ClinicalTrials.gg
CompletedNCT03450486Updated May 7, 2018

Exercise on Knee OA With the Star Excursion Balance Test

An interventional study of exercise in Osteoarthritis and Osteo Arthritis Knee, sponsored by Western University, Canada. Completed at 1 site in Canada. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2018-05-07.

Sponsored by Western University, Canada · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Non-randomized
Ages
50 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 205 studies in Osteoarthritis with a site in Canada — 25 open to participants now, 46 under way, 4 of them phase 3. Osteoarthritis · Canada.

Enrollment
158th of 176
20 · median 98
Started
2018
with 3 others
No phase
101 of 205
16 open now
Registered
141st of 205
by date

Among the 205 studies in Osteoarthritis with a site in Canada, this one is the 158th largest by enrollment of the 176 interventional ones that give a count, is one of 4 that started in 2018, is one of 101 with no phase, and was the 141st registered.

Osteoarthritis

2,974 studies on the registry are indexed under Osteoarthritis; 438 are open to participants now.

Browse Osteoarthritis studies →

Open to participants now

25 of the 205 studies in Osteoarthritis with a site in Canada are open now. Recruiting first, the newest first:

20 more — sign in →

All 25 open studies →

A study can be open while its sites in Canada have not opened yet or have stopped. Only those recruiting at a site in Canada →

Who these studies take

Of the 287 Osteoarthritis studies recruiting now, 158 (55%) set no upper age limit and 72 (25%) stop at 75 or younger; 22 take children under 18; 30 take healthy volunteers.

This study: 50 Years and older · all sexes · no healthy volunteers.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 205 studies in Osteoarthritis with a site in Canada, or all of them as a file.
02

Study summary

Osteoarthritis is a prevalent and disabling condition. Exercise is recommended to maintain strength and mobility, and to decrease pain. However, acute bouts of exercise have conflicting outcomes: they are fatiguing and they also can increase coordination and balance. The purpose of this study is to assess the effects of a single bout of exercise (30 minutes) on balance performance of individuals with self-identified unilateral knee osteoarthritis. Balance will be assessed using the star excursion balance test before and after the exercise session. Differences in performance between the two star excursion balance tests will reflect the changes due to exercise. The changes between their balance performance on each limb will reflect the changes due to osteoarthritis.

Read the detailed description

Knee OA affects over 241 million people worldwide, and poses a significant burden to the healthcare system (Cross et al., 2014). Knee OA leads to decreased quadriceps muscle strength, and impaired postural control and joint proprioception (Hurley et al., 1997). These factors lead to balance impairments in individuals with osteoarthritis compared to controls (Wegener et al., 1997). It has been reported that the completion of a warm-up program improves the dynamic and static balance of healthy individuals (Daneshjoo et al., 2012). Therefore, exercise may acutely facilitate neuromuscular control, reduce stiffness and significantly improve dynamic balance in individuals with knee OA. Alternatively, muscular fatigue that may negate these benefits (Nardone et al., 1997). Given that falls are a devastating injury in the elderly (Sri-On et al, 2017), and that exercise programs improve balance (Carter et al, 2001; Tse et al, 2015) it is important to evaluate the acute effects of a single bout of exercise on balance performance in individuals with osteoarthritis. The Star Excursion Balance Test (SEBT) has been validated for quantifying dynamic balance in healthy individuals (Kinzey \& Armstrong, 1998) and individuals with knee OA (Kanko, 2017). It is important to evaluate the effects of exercise on balance in individuals with OA as changes in balance following exercise may lead to either impairments or improvements, and have direct implications for the safety of exercise as a recommended approach in OA.

This study will recruit 35 individuals with self-identified unilateral knee osteoarthritis, according to clinical criteria for classification of idiopathic knee OA (Altman et al., 1986). They will complete a Physical Activity Readiness Questionnaire for Everyone (PAR-Q+) to clear them for participation in physical activity (Warburton et al, 2011). They will complete a standard questionnaire assessing knee function: the Knee injury and Osteoarthritis Outcome Score (KOOS) (Roos et al, 2003). They will complete the star excursion balance test, on each of their affected and unaffected limbs, before and after completing a 30 minute bout of exercise. This exercise session will be supervised, and emphasizes optimal alignment of the trunk and lower limb joints relative to one another, as well as quality of movement performance, while dynamically and functionally strengthening the lower limb muscles (Bennell et al, 2011). The research participants will dictate the intensity and duration of the program.

