ANZCTR - Registration

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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

25/02/2020

Date data sharing statement initially provided

22/02/2019

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]

Nil known

Universal Trial Number (UTN)

U1111-1189-1726

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Hand osteoarthritis

Condition category

Condition code

Musculoskeletal

Osteoarthritis

Physical Medicine / Rehabilitation

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]

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]

OARSI-OMERACT responder criteria

Timepoint [1]

7 weeks.

Primary outcome [2]

Maximum grip strength (kg), hand held dynamometer.

Timepoint [2]

0 and 7 weeks.

Primary outcome [3]

Hand pain, 11-points Numerical Pain Rating Scale (NRS).

Timepoint [3]

0 and 7 weeks.

Secondary outcome [1]

Patient specific functional scale (PFSF).

Timepoint [1]

0 and 7 weeks.

Secondary outcome [2]

Functional Index of Hand Osteoarthritis (FIHOA).

Timepoint [2]

0 and 7 weeks.

Secondary outcome [3]

Disability of the Arm, Shoulder and Hand (DASH) questionnaire.

Timepoint [3]

0 and 7 weeks.

Secondary outcome [4]

Exercise induced pain, 11-point NRS.

Timepoint [4]

At every training session.

Secondary outcome [5]

Participant's intervention acceptability, using a 6 points Likert scale

Timepoint [5]

7 weeks.

Secondary outcome [6]

Hand left/right judgment task and a control left/right judgement task

Timepoint [6]

0 and 7 weeks

Eligibility

Key inclusion criteria

Symptomatic and radiographic hand osteoarthritis.

Minimum age

18 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

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

Completed

Date of first participant enrolment

Anticipated

15/09/2017

Actual

14/09/2017

Date of last participant enrolment

Anticipated

Actual

16/09/2019

Date of last data collection

Anticipated

Actual

5/11/2019

Sample size

Target

Accrual to date

Final

Recruitment outside Australia

Country [1]

New Zealand

State/province [1]

Auckland

Funding & Sponsors

Funding source category [1]

University

Name [1]

Auckland University of Technology

Address [1]

90 Akoranga Drive, Northcote, Auckland, 0627

Country [1]

New Zealand

Funding source category [2]

Charities/Societies/Foundations

Name [2]

Physiotherapy New Zealand

Address [2]

PO Box 27386, Wellington, 6141

Country [2]

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]

Individual

Name [1]

Peter John McNair

Address [1]

Auckland University of Technology
90 Akoranga Drive
Northcote
Auckland
0627

Country [1]

New Zealand

Secondary sponsor category [2]

Individual

Name [2]

David Andrew Rice

Address [2]

Auckland University of Technology
90 Akoranga Drive
Northcote
Auckland
0627

Country [2]

New Zealand

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Central Health and Disability Ethics Committee

Ethics committee address [1]

Health and Disability Ethics Committees
Ministry of Health
133 Molesworth Street
PO Box 5013
Wellington
6011

Ethics committee country [1]

New Zealand

Date submitted for ethics approval [1]

16/11/2016

Approval date [1]

27/01/2017

Ethics approval number [1]

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

Mr Nicoló Edoardo Magni

Address

Auckland University of Technology
90 Akoranga Drive
Northcote
Auckland
0627

Country

New Zealand

Phone

+64 99219999 ext 6581

Fax

nico.magni@aut.ac.nz

Contact person for public queries

Name

Nicoló Edoardo Magni

Address

Auckland University of Technology
90 Akoranga Drive
Northcote
Auckland
0627

Country

New Zealand

Phone

+64 99219999 ext 6581

Fax

nico.magni@aut.ac.nz

Contact person for scientific queries

Name

Nicoló Edoardo Magni

Address

Auckland University of Technology
90 Akoranga Drive
Northcote
Auckland
0627

Country

New Zealand

Phone

+64 99219999 ext 6581

Fax

nico.magni@aut.ac.nz

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

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

Source	Title	Year of Publication	DOI
Embase	Impairments in grip and pinch force accuracy and steadiness in people with osteoarthritis of the hand: A case-control comparison.	2021	https://dx.doi.org/10.1016/j.msksp.2021.102432
Embase	Development of a prediction model to determine responders to conservative treatment in people with symptomatic hand osteoarthritis: A secondary analysis of a single-centre, randomised feasibility trial.	2022	https://dx.doi.org/10.1016/j.msksp.2022.102659
Embase	Six weeks of resistance training (plus advice) vs advice only in hand osteoarthritis: A single-blind, randomised, controlled feasibility trial.	2022	https://dx.doi.org/10.1016/j.msksp.2021.102491

N.B. These documents automatically identified may not have been verified by the study sponsor.

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Documents added manually

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