Prevention, Management and Rehabilitation of Knee Osteoarthritis at the Workplace

• Sponsor: National Research Centre for the Working Environment, Denmark (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05822401
• Collaborator: University of Southern Denmark (Other), University Hospital Bispebjerg and Frederiksberg (Other)
• Enrollment: 80
• Arms: 2
• Anticipated Duration (Months): 8.7

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Knee Pain Chronic; Knee Osteoarthritis; Knee Discomfort	Behavioral: Blood flow restriction (BFR); Behavioral: Usual care (control)	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 80 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Prevention, Management and Rehabilitation of Knee Osteoarthritis at the Workplace
• Anticipated Study Start Date: Apr 11, 2023
• Anticipated Primary Completion Date: Dec 31, 2023
• Anticipated Study Completion Date: Dec 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Blood flow restriction (BFR) Blood flow restricted training (BFR) integrated into the daily work tasks for 8 weeks.	Behavioral: Blood flow restriction (BFR); Blood flow restricted training integrated into the daily work tasks for 8 weeks.; Behavioral: Usual care (control); Will continue their work as usual
Active Comparator: Usual care (control) Will continue their work as usual	Behavioral: Usual care (control); Will continue their work as usual

Outcome Measures

Primary Outcome Measures

1. Pain intensity [Change pre-post 8 weeks of intervention]

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

Secondary Outcome Measures

1. Functional performance [Change pre-post 8 weeks of intervention]

   30-s chair-stand test, 40 m fast-paced walk test, a stair-climb test, maximal isometric knee extensor muscle strength

2. Work ability [Change pre-post 8 weeks of intervention]

   Single-item on physical work ability derived from the Work Ability Index (WAI)

Other Outcome Measures

1. Work-limiting pain [Change pre-post 8 weeks of intervention]

   Rating of the degree of work limitations due to pain

2. Work-related fatigue [Change pre-post 8 weeks of intervention]

   Rating af work-related fatigue in different body parts

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 67 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• National Research Centre for the Working Environment, Denmark
• University of Southern Denmark
• University Hospital Bispebjerg and Frederiksberg

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Lars L. Andersen, Professor, National Research Centre for the Working Environment, Denmark
• ClinicalTrials.gov Identifier: NCT05822401
• Other Study ID Numbers: 10429; H-22016339
• First Posted: Apr 20, 2023
• Last Update Posted: Apr 20, 2023
• Last Verified: Apr 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Osteoarthritis; Osteoarthritis, Knee

Study Results

No Results Posted as of Apr 20, 2023