Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624001262594p
Ethics application status
Submitted, not yet approved
Date submitted
29/08/2024
Date registered
16/10/2024
Date last updated
3/11/2024
Date data sharing statement initially provided
16/10/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
A clinician-led feasibility, acceptability, and pilot efficacy intervention on bone health and muscle strength in people with multiple sclerosis.
Scientific title
Evaluating the effectiveness of High-intensity Resistance Impact Training (HiRIT) on bone health and muscle strength in people with multiple sclerosis: A randomised controlled trial.
Secondary ID [1] 312834 0
None
Universal Trial Number (UTN)
Trial acronym
STRONG-MS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Multiple Sclerosis 334945 0
Osteoporosis 334947 0
Reduced Physical Activity 334948 0
Condition category
Condition code
Neurological 331481 331481 0 0
Multiple sclerosis
Musculoskeletal 331482 331482 0 0
Osteoporosis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The STRONG-MS intervention involves a structured Onero High-intensity Resistance Impact Training (HiRIT) program tailored to people with multiple sclerosis (MS). This includes 45-minute supervised sessions (in small groups of 6) twice a week for 12 months, focusing on improving bone density, muscle strength, and overall physical function. The exercise regimen incorporates high-impact and resistance exercises (e.g., deadlifts, squats, overhead presses), with a progressive adjustment period to accommodate each participant's abilities and safety needs. The intervention is delivered across several specialised sites, with each group being facilitated by a qualified physiotherapist and exercise physiologist to support participant engagement and adherence over a long duration. Weekly exercise logs are also filled out by supervisors to monitor adherence, and 3-month feasibility is completed to assess participant's overall attendance and progress. The Onero HiRIT program's intensity level has been measured using the One Repetition Maximum (1RM) method.
Intervention code [1] 329379 0
Lifestyle
Intervention code [2] 329380 0
Behaviour
Intervention code [3] 329579 0
Treatment: Other
Comparator / control treatment
Participants randomised to the control group will continue with their usual/standard care practices for 12 months. Usual care in this study is defined as participants who maintain existing health practices (e.g., GP appointments, standard physiotherapy, medications) and do not receive the Onero HiRIT intervention during the 12-month intervention phase. After this period, they will have the opportunity to participate in the Onero HiRIT intervention at no cost to them.
Control group
Active

Outcomes
Primary outcome [1] 339223 0
Health-related quality of life (HR-QoL).
Assessment method [1] 339223 0
Multiple Sclerosis Impact Scale (MSIS-8D).
Timepoint [1] 339223 0
Baseline, 12-months end of intervention, 24-months post-intervention.
Primary outcome [2] 339224 0
Areal Bone Mineral Density (aBMD).
Assessment method [2] 339224 0
Dual-Energy X-ray Absorptiometry (DXA).
Timepoint [2] 339224 0
Baseline, 12-months end of intervention, 24-months post-intervention.
Primary outcome [3] 339225 0
Feasibility.
Assessment method [3] 339225 0
Attendance at greater than or equal to 80% of the exercise sessions (Y/N). The number of exercises (out of 4) that the participant was able to undertake successfully at 3-months and 12-months.
Timepoint [3] 339225 0
3-months feasibility, 12-months end of intervention.
Secondary outcome [1] 439156 0
Anthropometry.
Assessment method [1] 439156 0
Measurements of weight, height, appendicular lean mass, and whole-body fat mass using DXA.
Timepoint [1] 439156 0
Baseline, 12-months end of intervention, 24-months post-intervention.
Secondary outcome [2] 439157 0
Fasting Blood Samples.
Assessment method [2] 439157 0
Bone turnover markers (P1NP and CTX), calcium, phosphate, and vitamin D levels is collected through blood serum analysis.
Timepoint [2] 439157 0
Baseline, 12-months end of intervention, 24-months post-intervention.
Secondary outcome [3] 439158 0
Disability.
Assessment method [3] 439158 0
Expanded Disability Status Scale (EDSS) and Patient Determined Disability Steps (PDDS).
Timepoint [3] 439158 0
Baseline, 12-months end of intervention, 24-months post-intervention.
Secondary outcome [4] 439159 0
Short Physical Performance Battery (SPPB).
Assessment method [4] 439159 0
Performance in gait speed, chair rise, and standing balance tests.
Timepoint [4] 439159 0
Baseline, 12-months end of intervention, 24-months post-intervention.
Secondary outcome [5] 439160 0
Hand Grip Strength (HGS).
Assessment method [5] 439160 0
Tested by the Jamar hand dynamometer.
Timepoint [5] 439160 0
Baseline, 12-months end of intervention, 24-months post-intervention.
Secondary outcome [6] 439161 0
Mobility.
Assessment method [6] 439161 0
Timed 25-Foot Walk (T25-FW).
Timepoint [6] 439161 0
Baseline, 12-months end of intervention, 24-months post-intervention.
Secondary outcome [7] 439162 0
Finger Dexterity.
Assessment method [7] 439162 0
9-Hole Peg Test (9-HPT).
Timepoint [7] 439162 0
Baseline, 12-months end of intervention, 24-months post-intervention.
Secondary outcome [8] 439163 0
Physical Activity.
Assessment method [8] 439163 0
Bone-specific Physical Activity Questionnaire (BPAQ)
Timepoint [8] 439163 0
Baseline, 12-months end of intervention, 24-months post-intervention.
Secondary outcome [9] 439165 0
Fatigue.
Assessment method [9] 439165 0
Fatigue Severity Scale (FSS).
Timepoint [9] 439165 0
Baseline, 12-months end of intervention, 24-months post-intervention for the intervention group.
Secondary outcome [10] 439166 0
Composite outcome of Depression and Anxiety.
Assessment method [10] 439166 0
Hospital Anxiety and Depression Scale (HADS).
Timepoint [10] 439166 0
Baseline, 12-months end of intervention, 24-months post-intervention for the intervention group.
Secondary outcome [11] 439167 0
Costs.
Assessment method [11] 439167 0
Estimation of costs associated with the Onero HiRIT program using healthcare utilisation data from surveys and Services Australia (MBS and PBS records).
Timepoint [11] 439167 0
12-months end of intervention.
Secondary outcome [12] 439168 0
Post-intervention Adoption.
Assessment method [12] 439168 0
Sustainability and adoption measures via a composite of participant attendance and adherence to the HiRIT exercise program, and analysis of drop-out rate (session attendance monitoring via weekly exercise log). Sustainability will also be assessed in the 2nd year of the intervention, when intervention group participants will be able to self-fund (or use NDIS/Aged care) their exercise sessions. Translation of behaviour change (or lack thereof) once the program is no longer funded will provide an additional measure of sustainability.
Timepoint [12] 439168 0
Two-year follow-up.
Secondary outcome [13] 440680 0
Physical Activity
Assessment method [13] 440680 0
International Physical Activity Questionnaire – Short Form (IPAQ-SF).
Timepoint [13] 440680 0
Baseline, 12-months end of intervention, 24-months post-intervention.

