Osteoarthritis, KneeNCT03050320
Improving Resilience and Longevity for Workers Through Exercise
A study testing Exercise and No Exercise in people with Osteoarthritis, Knee and Osteoarthritis, Hip, run by McMaster University at 1 site in Canada.
Trial summary
The purpose of this study is to examine the impact of an OA-specific aerobic and strengthening exercise program, delivered within the workplace, on mobility, pain, physical capacity, and resilience among workers with knee or hip OA as well as those with no joint pain. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Osteoarthritis, Knee, Osteoarthritis, Hip
- What is being tested?
- Exercise and No Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteCanada
- Study dates
- 8 Feb 2017to 30 Jun 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- full-time or part-time administrative employees
Who cannot join
- Any other forms of arthritis
- Osteoporosis-related fracture
- History of patellofemoral symptoms
- Active non-arthritic hip or knee disease
- Hip or knee surgery
- Use of cane or walking aid
Show all 14Show fewer
- Unstable heart condition
- Neurological conditions
- Hip, knee or ankle injuries in past 3 months
- Physician-advised restriction to physical activity
- Any injuries that would prohibit participation in exercise
- Ipsilateral ankle conditions
- Currently receiving cancer treatment
- Currently pregnant
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to examine the impact of an OA-specific aerobic and strengthening exercise program, delivered within the workplace, on mobility, pain, physical capacity, and resilience among workers with knee or hip OA as well as those with no joint pain. The investigators hypothesize that exercise designed for OA, delivered at work, will improve all of these outcomes.
Read the detailed description
The Canadian workforce is aging. The most prevalent age group is 50-54 years and most of these Canadians will aim to continue working over the next 10 years. However, the impact of arthritis on aging Canadians compromises their ability to continue working. By 2031, over 2 million Canadians aged 45 to 64 years will have arthritis. The investigators aim to boost the ability of adults with the most common arthritis, osteoarthritis (OA), as well as adults without OA, to engage in the workforce for as long as they desire. Identifying strategies to promote productivity among workers with knee and hip OA will be of great public health significance in the coming decades. However, the investigators face two challenges. First, obesity among sedentary workers is a risk for worsening knee and hip OA. Second, large occupational loads on the knee and hip worsen OA. Exercise has the most promise in addressing these challenges because it reduces pain and sick time, and improves mental health. Thus, there is a call for studies examining exercise for workers with knee and hip OA.
- Conditions
- Osteoarthritis, Knee, Osteoarthritis, Hip
- Being tested
- Exercise, No Exercise
- Keywords
- Resilience, Exercise in the workplace
- Medical subject headings
- Osteoarthritis, Knee, Osteoarthritis, Hip
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseOther
A biomechanical exercise program shown to decrease joint loading will be administered 3 times a week for 12 weeks. Outcomes included mobility performance; pain; strength; cardiovascular fitness; and resilience.
No ExerciseOther
A no exercise (control) group will be asked to maintain their existing activity level for 12 weeks. Outcomes included mobility performance; pain; strength; cardiovascular fitness; and resilience.
