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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05822401
Other study ID # 10429
Secondary ID H-22016339
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date April 11, 2023
Est. completion date December 31, 2023

Study information

Verified date April 2023
Source National Research Centre for the Working Environment, Denmark
Contact Sebastian Skovlund
Phone 40385166
Email svs@nfa.dk
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 80
Est. completion date December 31, 2023
Est. primary completion date December 31, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 67 Years
Eligibility 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

Study Design


Intervention

Behavioral:
Blood flow restriction (BFR)
Blood flow restricted training integrated into the daily work tasks for 8 weeks.
Usual care (control)
Will continue their work as usual

Locations

Country Name City State
n/a

Sponsors (3)

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

Outcome

Type Measure Description Time frame Safety issue
Other Work-limiting pain Rating of the degree of work limitations due to pain Change pre-post 8 weeks of intervention
Other Work-related fatigue Rating af work-related fatigue in different body parts Change pre-post 8 weeks of intervention
Primary 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 Functional performance 30-s chair-stand test, 40 m fast-paced walk test, a stair-climb test, maximal isometric knee extensor muscle strength Change pre-post 8 weeks of intervention
Secondary Work ability Single-item on physical work ability derived from the Work Ability Index (WAI) Change pre-post 8 weeks of intervention
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