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Trial registered on ANZCTR


Registration number
ACTRN12617001270303
Ethics application status
Approved
Date submitted
30/08/2017
Date registered
1/09/2017
Date last updated
1/09/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Blood flow restriction training for hand osteoarthritis: A randomised controlled trial
Scientific title
The effect of blood flow restriction training on strength, function, and pain in people with hand osteoarthritis: A randomised controlled trial
Secondary ID [1] 291330 0
Nil known
Universal Trial Number (UTN)
U111111891726
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hand osteoarthritis 302310 0
Condition category
Condition code
Musculoskeletal 301895 301895 0 0
Osteoarthritis
Physical Medicine / Rehabilitation 301896 301896 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Arm 1: Blood flow restriction exercise.
Training period: 6 weeks.
Training frequency: 3 days per week.
Exercise mode: Thumb abductors/extensors, interosseous, pinching, gripping muscle exercises.
Training intensity: 30% to 40% of maximum voluntarily contraction.
A physiotherapist will prescribe the exercises. Blood flow restriction will be applied using a pneumatic cuff with a handheld sphygmomanometer. The cuff will be applied to the arm, proximally to the muscles exercised. The cuff will provide an individualised restriction of the blood flow, but will not cause arterial occlusion. Participants will be individually supervised throughout the training session by a physiotherapist, ensuring adherence and safety. Each exercise session will last approximately 30 minutes.
The blood flow restriction exercise group will receive education about disease through a brochure provided after group randomisation.

Arm 2: Traditional high intensity exercise.
Training period: 6 weeks.
Training frequency: 3 days per week.
Exercise mode: Thumb abductors/extensors, interosseous, pinching, gripping muscle exercises.
Training intensity: 60% to 70% of maximum voluntarily contraction.
The same physiotherapist as for arm 1 will prescribe the exercises. The traditional high intensity group will undertake exercise without blood flow restriction, and without application of a blood flow restriction cuff. Each exercise session will last approximately 30 minutes.
The traditional high intensity exercise group will receive education about disease through a brochure provided after group randomisation.
Intervention code [1] 297359 0
Rehabilitation
Comparator / control treatment
Arm 3: Advice only
Training period: Not applicable.
Training frequency: Not applicable.
Exercise mode: Not applicable.
Training intensity: Not applicable.
The control group will receive education about disease through a brochure provided after group randomisation.
Control group
Active

Outcomes
Primary outcome [1] 301326 0
OARSI-OMERACT responder criteria
Timepoint [1] 301326 0
7 weeks.
Primary outcome [2] 301327 0
Maximum grip strength (kg), hand held dynamometer.
Timepoint [2] 301327 0
0 and 7 weeks.
Primary outcome [3] 301328 0
Hand pain, 11-points Numerical Pain Rating Scale (NRS).
Timepoint [3] 301328 0
0 and 7 weeks.
Secondary outcome [1] 332301 0
Patient specific functional scale (PFSF).
Timepoint [1] 332301 0
0 and 7 weeks.
Secondary outcome [2] 332302 0
Functional Index of Hand Osteoarthritis (FIHOA).
Timepoint [2] 332302 0
0 and 7 weeks.
Secondary outcome [3] 332303 0
Disability of the Arm, Shoulder and Hand (DASH) questionnaire.
Timepoint [3] 332303 0
0 and 7 weeks.
Secondary outcome [4] 332305 0
Exercise induced pain, 11-point NRS.
Timepoint [4] 332305 0
At every training session.
Secondary outcome [5] 334204 0
Participant's intervention acceptability, using a 6 points Likert scale
Timepoint [5] 334204 0
7 weeks.
Secondary outcome [6] 335136 0
Hand left/right judgment task and a control left/right judgement task
Timepoint [6] 335136 0
0 and 7 weeks

Eligibility
Key inclusion criteria
Symptomatic and radiographic hand osteoarthritis.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participated in strength training in the last six months. Uncontrolled cardiovascular disease such as high blood pressure, history of rhabdomyolysis, conditions affecting blood clotting, and neurological diseases.

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)
The allocation will be concealed to the researchers enrolling and assessing participants. Sequentially numbered, opaque, sealed envelopes will be prepared by a researcher who is independent from participants’ enrollment and participants assessment. Envelopes will be kept in a locked drawer and opened only after the enrolled participant completes all baseline assessments.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A computerised random number generator will be uitilised.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
A power calculation was performed to determine the sample size. A Fisher’s exact test with an a priori computation for sample size was utilised. The calculated relative probability, based on the OARSI-OMERACT responder criteria in the study by Hennig et al. (2015), was seven. Using G*power 3.1.7 software (Faul, Erdfelder, Lang, & Buchner, 2007) with an alpha level (p-value) of 0.05 and a power of 0.80, the sample size calculated, for a one-tailed hypothesis, was 57 participants in total. The sample size was increased to 66 participants to account for 16% attrition rate.

