Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616001382460
Ethics application status
Approved
Date submitted
3/10/2016
Date registered
6/10/2016
Date last updated
9/11/2018
Date data sharing statement initially provided
9/11/2018
Date results information initially provided
9/11/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
High speed resistance training and balance training for people with knee osteoarthritis to reduce falls risk
Scientific title
High speed resistance training and balance training for people with knee osteoarthritis to reduce falls risk: a pilot randomised controlled trial
Secondary ID [1] 290257 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Osteoarthritis 300474 0
Condition category
Condition code
Musculoskeletal 300330 300330 0 0
Osteoarthritis
Physical Medicine / Rehabilitation 300331 300331 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Two intervention arms will be included:
Eight weeks of high speed strengthening exercise program (twice per week)
or
Eight weeks of combination of high speed strengthening and balance exercises (twice per week).
High speed resistance training: the program will include 6-8 exercises targeting the lower limbs as follows: leg press, squat, step-up, lunges, going up stairs, sit to stand, calf raises. Exercise program will be performed twice a week for 8 weeks for approximately 30min for each exercise session. Participants will be instructed to perform the exercises in a rapid and explosive manner.
The 8 weeks program will be divided into the following phases to allow gradual progression and increase of the resistance for the high speed resistance training exercises (weight/training load) as follows:
Phase 1 – week 1-2 (4 sessions). Participants will perform 2 sets of 8-12 repetitions with 20-40% 1RM
Phase 2 – week 3-5 (6 sessions). Participants will perform 2 sets of 5-10 repetitions with 40-60% 1RM
Phase 3 – week 6-8 (6 sessions). Participants will perform 2-3 sets of 2-5 repetitions with 60-80% 1RM
Intensity will be monitored using the RPE scale with expected RPE between 11-17/20.
High speed resistance and balance training: the program will include the same exercises as the high speed resistance training group with the addition of 6 balance exercises. Exercise program will be performed twice a week for 8 weeks for approximately 45min for each exercise session. The balance exercises will include the following: walking forward and backward, single leg standing, single leg tapping, side stepping and backward walking. Each balance exercise will initially be of 15-30 seconds duration and be performed twice per session.
Both exercise programs of both groups will be supervised by accredited exercise physiologist or physiotherapist. Exercise sessions will be one on one with the participants and will take place at Victoria University Exercise Rehabilitation Clinic, Footscray Campus. Attendance will be monitored using individual training log to be recorded by the supervisor.
Intervention code [1] 296050 0
Rehabilitation
Intervention code [2] 296054 0
Treatment: Other
Comparator / control treatment
Control group will be advised to continue with their usual activities. Usual activities is defined as any day to day activities and or any current usage of health services.
Control group
Active