Differences in performance between the two star excursion balance tests will reflect the changes due to exercise. The changes between their balance performance on each limb will reflect the changes due to osteoarthritis.

03

Conditions studied

  • Osteoarthritis
  • Osteo Arthritis Knee

Keywords

  • dynamic balance
  • star excursion balance test
  • exercise
04

Who can participate

Ages eligible
50 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • unilateral knee osteoarthritis according to clinical criteria for classification of idiopathic osteoarthritis (OA) of the knee (Altman et al., 1986)
  • routinely engaging in mild exercise, such as walking or gardening.
  • a completed PAR-Q+ indicating no

Exclusion criteria

Exclusion Criteria:

  • lower extremity joint replacement
  • Inflammatory or Infectious Arthritis
  • Major neurological disorder (ex. Parkinson's disease, Huntington's disease, Multiple Sclerosis, peripheral neuropathy)
  • Major medical illness that would interfere with participating in a 30 minute bout of exercise
  • Inability to engage in moderate physical activity for 30-40 minutes
  • Inability to read English
  • Psychiatric illness that limits
  • Inability to stand on limb for more than 5 seconds
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
20 participants (actual)

Study arms

  • Experimental
    affected limb

    measurements of balance from the affected side of individuals with unilateral knee osteoarthritis following an exercise session

    Other: exercise

  • Active comparator
    unaffected limb

    measurements of balance from the unaffected side of individuals with unilateral knee osteoarthritis following an exercise session

    Other: exercise

Interventions

  • Otherexercise

    one 30 minute bout of mild exercise

06

What researchers measure

Primary outcomes

  1. star excursion balance test

    standard test for assessing dynamic balance. Individuals stand on one limb and reach their other limb in each of eight directions (eg anterior, lateral, antero-lateral, etc) and the length of the reach is measured. The reach measurements are normalized by dividing by leg length.

    Time frame: change in star excursion balance test after the 30 minute bout of exercise

