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Trial registered on ANZCTR


Registration number
ACTRN12615000011583
Ethics application status
Approved
Date submitted
10/12/2014
Date registered
9/01/2015
Date last updated
16/11/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effect of Trauma release exercises (TRE) on symptoms of restless legs syndrome (RLS): A randomised controlled trial
Scientific title
The effect of Trauma Release Exercises (TRE) on International Restless Legs Syndrome Rating Scale (IRLS) scores in Adults with Restless Legs Syndrome (RLS)
Secondary ID [1] 285818 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Restless Legs Syndrome 293724 0
Condition category
Condition code
Physical Medicine / Rehabilitation 294024 294024 0 0
Physiotherapy
Neurological 294072 294072 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Tension and Trauma Release Exercises (TRE). TRE are a series of exercises that stretch and fatigue specific muscles in the body, invoking self-induced therapeutic tremors (SITT).
Participants in the intervention group will receive 6 TRE sessions under direct physiotherapist supervision (1 each week) and will complete home based exercises. The first physiotherapy session will be 3 hours, followed by five 1 hour sessions. At least 1.5 hours of home exercises will be required each week during this time or as required for symptom relief.
After the 6 week intervention, participants will then complete home based exercises alone for 6 weeks (minimum 1 hour per week).
Participants will be asked to keep a diary of when they complete home exercises.

Intervention code [1] 290791 0
Treatment: Other
Intervention code [2] 290837 0
Rehabilitation
Comparator / control treatment
6 weekly sessions (1 each week) where participants will take part in focus groups discussing the lived experience of RLS.
They will then complete 6 weeks of TRE (the same as the first 6 weeks for the intervention group).
Control group
Active

Outcomes
Primary outcome [1] 293802 0
International Restless Legs Syndrome Rating Scale (IRLS). Measures severity of RLS on a 10 item questionnaire
Timepoint [1] 293802 0
Baseline, and at the end of each week (12 weeks total)
Secondary outcome [1] 311904 0
Visual analogue scale (0-10) for global RLS severity, where 0 indicates no RLS symptoms and 10 indicates very severe RLS symptoms
Timepoint [1] 311904 0
Baseline, and at the end of each week (12 weeks total)
Secondary outcome [2] 311905 0
Visual analogue scale (0-10) for overall stress levels, where 0 indicates no stress and 10 indicates very severe stress
Timepoint [2] 311905 0
Baseline, and at the end of each week (12 weeks total)
Secondary outcome [3] 311906 0
The Major Depression Inventory (MDI), used to measure depression.
Timepoint [3] 311906 0
Baseline, and at the end of each week (12 weeks total)
Secondary outcome [4] 311907 0
Modified 20 item version of the Pittsburgh Insomnia Rating Scale (PIRS), a 65 item scale used to assess the severity of insomnia
Timepoint [4] 311907 0
Baseline, and at the end of each week (12 weeks total)

Eligibility
Key inclusion criteria
Participants must have all four of the RLS diagnostic criteria below
1. An urge to move the legs, usually accompanied or caused by uncomfortable and unpleasant sensations in the legs
2. The urge to move or unpleasant sensations begin or worsen during periods of rest or inactivity such as lying or sitting
3. The urge to move or unpleasant sensations are partially or totally relieved by movement, such as walking or stretching, at least as long as the activity continues
4. The urge to move or unpleasant sensations are worse in the evening or night than during the day or only occur in the evening or night

Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Acute mental health issue, physically unable to complete the TRE exercises.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Advertisements will include an email address and phone number where participants can leave expressions of interest in participating in the study. Participants will be screened for eligibility over the phone, and those who meet the inclusion criteria will be advised that they will be randomised to either immediate or delayed intervention. They will be advised regarding the nature of the intervention and control conditions, the attendance requirements and the location of the program. Those who remain interested will be invited to enter the study and enrolled.
After enrollment, participants will be stratified for age and severity of RLS and randomly allocated to intervention or control groups using a computer generated sequence. A research assistant without any role in enrollment will complete the randomisation procedures using participant ID numbers only, and will then provide the research team with group allocation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis
Intervention and control groups will be compared for primary and secondary outcomes at baseline, and at each of the subsequent 12 weeks.
Sample size was determined using a power analysis for IRLS scores (scale 0-40) based on results of similar studies where physical interventions for RLS were compared to control groups. With a sample of six in each group the study would be powered (.8) to detect a difference between means of 9 IRLS points when alpha was set at .05 using a two-tailed t test.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment postcode(s) [1] 9025 0
3931 - Mornington
Recruitment postcode(s) [2] 9026 0
3930 - Mount Eliza
Recruitment postcode(s) [3] 9027 0
3910 - Langwarrin
Recruitment postcode(s) [4] 9028 0
3199 - Frankston

Funding & Sponsors
Funding source category [1] 290379 0
University
Name [1] 290379 0
Monash University
Address [1] 290379 0
Building C, Level 2, McMahons Road, Frankston VIC 3199
Country [1] 290379 0
Australia
Primary sponsor type
Individual
Name
Eloise Harrison
Address
Monash University Peninsula Campus
Building C, Level 2, McMahons Road, Frankston VIC 3199
Country
Australia
Secondary sponsor category [1] 289105 0
Individual
Name [1] 289105 0
Jenny Keating
Address [1] 289105 0
Monash University Peninsula Campus
Building C, Level 2, McMahons Road, Frankston VIC 3199
Country [1] 289105 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292082 0
Monash University Human Research Ethics Committee (MUHREC)
Ethics committee address [1] 292082 0
Monash Research Office
Building 3d
Monash University
Victoria 3800
Australia
Ethics committee country [1] 292082 0
Australia
Date submitted for ethics approval [1] 292082 0
26/06/2014
Approval date [1] 292082 0
20/08/2014
Ethics approval number [1] 292082 0
CF14/1931 - 2014000986

Summary
Brief summary
The purpose of the study is to determine the effect of Tension and Trauma Release exercises (TRE) on the severity of symptoms of Restless Legs Syndrome (RLS). This treatment is currently offered to sufferers but no data supports its effectiveness.
Trial website
www.restlesslegsresearch.com.au
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 53394 0
Prof Jenny Keating
Address 53394 0
Monash University Peninsula Campus
Building C, Level 2, McMahons Road, Frankston VIC 3199
Country 53394 0
Australia
Phone 53394 0
+613 9904 4817
Fax 53394 0
Email 53394 0
jenny.keating@monash.edu
Contact person for public queries
Name 53395 0
Ms Eloise Harrison
Address 53395 0
Monash University Peninsula Campus
Building C, Level 2, McMahons Road, Frankston VIC 3199
Country 53395 0
Australia
Phone 53395 0
+613 9904 4817
Fax 53395 0
Email 53395 0
eghar3@student.monash.edu
Contact person for scientific queries
Name 53396 0
Prof Jenny Keating
Address 53396 0
Monash University Peninsula Campus
Building C, Level 2, McMahons Road, Frankston VIC 3199
Country 53396 0
Australia
Phone 53396 0
+613 9904 4817
Fax 53396 0
Email 53396 0
jenny.keating@monash.edu

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary