NCT02609672

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2015

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

November 17, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 20, 2015

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
8 months until next milestone

Results Posted

Study results publicly available

March 10, 2017

Completed
Last Updated

March 22, 2018

Status Verified

September 1, 2017

Enrollment Period

11 months

First QC Date

November 17, 2015

Results QC Date

September 27, 2016

Last Update Submit

March 20, 2018

Conditions

Keywords

ExerciseResilience

Outcome Measures

Primary Outcomes (1)

  • 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.

    Week 1 and Week 13

Secondary Outcomes (14)

  • Change in Self-reported Knee and Hip Pain

    Week 1 and Week 13

  • Change in Resilience

    Week 1 and Week 13

  • Change in Mobility Performance (Six-Minute Walk Test)

    Week 1 and Week 13

  • Change in Mobility Performance (40 Metre Walk Test)

    Week 1 and Week 13

  • Change in Mobility Performance (Stair Ascent)

    Week 1 and Week 13

  • +9 more secondary outcomes

Study Arms (2)

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.

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.

Other: No Exercise

Interventions

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.

Exercise

A no exercise (control) group maintained their existing activity level for 12 weeks. Outcomes included mobility performance; pain; strength; cardiovascular fitness; and resilience.

No Exercise

Eligibility Criteria

Age45 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

McMaster University

Hamilton, Ontario, L8P 3Y4, Canada

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Osteoarthritis, KneeOsteoarthritis, HipMotor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesBehavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Limitations and Caveats

* Sample size in this trial was limited * Adherence to the exercise classes in the exercise group was poor

Results Point of Contact

Title
Dr. Monica Maly
Organization
McMaster University/University of Waterloo

Study Officials

  • Monica R Maly, PT, PhD

    McMaster University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 17, 2015

First Posted

November 20, 2015

Study Start

August 1, 2015

Primary Completion

July 1, 2016

Study Completion

July 1, 2016

Last Updated

March 22, 2018

Results First Posted

March 10, 2017

Record last verified: 2017-09

Data Sharing

IPD Sharing
Will not share

Locations