Osteoarthritis, KneeNCT02609672
Resilience for Older Workers With OA 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
Exercise is effective at reducing pain while improving physical function. However we do not know if exercise can boost resilience in the workplace, to allow people with osteoarthritis to work as long as they desire. Read more about this study
- Who is it for?
- Ages 45 years and older
- 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
- 24 participants
- Where
- 1 siteCanada
- Study dates
- Aug 2015to Jul 2016
- 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 45 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 45 years of age or older
- McMaster employee
- Sedentary job (stand or walk for <1/3 of work day)
- Able to safely climb two flights of stairs
- Hip pain
- Hip pain during internal rotation and hip flexion
Show all 12Show fewer
- Knee pain
- Less than 30 minutes of morning stiffness in the knee
- Crepitus in the knee with active range of motion
- Bony enlargement around the knee
- Bony tenderness to palpation at the knee
- No warmth around the knee
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
Official title: Resilience and Longevity for Older Workers With Arthritis Through Exercise
Exercise is effective at reducing pain while improving physical function. However we do not know if exercise can boost resilience in the workplace, to allow people with osteoarthritis to work as long as they desire. Previous research shows that exercise holds the most promise for helping people enjoy their work because it reduces sick time, reduces pain, and improves productivity. However, little work has examined the effect of exercise for people with arthritis in the workplace. The purpose of the study is to investigate whether exercise improves resilience in the workplace, mobility, fitness, strength, and pain in comparison to no exercise in those with knee and/or hip osteoarthritis.
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. We aim to boost the ability of older adults with the most common arthritis, osteoarthritis (OA), to engage in the workforce for as long as they desire. Identifying strategies to promote productivity among older workers with knee and hip OA will be of great public health significance in the coming decades. However, we 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 the aging worker with knee and hip OA. The purpose of this study is to examine the impact of an OA-specific leg strengthening exercise program, delivered within the workplace, on mobility, pain, physical capacity, and resilience among older workers with knee or hip OA.
- Conditions
- Osteoarthritis, Knee, Osteoarthritis, Hip
- Being tested
- Exercise, No Exercise
- Keywords
- Exercise, Resilience
- Medical subject headings
- Osteoarthritis, Knee, Osteoarthritis, Hip, Motor Activity
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 was 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 maintained 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 were asked to attend 3 group classes per week for 12 weeks taught by a certified exercise instructor. Four class times were 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 were 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 were 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 were offered a free exercise pass following completion of the study. Measurements were 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 Function
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: Week 1 and Week 13
Secondary outcomes (14)
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: Week 1 and Week 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: Week 1 and Week 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: Week 1 and Week 13
Change in Mobility Performance (40 Metre Walk Test)
Mobility performance will be measured using the 40 Metre Walk Test. This test measures the time taken to complete a fast-paced 40 metre walk. The time taken to walk 40 metres is recorded in seconds. This measure has produced reliable and valid data in persons with knee OA.
Measured: Week 1 and Week 13
Change in Mobility Performance (Stair Ascent)
Mobility performance will be measured using the Stair Ascent Test. For this test, the time taken to ascend nine stairs is recorded in seconds. This measure has produced reliable and valid data in persons with knee OA.
Measured: Week 1 and Week 13
Change in Mobility Performance (Stair Descent)
Mobility performance will be measured using the Stair Descent Test. For this test, the time taken to descend nine stairs is recorded in seconds. This measure has produced reliable and valid data in persons with knee OA.
Measured: Week 1 and Week 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: Week 1 and Week 13
Change in Mobility Performance (Timed Up and Go Test)
Mobility performance will be measured using the Timed Up and Go Test. This test measures the time taken to rise from a standard chair with arm rests, walk 3 metres, and return to a seated position. This measure has produced reliable and valid data in persons with knee OA.
Measured: Week 1 and Week 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: Week 1 and Week 13
Change in Depression Status
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: Week 1 and Week 13
Change in Grip Strength (Absolute)
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: Week 1 and Week 13
Change in Grip Strength (Relative)
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/kg (grip force/body mass).
Measured: Week 1 and Week 13
Change in Isometric Knee and Hip Extensor and Flexor Strength
The peak torque developed during knee and hip extension and flexion during a maximum isometric contraction will be measured by use of a Biodex System 2 isokinetic dynamometer. Data will be presented as Nm/kg (torque/body mass).
