- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02609672
Resilience for Older Workers With OA Through Exercise
March 20, 2018 updated by: McMaster University
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
24
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Ontario
-
Hamilton, Ontario, Canada, L8P 3Y4
- McMaster University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
45 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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
- 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
Exclusion Criteria:
- 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
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Exercise
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.
|
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.
|
|
Other: No Exercise
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.
|
A no exercise (control) group maintained their existing activity level for 12 weeks.
Outcomes included mobility performance; pain; strength; cardiovascular fitness; and resilience.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Week 1 and Week 13
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Self-reported Knee and Hip Pain
Time Frame: Week 1 and Week 13
|
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).
|
Week 1 and Week 13
|
|
Change in Resilience
Time Frame: Week 1 and Week 13
|
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.
|
Week 1 and Week 13
|
|
Change in Mobility Performance (Six-Minute Walk Test)
Time Frame: Week 1 and Week 13
|
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.
|
Week 1 and Week 13
|
|
Change in Mobility Performance (40 Metre Walk Test)
Time Frame: Week 1 and Week 13
|
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.
|
Week 1 and Week 13
|
|
Change in Mobility Performance (Stair Ascent)
Time Frame: Week 1 and Week 13
|
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.
|
Week 1 and Week 13
|
|
Change in Mobility Performance (Stair Descent)
Time Frame: Week 1 and Week 13
|
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.
|
Week 1 and Week 13
|
|
Change in Mobility Performance (30-second Chair Stand Test)
Time Frame: Week 1 and Week 13
|
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.
|
Week 1 and Week 13
|
|
Change in Mobility Performance (Timed Up and Go Test)
Time Frame: Week 1 and Week 13
|
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.
|
Week 1 and Week 13
|
|
Change in Arthritis-related Self-efficacy
Time Frame: Week 1 and Week 13
|
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.
|
Week 1 and Week 13
|
|
Change in Depression Status
Time Frame: Week 1 and Week 13
|
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.
|
Week 1 and Week 13
|
|
Change in Grip Strength (Absolute)
Time Frame: Week 1 and Week 13
|
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.
|
Week 1 and Week 13
|
|
Change in Grip Strength (Relative)
Time Frame: Week 1 and Week 13
|
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).
|
Week 1 and Week 13
|
|
Change in Isometric Knee and Hip Extensor and Flexor Strength
Time Frame: Week 1 and Week 13
|
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).
|
Week 1 and Week 13
|
|
Change in Cardiovascular Fitness
Time Frame: Week 1 and Week 13
|
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.
|
Week 1 and Week 13
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Monica R Maly, PT, PhD, McMaster University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2015
Primary Completion (Actual)
July 1, 2016
Study Completion (Actual)
July 1, 2016
Study Registration Dates
First Submitted
November 17, 2015
First Submitted That Met QC Criteria
November 17, 2015
First Posted (Estimate)
November 20, 2015
Study Record Updates
Last Update Posted (Actual)
March 22, 2018
Last Update Submitted That Met QC Criteria
March 20, 2018
Last Verified
September 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- ResilienceAtWork
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Osteoarthritis, Knee
-
Istanbul University - CerrahpasaCompletedKnee Osteoarthritis | Knee Osteoarthritis (Knee OA)Turkey (Türkiye)
-
Edin MešanovićCompletedOsteoarthritis | Osteoarthritis of the Knee | Osteoarthritis of Knee | Osteoarthritis of the Knees | Osteoarthritis (OA) of the Knee | Osteoarthritis Knee | Osteoarthritis in the Knee | Osteoarthritis of Knee JointBosnia and Herzegovina
-
Golden Jubilee National HospitalJohnson & Johnson; DePuy OrthopaedicsNot yet recruitingOsteoarthritis | Knee Osteoarthritis | Osteoarthritis (OA) | Osteo Arthritis | Osteoarthritis in the Knee | Osteoarthritis (Knee) | Osteo Arthritis of the KneeUnited Kingdom
-
Dr. David WassersteinSunnybrook Research InstituteRecruitingKnee Osteoarthritis (Knee OA) | Knee Osteoarthritis (OA)Canada
-
LifeBridge HealthMicroPort Orthopedics Inc.; Rubin Institute for Advanced OrthopedicsRecruitingKnee Osteoarthritis | Osteoarthritis, Knee | Knee Pain Chronic | Arthropathy of Knee Joint | Knee Disease | Osteoarthritis Knees Both | Osteoarthritis Knee Left | Osteoarthritis Knee RightUnited States
-
Lucas R. Cusumano, MDNot yet recruitingKnee Osteoarthritis | Knee Discomfort | Knee Pain Chronic | Knee Swelling PainUnited States
-
VA Office of Research and DevelopmentNot yet recruitingKnee Osteoarthritis (Knee OA)United States
-
The Hong Kong Polytechnic UniversityChinese University of Hong Kong; Zhujiang HospitalNot yet recruitingKnee Osteoarthritis (Knee OA)
-
University of MiamiNot yet recruiting
-
Kutahya Health Sciences UniversityActive, not recruitingKnee Osteoarthritis | Knee DiseaseTurkey (Türkiye)
Clinical Trials on Exercise
-
National Institute of Neurological Disorders and...TerminatedTraumatic Brain InjuryUnited States
-
University of Texas, El PasoRecruitingKnee Osteoarthritis | Knee Pain Chronic | Central Pain SyndromeUnited States
-
Aksaray University Training and Research HospitalCompletedExercise Training | Lactate Blood Increase | Cognitive Functions | BDNFTurkey (Türkiye)
-
University of Alabama at BirminghamCompletedCystic FibrosisUnited States
-
Toronto Rehabilitation InstituteCompletedAcute Myeloid LeukemiaCanada
-
University of LisbonFundação para a Ciência e a TecnologiaActive, not recruiting
-
University of Missouri-ColumbiaCompleted
-
University of AlcalaCompletedMyofascial Pain | Myofascial Pain Syndrome | Post Needling Soreness | Myofascial Trigger Point PainSpain
-
University College CorkRecruitingDepressive Disorder, MajorIreland
-
Sahmyook UniversityRecruitingChronic Nonspecific Neck PainKorea, Republic of