Analysis will be performed on an intention-to-treat basis.
Chi-square procedures will be utilised to assess differences in numbers of treatment responders (OMERACT-OARSI criteria) between the intervention groups and the control group.
If normality assumptions are met, two-way repeated measures Analyses of Variance (ANOVAs) will be utilised to assess differences between groups at pre and post treatment. In case of differences on baseline measures a two-way repeated measures Analysis of Covariance (ANCOVAs) will be utilised to control for confounding variables. Planned contrasts will be used to test the main effects. Percentage error calculations will be used to calculate the proportion of results likely to be type I errors (Ottenbacher, 1991).

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 8705 0
New Zealand
State/province [1] 8705 0

Funding & Sponsors
Funding source category [1] 295793 0
University
Name [1] 295793 0
Auckland University of Technology
Address [1] 295793 0
90 Akoranga Drive, Northcote, Auckland, 0627
Country [1] 295793 0
New Zealand
Funding source category [2] 295796 0
Charities/Societies/Foundations
Name [2] 295796 0
Physiotherapy New Zealand
Address [2] 295796 0
PO Box 27386, Wellington, 6141
Country [2] 295796 0
New Zealand
Primary sponsor type
Individual
Name
Nicoló Edoardo Magni
Address
Auckland University of Technology
90 Akoranga Drive
Northcote
Auckland
0627
Country
New Zealand
Secondary sponsor category [1] 294641 0
Individual
Name [1] 294641 0
Peter John McNair
Address [1] 294641 0
Auckland University of Technology
90 Akoranga Drive
Northcote
Auckland
0627
Country [1] 294641 0
New Zealand
Secondary sponsor category [2] 294644 0
Individual
Name [2] 294644 0
David Andrew Rice
Address [2] 294644 0
Auckland University of Technology
90 Akoranga Drive
Northcote
Auckland
0627
Country [2] 294644 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297089 0
Central Health and Disability Ethics Committee
Ethics committee address [1] 297089 0
Health and Disability Ethics Committees
Ministry of Health
133 Molesworth Street
PO Box 5013
Wellington
6011
Ethics committee country [1] 297089 0
New Zealand
Date submitted for ethics approval [1] 297089 0
16/11/2016
Approval date [1] 297089 0
27/01/2017
Ethics approval number [1] 297089 0
16/CEN/191

Summary
Brief summary
Rationale. Hand osteoarthritis (OA) is a painful degenerative condition, which often leads to muscle performance impairments and disability in older people. Despite its social and economic burden on the health care system, limited interventions are available. Conservative interventions such as high intensity strength training have been successfully trialled and utilised in people with knee and hip OA. In people with hand OA however, high intensity training is not always possible due to pain exacerbations. An alternative form of low load strength training called blood flow restriction training (BFR) has been shown to be effective and more acceptable than traditional high intensity strength training in people with knee OA. It is the aim of this study to explore the effectiveness of BFR in people with hand OA and compare its acceptability to a traditional high intensity strength training.
Methods. A randomised controlled trial will assess the differences across three groups, which will undergo blood flow restriction training exercise, traditional high intensity exercise or a control group undergoing no exercise. Each group will include 22 participants for a total of 66 participants. The intervention will last 6 weeks and outcome measures, which include grip strength, joint pain and hand function, will be measured immediately before starting the intervention and one week after trial completion. Repeated measures Analysis of Variance, Pearson’s correlation, t-test and chi square tests will be utilised to analyse the data collected.
Expected Outcomes. The present study may improve participants grip strength, joint pain and hand function. Furthermore, clinicians may be provided with additional treatments to improve patients function and quality of life. Finally, if BFR is effective, its use for additional rehabilitation studies may be justified.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 72942 0
Mr Nicoló Edoardo Magni
Address 72942 0
Auckland University of Technology
90 Akoranga Drive
Northcote
Auckland
0627
Country 72942 0
New Zealand
Phone 72942 0
+64 99219999 ext 6581
Fax 72942 0
Email 72942 0
nico.magni@aut.ac.nz
Contact person for public queries
Name 72943 0
Mr Nicoló Edoardo Magni
Address 72943 0
Auckland University of Technology
90 Akoranga Drive
Northcote
Auckland
0627
Country 72943 0
New Zealand
Phone 72943 0
+64 99219999 ext 6581
Fax 72943 0
Email 72943 0
nico.magni@aut.ac.nz
Contact person for scientific queries
Name 72944 0
Mr Nicoló Edoardo Magni
Address 72944 0
Auckland University of Technology
90 Akoranga Drive
Northcote
Auckland
0627
Country 72944 0
New Zealand
Phone 72944 0
+64 99219999 ext 6581
Fax 72944 0
Email 72944 0
nico.magni@aut.ac.nz

No data has been provided for results reporting
Summary results
Not applicable