Outcomes
Primary outcome [1] 299792 0
Percentage of participants who complete the intervention,
Timepoint [1] 299792 0
At 8 weeks follow up
Primary outcome [2] 299793 0
Number of sessions and or number of exercises stopped due to pain.
Timepoint [2] 299793 0
At 8 weeks follow up
Primary outcome [3] 299794 0
Any adverse event or incident that stops the participant from completing the prescribed exercise.
Timepoint [3] 299794 0
At 8 weeks follow up
Secondary outcome [1] 328133 0
Physiological test - function assesed by 30s chair stand test
Timepoint [1] 328133 0
Baseline and 8 weeks follow up
Secondary outcome [2] 328134 0
Physiological test - function assessed by Timed Get Up and Go test
Timepoint [2] 328134 0
Baseline and 8 weeks follow up
Secondary outcome [3] 328135 0
Physiological test - function and coordination will be assessed using The Four Square Step Test
Timepoint [3] 328135 0
Baseline and 8 weeks follow up
Secondary outcome [4] 328136 0
Physiological test - lower limb strength and power will be assessed using Timed Stair Climb Test
Timepoint [4] 328136 0
Baseline and 8 weeks follow up
Secondary outcome [5] 328137 0
Physiological test - Static balance will be assessed by measuring Postural sway while standing on a foam
Timepoint [5] 328137 0
Baseline and 8 weeks follow up
Secondary outcome [6] 328138 0
Physiological test -knee proprioception will be measured during sitting by matching the position of the legs on either side of a clear plastic sheet with the eyes closed
Timepoint [6] 328138 0
Baseline and 8 weeks follow up
Secondary outcome [7] 328139 0
Physiological test - the ability to step maximally and rapidly in multiple directions will be assessed using the Rapid step test
Timepoint [7] 328139 0
Baseline and 8 weeks follow up
Secondary outcome [8] 328140 0
Lower limb Strength - three repetitions maximum (3RM) during bilateral leg press
Timepoint [8] 328140 0
Baseline and 8 weeks follow up
Secondary outcome [9] 328141 0
Cognitive test - set-shifting and psychomotor speed will be assessed using the The Trail Making Test
Timepoint [9] 328141 0
Baseline and 8 weeks follow up
Secondary outcome [10] 328142 0
Cognitive test - working memory will be assessed using The Wechsler Adult Intelligence Scale-III (WAIS-III)
Timepoint [10] 328142 0
Baseline and 8 weeks follow up
Secondary outcome [11] 328143 0
Cognitive test - selective attention, response inhibition, and speed of processing will be assessed using The Stroop Color and Word Test
Timepoint [11] 328143 0
Baseline and 8 weeks follow up
Secondary outcome [12] 328144 0
Joint pain - using Western Ontario and McMasters University Osteoarthritis Index (WOMAC) subscore
Timepoint [12] 328144 0
Baseline and 8 weeks follow up
Secondary outcome [13] 328145 0
Joint function - using Western Ontario and McMasters University Osteoarthritis Index (WOMAC) subscore
Timepoint [13] 328145 0
Baseline and 8 weeks follow up
Secondary outcome [14] 328146 0
Joint stiffness - using Western Ontario and McMasters University Osteoarthritis Index (WOMAC) subscore
Timepoint [14] 328146 0
Baseline and 8 weeks follow up
Secondary outcome [15] 328147 0
Total score of Western Ontario and McMasters University Osteoarthritis Index (WOMAC) subscore
Timepoint [15] 328147 0
Baseline and 8 weeks follow up
Secondary outcome [16] 328148 0
Assessment of Quality of Life (AQoL) utility instrument - total score
Timepoint [16] 328148 0
Baseline and 8 weeks follow up
Secondary outcome [17] 328149 0
The Incidental And Planned Exercise Questionnaire - incidental subscore
Timepoint [17] 328149 0
Baseline and 8 weeks follow up
Secondary outcome [18] 328150 0
The Incidental And Planned Exercise Questionnaire - planned subscore
Timepoint [18] 328150 0
Baseline and 8 weeks follow up
Secondary outcome [19] 328151 0
The Incidental And Planned Exercise Questionnaire - total score
Timepoint [19] 328151 0
Baseline and 8 weeks follow up
Secondary outcome [20] 328152 0
The falls efficacy scale (Short FES-I) - total score
Timepoint [20] 328152 0
Baseline and 8 weeks follow up
Secondary outcome [21] 328153 0
Participant satisfaction - using the Short Assessment for Patient Satisfaction measure (SAPS). Only for participants from the intervention groups
Timepoint [21] 328153 0
Eight weeks follow up

Eligibility
Key inclusion criteria
Participants aged 60-90 years with knee osteoarthritis who have had a fall in the previous 12 months or who are concerned about having a fall will be recruited.
Participants will need to have knee pain for at least 6 months and experience current average pain of at least 3 (on an 11 point numerical rating scale) and be able to ambulate independently.
Minimum age
60 Years
Maximum age
90 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1) any uncontrolled non-musculoskeletal conditions that would make testing difficult and uncomfortable, such as chronic obstructive airways disease and congestive heart failure;
2) a pre-existing neurological condition that affects lower limb strength, balance and or ambulation (e.g. polio, stroke);
3) any uncontrolled musculoskeletal or orthopaedic conditions that may affect ambulation (rheumatoid arthritis, gout, etc.);
4) currently taking part in a structured resistance training and or an organised balance training program more than once a week;
5) Participants with any documented medical condition or physical impairment that is deemed by the medical practitioner to contraindicate their inclusion will be excluded from the study ;
6) participants with severe cognitive impairment or dementia

