NCT03050320

Brief 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. The investigators hypothesize that exercise designed for OA, delivered at work, will improve all of these outcomes.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
43

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2017

Shorter than P25 for not_applicable

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

First Submitted

Initial submission to the registry

February 8, 2017

Completed
Same day until next milestone

Study Start

First participant enrolled

February 8, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 10, 2017

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2017

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

August 10, 2018

Completed
Last Updated

August 10, 2018

Status Verified

November 1, 2017

Enrollment Period

5 months

First QC Date

February 8, 2017

Results QC Date

September 26, 2017

Last Update Submit

November 16, 2017

Conditions

Keywords

ResilienceExercise in the workplace

Outcome Measures

Primary Outcomes (1)

  • 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

    Weeks 1 and 13

Secondary Outcomes (12)

  • Change in Self-reported Knee and Hip Pain

    Weeks 1 and 13

  • Change in Self-reported Upper Extremity Pain

    Weeks 1 and 13

  • Change in Isometric Knee Extensor and Flexor Strength

    Weeks 1 and 13

  • Change in Grip Strength

    Weeks 1 and 13

  • Change in Cardiovascular Fitness

    Weeks 1 and 13

  • +7 more secondary outcomes

Study Arms (2)

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.

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.

Other: No Exercise

Interventions

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.

Exercise

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.

No Exercise

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • full-time or part-time administrative employees

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, L8S4L8, Canada

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Osteoarthritis, KneeOsteoarthritis, Hip

Interventions

Exercise

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Limitations and Caveats

* a limited number of participants were recruited due to time and space limitations within the exercise facility * physical activity levels of the control group during the 12-week intervention period were not quantified

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

February 8, 2017

First Posted

February 10, 2017

Study Start

February 8, 2017

Primary Completion

June 30, 2017

Study Completion

June 30, 2017

Last Updated

August 10, 2018

Results First Posted

August 10, 2018

Record last verified: 2017-11

Data Sharing

IPD Sharing
Will not share

Locations