| Study group | Role | What they receive |
|---|---|---|
| Exercise | Experimental | The participants in this arm will be asked to attend 3 group classes per week for 12 weeks taught by a certified exercise instructor. Five class times will be offered per week. These classes included a warm-up, static poses shown to decrease knee joint loading, and a cool down including flexibility exercises. Measurements will be obtained at baseline (before intervention) and at follow-up (following intervention). Outcomes included clinical mobility; pain; isometric leg strength; cardiovascular fitness; and resilience. Receives: Other: Exercise |
| No Exercise | Other | The participants in this arm will be asked to refrain from changing their physical activity over the 12 weeks and maintain any strategies typically used to manage knee and/or hip pain. Since it is known that exercise is beneficial for pain management and strengthening in knee OA, participants randomized to the no exercise group will be offered the same exercise program following completion of the study. Measurements will be obtained at baseline (before intervention) and at follow-up (following intervention). Outcomes included clinical mobility; pain; isometric leg strength; cardiovascular fitness; and resilience. Receives: Other: No Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Lower Extremity Functional Scale
The Lower Extremity Function Scale (LEFS) consists of 20 items, on an adjectival scale, that assess difficulty during mobility tasks ranging from transfers to running. Each item is scored from 0 (extreme difficulty or unable to perform activity), to 4 (no difficulty to perform activity). The minimum possible score is 0, and the maximum possible score is 80. Scores closer to 80 represent better self-reported physical function. It is reliable and valid in knee OA and has superior sensitivity to change compared to similar measures
Measured: Weeks 1 and 13
Secondary outcomes (12)
Change in Self-reported Knee and Hip Pain
Change in self-reported knee and hip pain will be assessed with 3 valid and reliable questionnaires: the Knee injury and Osteoarthritis Outcome Score (KOOS), the Hip disability and Osteoarthritis Outcome Score (HOOS), and the Intermittent and Constant Osteoarthritis Pain (ICOAP) score. The KOOS and HOOS pain scores represent a normalized score from 0 (extreme symptoms) to 100 (no symptoms). KOOS and HOOS scores closer to 100 indicate fewer symptoms. The ICOAP consists of two sub-scales: constant pain (5 items) and intermittent pain (6 items). The score from each subscale represents a normalized score from 0 (no pain) to 100 (extreme pain). ICOAP scores closer to 0 indicate less pain. The items from each subscale are averaged to produce a normalized ICOAP total score, ranging from 0 (no pain) to 100 (extreme pain).
Measured: Weeks 1 and 13
Change in Self-reported Upper Extremity Pain
The Disabilities of the Arm Shoulder and Hand is a 30-item questionnaire addressing upper extremity physical function and symptoms. The DASH is suitable for people with any upper limb musculoskeletal disorders and can also monitor changes in severity of symptoms and functional abilities over time. Each item is scored from 1 (no difficulty) to 5 (unable). Total scores range from 0 to 100, with higher scores indicating more upper limb problems.
Measured: Weeks 1 and 13
Change in Isometric Knee Extensor and Flexor Strength
The peak torque developed during knee extension and flexion during a maximum isometric contraction will be measured by use of a ergoFET hand-held dynamometer.
Measured: Weeks 1 and 13
Change in Grip Strength
Grip strength will be assessed using a Jamar hand dynamometer. The hand dynamometer will be set to a fixed position and all values of grip force will be expressed in kg.
Measured: Weeks 1 and 13
Change in Cardiovascular Fitness
Cardiovascular fitness will be calculated using the Single Stage Treadmill Walking Test. Predictions of VO2max will be made from heart rate (measured with a heart rate monitor), walking speed, age and gender.
Measured: Weeks 1 and 13
Change in Mobility Performance (Six-Minute Walk Test)
Mobility performance will be measured using the Six-Minute Walk Test (6MWT). For this test, participants are instructed to walk as far as possible in 6 minutes. The distance covered in 6 minutes is recorded in metres. This measure has produced reliable and valid data in persons with knee OA.
Measured: Weeks 1 and 13
Change in Mobility Performance (Stair Ascent and Descent)
Mobility performance will be measured using the Stair Ascent and Descent Test. For this test, the time taken to ascend, as well as descend nine stairs is recorded in seconds. This measure has produced reliable and valid data in persons with knee OA.
Measured: Weeks 1 and 13
Change in Mobility Performance (30-second Chair Stand Test)
Mobility performance will be measured using the 30-second Chair Stand Test. This test measures the number of times participants can rise and lower from a standard height chair, without using arm rests, in a 30-second period.This measure has produced reliable and valid data in persons with knee OA.
Measured: Weeks 1 and 13
Change in Resilience
Resilience will be measured using the Resilience Scale 25 Survey, which is a 25-item questionnaire designed to evaluate a participants ability to adapt to stress and adversity. The test is scored out of 175 (scores ranging from 25 to 175), with higher scores indicating higher resilience.