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)
Block randomization will be undertaken using opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Data collected for feasibility and safety will be analysed using descriptive statistics (mean and standard deviation) as follows: The percentage of participants who complete the intervention, overall percentage of sessions attended, number of participants who dropout, number of sessions and or number of exercises stopped due to pain, any adverse event or incident that stopped the participant from completing the prescribed exercise.
Reported pain level will also be analysed using descriptive statistic as follows: pain level during the exercise program, 2 hours and 24 hours after the a session, any substantial increase in pain level, and overall pain level before and at the completion of the program.
To determine statistical trends of effectiveness, analyses of the selected outcomes such as pain, strength, balance, physical function and executive functions will be performed to assess the changes within and between groups over time (pre/post). Therefore, repeated measure ANOVA with factors of intervention (exercise group 1, exercise group 2, control) and time (pre-post intervention) will be used.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
16/03/2016
Date of last participant enrolment
Anticipated
1/06/2017
Actual
6/07/2017
Date of last data collection
Anticipated
2/10/2017
Actual
23/10/2017
Sample size
Target
30
Accrual to date
Final
30
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 294625 0
University
Name [1] 294625 0
Victoria University
Country [1] 294625 0
Australia
Funding source category [2] 295063 0
Charities/Societies/Foundations
Name [2] 295063 0
Arthritis Australia
Country [2] 295063 0
Australia
Primary sponsor type
University
Name
Victoria University
Address
Ballarat Rd, Footscray 3011, Melbourne
Country
Australia
Secondary sponsor category [1] 293487 0
None
Name [1] 293487 0
Address [1] 293487 0
Country [1] 293487 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296065 0
Victoria University Human Research Ethics Committee
Ethics committee address [1] 296065 0
Ballarat Rd, Footscray 3011, Melbourne
Ethics committee country [1] 296065 0
Australia
Date submitted for ethics approval [1] 296065 0
23/11/2015
Approval date [1] 296065 0
20/01/2016
Ethics approval number [1] 296065 0
HRE15-285

Summary
Brief summary
This study aims to examine the feasibility, safety, and patient satisfaction of a high speed resistance training program with and without balance exercises in people with knee osteoarthritis compared to a control group. Given the pain associated with knee osteoarthritis, it is crucial to determine what effect high speed resistance training that focuses on muscle power has on knee pain. The effect of the exercise interventions on strength, physiological and functional risk factors for falls, pain, and executive function will also be assessed.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 69418 0
A/Prof Pazit Levinger
Address 69418 0
College of Sport and Exercise Science
VICTORIA UNIVERSITY
PO Box 14428
MELBOURNE VIC 8001
Country 69418 0
Australia
Phone 69418 0
+61-3-99195525
Fax 69418 0
Email 69418 0
pazit.levinger@vu.edu.au
Contact person for public queries
Name 69419 0
A/Prof Pazit Levinger
Address 69419 0
College of Sport and Exercise Science
VICTORIA UNIVERSITY
PO Box 14428
MELBOURNE VIC 8001
Country 69419 0
Australia
Phone 69419 0
+61-3-99195525
Fax 69419 0
Email 69419 0
pazit.levinger@vu.edu.au
Contact person for scientific queries
Name 69420 0
A/Prof Pazit Levinger
Address 69420 0
College of Sport and Exercise Science
VICTORIA UNIVERSITY
PO Box 14428
MELBOURNE VIC 8001
Country 69420 0
Australia
Phone 69420 0
+61-3-99152252
Fax 69420 0
Email 69420 0
pazit.levinger@vu.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
No individual data be available due to ethics requirements, only group data be reported


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
185Study protocol    https://trialsjournal.biomedcentral.com/articles/1... [More Details]



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Study results articleYes Levinger P, Dunn J, Bifera N, Butson M, Elias G, H... [More Details]
Plain language summaryNo Twenty-eight participants, average age 67.8 years,... [More Details]

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseSafety and feasibility of high speed resistance training with and without balance exercises for knee osteoarthritis: A pilot randomised controlled trial.2018https://dx.doi.org/10.1016/j.ptsp.2018.10.001
EmbaseHigh-speed resistance training and balance training for people with knee osteoarthritis to reduce falls risk: Study protocol for a pilot randomized controlled trial.2017https://dx.doi.org/10.1186/s13063-017-2129-7
N.B. These documents automatically identified may not have been verified by the study sponsor.