Prevention, Management and Rehabilitation of Knee Osteoarthritis at the Workplace

NCT05822401 | Unknown

• 2 other identifiers: 10429H-22016339
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Knee Pain Chronic; Knee Osteoarthritis; Knee Discomfort

Outcome Measures

Primary Outcomes (1)

• Pain intensity

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

  Change pre-post 8 weeks of intervention

Secondary Outcomes (2)

• Functional performance

  Change pre-post 8 weeks of intervention

• Work ability

  Change pre-post 8 weeks of intervention

Other Outcomes (2)

• Work-limiting pain

  Change pre-post 8 weeks of intervention

• Work-related fatigue

  Change pre-post 8 weeks of intervention

Study Arms (2)

Blood flow restriction (BFR)

EXPERIMENTAL

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

Behavioral: Blood flow restriction (BFR); Behavioral: Usual care (control)

Usual care (control)

ACTIVE COMPARATOR

Will continue their work as usual

Behavioral: Usual care (control)

Interventions

Blood flow restriction (BFR) BEHAVIORAL

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

Blood flow restriction (BFR)

Usual care (control) BEHAVIORAL

Will continue their work as usual

Blood flow restriction (BFR); Usual care (control)

Eligibility Criteria

• Age: 18 Years - 67 Years
• Gender Eligibility Details: Based on self-representation of gender identity.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Hospital workers working at least 20 hours per week with or without chronic knee pain (\>3 months)

You may not qualify if:

• 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

Sponsors & Collaborators

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

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Blood Flow Restriction Therapy

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities

Central Study Contacts

Sebastian Skovlund

CONTACT

40385166; svs@nfa.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 10, 2023
• First Posted: April 20, 2023
• Study Start: April 11, 2023
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: April 20, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share