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Prevention, Management and Rehabilitation of Knee Osteoarthritis at the Workplace

Primary Purpose

Knee Pain Chronic, Knee Osteoarthritis, Knee Discomfort

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Blood flow restriction (BFR)
Usual care (control)
Sponsored by
National Research Centre for the Working Environment, Denmark
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Knee Pain Chronic

Eligibility Criteria

18 Years - 67 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Hospital workers working at least 20 hours per week with or without chronic knee pain (>3 months) Exclusion Criteria: Life-threatening disease Conditions where BFR training may be contraindicated, e.g. pregnancy, cancer, diabetes, major cardiovascular disease, current, previous or family history of clotting disorders, recent immobilization, major surgery or injections into the joint (i.e. corticosteroid injection) Systolic/diastolic blood pressure above 160/100 mmHg

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Blood flow restriction (BFR)

    Usual care (control)

    Arm Description

    Blood flow restricted training (BFR) integrated into the daily work tasks for 8 weeks.

    Will continue their work as usual

    Outcomes

    Primary Outcome Measures

    Pain intensity
    Change in worst knee pain intensity during the last week rated on a 11-point numeric rating scale (NRS)

    Secondary Outcome Measures

    Functional performance
    30-s chair-stand test, 40 m fast-paced walk test, a stair-climb test, maximal isometric knee extensor muscle strength
    Work ability
    Single-item on physical work ability derived from the Work Ability Index (WAI)

    Full Information

    First Posted
    April 10, 2023
    Last Updated
    April 10, 2023
    Sponsor
    National Research Centre for the Working Environment, Denmark
    Collaborators
    University of Southern Denmark, University Hospital Bispebjerg and Frederiksberg
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05822401
    Brief Title
    Prevention, Management and Rehabilitation of Knee Osteoarthritis at the Workplace
    Official Title
    Prevention, Management and Rehabilitation of Knee Osteoarthritis at the Workplace
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    April 11, 2023 (Anticipated)
    Primary Completion Date
    December 31, 2023 (Anticipated)
    Study Completion Date
    December 31, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    National Research Centre for the Working Environment, Denmark
    Collaborators
    University of Southern Denmark, University Hospital Bispebjerg and Frederiksberg

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    The goal of this intervention study is to assess the effect of blood flow restricted (BFR) exercise integrated into the daily work tasks among hospital workers with or at increased risk of chronic knee pain. The main questions are: Can BFR exercise integrated into the daily work tasks reduce knee pain (primary outcome) and improve function and work ability among hospital workers with or at increased risk of chronic knee pain? Participants in the intervention group will for shorts bouts during their workdays integrate BFR into their daily work tasks involving walking, whereas the control group will continue as usual.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Knee Pain Chronic, Knee Osteoarthritis, Knee Discomfort

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    80 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Blood flow restriction (BFR)
    Arm Type
    Experimental
    Arm Description
    Blood flow restricted training (BFR) integrated into the daily work tasks for 8 weeks.
    Arm Title
    Usual care (control)
    Arm Type
    Active Comparator
    Arm Description
    Will continue their work as usual
    Intervention Type
    Behavioral
    Intervention Name(s)
    Blood flow restriction (BFR)
    Intervention Description
    Blood flow restricted training integrated into the daily work tasks for 8 weeks.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Usual care (control)
    Intervention Description
    Will continue their work as usual
    Primary Outcome Measure Information:
    Title
    Pain intensity
    Description
    Change in worst knee pain intensity during the last week rated on a 11-point numeric rating scale (NRS)
    Time Frame
    Change pre-post 8 weeks of intervention
    Secondary Outcome Measure Information:
    Title
    Functional performance
    Description
    30-s chair-stand test, 40 m fast-paced walk test, a stair-climb test, maximal isometric knee extensor muscle strength
    Time Frame
    Change pre-post 8 weeks of intervention
    Title
    Work ability
    Description
    Single-item on physical work ability derived from the Work Ability Index (WAI)
    Time Frame
    Change pre-post 8 weeks of intervention
    Other Pre-specified Outcome Measures:
    Title
    Work-limiting pain
    Description
    Rating of the degree of work limitations due to pain
    Time Frame
    Change pre-post 8 weeks of intervention
    Title
    Work-related fatigue
    Description
    Rating af work-related fatigue in different body parts
    Time Frame
    Change pre-post 8 weeks of intervention

    10. Eligibility

    Sex
    All
    Gender Based
    Yes
    Gender Eligibility Description
    Based on self-representation of gender identity.
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    67 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Hospital workers working at least 20 hours per week with or without chronic knee pain (>3 months) Exclusion Criteria: Life-threatening disease Conditions where BFR training may be contraindicated, e.g. pregnancy, cancer, diabetes, major cardiovascular disease, current, previous or family history of clotting disorders, recent immobilization, major surgery or injections into the joint (i.e. corticosteroid injection) Systolic/diastolic blood pressure above 160/100 mmHg
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Sebastian Skovlund
    Phone
    40385166
    Email
    svs@nfa.dk

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Prevention, Management and Rehabilitation of Knee Osteoarthritis at the Workplace

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