Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000519752
Ethics application status
Approved
Date submitted
22/03/2022
Date registered
1/04/2022
Date last updated
12/05/2023
Date data sharing statement initially provided
1/04/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Understanding rheumatoid arthritis sufferers motivations and intentions towards exercise prior and post undertaking a five week exercise trial.
Scientific title
Understanding rheumatoid arthritis sufferers motivations and intentions towards exercise prior and post undertaking a five week exercise trial.
Secondary ID [1] 306731 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Rheumatoid Arthritis 325745 0
Condition category
Condition code
Inflammatory and Immune System 323082 323082 0 0
Rheumatoid arthritis
Physical Medicine / Rehabilitation 323083 323083 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will undertake an 8-week intervention that incorporates education, behaviour change and exercise. The aim of this pilot prospective trial is to determine the effect of an all-inclusive education, exercise and psychological intervention on motivations and intentions to exercise along with physical function outcomes in rheumatoid arthritis suffers. Participants will complete an initial 1 h assessment with a psychologist to develop and capture their intentions and motivations towards exercise. After completing the pre-exercise trial participants will receive individualised counselling (1 h per week for two weeks) from the exercise psychologist to develop psychological skills and enhance their motivational orientation towards taking up exercise to invoke positive health behaviour change. Counselling may be undertaking via telehealth or face to face depending on participant preference utilising a semi-structured presentation. Counselling sessions will target the participants identified barriers, motivations, goals and limitations to exercise identified by their baseline questionnaires.
Following this participants will undertake a patient specific exercise test with 5 weeks of individualised and partly supervised exercise training and a final assessment in the following week (fitness and completion of questionnaires). Supervised exercise training will be supervised by an Accredited Exercise Physiologist in groups of five. Participants will exercise at a moderate intensity (measured via Borg scale). Face to face exercise sessions (1 h per week) will be undertaken at the QUT Health Clinics with participants also provided a home program to complete twice weekly (45 min per session). Prescribed exercises will include a mixture of upper body push and pull movements e.g. chest press and seated row, lower limb exercises e.g. leg press and sit to stand, balance exercises and cardiorespiratory activity e.g. walking and cycling. Exercise prescription will follow the recommendations from the American College of Sports Medicine with consideration for the participants individual preferences, barriers and goals. Adherence and compliance to the exercise program will be recorded via exercise logs. Education sessions will be delivered face to face by the accredited exercise physiologist during the same weeks as the exercise sessions (1 h per week for four weeks). Education sessions cover the topics of pain, diet, exercise for rheumatoid arthritis and maintaining healthy behaviours.

Finally, the participants will undertake a semi-structured interview (30 mins) on their experiences and thoughts from partaking in the trial. Outcome measures utilised in this study have been selected based on industry relevant practitioner based outcomes, exercise intentions, exercise motivators, patient specific function, activities of daily living and quality of life. All assessments will be undertaken by an Accredited Exercise Physiologist and an Accredited Psychologist will conduct the initial pre-intervention counselling.
Intervention code [1] 323188 0
Lifestyle
Intervention code [2] 323189 0
Behaviour
Comparator / control treatment
No Control Group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 330844 0
Exercise Self-Efficacy Scale
Timepoint [1] 330844 0
Week 8 (final week) after starting the intervention
Primary outcome [2] 330845 0
Perceived Competence Scale
Timepoint [2] 330845 0
Week 8 (final week) after starting the intervention
Primary outcome [3] 330846 0
Treatment (exercise) Self-Regulation Survey
Timepoint [3] 330846 0
Week 8 (final week) after starting the intervention
Secondary outcome [1] 407798 0
Cardiorespiratory fitness assessed by Six Minute Walk Test
Timepoint [1] 407798 0
Week 8 (final week) after starting the intervention
Secondary outcome [2] 407799 0
Balance and mobility assessed by Timed Up and Go (TUG)
Timepoint [2] 407799 0
Week 8 (final week) after starting the intervention
Secondary outcome [3] 407800 0
Lower limb strength assessed by 30 Second Sit to Stand (30 STS)
Timepoint [3] 407800 0
Week 8 (final week) after starting the intervention
Secondary outcome [4] 407801 0
Overall body strength assessed by Grip Strength using a hand-held dynamometer
Timepoint [4] 407801 0
Week 8 (final week) after starting the intervention
Secondary outcome [5] 407802 0
Body Composition assessed by dual-energy x-ray absorptiometry
Timepoint [5] 407802 0
Week 8 (final week) after starting the intervention
Secondary outcome [6] 407803 0
Physical Activity Patterns assessed by tri-axial accelerometry
Timepoint [6] 407803 0
Week 8 (final week) after starting the intervention
Secondary outcome [7] 408261 0
Physical Activity Patterns assessed by d Godin leisure-time exercise questionnaire
Timepoint [7] 408261 0
Week 8 (final week) after starting the intervention

