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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
24

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Canada
    • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Other: Exercise
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.
Other: No Exercise
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
McMaster University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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.

General Publications

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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 17, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 17, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 20, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 22, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 20, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

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