Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617000764336
Ethics application status
Approved
Date submitted
17/05/2017
Date registered
24/05/2017
Date last updated
24/05/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
The benefits of exercising in a group vs at home independently for ambulatory people with multiple sclerosis
Scientific title
The physical benefit of exercising in a group vs at home independently for ambulatory people with multiple sclerosis
Secondary ID [1] 281918 0
Nil known
Universal Trial Number (UTN)
U1111-1139-3476
Trial acronym
Linked study record

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

 2491 0
Condition category
Condition code
Neurological 2589 2589 0 0
Multiple sclerosis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
There is one intervention arm, Group circuit training.
Group circuit training consists of; - twice weekly balance training strategy exercise class (60 minutes, 8 weeks) aimed at improving gait speed, endurance, balance and reported fatigue. The training intervention providers were registered Physiotherapists with experience working with people with Multiple Sclerosis. Each training intervention Physiotherapist was provided with a list of exercises per station with progression strategies and modifications to be provided as suitable to progress the participant and manage any safety concerns.
All classes were undertaken at local community halls. Exercises were performed for 5 minutes per station at intensity selected by the participant - best effort - but no more than borg rating of 6/10. A total of 10 stations were included, each lasting for 5 minutes (total of 50 minutes, with 2 stations dedicated to warm up (5 minutes) and cool down (5 minutes). There transition from station to station was 1 minute (total of 9 minutes). Each participant completed 59 minutes of activity, the final minutes used to answer any participant concerns. Rests were provided as required for each participant with no formal time period designated, however each participant was encouraged to pace themselves and to limit their rests to no more than 30 seconds at a time if taken.
Examples of exercises performed
Sit to stand from variable height chair - progressions: speed, base of support, preferential loading, height of chair.
Marching on the spot - progressions, lifting legs higher, starting from toe off - into claw, reducing hand support, speed.
walking forward and backward - progressions longer steps, faster, narrower base of support
Balance standing dynamic - progression with reduced / altered base of support, increase dynamic trunk and arm movement, distance reached, holding distance reached, changing direction of distances reached, adding unstable surfaces
each interventions is personalised and adapted individually for the group program by the treating physiotherapists monitoring the participants skill of execution and encouraging variances to the task. At 4 weeks all participants were encouraged to increase intensity and beat personal goals of repetitions, speed, distances covered.
The treating physiotherapists provided ongoing feedback and monitoring of participant adherence and needs. If a participant failed to attend without prior notification, phone contact was made to ascertain concerns / problems and encourage return.
Intervention code [1] 2219 0
Rehabilitation
Comparator / control treatment
Home exercise - twice weekly balance training strategy exercises performed at home independently (60 minutes, 8 weeks) aimed at improving gait speed, endurance, balance and reported fatigue.
Initial training intervention 1;1. lasting for 60 minutes provided by registered Physiotherapists with experience working with people with Multiple Sclerosis.
Each participant taken through a list of predetermined exercises (same as provided for intervention arm). Each 5 minute station exercise had a progression strategy and modifications. There were 8 stations in total with two dedicated to warm up and cool down (total 50 minutes activity). 1 minute was allocated to allow transition / set up for next station (total 9 minutes). in total 59 minutes of activity was completed. The treating physiotherapist provided education on when, how and why to modify to ensure safety and participant engagement. Each participant was provided with a written instruction / pictorial booklet for each exercise and station including modifications and progressions strategies. They were also provided with a exercise recording sheet.
Each exercise was performed at an intensity selected by the participant - best effort - but no more than borg rating of 6/10. Rests were allowed, however participants were encouraged to pace themselves so they were active for the full 5 minutes of each station and if a rest was required to be no more than 30seconds.
Equipment required for completion of each station were usual home furniture and environments, including, dinning room chair, lounge chair, step, table, hallway or bench. If the participant did not have a step a phone book of 10-12cm height was provided which had been bound with masking tape to form a solid block.
Examples of exercises performed
Sit to stand from variable height chair - progressions: speed, base of support, preferential loading, height of chair.
Marching on the spot - progressions, lifting legs higher, starting from toe off - into claw, reducing hand support, speed.
walking forward and backward - progressions longer steps, faster, narrower base of support
Balance standing dynamic - progression with reduced / altered base of support, increase dynamic trunk and arm movement, distance reached, holding distance reached, changing direction of distances reached, adding unstable surfaces
The treating physiotherapist contacted the participant every 2 weeks via phone to discuss any concerns, ideas for modifications etc... The participant returned the exercise recording sheets at week 4 and 8. The participant were also provided with the treating physiotherapist contact number should they have urgent concerns or questions. At 4 weeks all participants were encouraged to increase intensity and beat personal goals of repetitions, speed, distances covered.
The treating physiotherapists contacted the participant via phone if the returned exercise recording sheets had low adherence recorded. The contact goal was to encourage increased adherence and provide further feedback or support should that be needed.
Control group
Active

Outcomes
Primary outcome [1] 3499 0
10 meter walk test
Timepoint [1] 3499 0
Baseline, pre-intervention, post intervention, follow up 8 weeks post intervention.
Secondary outcome [1] 5837 0
6 minute walk distance
Timepoint [1] 5837 0
Baseline, pre-intervention, post intervention, follow up 8 weeks post intervention.
Secondary outcome [2] 5838 0
Berg Balance Scale
Timepoint [2] 5838 0
Baseline, pre-intervention, post intervention, follow up 8 weeks post intervention.
Secondary outcome [3] 5839 0
Modified Fatigue Impact Scale
Timepoint [3] 5839 0
Baseline, follow up 8 weeks post intervention.
Secondary outcome [4] 5843 0
Psychological Adjustment Inventory Scale
Timepoint [4] 5843 0
Baseline, follow up 8 weeks post intervention.
Secondary outcome [5] 5844 0
Ease of transport scale
Timepoint [5] 5844 0
Baseline, follow up 8 weeks post intervention.
Secondary outcome [6] 5845 0
Satisfaction to exercise scale
Timepoint [6] 5845 0
Baseline, follow up 8 weeks post intervention.