Measured: Week 1 and Week 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: Week 1 and Week 13
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2015 (estimated)
- Study startAug 2015
- Primary completionJul 2016
- Study completionJul 2016
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
- 24 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
- NCT02609672
- Sponsor's protocol ID
- ResilienceAtWork
- Status last verified
- Sep 2017
- First submitted
- 17 Nov 2015
- Last updated
- 22 Mar 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Chopp-Hurley JN, Brenneman EC, Wiebenga EG, Bulbrook B, Keir PJ, Maly MR. Randomized Controlled Trial Investigating the Role of Exercise in the Workplace to Improve Work Ability, Performance, and Patient-Reported Symptoms Among Older Workers With Osteoarthritis. J Occup Environ Med. 2017 Jun;59(6):550-556. doi: 10.1097/JOM.0000000000001020.
PubMed 28379878
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Resilience and Longevity for Older Workers With Arthritis Through Exercise
- ClinicalTrials.gov ID
- NCT02609672
- Acronym / sponsor ID
- ResilienceAtWork
- Conditions
- Osteoarthritis, Knee, Osteoarthritis, Hip
- Keywords
- Exercise, Resilience
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Study start
- Aug 2015
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 20 Nov 2015 (estimated)
- Results
- Posted 10 Mar 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Exercise is effective at reducing pain while improving physical function. However we do not know if exercise can boost resilience in the workplace, to allow people with osteoarthritis to work as long as they desire. Previous research shows that exercise holds the most promise for helping people enjoy their work because it reduces sick time, reduces pain, and improves productivity. However, little work has examined the effect of exercise for people with arthritis in the workplace. The purpose of the study is to investigate whether exercise improves resilience in the workplace, mobility, fitness, strength, and pain in comparison to no exercise in those with knee and/or hip osteoarthritis.
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. We aim to boost the ability of older adults with the most common arthritis, osteoarthritis (OA), to engage in the workforce for as long as they desire. Identifying strategies to promote productivity among older workers with knee and hip OA will be of great public health significance in the coming decades. However, we 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 the aging worker with knee and hip OA. The purpose of this study is to examine the impact of an OA-specific leg strengthening exercise program, delivered within the workplace, on mobility, pain, physical capacity, and resilience among older workers with knee or 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 were asked to attend 3 group classes per week for 12 weeks taught by a certified exercise instructor. Four class times were 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 were 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 were 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 were offered a free exercise pass following completion of the study. Measurements were 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
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 45 years of age or older
- McMaster employee
- Sedentary job (stand or walk for <1/3 of work day)
- Able to safely climb two flights of stairs
- Hip pain
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 was 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 maintained 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 Function
Time frame: Week 1 and Week 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.
14 secondary outcomes
Change in Self-reported Knee and Hip Pain
Time frame: Week 1 and Week 13
Change in Resilience
Time frame: Week 1 and Week 13
Change in Mobility Performance (Six-Minute Walk Test)
Time frame: Week 1 and Week 13
Change in Mobility Performance (40 Metre Walk Test)
Time frame: Week 1 and Week 13
Change in Mobility Performance (Stair Ascent)
Time frame: Week 1 and Week 13
Change in Mobility Performance (Stair Descent)
Time frame: Week 1 and Week 13
Change in Mobility Performance (30-second Chair Stand Test)
Time frame: Week 1 and Week 13
Change in Mobility Performance (Timed Up and Go Test)
Time frame: Week 1 and Week 13
Change in Arthritis-related Self-efficacy
Time frame: Week 1 and Week 13
Change in Depression Status
Time frame: Week 1 and Week 13
Change in Grip Strength (Absolute)
Time frame: Week 1 and Week 13
Change in Grip Strength (Relative)
Time frame: Week 1 and Week 13
Change in Isometric Knee and Hip Extensor and Flexor Strength
Time frame: Week 1 and Week 13
Change in Cardiovascular Fitness
Time frame: Week 1 and Week 13
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 28379878Chopp-Hurley JN, Brenneman EC, Wiebenga EG, Bulbrook B, Keir PJ, Maly MR. Randomized Controlled Trial Investigating the Role of Exercise in the Workplace to Improve Work Ability, Performance, and Patient-Reported Symptoms Among Older Workers With Osteoarthritis. J Occup Environ Med. 2017 Jun;59(6):550-556. doi: 10.1097/JOM.0000000000001020.
- 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 12 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 22 Mar 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 Mar 2017). 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 Function (time frame: Week 1 and Week 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 NCT02609672, 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 22 Mar 2018.