NCT03450486

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 20, 2018

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 1, 2018

Completed
1 day until next milestone

Study Start

First participant enrolled

March 2, 2018

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2018

Completed
Last Updated

May 7, 2018

Status Verified

February 1, 2018

Enrollment Period

2 months

First QC Date

February 20, 2018

Last Update Submit

May 1, 2018

Conditions

Keywords

dynamic balancestar excursion balance testexercise

Outcome Measures

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.

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

Study Arms (2)

affected limb

EXPERIMENTAL

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

Other: exercise

unaffected limb

ACTIVE COMPARATOR

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

Other: exercise

Interventions

one 30 minute bout of mild exercise

affected limbunaffected limb

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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 contraindications

You may not qualify if:

  • 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 informed consent
  • Inability to stand on limb for more than 5 seconds

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Western Ontario

London, Ontario, N6A3K7, Canada

Location

Related Publications (15)

  • 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.

    PMID: 15353613BACKGROUND
  • 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.

    PMID: 3741515BACKGROUND
  • 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.

    PMID: 24553908BACKGROUND
  • 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.

    PMID: 9462165BACKGROUND
  • 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.

    PMID: 12801417BACKGROUND
  • 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.

    PMID: 8979171BACKGROUND
  • 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.

    PMID: 23251579BACKGROUND
  • 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.

    PMID: 9284239BACKGROUND
  • 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.

    PMID: 28688769BACKGROUND
  • 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.

    PMID: 11394562BACKGROUND
  • 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.

    PMID: 26512340BACKGROUND
  • 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.

    PMID: 9580895BACKGROUND
  • 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.

    PMID: 22141334BACKGROUND
  • Kanko L:

    BACKGROUND
  • 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.

    PMID: 21800945BACKGROUND

MeSH Terms

Conditions

OsteoarthritisMotor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesBehavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • James P Dickey, PhD

    Western University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Model Details: This study will include one intervention arm and one control arm. The intervention arm will include balance measurements from the affected side of individuals with unilateral knee osteoarthritis. The control arm will will include balance measurements from the unaffected side of individuals with unilateral knee osteoarthritis.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 20, 2018

First Posted

March 1, 2018

Study Start

March 2, 2018

Primary Completion

April 30, 2018

Study Completion

April 30, 2018

Last Updated

May 7, 2018

Record last verified: 2018-02

Data Sharing

IPD Sharing
Will not share

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.

Locations