Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000976088
Ethics application status
Approved
Date submitted
12/11/2010
Date registered
12/11/2010
Date last updated
12/11/2010
Type of registration
Prospectively registered

Titles & IDs
Public title
Exercise Training for Multiple Sclerosis (MS) Patients
Scientific title
Upper body ergometry in patients with MS
Secondary ID [1] 253072 0
NONE
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Multiple Sclerosis 258634 0
Condition category
Condition code
Neurological 258775 258775 0 0
Multiple sclerosis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Individuals will be required to train twice weekly for up to 30 minutes at a prescibed intensity of 70% VO2 max using an arm ergometer for 12 weeks. The prescribed intensity will be monitored via a heart rate monitor and will be increased as necessary to facilitate training adaptations.
Intervention code [1] 257592 0
Lifestyle
Comparator / control treatment
The control group will receive no exercise for 12 weeks.
Control group
Active

Outcomes
Primary outcome [1] 259639 0
12 weeks of upper body exercise will be effective in maintaining or improving cardiovascular fitness, increased mobility assessed by an incremental exercise test using upper body ergometry to voltional exhaustion, timed up and go and a timed walk test.
Timepoint [1] 259639 0
Timepoint will be after participant has completed the 12 week intervention
Secondary outcome [1] 266299 0
12 weeks of upper body exercise will be effective in increasing quality of life as measured through changes in the SF36 questionnaire
Timepoint [1] 266299 0
This will be assessed after 12 weeks of the intervention have been completed
Secondary outcome [2] 266317 0
12 weeks of upper body exercise wil be effective in increasing balance as measured by the standing balance test.
Timepoint [2] 266317 0
This will be assessed after 12 weeks of the intervention have been completed

Eligibility
Key inclusion criteria
Individuals with Multiple Sclerosis
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Individuals who are wheelchair bound or who are on multiple medication which may be affected by the exercise prescribed.

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)
Allocation is not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A computer program will be used to generate the sequence.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
11/01/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
24
Accrual to date
Final
Recruitment outside Australia
Country [1] 3034 0
New Zealand
State/province [1] 3034 0
Manawatu

Funding & Sponsors
Funding source category [1] 258039 0
University
Name [1] 258039 0
Massey University
Country [1] 258039 0
New Zealand
Primary sponsor type
University
Name
Massey University
Address
College of Sciences
Massey University
Private Bag 11-222
Palmerston North
4442
Country
New Zealand
Secondary sponsor category [1] 257233 0
None
Name [1] 257233 0
Address [1] 257233 0
Country [1] 257233 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 260043 0
Central Committee: Health and Disability Ethics Committee
Ethics committee address [1] 260043 0
PO Box 53,
Wellington
Ethics committee country [1] 260043 0
New Zealand
Date submitted for ethics approval [1] 260043 0
19/11/2010
Approval date [1] 260043 0
Ethics approval number [1] 260043 0

Summary
Brief summary
Multiple Sclerosis (MS) can lead to a reduction in mobility, co-ordination, muscular strength and impact an individual’s ability to maintain regular exercise. As a result, the risk of developing diabetes, obesity and cardiovascular disease are high. Upper body exercise may provide important health benefits. This study aims to investigate whether 12 weeks of upper body exercise is effective in improving or maintaining cardiovascular fitness, increased mobility, strength and quality of life.
Participants will complete a series of tests (incremental upper body exercise, timed up and go, standing balance, functional reach, timed walk test and an SF36 quality of life questionnaire). Participants will then be randomly assigned to training or no training. The training group will be required to complete 30 minutes of upper body ergometry exercise twice weekly for 12 weeks. Individuals in the no exercise group will be asked to refrain from exercise for the 12 week period.
The results obtained from these experiments will be used to develop a greater understanding of exercise training in this group. Improved understanding will be of value to the field of human physiology and will be useful to clinicians in the assessment of the progression of cardiovascular disease in this patient group.
Trial website
None
Trial related presentations / publications
None to date
Public notes

Contacts
Principal investigator
Name 31902 0
Address 31902 0
Country 31902 0
Phone 31902 0
Fax 31902 0
Email 31902 0
Contact person for public queries
Name 15149 0
Dr Lynette Singleton
Address 15149 0
Department of Sport and Exercise Science,
Institute of Food, Nutrition and Human Health,
Massey University,
Private Bag 11-222
Palmerston North
4442
Country 15149 0
New Zealand
Phone 15149 0
+64 6 350 4335 ext 7613
Fax 15149 0
+64 6 350 5657
Email 15149 0
[email protected]
Contact person for scientific queries
Name 6077 0
Dr Lynette Singleton
Address 6077 0
Department of Sport and Exercise Science,
Institute of Food, Nutrition and Human Health,
Massey University,
Private Bag 11-222
Palmerston North
4442
Country 6077 0
New Zealand
Phone 6077 0
+64 6 350 4335 ext 7613
Fax 6077 0
+64 6 350 5657
Email 6077 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.