Eligibility
Key inclusion criteria
Inclusion criteria :
Confirmed diagnosis of Multiple Sclerosis by Neurologist
Able to walk 10 meters in 2 minutes with or without an aid, able to provide informed consent.
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria
Active Multiple Sclerosis exacerbation within last 4 weeks.
Other neurological or orthopeadic condition that limits active exercise or medical conditions that preclude exercise
Already actively participating in exercise twice per week for more than 30 minutes at each session.

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)
Offsite concealed randomisation prepared by researcher. Consecutively numbered opaque envelopes containing random group allocation to be opened by therapist implementing intervention.

Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A computer generated random number will be used to generate the sequence.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Intention to treat principal with repeated measure analysis of variance and Mann Whitney T-tests.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
1/09/2003
Date of last participant enrolment
Anticipated
Actual
8/04/2005
Date of last data collection
Anticipated
Actual
28/09/2005
Sample size
Target
44
Accrual to date
Final
50
Recruitment in Australia
Recruitment state(s)
NSW,SA
Recruitment hospital [1] 8032 0
Multiple Sclerosis Ltd (MS Ltd) - Studdy MS Centre - Lidcombe
Recruitment postcode(s) [1] 529 0
2576
Recruitment postcode(s) [2] 530 0
2037
Recruitment postcode(s) [3] 531 0
5000
Recruitment postcode(s) [4] 532 0
2042
Recruitment postcode(s) [5] 533 0
2022
Recruitment postcode(s) [6] 534 0
2026
Recruitment postcode(s) [7] 535 0
2035
Recruitment postcode(s) [8] 536 0
2750
Recruitment postcode(s) [9] 537 0
2751
Recruitment postcode(s) [10] 16019 0
2141 - Lidcombe

Funding & Sponsors
Funding source category [1] 2924 0
Charities/Societies/Foundations
Name [1] 2924 0
Multiple Sclerosis Research Foundation
Country [1] 2924 0
Australia
Primary sponsor type
Individual
Name
Ms Katrina Williams
Address
University of Queensland
Therapies Building 84A
St Lucia
QLD 4072
Country
Australia
Secondary sponsor category [1] 285478 0
None
Name [1] 285478 0
NONE
Address [1] 285478 0
Country [1] 285478 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 4869 0
Multiple Sclerosis Research and Ethics committee NSW
Ethics committee address [1] 4869 0
MS Society of NSW
Lidcombe
NSW 1825
Ethics committee country [1] 4869 0
Australia
Date submitted for ethics approval [1] 4869 0
Approval date [1] 4869 0
02/07/2002
Ethics approval number [1] 4869 0
Ethics committee name [2] 297771 0
Medical Research Ethics Committee (MREC) University of Queensland
Ethics committee address [2] 297771 0
St Lucia Campus
St Lucia
QLD 4072
Ethics committee country [2] 297771 0
Australia
Date submitted for ethics approval [2] 297771 0
Approval date [2] 297771 0
10/05/2013
Ethics approval number [2] 297771 0
2013000418

Summary
Brief summary
This study is to measure the effect of a functional balance training program on gait, endurance, balance and fatigue in people with MS performed by the participant in a group setting or by the participant independently at home twice per week. The secondary aim is to investigate any predictors of adherence to exercises.
Trial website
Trial related presentations / publications
None
Public notes
Ethics approval was originally obtained by the Multiple Sclerosis Society of ACT, NSW and Victoria ethics and research committee prior to the commencement of the project and first participant enrolment in 2003. This was completed during my employment with the Multiple Sclerosis Society of NSW (now MS Society of ACT, NSW and Vic) . Further ethics approval was obtained from the University of Queensland to obtain an official ethics approval number in 2013 to facilitate publication of the findings. Levels of requirement for ethics had altered over the ensuing years necessitating this action.

Contacts
Principal investigator
Name 28137 0
Ms Katrina Williams
Address 28137 0
University of Queensland
Therapies Building 84A
St Lucia
QLD 4072
Country 28137 0
Australia
Phone 28137 0
+ 61 7 33654507
Fax 28137 0
Email 28137 0
[email protected]
Contact person for public queries
Name 11294 0
Ms Katrina Williams
Address 11294 0
University of Queensland
Therapies Building 84
St Lucia
QLD 4072
Country 11294 0
Australia
Phone 11294 0
+ 61 7 33654507
Fax 11294 0
Email 11294 0
[email protected]
Contact person for scientific queries
Name 2222 0
Ms Katrina Williams
Address 2222 0
Physiotherapy Department
University of QLD
St Lucia
QLD 4072
Country 2222 0
Australia
Phone 2222 0
+ 61 7 33654507
Fax 2222 0
Email 2222 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.