None listed
Conditions
Brief summary
This study evaluates the feasibility, acceptability, and pilot efficacy of the ONERO High-Intensity Resistance and Training (HiRIT) program in improving bone health, muscle strength and overall physical function in people with Multiple Sclerosis (MS). Total enrolment period is for 24 months. In the first 12 months, participants will be randomly allocated to the intervention group, who will attend the ONERO HiRIT program twice-weekly, or the control group, who will attend usual healthcare practices. In the second 12 months, the intervention group will be offered to continue the ONERO HiRIT program (at a cost subsidised by NDIS/Aged Care Packages or self-funding), and the control group will be able to join the program at no cost (equity between groups). The primary outcomes include changes in areal bone mineral density (aBMD) health-related quality of life (HR-QoL), while secondary outcomes assess physical function, mood (depression, anxiety) and cognition. Sustainability and acceptability will be measured using a health utilisation economic analysis and self-reported questionnaires. The findings will help support the use of the ONERO HiRIT program for people with MS within different healthcare settings.
Interventions
The STRONG-MS intervention involves a structured ONERO High-intensity Resistance Impact Training (HiRIT) program tailored to people with multiple sclerosis (MS). This is designed as 30-minute supervised sessions (in small groups of 6) twice a week for 12 months, focusing on balance/mobility exercises, deadlifts, squats, overhead presses, and impact movements. A progressive adjustment/assessment period will accommodate each participant's weight bearing abilities and safety needs. The intervention
The STRONG-MS intervention involves a structured ONERO High-intensity Resistance Impact Training (HiRIT) program tailored to people with multiple sclerosis (MS). This is designed as 30-minute supervised sessions (in small groups of 6) twice a week for 12 months, focusing on balance/mobility exercises, deadlifts, squats, overhead presses, and impact movements. A progressive adjustment/assessment period will accommodate each participant's weight bearing abilities and safety needs. The intervention is delivered across several specialised sites, with each group being facilitated by a qualified physiotherapist and/or exercise physiologist to support participant engagement and technique. The ONERO HiRIT program aims to improve bone mineral density, muscle strength and physical function. Weekly exercise logs and a 3-month feasibility check-in are are also conducted by supervisors to monitor participants progress, adherence and attendance. The ONERO HiRIT program's intensity level has been measured using the One Repetition Maximum (1RM) method.
Sponsors
Deakin University
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
30 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1) 30 years or older 2) A medically confirmed diagnosis of multiple sclerosis of any MS subtype 3) All disability levels, so long as person can (to be used in the screening questionnaire): a. sit down and stand up from a chair with no handrails b. weight bear for greater than or equal to 10 minutes independently without specialised equipment c. bend down and pick up a washing basket of clothes (or broom handle for in person screen) d. hang a pair of jeans on an overhead washing line (or broom handle for in person screen) 4) Willingness to engage in an on-site exercise intervention twice weekly for 12-months 5) Able to undertake a minimum of three of the four core resistance exercises 6) Proficient in English 7) Adequate cognition to be able to give informed consent and to accurately and consistently follow instructions about lifting techniques
Exclusion criteria
1) Clinically isolated syndrome (CIS; prodromal, but not confirmed MS) 2) Comorbid neurological condition 3) Demonstrated cognitive or psychological difficulties that would preclude study participation as identified by the research team, their carers and/or their treating clinician 4) Not able to independently weight bear for greater than or equal to 10 minutes 5) Not able to attend one of the 5 intervention sites 6) Has had a bone fracture within the previous 3-month period 7) A t-score of greater than or equal to 3.0
Outcome results
None listed