Trial Review

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Trial registered on ANZCTR


Registration number
Help: Registration number
ACTRN12626000632392
Ethics application status
Help: Ethics application status
Approved
Date submitted
Help: Date submitted
8/05/2026
Date registered
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25/05/2026
Date last updated
Help: Date last updated
25/05/2026
Date data sharing statement initially provided
Help: Data sharing statement date
25/05/2026
Type of registration
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Prospectively registered

Titles & IDs
Public title
The effects of resistance training on women with fibromyalgia.
Scientific title
Assessing physical strength and pain levels following a resistance training intervention in women with fibromyalgia.
Additional trial identifiers [1] 311665 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Related trial records

Health condition
Health condition(s) studied:
Fibromyalgia 333122 0
Condition category
Condition code
Inflammatory and Immune System 329815 329815 0 0
Connective tissue diseases
Physical Medicine / Rehabilitation 331260 331260 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of the intervention or exposure
The resistance training intervention will include 3 blocks of exercise conditioning. Foundational strength will be developed from weeks one to four in block 1. In block 2, strength capacity is developed, from weeks five to eight. In the final block weeks nine to 12, velocity conditioning is programmed. Exercise Sport Science Australia accredited academic staff will supervise the exercise sessions. Sessions will be aimed to be grouped, or will be organised as one on one sessions in the Footscray Hospital Research Building. Two (60 minute) sessions a week over the 12 weeks is programmed for the intervention, with 20 participants total. The exertion, fatiguability and breathlessness of participants during working sets will be measured using the Borg scale (1-10) rate of perceived exertion, aiming to remain at or below a score of 5/10 (hard). Exercises will progress from seated cable resistance machines to free weighs, and is dependent on individual preferences and capabilities. Exercises intensity will be cued to be explosive on the concentric phase and slow (a count of minimum 2 seconds tempo) on the eccentric phase. Repetitions in reserve will be used to monitor auto-regulation of each exercise session, completing each set with a minimum of two repetitions in reserve. This is a strategy for adherence in this population, and will also use attendance lists and reminder notifications via text. Where participants did not attend exercise sessions, they will be required to attend the total 24 sessions within two weeks of the original trial completion date, failure to do so means participants will be considered not have met the adherence requirements of the study.

After the 12 weeks, participants will either undergo post- intervention testing and cross-over into the symptom monitoring group, or enter into the 12 week intervention. Wash out period after the post-intervention testing, will be 6 weeks, where testing will take place.
Intervention code [1] 328128 0
Lifestyle
Intervention code [2] 329220 0
Treatment: Other
Description of the comparator or control
Cross-over designed trial, 12 weeks resistance training, then 12 weeks symptom monitoring control, with no active treatment or intervention. Participants will continue testing, without any resistance training activities in this period. Washout period is 6 weeks from baseline or post intervention testing.
Control group
Active

Outcomes
Primary outcome [1] 337590 0
Strength will be assessed as a composite of outcomes, the 3 repetition maximum strength test (3RM), hand grip dynamometer strength, and speed of movement velocity.
Timepoint [1] 337590 0
Testing will be the same for both groups. At week 0 (baseline), week 6*, week 13, week 19* and week 26. The primary timepoint for strength outcomes is at the end of the 12 week intervention for both groups, either week 13 or 26. *hand grip strength dynamometer testing is the only strength measure for weeks 6 and 19.
Primary outcome [2] 337591 0
Pain will be measured as a composite of total pain reported by participants.
Timepoint [2] 337591 0
Pain survey outcomes will be collected in weeks 0, 6, 13, 19, and 26. The primary timepoint for pain outcomes is the testing following the 12 week intervention (either week 13 or 26).
Secondary outcome [1] 437001 0
Body composition, (lean muscle mass with Dual-energy X-ray Absorptiometry (DXA) and ultrasound).
Timepoint [1] 437001 0
Body composition will be measures at week 0 (baseline), week 13 and week 26 .