Eligibility
Key inclusion criteria
• Medically confirmed diagnosis of multiple sclerosis (all subtypes).
• Age 30 years or older.
• Capable of weight-bearing for at least 10 minutes.
• Proficient in English.
• Willingness to participate in a year-long supervised exercise program.
Minimum age
30 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Diagnosis of Clinically Isolated Syndrome (CIS)
• Presence of comorbid neurological conditions other than MS.
• No bone fractures in the last 3 months.
• No metal implants/surgeries that could interfere with bone density scans.
• Cognitive or psychological impairments that hinder participation.
• Inability to attend intervention sessions at designated sites.

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Block randomisation (with a randomly chosen block size of 6 or 9)
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
Mixed-effects models will be used to account for repeated measures over time, ensuring robust analyses of primary and secondary outcomes. Subgroup analyses will also be conducted based on disability level and MS subtype. Missing data will be handled using multiple imputation techniques. Interim analyses will be conducted to monitor the safety and efficacy of the intervention.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/02/2025
Actual
Date of last participant enrolment
Anticipated
10/11/2025
Actual
Date of last data collection
Anticipated
9/11/2027
Actual
Sample size
Target
180
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD,WA,VIC

Funding & Sponsors
Funding source category [1] 317748 0
University
Name [1] 317748 0
Deakin University
Country [1] 317748 0
Australia
Primary sponsor type
University
Name
Deakin University
Country
Australia
Secondary sponsor category [1] 319552 0
None
Name [1] 319552 0
Deakin University
Country [1] 319552 0
Australia
Other collaborator category [1] 283224 0
University
Name [1] 283224 0
Edith Cowan University
Country [1] 283224 0
Australia
Other collaborator category [2] 283225 0
University
Name [2] 283225 0
Griffith University
Country [2] 283225 0
Australia
Other collaborator category [3] 283226 0
Other Collaborative groups
Name [3] 283226 0
Perron Institute
Country [3] 283226 0
Australia
Other collaborator category [4] 283227 0
Other Collaborative groups
Name [4] 283227 0
MS Plus
Country [4] 283227 0
Australia
Other collaborator category [5] 283228 0
Other Collaborative groups
Name [5] 283228 0
The Bone Clinic
Country [5] 283228 0
Australia
Other collaborator category [6] 283229 0
Other Collaborative groups
Name [6] 283229 0
People with MS
Country [6] 283229 0
Australia
Other collaborator category [7] 283230 0
Other Collaborative groups
Name [7] 283230 0
Healthy Bones Australia
Country [7] 283230 0
Australia
Other collaborator category [8] 283231 0
Other Collaborative groups
Name [8] 283231 0
MS Australia
Country [8] 283231 0
Australia
Other collaborator category [9] 283275 0
University
Name [9] 283275 0
Monash University | Monash Health
Country [9] 283275 0
Australia

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 316012 0
Monash Health Human Research Ethics Committee A
Ethics committee address [1] 316012 0
Ethics committee country [1] 316012 0
Australia
Date submitted for ethics approval [1] 316012 0
18/09/2024
Approval date [1] 316012 0
Ethics approval number [1] 316012 0

Summary
Brief summary
Trial website
Public notes

Contacts
Principal investigator
Name 136498 0
Dr Lisa Grech
Address 136498 0
Deakin University, 221 Burwood Hwy, Burwood VIC 3125
Country 136498 0
Australia
Phone 136498 0
+61 3 924 68920
Email 136498 0
l.grech@deakin.edu.au
Contact person for public queries
Name 136499 0
Lisa Grech
Address 136499 0
Deakin University, 221 Burwood Hwy, Burwood VIC 3125
Country 136499 0
Australia
Phone 136499 0
+61 3 924 68920
Email 136499 0
l.grech@deakin.edu.au
Contact person for scientific queries
Name 136500 0
Lisa Grech
Address 136500 0
Deakin University, 221 Burwood Hwy, Burwood VIC 3125
Country 136500 0
Australia
Phone 136500 0
+61 3 924 68920
Email 136500 0
l.grech@deakin.edu.au

Data sharing statement
Will the study consider sharing individual participant data?
No


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.