Exercise on Knee OA With the Star Excursion Balance Test
Primary Purpose
Osteoarthritis, Osteo Arthritis Knee
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
exercise
Sponsored by
About this trial
This is an interventional basic science trial for Osteoarthritis focused on measuring dynamic balance, star excursion balance test, exercise
Eligibility Criteria
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 contraindications
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 informed consent
- Inability to stand on limb for more than 5 seconds
Sites / Locations
- University of Western Ontario
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
affected limb
unaffected limb
Arm Description
measurements of balance from the affected side of individuals with unilateral knee osteoarthritis following an exercise session
measurements of balance from the unaffected side of individuals with unilateral knee osteoarthritis following an exercise session
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT03450486
First Posted
February 20, 2018
Last Updated
May 1, 2018
Sponsor
Western University, Canada
1. Study Identification
Unique Protocol Identification Number
NCT03450486
Brief Title
Exercise on Knee OA With the Star Excursion Balance Test
Official Title
Effects of Exercise on Joint Stiffness and Dynamic Balance in Individuals With Knee Osteoarthritis Evaluated Through Star Excursion Balance Test
Study Type
Interventional
2. Study Status
Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
March 2, 2018 (Actual)
Primary Completion Date
April 30, 2018 (Actual)
Study Completion Date
April 30, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Western University, Canada
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Osteo Arthritis Knee
Keywords
dynamic balance, star excursion balance test, exercise
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
affected limb
Arm Type
Experimental
Arm Description
measurements of balance from the affected side of individuals with unilateral knee osteoarthritis following an exercise session
Arm Title
unaffected limb
Arm Type
Active Comparator
Arm Description
measurements of balance from the unaffected side of individuals with unilateral knee osteoarthritis following an exercise session
Intervention Type
Other
Intervention Name(s)
exercise
Intervention Description
one 30 minute bout of mild exercise
Primary Outcome Measure Information:
Title
star excursion balance test
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 contraindications
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 informed consent
Inability to stand on limb for more than 5 seconds
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James P Dickey, PhD
Organizational Affiliation
Western University
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Western Ontario
City
London
State/Province
Ontario
ZIP/Postal Code
N6A3K7
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
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.
Citations:
PubMed Identifier
15353613
Citation
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.
Results Reference
background
PubMed Identifier
3741515
Citation
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.
Results Reference
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PubMed Identifier
24553908
Citation
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Results Reference
background
PubMed Identifier
9462165
Citation
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.
Results Reference
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PubMed Identifier
12801417
Citation
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.
Results Reference
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PubMed Identifier
8979171
Citation
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.
Results Reference
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PubMed Identifier
23251579
Citation
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.
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PubMed Identifier
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Citation
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Results Reference
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PubMed Identifier
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Citation
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.
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PubMed Identifier
11394562
Citation
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Citation
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Results Reference
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Citation
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Citation
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Kanko L:
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Exercise on Knee OA With the Star Excursion Balance Test
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