Measured: Weeks 1 and 13
Change in Work Ability
The Work Ability Index (WAI) is a widely-used self-report questionnaire that evaluates a worker's capacity to perform a job accounting for their physical and mental well-being in addition to the demands of their job. The WAI consists of seven dimensions including current work ability relative to life-time best, work ability related to job demands, number of current physician-diagnosed health conditions, estimated work impairment due to the conditions, sick leave over the past year, own prognosis, and mental resources. Total scores range from 7 to 49 and can fall under one of four classifications: poor work ability that should be restored (7-27), moderate work ability that should be improved (28-36), good work ability that should be supported (37-43), and excellent work ability that should be maintained (44-49). The WAI produces reliable data.
Measured: Weeks 1 and 13
Change in Depressive Symptoms
Depression will be assessed with the Centre of Epidemiological Studies Depression (CES-D) Scale, a 20-item scale developed for the general population with emphasis on affect. Elements of affect include mood, guilt, worthlessness, helplessness, appetite, and sleep. Each item is scored from 0 (rarely or none of the time), to 3 (most of the time). The items are summed to produce a total score between 0 and 60 with a score of 16 or higher indicating depression.
Measured: Weeks 1 and 13
Change in Arthritis-related Self-Efficacy
The Arthritis Self-Efficacy Scale (ASES) measures arthritis-specific beliefs regarding perception of performance on certain tasks to cope with the disease. The ASES is measured using 20 questions on a 10-100 scale with respect to three main areas: pain management (5 questions), physical function (9 questions), and other symptoms (6 questions). Each question is scored from 10 (very uncertain), to 100 (very certain), in 10-point increments. The minimum score for each subscale is 10, and the maximum score for each subscale is 100. The scores from each subscale are averaged to produce a normalized total score. Scores closer to 100 indicate greater certainty that a participant can cope with a particular task as a consequence of their disease.
Measured: Weeks 1 and 13
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2017
- Study start8 Feb 2017
- Primary completion30 Jun 2017
- Study completion30 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Osteoarthritis, KneeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Monica R Maly, PT, PhD, Principal investigator, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03050320
- Sponsor's protocol ID
- Workplace Exercise
- Status last verified
- Nov 2017
- First submitted
- 8 Feb 2017
- Last updated
- 10 Aug 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mulla DM, Wiebenga EG, Chopp-Hurley JN, Kaip L, Jarvis RS, Stephens A, Keir PJ, Maly MR. The Effects of Lower Extremity Strengthening Delivered in the Workplace on Physical Function and Work-Related Outcomes Among Desk-Based Workers: A Randomized Controlled Trial. J Occup Environ Med. 2018 Nov;60(11):1005-1014. doi: 10.1097/JOM.0000000000001408.
PubMed 30020219
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Resilience and Longevity for Workers Through Exercise
- ClinicalTrials.gov ID
- NCT03050320
- Acronym / sponsor ID
- Workplace Exercise
- Conditions
- Osteoarthritis, Knee, Osteoarthritis, Hip
- Keywords
- Resilience, Exercise in the workplace
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Study start
- 8 Feb 2017 (actual)
- Primary completion
- 30 Jun 2017 (actual)
- Study completion
- 30 Jun 2017 (actual)
- First posted
- 10 Feb 2017 (actual)
- Results
- Posted 10 Aug 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to examine the impact of an OA-specific aerobic and strengthening exercise program, delivered within the workplace, on mobility, pain, physical capacity, and resilience among workers with knee or hip OA as well as those with no joint pain. The investigators hypothesize that exercise designed for OA, delivered at work, will improve all of these outcomes.
