Trial Review

The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.

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
ACTRN12617000984392
Ethics application status
Approved
Date submitted
8/06/2017
Date registered
10/07/2017
Date last updated
10/07/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
The impact of two different-home based physical training interventions to reduce fatigue and improve, strength, dexterity, and activities of daily living in adults with Multiple Sclerosis.
Scientific title
All Hands-on Deck: Determining the impact of two different-home based physical training interventions to reduce fatigue and improve, strength, dexterity, and activities of daily living in adults with Multiple Sclerosis.
Secondary ID [1] 292155 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Multiple Sclerosis 303595 0
Condition category
Condition code
Neurological 303005 303005 0 0
Multiple sclerosis
Physical Medicine / Rehabilitation 303019 303019 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
1. Home-based physical training to reduce fatigue and improve strength, dexterity and activities of daily living in adults with Multiple Sclerosis.

2. This research project aims to investigate the effect of two different home-based physical training programs on the functional well-being of adults with Multiple Sclerosis (MS). Functional well-being is often hindered by MS, as it affects the ability to perform Activities of Daily Living (ADLs). ADLs are the tasks that one completes every day, such as using cutlery, tying shoelaces and brushing one’s teeth. These tasks require fine motor skills that involve the use of small intricate muscles in the hands and arms. When these muscles become tired, completing ADLs can feel taxing due to fatigue, which can result in losses of concentration and difficulty maintaining focus. Both yoga and strength training have separately been recognised as forms of therapy for their ability to improve body awareness, release tension and decrease fatigue. Fine motor training has also been reported as having an impact in improving ADL’s and reducing fatigue in adults with MS. For this project, we wish to combine a strength and yoga home program and compare it to a fine motor home program. The aim of this project is to examine the impact of two separate home-based physical training programs, (1) fine motor training and (2) strength and yoga training to determine which one has an impact in reducing fatigue, and improving ADLs, dexterity, and strength to hopefully maintain physical independence at home.

3. Each person/participant will be required to complete the Jamar Dynamometer, Modified Fatigue Impact Scale (MFIS) questionnaire, Nine-Hole Peg Test (9-HPT) and the Nottingham Extended Activities of Daily Living (NEADL) questionnaire before and after their allocated program.

4. Participants will either be randomly allocated to the Fine Motor group, or the Strength/yoga group. Each training program will run for a total of 4-weeks, taking approximately 30 minutes to complete and is required to be performed 4-days of the week. For those who are allocated the Fine Motor training program, they will complete six exercises, 4-days a week. For those allocated to the combination training of Strength and Yoga training program, the strength component will involve the use of a Theraband, which seven exercises will be performed. The Yoga requires seven poses to be performed, with modifications available.

Orientation of the program prior to commencement:
Each person will be required to visit the Multiple Sclerosis Society of Western Australia (MSWA), in Wilson to complete and an introductory/orientation session. This session will run for 60 to 90 minutes, allowing time for questions and queries to be answered. The aim of this orientation will to provide the participants with the opportunity to perform their required exercises and ask any questions about their chosen program. There will be multiple orientation sessions on offer for each person to attend at a time that suits their availability. After an orientation session is completed, each person will commence their program the following day by watching videos on an USB provided by the researcher/ watching videos posted on a personal YouTube channel.

5. The intervention provider will be conducted by the researcher, who has a Bachelor's degree in Exercise and Sport Science.

6. Each person must allocate approximately 30 minutes on 4 days of the week, for a period of 4 weeks to complete their allocated program.

7. This is a home-based physical training program.

8. Fine Motor Training Program was adapted from an Arm Ability Training program in people with mild arm paresis after stroke and traumatic brain injury. This program consists of six different exercises including finger tapping, crossing circles, turning discs, nuts on bolts and modelling clay (Platz et al., 2001; Plazt, 2006). Exercises 1-4 are to be performed as fast as possible with the time taken to complete each task being recorded. Exercises 5-6 are to be performed without measuring the time. Participants will record the quality of their movement.

Strength Program involves seven upper extremity strength-training exercises using a Theraband. The tempo of each lift set at 5-0-2; where 5 sec indicates the length of the eccentric phase of the lift, 0 sec isometric (pause) within the lift, and 2 sec concentric phase of the lift (Dibble et al., 2006). The exercises include elbow-flexion, elbow extension, hand-abduction, hand pronation, hand-supination, hand-extension and hand-flexion (Romberg et al., 2004). The selection of the Therabands is in accordance with Santos et al. (2009). Each week participants will be given a new Theraband to increase their strength. Each band has a difference in resistance of 15 to 25% (Santos et al., 2009). Participants will start with the lowest (red) and then progress to blue, green and black (Santos et al., 2009) each week. The Theraband website (http://tbdev.performancehealthdev.com/media/theraband/instructions/Resistance_Band-Tubing_Instruction_Manual(1).pdf) prescribes a load calculation of the percentage of elongation of the Therabad. The calculation: % elongation = [(final length – initial length) / (initial length)] x 100 (Colado et al., 2010). The values produced are the values specific to each Theraband colour (Page et al., 2000). A protocol of three sets of ten repetitions for each exercise, with a 60-second rest interval between sets will be implemented (Areas et al., 2013). Each participant is to record the exercises they performed. If participants are not able to complete the required amount of repetitions they will record what repetitions they could complete and the reason why they had to stop, such as fatigue.