Eligibility
Key inclusion criteria
1) >18 years of age and 2) RA stable with no changes in medication in the last 2 months (small changes up to 5 mg in prednisone are allowed) and 3) located within the Brisbane metropolitan area for access to the Queensland University Technology health clinics and 4) English speaking. All participants will consult with their general medical practitioner prior to inclusion to confirm diagnosis and safety to participate.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1) already undertaking >2 days a week of regular moderate intensity exercise training; 2) no other underlying uncontrolled medical conditions that may limit their participation in an exercise program for example including heart disease (heart failure, clinically significant coronary stenosis and previous myocardial infarction), all forms of cancer (both remission and ongoing), knee and hip replacement, and metabolic disease (Type I and II diabetes) and 3) commencement of a new synthetic disease- or biological modifying drug

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised 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)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
10/07/2023
Actual
Date of last participant enrolment
Anticipated
29/03/2024
Actual
Date of last data collection
Anticipated
31/05/2024
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 311062 0
Charities/Societies/Foundations
Name [1] 311062 0
Arthritis Australia
Country [1] 311062 0
Australia
Primary sponsor type
University
Name
Queensland University Technology
Address
2 George St, Brisbane City QLD 4000
Country
Australia
Secondary sponsor category [1] 312394 0
Individual
Name [1] 312394 0
Justin Holland
Address [1] 312394 0
School of Exercise and Nutrition Sciences, Queensland University Technology, Kelvin Grove, QLD, 4056
Country [1] 312394 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310607 0
Queensland University Technology HREC
Ethics committee address [1] 310607 0
Ethics committee country [1] 310607 0
Australia
Date submitted for ethics approval [1] 310607 0
20/03/2020
Approval date [1] 310607 0
04/03/2022
Ethics approval number [1] 310607 0
3013

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

Contacts
Principal investigator
Name 118246 0
Dr Justin Holland
Address 118246 0
School of Exercise & Nutrition Sciences Faculty of Health, Queensland University of Technology O Block A Wing, A420 Victoria Park Rd, Kelvin Grove, QLD 4059
Country 118246 0
Australia
Phone 118246 0
+61 7 3136 0669
Fax 118246 0
Email 118246 0
[email protected]
Contact person for public queries
Name 118247 0
Justin Holland
Address 118247 0
School of Exercise & Nutrition Sciences Faculty of Health, Queensland University of Technology O Block A Wing, A420 Victoria Park Rd, Kelvin Grove, QLD 4059
Country 118247 0
Australia
Phone 118247 0
+61 7 3136 0669
Fax 118247 0
Email 118247 0
[email protected]
Contact person for scientific queries
Name 118248 0
Justin Holland
Address 118248 0
School of Exercise & Nutrition Sciences Faculty of Health, Queensland University of Technology O Block A Wing, A420 Victoria Park Rd, Kelvin Grove, QLD 4059
Country 118248 0
Australia
Phone 118248 0
+61 7 3136 0669
Fax 118248 0
Email 118248 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.