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Trial registered on ANZCTR


Registration number
ACTRN12612000862842
Ethics application status
Approved
Date submitted
9/08/2012
Date registered
15/08/2012
Date last updated
22/08/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effect of cooling in aerobic exercise on fatigue and physical performance for people with Multiple Sclerosis: A preliminary crossover trial
Scientific title
Effect of cooling in aerobic exercise on fatigue and physical performance for people with Multiple Sclerosis: A preliminary crossover trial
Secondary ID [1] 280993 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Fatigue in people with multiple sclerosis 287122 0
Condition category
Condition code
Neurological 287443 287443 0 0
Multiple sclerosis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Subjects will attend 3 visits in the duration of the trial. Exercise sessions will be one-on-one supervised by an exercise physiologist or physiotherapist. Visit 1 will determine each individuals maximum exercise capacity. Baseline assessment will be conducted on a recumbent bike. After a 5 minute warm up of cycling with no resistance, participants will begin to cycle at a low workload (30 Watts for MS patients, 50 Watts for controls). After each completed minute of exercise, workload will be increased by 10 Watts. Maximum workrate is defined as the wattage at the last completed minute of exercise. Visits 2 and 3 will occur on days 7 and 14, allowing a 7 day wash out period between experiments. Participants will exercise for up to 30 minutes at 65% of their determined maximum while wearing a cooling vest cooled to either 10 degrees or 21 degrees. The vest will be worn for 30 minutes seated resting prior to exercise and during warm up and aerobic exercise. All participants (both MS and controls) will take part in both conditions.
Intervention code [1] 285454 0
Rehabilitation
Intervention code [2] 285496 0
Treatment: Other
Intervention code [3] 285497 0
Prevention
Comparator / control treatment
Both MS and control participants will be randomly assigned their cross-over trial sequence in their 2nd and 3rd trial - cycling at 65% of maximal workload with 10 degrees passive cooling vest and cycling at 65% of maximal workload with 21 degrees sham cooling vest. The Cooling vest is placed in the freezer for 24 hours before testing. In the sham condition the vest is not frozen, ie left at room temperature. As it is likely that participants will be able to tell if the vest is cooled or not, no placebo effect of sham cooling is anticipated.
Control group
Active

Outcomes
Primary outcome [1] 287713 0
Core temperature analysis
The subject will swallow a disposable silicon-coated pill (CorTemp, Human Technology International, Glendora, California, USA) 3 - 8 hours before the beginning of second and third experimental trial. Each pill transmits a harmless low frequency signal to an external receiver which monitors the changes of core body temperature every 5 seconds throughout the trial.
Timepoint [1] 287713 0
2nd and 3rd visit (day 7 and 14)
Primary outcome [2] 287714 0
Heart rate analysis
Participant will be wearing a heart rate transmitter strap during all the trials, allowing constant monitoring of the individual's heart rate from the beginning to the end of test (Polar, USA). Subject's resting heart rate, rate of changes of heart rate along the aerobic exercise and heart rate recovery time will be recorded for further analysis.
Timepoint [2] 287714 0
2nd and 3rd visit (day 7 and 14)
Primary outcome [3] 287715 0
Blood lactate
Immediately before, and after stopping exercise, blood lactate level will be tested via a finger prick. A drop of blood will be deposited onto a special testing paper and blood lactate concentration will be measured (AccuTrend Lactate, USA). Lactate response to endurance test should >1 mmol/L over baseline if individual's exhaustion is due to cardiovascular fitness or <1 mmol/L by MS induced fatigue (Schulz et al, 2004).
Timepoint [3] 287715 0
Baseline, 2nd and 3rd visit (day 0, 7 and 14), pre and post exercise
Secondary outcome [1] 298680 0
Perceived exertion
The subject will rate their perceived exertion using the modified Borg Scale (RPE) (Borg, 1982) at each minute of exercise.
Timepoint [1] 298680 0
2nd and 3rd visit (day 7 and 14)
Secondary outcome [2] 298681 0
Perceived fatigue
Subjects will rate their fatigue levels on a Visual Analogue Scale immediately before, immediately after, and 24 hours after exercise.
Timepoint [2] 298681 0
2nd and 3rd visit (day 7 and 14)
Secondary outcome [3] 298682 0
Static standing balance test
Participants will stand on a force plate which will record their postural sway as a measure of static standing balance. Measurements will be taken into two conditions, (1) feet together (~0.5cm apart) with eyes open; and (2) feet together (~0.5cm apart) with eyes closed (Ramdharry et al, 2006). Each condition will be repeated 2 times. To ensure safety and prevent falling, there will be a close standby in this procedure and each condition will consist of 30 seconds test, and data will be collected by the force plates. The order of the two balance conditions will be randomized.
Timepoint [3] 298682 0
2nd and 3rd visit (day 7 and 14), pre and immediately post exercise completion.
Secondary outcome [4] 298683 0
Functional Reach Test (FRT)
The FRT can capture individual's margin of stability and postural control in balance over a fixed base of support by shifting the centre of gravity (Duncan et al, 1990).The participant will stand next to the wall with their dominant arm raised and out stretched beyond arm's length as far as possible with their hand in fist. The maximum distance of reaching forward from initial hand position to maximal leaning posture will be recorded as the change in position of third finger knuckle.
Timepoint [4] 298683 0
2nd and 3rd visit (day 7 and 14), pre and immediately post exercise completion.
Secondary outcome [5] 298684 0
10-Metre Walk Test (10MWT)
This test involves the subject walking along a 10m path and the individual's gait speed will be measured. The subject will be instructed to walk at a comfortable and maximum speed. This will be repeated 2 times and the average time will be recorded.
Timepoint [5] 298684 0
2nd and 3rd visit (day 7 and 14), pre and immediately post exercise completion.
Secondary outcome [6] 298685 0
Time Up and Go Test (TUG)
Performance on the Time Up and Go Test (TUG) is correlated with functional mobility level and risk of fall. All subjects will be seated, and then they will be asked to stand up from the chair, walk to the line on the floor (3 metres), turn around, walk back to the chair and be seated. Timing will start when instructors inform the test can be started and stop when subject is seated again (Podsiadlo & Richardson, 1991). A practice trial that is not timed will be given before testing.
Timepoint [6] 298685 0
2nd and 3rd visit (day 7 and 14), pre and immediately post exercise completion
Secondary outcome [7] 298686 0
Fatigue Severity Scale
The Fatigue Severity Scale (FSS) (Krupp et al, 1989) is a self-score questionnaire to measure the impact of fatigue on daily function over the last 7 days.
Timepoint [7] 298686 0
2nd and 3rd visit (day 7 and 14), pre and immediately post exercise completion