Yoga program is Three elements of the home yoga program are outlined below, the completion of the program taking 15 minutes (Komatsu et al., 2015). The participants will progress through the three different programs over the first 3 weeks, which includes:
1. Fullbody stretching including isometrics and deep breathing (Week 1).
2. Low intensity with sedentary poses (Week 2)
3. Higher intensity with standing poses (Week 3)
Week four will allow the participants to choose either one program or combining multiple programs to practice based on their preferences and how they are feeling (Komatsu et al., 2015). The participants will keep a diary and write down the date, the specific yoga program and the practice time (Komatsu et al., 2015). This will be noted for data analysis.
Each pose will be held for 10-30seconds, followed by a resting period lasting from 30-seconds to 1-minute (Guner & Inanici, 2015).
Intervention code [1] 298301 0
Treatment: Other
Comparator / control treatment
The aim of the project is compare fine motor training to a strength and yoga training program.
Control group
Active

Outcomes
Primary outcome [1] 302378 0
Fatigue is measured by Modified Fatigue Impact Scale (MFIS)
Timepoint [1] 302378 0
Pre and Post 4-week intervention.
Secondary outcome [1] 335777 0
Activities of daily living measured using the Nottingham Extended Activities of Daily Living (NEADL) Scale.
Timepoint [1] 335777 0
pre and post 4-week intervention.
Secondary outcome [2] 335779 0
Manual dexterity is measured using the Nine Hole Peg Test (9-HPT)
Timepoint [2] 335779 0
pre and post 4-week intervention
Secondary outcome [3] 335780 0
Strength is measured using the Jamar Dynamometer
Timepoint [3] 335780 0
pre and post 4-week intervention

Eligibility
Key inclusion criteria
Inclusion criteria for participants in this study include: Male and Female Adults (over 18) with no ongoing relapse, upper extremity dysfunction due to muscle weakness related to their Multiple Sclerosis (MS), ability to use test materials with capable cognitive function, and have not previously engaged in a hand exercise intervention program. Adults identified and categorised within the mild-moderate spectrum of MS are to be included into the study.

Participants on the mild to moderate spectrum of MS will be recruited through Multiple Sclerosis Western Australia (MSWA). The spectrum of MS is assessed using the Expanded Disability Status Scale (EDSS), which is a measure of the neurologic impact of MS (Kurtzke, 1983). Participants will range from 2.0-3.5 on the EDSS will be recruited to participate (Kurtzke, 1983). EDSS score 2.0 refers to individuals who have a minimal disability in one functional system (FS). A score of 3.5 refers to individuals with a moderate disability in one FS and more than minimal disability in several others; there is no impairment to walking. Participants within this range are at the mild to moderate end of the spectrum of MS and will be able to complete the programs.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants with recent exacerbation of their MS, previous surgery on their upper extremity, any disorder that affected upper extremity performance, acute major comorbidities, any major serious chronic illness, and any other neurological illness other than Multiple Sclerosis will be excluded.

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)
Simple randomisation using a randomisation table created by computer software
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
SPSS v.24 will be used to analyse the data. The appropriate descriptive statistics as well as parametric (T-tests) and non-parametric tests will be used dependent on the normality of the data. Paired sample t-tests (or the non-parametric alternative) will examine pre-post changes to manual dexterity, strength, MFIS and ADL’s for the different programs. A linear mixed model will be used to control for functional status of participants when examining outcomes. The significance level for statistical tests will be set at p < .05.

Kamm et al.’s (2015) study included 40 participants and found statistically significant improvements in dexterity and ADL outcomes. This number was also based on previous randomised controlled trials that evaluated similar training programs in other neurological diseases (Platz et al., 2001; Platz, 2006). These two studies found that a sample size of 20 participants per group was necessary to achieve an 80% chance (power = 0.80) to observe a statistically significant differential effect.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/08/2017
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 296690 0
Government body
Name [1] 296690 0
Australian Government
Country [1] 296690 0
Australia
Primary sponsor type
University
Name
The University of Notre Dame
Address
PO Box 1225, Fremantle, WA, 6959. School of Health Sciences, UND
Country
Australia
Secondary sponsor category [1] 295649 0
None
Name [1] 295649 0
Address [1] 295649 0
Country [1] 295649 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297916 0
Notre Dame's Australia Human Research Ethics Committee
Ethics committee address [1] 297916 0
Ethics committee country [1] 297916 0
Australia
Date submitted for ethics approval [1] 297916 0
10/05/2017
Approval date [1] 297916 0
30/05/2017
Ethics approval number [1] 297916 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 75454 0
Miss Lauren Jones
Address 75454 0
School of Health Sciences, University of Notre Dame, PO Box 1225, Fremantle, WA, 6959
Country 75454 0
Australia
Phone 75454 0
+61 423343663
Fax 75454 0
Email 75454 0
[email protected]
Contact person for public queries
Name 75455 0
Lauren Jones
Address 75455 0
School of Health Sciences, University of Notre Dame, PO Box 1225, Fremantle, WA, 6959
Country 75455 0
Australia
Phone 75455 0
+61 423343663
Fax 75455 0
Email 75455 0
[email protected]
Contact person for scientific queries
Name 75456 0
Lauren Jones
Address 75456 0
School of Health Sciences, University of Notre Dame, PO Box 1225, Fremantle, WA, 6959
Country 75456 0
Australia
Phone 75456 0
+61 423343663
Fax 75456 0
Email 75456 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.