Effectiveness of Technology-enabled Exercise Program in Firefighters With Shoulder Pain.

May 1, 2018 updated by: Western University, Canada

Development of A Technology-Enabled Intervention for Musculoskeletal Health: The Effectiveness of Technology-enabled Exercise Program in Firefighters With Shoulder Pain. A Randomized Controlled Trial.

To assess if a technology-enabled Exercise program plus Education (TEEP + E) is more effective than Education program (EP) alone, in providing better outcomes (quality of life, at-work disability and productivity loss, firefighters' perception, adherence, overall improvement/deterioration) in firefighters with shoulder pain, at 3-, 6-and 12-month follow ups.

Study Overview

Study Type

Interventional

Enrollment (Anticipated)

180

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 Contact

  • Name: Goris Nazari, PhD(C)
  • Phone Number: 88912 519 661 2111
  • Email: gnazari@uwo.ca

Study Contact Backup

  • Name: Joy C MacDermid, PhD
  • Phone Number: 88912 519 661 2111
  • Email: jmacderm@uwo.ca

Study Locations

    • Ontario
      • Hamilton, Ontario, Canada
        • Hamilton Fire Station
        • Principal Investigator:
          • Joy MacDermid, PhD
        • Contact:
          • Joy C MacDermid, PhD
          • Phone Number: 88912 519 661 2111
          • Email: jmacderm@uwo.ca
        • Contact:
        • Principal Investigator:
          • Goris Nazari, PhD (C)
        • Sub-Investigator:
          • George Athwal, PhD

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

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Active duty firefighters aged 18 to 100 years, with shoulder pain.
  • Do not permanently use strong pain medications.
  • Able to understand spoken and written English.
  • Access to computer, internet and telecommunications application software (Skype).

Exclusion Criteria:

  • Firefighters who have had shoulder related surgeries in the last 6 months.

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Exercise Program plus Education.
Rotator cuff stretching and strengthening exercises outlined in the American Academy of Orthopedic Surgeons (AAOS) guidelines on management of rotator cuff problems.
Rotator cuff exercises outlined in the American Academy of Orthopedic Surgeons (AAOS) guidelines on management of rotator cuff problems.
Other Names:
  • Exercise and Education
An information sheet form AAOS, outlining the anatomy, description, causes, symptoms, examination and imaging tests performed on individuals with shoulder conditions
Other Names:
  • Education.
Active Comparator: Educational Program (EP).
An information sheet form AAOS, outlining the anatomy, description, causes, symptoms, examination and imaging tests performed on individuals with shoulder conditions
An information sheet form AAOS, outlining the anatomy, description, causes, symptoms, examination and imaging tests performed on individuals with shoulder conditions
Other Names:
  • Education.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Firefighter Work Limitation Questionnaire
Time Frame: 3-months
at-work disability and productivity loss
3-months
Firefighter Work Limitation Questionnaire
Time Frame: 6-months
at-work disability and productivity loss
6-months
Firefighter Work Limitation Questionnaire
Time Frame: 12-months
at-work disability and productivity loss
12-months
Short- Western Ontario Rotator Cuff Index
Time Frame: 3-months
Quality of life
3-months
Short- Western Ontario Rotator Cuff Index
Time Frame: 6-months
Quality of life
6-months
Short- Western Ontario Rotator Cuff Index
Time Frame: 12-months
Quality of life
12-months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Single Assessment Numeric Evaluation
Time Frame: 3-, 6- and 12-months
Patient's perception of the condition
3-, 6- and 12-months
Number of days lost
Time Frame: 3-, 6- and 12-months
Work days lost due to the condition
3-, 6- and 12-months
Therapy Adherence Assessment Tool
Time Frame: 3-, 6- and 12-months
Exercise adherence
3-, 6- and 12-months
Global Rating of Change Scale
Time Frame: 6- and 12-months
To quantify a patient's improvement or deterioration over time
6- and 12-months
Adverse Effects
Time Frame: 3-, 6- and 12-months
Have you experienced any exercise-induced pain
3-, 6- and 12-months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Chair: Joy C MacDermid, PhD, Western University, jmacderm@uwo.ca, 519 661 2111 x (88912)

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 (Anticipated)

June 1, 2018

Primary Completion (Anticipated)

June 1, 2019

Study Completion (Anticipated)

September 1, 2019

Study Registration Dates

First Submitted

April 11, 2018

First Submitted That Met QC Criteria

May 1, 2018

First Posted (Actual)

May 14, 2018

Study Record Updates

Last Update Posted (Actual)

May 14, 2018

Last Update Submitted That Met QC Criteria

May 1, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

  • UWO Firefighters 2018

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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