07

Study locations

1 site
  • University of Western Ontario
    London, Ontario N6A3K7, Canada
08

References and documents

Publications

  • Roddy E, Zhang W, Doherty M, Arden NK, Barlow J, Birrell F, Carr A, Chakravarty K, Dickson J, Hay E, Hosie G, Hurley M, Jordan KM, McCarthy C, McMurdo M, Mockett S, O'Reilly S, Peat G, Pendleton A, Richards S. Evidence-based recommendations for the role of exercise in the management of osteoarthritis of the hip or knee--the MOVE consensus. Rheumatology (Oxford). 2005 Jan;44(1):67-73. doi: 10.1093/rheumatology/keh399. Epub 2004 Sep 7. PubMed 15353613 ↗
  • Altman R, Asch E, Bloch D, Bole G, Borenstein D, Brandt K, Christy W, Cooke TD, Greenwald R, Hochberg M, et al. Development of criteria for the classification and reporting of osteoarthritis. Classification of osteoarthritis of the knee. Diagnostic and Therapeutic Criteria Committee of the American Rheumatism Association. Arthritis Rheum. 1986 Aug;29(8):1039-49. doi: 10.1002/art.1780290816. PubMed 3741515 ↗
  • Cross M, Smith E, Hoy D, Nolte S, Ackerman I, Fransen M, Bridgett L, Williams S, Guillemin F, Hill CL, Laslett LL, Jones G, Cicuttini F, Osborne R, Vos T, Buchbinder R, Woolf A, March L. The global burden of hip and knee osteoarthritis: estimates from the global burden of disease 2010 study. Ann Rheum Dis. 2014 Jul;73(7):1323-30. doi: 10.1136/annrheumdis-2013-204763. Epub 2014 Feb 19. PubMed 24553908 ↗
  • Hurley MV, Scott DL, Rees J, Newham DJ. Sensorimotor changes and functional performance in patients with knee osteoarthritis. Ann Rheum Dis. 1997 Nov;56(11):641-8. doi: 10.1136/ard.56.11.641. PubMed 9462165 ↗
  • Roos EM, Toksvig-Larsen S. Knee injury and Osteoarthritis Outcome Score (KOOS) - validation and comparison to the WOMAC in total knee replacement. Health Qual Life Outcomes. 2003 May 25;1:17. doi: 10.1186/1477-7525-1-17. PubMed 12801417 ↗
  • Wegener L, Kisner C, Nichols D. Static and dynamic balance responses in persons with bilateral knee osteoarthritis. J Orthop Sports Phys Ther. 1997 Jan;25(1):13-8. doi: 10.2519/jospt.1997.25.1.13. PubMed 8979171 ↗
  • Daneshjoo A, Mokhtar AH, Rahnama N, Yusof A. The effects of comprehensive warm-up programs on proprioception, static and dynamic balance on male soccer players. PLoS One. 2012;7(12):e51568. doi: 10.1371/journal.pone.0051568. Epub 2012 Dec 12. PubMed 23251579 ↗
  • Nardone A, Tarantola J, Giordano A, Schieppati M. Fatigue effects on body balance. Electroencephalogr Clin Neurophysiol. 1997 Aug;105(4):309-20. doi: 10.1016/s0924-980x(97)00040-4. PubMed 9284239 ↗
  • Sri-On J, Tirrell GP, Bean JF, Lipsitz LA, Liu SW. Revisit, Subsequent Hospitalization, Recurrent Fall, and Death Within 6 Months After a Fall Among Elderly Emergency Department Patients. Ann Emerg Med. 2017 Oct;70(4):516-521.e2. doi: 10.1016/j.annemergmed.2017.05.023. Epub 2017 Jul 5. PubMed 28688769 ↗
  • Carter ND, Kannus P, Khan KM. Exercise in the prevention of falls in older people: a systematic literature review examining the rationale and the evidence. Sports Med. 2001;31(6):427-38. doi: 10.2165/00007256-200131060-00003. PubMed 11394562 ↗
  • Tse AC, Wong TW, Lee PH. Effect of Low-intensity Exercise on Physical and Cognitive Health in Older Adults: a Systematic Review. Sports Med Open. 2015;1(1):37. doi: 10.1186/s40798-015-0034-8. Epub 2015 Oct 20. PubMed 26512340 ↗
  • Kinzey SJ, Armstrong CW. The reliability of the star-excursion test in assessing dynamic balance. J Orthop Sports Phys Ther. 1998 May;27(5):356-60. doi: 10.2519/jospt.1998.27.5.356. PubMed 9580895 ↗
  • Bennell KL, Egerton T, Wrigley TV, Hodges PW, Hunt M, Roos EM, Kyriakides M, Metcalf B, Forbes A, Ageberg E, Hinman RS. Comparison of neuromuscular and quadriceps strengthening exercise in the treatment of varus malaligned knees with medial knee osteoarthritis: a randomised controlled trial protocol. BMC Musculoskelet Disord. 2011 Dec 5;12:276. doi: 10.1186/1471-2474-12-276. PubMed 22141334 ↗
  • Kanko L:
  • Warburton DE, Gledhill N, Jamnik VK, Bredin SS, McKenzie DC, Stone J, Charlesworth S, Shephard RJ. Evidence-based risk assessment and recommendations for physical activity clearance: Consensus Document 2011. Appl Physiol Nutr Metab. 2011 Jul;36 Suppl 1:S266-98. doi: 10.1139/h11-062. PubMed 21800945 ↗

Individual participant data

Plan to share: No — Each participant will be identified with a code (eg. STAR001) that correlates to his or her addition to the study. The master sheet will be the only document that contains the decoding system, and will be stored in a locked filing cabinet. All other data will be labeled using the participant's identification code.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Mar 2018 to primary completion in Apr 2018, 1 month.

Of 578 non-industry interventional studies with no phase under Osteoarthritis, half reached primary completion within 26 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 52. This study's 1 month is below that.

Counting every sponsor, half of 713 studies reached it within 29 months; a quarter within 11 and three quarters within 58.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 20, 2018
First posted
Mar 1, 2018
StartActual
Mar 2, 2018
Primary completionActual
Apr 30, 2018
CompletionActual
Apr 30, 2018
Last update
May 7, 2018
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 7, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03450486
Responsible party
Sponsor
First posted
Mar 1, 2018
Start date
Mar 2, 2018
Primary completion
Apr 30, 2018
Completion
Apr 30, 2018
Last update
May 7, 2018

Study contacts

James P Dickey, PhD
principal investigator · Western University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2018. You cannot join it, but the record below documents what was studied.

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