CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 40 enrolled
Drug / intervention
Aerobic training +1 moreother
Likely dose
Not stated in record
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Search/NCT04316052
NCT04316052N/ACompleted

Comparing the Effect of Aerobic And Strength Training Exercises For Restless Leg Syndrome In Patients With Diabetes

Riphah International University·interventional·Posted Mar 20, 2020·Updated Mar 24, 2021

In Brief

A clinical study evaluating Aerobic training and strength training for Restless Legs Syndrome and Diabetes. Completed, enrolled 40 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesPakistan
Collaborators--

Timeline

N/ACompletedFinished
2020202120222023202420252026
First PostedMar 20, 2020
Enrollment StartFeb 15, 2020
Primary CompletionFeb 15, 2021
TodayJul 1, 2026
Enrollment to primary: 1 yearPosted 6.3 years ago

Interventions

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.