Eligibility
Key inclusion criteria
MS Subjects fulfilling the following criteria will be eligible to participate in this study:
Definite diagnosis of MS;
Mild to moderate difficulty in ambulation with Expanded Disability Status Scale (EDSS) 2.0 – 5.0;
Able and agree to engage in maximal exercise test with minimal work load above 30 watts, which is the starting workload of graded incremental cycling test;
Able to walk independently;
Self-report in problem with fatigue;
Able to understand instructions and give informed consent
Inclusion criteria for healthy participants:
Healthy male or female
Over 18 years of age
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
The exclusion criteria include:
Use of medication prescribed for fatigue management (e.g Amantadine, Modafinil);
Currently participates in other clinical trials or exercise program;
Suffering from an exacerbation or relapse of MS within the past 3 months;
Severe depression;
Suffering form other neural, cardiovascular, orthopaedic or muscular disease besides MS;
Gastroesophageal disease or dysphagia which has difficulty in swallowing the disposable silicon-coated pill to measure core temperature;
Diverticulitis, which is a digestive disease could affect bowel and become contraindication to pill ingestion;
Subject who is known to be pregnant;
Subject with blood clotting problem prone to bleeding complications in blood lactate testing;
Known illness or infection

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
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)

Funding & Sponsors
Funding source category [1] 285786 0
Charities/Societies/Foundations
Name [1] 285786 0
Foundation Daw Park
Address [1] 285786 0
Daws Rd
DAW PARK SA 5041
Country [1] 285786 0
Australia
Primary sponsor type
Individual
Name
Chris Barr
Address
Department of Rehabilitation and Aged Care
Flinders University
Repatriation General Hospital
Daws Rd
Daws Park, SA 5041
Country
Australia
Secondary sponsor category [1] 284608 0
None
Name [1] 284608 0
Address [1] 284608 0
Country [1] 284608 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287794 0
Southern Adelaide Clinical Human Research Ethics Committee
Ethics committee address [1] 287794 0
Flinders University
Sturt Rd
BEDFORD PARK SA 5042
Ethics committee country [1] 287794 0
Australia
Date submitted for ethics approval [1] 287794 0
Approval date [1] 287794 0
Ethics approval number [1] 287794 0

Summary
Brief summary
The study aims to analyse the effect of cooling, combined pre-cooling and cooling during exercise, in cycling with a passive cooling vest on core body temperature, heart rate, balance, physical capacity and fatigue of individuals with MS and general people.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34552 0
Address 34552 0
Country 34552 0
Phone 34552 0
Fax 34552 0
Email 34552 0
Contact person for public queries
Name 17799 0
Chris Barr
Address 17799 0
Department of Rehabilitation and Aged Care
Flinders University
Repatriation General Hospital
Daws Rd
Daws Park, SA 5041
Country 17799 0
Australia
Phone 17799 0
+61 8 8275 2852
Fax 17799 0
+61 8 8275 1130
Email 17799 0
chris.barr@flinders.edu.au
Contact person for scientific queries
Name 8727 0
Chris Barr
Address 8727 0
Department of Rehabilitation and Aged Care
Flinders University
Repatriation General Hospital
Daws Rd
Daws Park, SA 5041
Country 8727 0
Australia
Phone 8727 0
+61 8 8275 2852
Fax 8727 0
+61 8 8275 1130
Email 8727 0
chris.barr@flinders.edu.au

No information has been provided regarding IPD availability
Summary results
No Results