Eligibility
Key inclusion criteria
Inclusion criteria:
• Women who self-report to be diagnosed with fibromyalgia
•Aged between 18-45 years


Minimum age
18 Years
Maximum age
45 Years
Sex
Females
Healthy volunteers
No
Key exclusion criteria
Participants will be excluded from the trial:
• If they currently partake in resistance exercise training
• If they have a musculoskeletal injury that prevents them from safely undertaking
resistance training
• If they are perimenopausal or menopausal
• If they have been diagnosed with diabetes (Type 1 or 2)
• If they are pregnant, or are lactating
• If they have uncontrolled hypertension (resting blood pressure 160/100)
• If they smoke, or have quit within the last six months
• If they drink more than 3 glasses of alcohol a day
• use anticonvulsant medication
• Are diagnosed rheumatoid arthritis
• Have renal failure
• Diagnosed with hepatitis
• Use corticosteroids, or have had a corticosteroid injection within the last 6 months
• Use Steroids (uncontrolled asthma)
• Immune suppressive therapy
• Supplement with Vitamin D

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation of groups will be performed by the primary investigator of the trial, who will have no contact to the participants. Concealment will be in person after baseline testing.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
block randomisation
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Differences between groups at baseline will be evaluated by one-way ANOVA. Two-way (group x time) repeated-measures ANOVA with
Bonferroni post hoc contrasts will be utilised to evaluate the post-pre changes within groups and compare differences between groups for the
following measures:
-Strength (kilograms) and velocity measures (m/s)
-skeletal muscle ultrasound, muscle thickness (mm), fascicle length (mm) and pennation angle
-Full body DXA, lean muscle mass (kilograms)
-Validated survey responses (fibromyalgia impact questionnaire, chronic pain acceptance questionnaire, poly-symptomatic distress scale).
Inter-session reliability between familiarisation and baseline the RPE, velocity and strength testing will be assessed by comparing the change in means and coefficient of variation (CV).

All data will be examined for normality and equality of variance using the Shapiro-Wilk and Levene's tests, respectively. The alpha level will be set
at p < 0.05 and all data will be reported as mean ± SD with 90% confidence intervals for all parametric tests. Effects sizes (Cohen's d) will be calculated to determine the magnitude of the effect.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
10/06/2026
Actual
Date of last participant enrolment
Anticipated
30/06/2027
Actual
Date of last data collection
Anticipated
31/12/2027
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 316450 0
University
Name [1] 316450 0
Victoria University
Country [1] 316450 0
Australia
Primary sponsor type
University
Name
Victoria University
Address
Country
Australia
Secondary sponsor category [1] 318621 0
None
Name [1] 318621 0
Address [1] 318621 0
Country [1] 318621 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314820 0
Victoria University Human Research Ethics Committee
Ethics committee address [1] 314820 0
Ethics committee country [1] 314820 0
Australia
Date submitted for ethics approval [1] 314820 0
09/05/2024
Approval date [1] 314820 0
26/03/2026
Ethics approval number [1] 314820 0
HRE24-071

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

Contacts
Principal investigator
Name 132826 0
Prof Andrew McAinch
Address 132826 0
College of Sport, Health and Engineering Victoria University PO Box 14428 Melbourne Vic 8001
Country 132826 0
Australia
Phone 132826 0
+61 3 99192019
Fax 132826 0
Email 132826 0
[email protected]
Contact person for public queries
Name 132827 0
Andrew McAinch
Address 132827 0
College of Sport, Health and Engineering Victoria University PO Box 14428 Melbourne Vic 8001
Country 132827 0
Australia
Phone 132827 0
+61 3 99192019
Fax 132827 0
Email 132827 0
[email protected]
Contact person for scientific queries
Name 132828 0
Andrew McAinch
Address 132828 0
College of Sport, Health and Engineering Victoria University PO Box 14428 Melbourne Vic 8001
Country 132828 0
Australia
Phone 132828 0
+61 3 99192019
Fax 132828 0
Email 132828 0
[email protected]

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.