Detailed description
The Canadian workforce is aging. The most prevalent age group is 50-54 years and most of these Canadians will aim to continue working over the next 10 years. However, the impact of arthritis on aging Canadians compromises their ability to continue working. By 2031, over 2 million Canadians aged 45 to 64 years will have arthritis. The investigators aim to boost the ability of adults with the most common arthritis, osteoarthritis (OA), as well as adults without OA, to engage in the workforce for as long as they desire. Identifying strategies to promote productivity among workers with knee and hip OA will be of great public health significance in the coming decades. However, the investigators face two challenges. First, obesity among sedentary workers is a risk for worsening knee and hip OA. Second, large occupational loads on the knee and hip worsen OA. Exercise has the most promise in addressing these challenges because it reduces pain and sick time, and improves mental health. Thus, there is a call for studies examining exercise for workers with knee and hip OA.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise | Experimental | Other: ExerciseThe participants in this arm will be asked to attend 3 group classes per week for 12 weeks taught by a certified exercise instructor. Five class times will be offered per week. These classes included a warm-up, static poses shown to decrease knee joint loading, and a cool down including flexibility exercises. Measurements will be obtained at baseline (before intervention) and at follow-up (following intervention). Outcomes included clinical mobility; pain; isometric leg strength; cardiovascular fitness; and resilience. |
| No Exercise | Other | Other: No ExerciseThe participants in this arm will be asked to refrain from changing their physical activity over the 12 weeks and maintain any strategies typically used to manage knee and/or hip pain. Since it is known that exercise is beneficial for pain management and strengthening in knee OA, participants randomized to the no exercise group will be offered the same exercise program following completion of the study. Measurements will be obtained at baseline (before intervention) and at follow-up (following intervention). Outcomes included clinical mobility; pain; isometric leg strength; cardiovascular fitness; and resilience. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- full-time or part-time administrative employees
Key exclusion criteria (14 listed)
- Any other forms of arthritis
- Osteoporosis-related fracture
- History of patellofemoral symptoms
- Active non-arthritic hip or knee disease
- Hip or knee surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ExerciseA biomechanical exercise program shown to decrease joint loading will be administered 3 times a week for 12 weeks. Outcomes included mobility performance; pain; strength; cardiovascular fitness; and resilience. | Other | Exercise |
| No ExerciseA no exercise (control) group will be asked to maintain their existing activity level for 12 weeks. Outcomes included mobility performance; pain; strength; cardiovascular fitness; and resilience. | Other | No Exercise |
Primary outcome
Change in Lower Extremity Functional Scale
Time frame: Weeks 1 and 13
The Lower Extremity Function Scale (LEFS) consists of 20 items, on an adjectival scale, that assess difficulty during mobility tasks ranging from transfers to running. Each item is scored from 0 (extreme difficulty or unable to perform activity), to 4 (no difficulty to perform activity). The minimum possible score is 0, and the maximum possible score is 80. Scores closer to 80 represent better self-reported physical function. It is reliable and valid in knee OA and has superior sensitivity to change compared to similar measures
12 secondary outcomes
Change in Self-reported Knee and Hip Pain
Time frame: Weeks 1 and 13
Change in Self-reported Upper Extremity Pain
Time frame: Weeks 1 and 13
Change in Isometric Knee Extensor and Flexor Strength
Time frame: Weeks 1 and 13
Change in Grip Strength
Time frame: Weeks 1 and 13
Change in Cardiovascular Fitness
Time frame: Weeks 1 and 13
Change in Mobility Performance (Six-Minute Walk Test)
Time frame: Weeks 1 and 13
Change in Mobility Performance (Stair Ascent and Descent)
Time frame: Weeks 1 and 13
Change in Mobility Performance (30-second Chair Stand Test)
Time frame: Weeks 1 and 13
Change in Resilience
Time frame: Weeks 1 and 13
Change in Work Ability
Time frame: Weeks 1 and 13
Change in Depressive Symptoms
Time frame: Weeks 1 and 13
Change in Arthritis-related Self-Efficacy
Time frame: Weeks 1 and 13
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 30020219Mulla DM, Wiebenga EG, Chopp-Hurley JN, Kaip L, Jarvis RS, Stephens A, Keir PJ, Maly MR. The Effects of Lower Extremity Strengthening Delivered in the Workplace on Physical Function and Work-Related Outcomes Among Desk-Based Workers: A Randomized Controlled Trial. J Occup Environ Med. 2018 Nov;60(11):1005-1014. doi: 10.1097/JOM.0000000000001408.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Monica R Maly, PT, PhD principal investigator
McMaster University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise and No Exercise in people with Osteoarthritis, Knee and Osteoarthritis, Hip, run by McMaster University at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Aug 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Lower Extremity Functional Scale (time frame: Weeks 1 and 13). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03050320, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2018.