training,; strength training

Outcome Measures

Primary Outcomes (1)

• 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

  12 weeks

Secondary Outcomes (1)

• The Pittsburgh Sleep Quality Index (PSQI).

  12 weeks

Other Outcomes (1)

• Epworth Sleepiness Scale (ESS)

  12 weeks

Study Arms (2)

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.

Other: Aerobic training

strength training group

EXPERIMENTAL

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

Other: strength training

Interventions

Aerobic training OTHER

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

aerobic training group

strength training OTHER

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.

strength training group

Eligibility Criteria

• Age: 40 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Riphah International University: lead

Study Sites (1)

Riphah International University

Islamabad, 44000, Pakistan

Location

Related Publications (12)

• 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.

  PMID: 14742594 BACKGROUND

• 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.

  PMID: 14744844 BACKGROUND

• 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.

  PMID: 14581252 BACKGROUND

• 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.

  PMID: 10905782 BACKGROUND

• Hening 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.

  PMID: 15165529 BACKGROUND

• 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.

  PMID: 8552117 BACKGROUND

• De 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.

  PMID: 15060518 BACKGROUND

• Abetz 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.

  PMID: 15262463 BACKGROUND

• Lopes 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.

  PMID: 16249531 BACKGROUND

• Omar 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.

  PMID: 31275546 BACKGROUND

• Merlino 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.

  PMID: 17682657 BACKGROUND

• Zobeiri 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.

  PMID: 24895540 BACKGROUND

MeSH Terms

Conditions

Restless Legs Syndrome; Diabetes Mellitus

Interventions

Resistance Training

Condition Hierarchy (Ancestors)

Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Parasomnias; Mental Disorders; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Dr.Aruba Saeed, PHD*

  Riphah International University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 6, 2020
• First Posted: March 20, 2020
• Study Start: February 15, 2020
• Primary Completion: February 15, 2021
• Study Completion: February 15, 2021
• Last Updated: March 24, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)