ANZCTR - Registration

The ANZCTR website is back online for trial registration and updates. We apologise for any inconvenience caused while the site was inactive.

With activity expected to increase on the ANZCTR again, there may be extended wait times while we process pending studies, with priority being given to those trials submitted in February. Thank you for your patience.

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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers

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]

NONE

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Multiple Sclerosis

Condition category

Condition code

Neurological

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]

Lifestyle

Comparator / control treatment

The control group will receive no exercise for 12 weeks.

Control group

Active

Outcomes

Primary outcome [1]

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]

Timepoint will be after participant has completed the 12 week intervention

Secondary outcome [1]

12 weeks of upper body exercise will be effective in increasing quality of life as measured through changes in the SF36 questionnaire

Timepoint [1]

This will be assessed after 12 weeks of the intervention have been completed

Secondary outcome [2]

12 weeks of upper body exercise wil be effective in increasing balance as measured by the standing balance test.

Timepoint [2]

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?

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

Accrual to date

Final

Recruitment outside Australia

Country [1]

New Zealand

State/province [1]

Manawatu

Funding & Sponsors

Funding source category [1]

University

Name [1]

Massey University

Address [1]

Institute of Food Nutrition and Human Health, Private Bag 11-222 Palmerston North 4442

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Central Committee: Health and Disability Ethics Committee

Ethics committee address [1]

PO Box 53,
Wellington

Ethics committee country [1]

New Zealand

Date submitted for ethics approval [1]

19/11/2010

Approval date [1]

Ethics approval number [1]

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

Address

Country

Phone

Fax

Contact person for public queries

Name

Dr Lynette Singleton

Address

Department of Sport and Exercise Science, Institute of Food, Nutrition and Human Health, Massey University, Private Bag 11-222 Palmerston North 4442

Country

New Zealand

Phone

+64 6 350 4335 ext 7613

Fax

+64 6 350 5657

[email protected]

Contact person for scientific queries

Name

Dr Lynette Singleton

Address

Department of Sport and Exercise Science, Institute of Food, Nutrition and Human Health, Massey University, Private Bag 11-222 Palmerston North 4442

Country

New Zealand

Phone

+64 6 350 4335 ext 7613

Fax

+64 6 350 5657

[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.

Trial Review

Documents added manually

Documents added automatically