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Trial registered on ANZCTR


Registration number
ACTRN12614001309673
Ethics application status
Approved
Date submitted
14/11/2014
Date registered
16/12/2014
Date last updated
16/12/2014
Type of registration
Retrospectively registered

Titles & IDs
Public title
Exercise, chronic fatigue syndrome and multiple sclerosis
Scientific title
Physiological and Gene Responses to Cardiopulmonary Exercise Testing in Individuals with Chronic Fatigue Syndrome and Multiple Sclerosis.
Secondary ID [1] 285662 0
None
Universal Trial Number (UTN)
U1111-1164-1193
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Multiple Sclerosis (MS)
293511 0
Myalgic Encephalopathy/Chronic Fatigue Syndrome (ME/CFS) 293576 0
Condition category
Condition code
Neurological 293793 293793 0 0
Multiple sclerosis
Physical Medicine / Rehabilitation 293794 293794 0 0
Other physical medicine / rehabilitation
Other 293859 293859 0 0
Conditions of unknown or disputed aetiology (such as chronic fatigue syndrome/myalgic encephalomyelitis)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Individuals will be asked to visit the Human Performance Lab at Massey University, Palmerston North on two occasions, 24 hours apart. During the first visit, individuals will have height, weight and blood pressure measured. Individuals will then be asked to provide a blood sample from a vein in their arm. Following this individuals will have their radial and corotid artery assessed via pulse wave analysis/velocity. Individuals will complete a 5 minute resting ECG. Each individual will then complete an incrememntal cycle ergometer test. Exercise commences at 0W and increased at 15W every minute until exhaustion. On completion of the exercise test you will be asked to repeat the blood sampling and corotid and radial pulse wave analysis/velocity measurement. Finally you will be asked to complete an exercise recovery questionnaire, SF36 questionnaire and the Multidisciplinary fatigue inventory-20. On return to the lab 24 hours later each participant will repeat the radial and corotid pulse wave analysis/velocity assessment, blood sampling, incremental exercise test, exercise recovery questionnaire and Multidisciplinary fatigue inventory. The approximate duration will be an hour and a half for the first day and one hour max on the second data. The tests are administered and supervised by an Exercise Physiologist.
Intervention code [1] 290605 0
Early detection / Screening
Comparator / control treatment
A Comparison of differences in physiological variables between individuals with ME/CFS, MS and healthy controls
Control group
Active

Outcomes
Primary outcome [1] 293588 0
Peak oxygen consumption will be assessed via Turbofit metabolic cart.
Timepoint [1] 293588 0
Individuals will complete two peak oxygen tests, separated by 24 hours.
Primary outcome [2] 293645 0
Cardiac output will be assessed using the Defares rebreathing method and will be monitored using power lab. Individuals will be asked to complete two rebreathing samples at anaerobic threshold and at peak oxygen consumption
Timepoint [2] 293645 0
Individuals will complete two measurements of cardiac output at anaerobic threshold and peak oxygen consumption which will be separated by 24 hours.
Primary outcome [3] 293646 0
Pulse wave analysis and velocity will be assessed with SphygmaCor
Timepoint [3] 293646 0
Individuals will have pulse wave analysis and velocity tested before the exercise testing. Individuals will have pulse wave analysis and velocity retested 24 hours after initial testing.
Secondary outcome [1] 311415 0
Individuals will be asked to complete 6 questions regarding their recovery from peak oxygen consumption exercise testing.
Timepoint [1] 311415 0
Individuals will be asked to complete questions, following the initial exercise test, one day post exercise testing, following the second exercise test, day three (day after 2nd exercise test and then to describe how long it takes them to recover in days.
Secondary outcome [2] 311514 0
Gene response to exercise testing measured by blood samples
Timepoint [2] 311514 0
Individuals will provide blood samples pre and post exercise testing. Individuals will provide 4 samples across 2 days. The samples will be analysed to see how they change pre and post exercise testing.

Eligibility
Key inclusion criteria
Individuals who have been diagnosed with Multiple Sclerosis or ME/Chronic Fatigue Syndrome or that meet the criteria based on the De Paul Symptom Questionnaire and those who are healthy aged matched controls
Minimum age
18 Years
Maximum age
80 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Individuals with co-mordibities such as cardiovascular disease, diabetes.

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
At Massey University we run an exercise clinic for Multiple Sclerosis, so these individuals will be recruited through our clinic. Individuals with ME/CFS will be recruited through completion of an online DePaul Symptom Questionnaire.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Individuals will not be randomised into treatment/non treatment. All individuals will undergo all tests
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis
Sample size calculation.
Taking peak oxygen consumption for the CFS subjects, Standard deviation appears to be around 1.8 ml/kg/min, take 0.05 as the significance level. An improvement would be of 1 ml/kg/min and the power 80%. Therefore it is possible to calculate a sample size of 21 required.

The use of SPSS will allow for descriptive data on each health condition. Results of each health condition will be compared using T-test and Anova.

Recruitment
Recruitment status
Active, not 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 outside Australia
Country [1] 6474 0
New Zealand
State/province [1] 6474 0
Manawatu

Funding & Sponsors
Funding source category [1] 290244 0
University
Name [1] 290244 0
Massey University
Address [1] 290244 0
School of Sport and Exercise
Massey University,
Private Bag 11-222
Palmerston North
4442
Country [1] 290244 0
New Zealand
Primary sponsor type
University
Name
Massey University
Address
School of Sport and Exercise,
Massey University
Private Bag 11-222
Palmerston North
4442
Country
New Zealand
Secondary sponsor category [1] 288950 0
None
Name [1] 288950 0
Address [1] 288950 0
Country [1] 288950 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291946 0
Central Health and Ethics Disability Committee
Ethics committee address [1] 291946 0
Health and Disability Ethics Committees
1 The Terrace
C/-MEDSAFE Level 6, Deloitte House
10 Brandon Street
PO Box 5013
Wellington
6011
Ethics committee country [1] 291946 0
New Zealand
Date submitted for ethics approval [1] 291946 0
Approval date [1] 291946 0
07/02/2014
Ethics approval number [1] 291946 0
13/CEN203

Summary
Brief summary
The purpose of the study is to show a difference in fatigue measured using physiological outcomes following repeated exercise in three groups of participants. These groups will include, Multiple Sclerosis, Chronic Fatigue Syndrome/Myalgic Encephalopathy and healthy age matched controls. Although individuals with MS, CFS/ME suffer from fatigue, it is expected that the type of fatigue and the way it affects the body is different and therefore the responses to physical incremental exercise separated by 24 hours will be different.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 52782 0
Dr Lynette Hodges
Address 52782 0
School of Sport and Exercise,
Massey University,
Private Bag 11-222
Palmerston North
4442
Country 52782 0
New Zealand
Phone 52782 0
+64 6 356 9099 ext 84536
Fax 52782 0
Email 52782 0
l.d.hodges@massey.ac.nz
Contact person for public queries
Name 52783 0
Dr Lynette Hodges
Address 52783 0
School of Sport and Exercise,
Massey University,
Private Bag 11-222
Palmerston North
4442
Country 52783 0
New Zealand
Phone 52783 0
+64 6 356 9099 ext 84536
Fax 52783 0
Email 52783 0
l.d.hodges@massey.ac.nz
Contact person for scientific queries
Name 52784 0
Dr Lynette Hodges
Address 52784 0
School of Sport and Exercise,
Massey University,
Private Bag 11-222
Palmerston North
4442
Country 52784 0
New Zealand
Phone 52784 0
+64 6 356 9099 ext 84536
Fax 52784 0
Email 52784 0
l.d.hodges@massey.ac.nz

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