Active@Work - Optimizing Physical Activity at Work.
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|ClinicalTrials.gov Identifier: NCT03354091|
Recruitment Status : Completed
First Posted : November 27, 2017
Last Update Posted : March 4, 2021
The aim of this project is to explore if monitoring physical activity including feedback can have any effect on physical activity level, function, work ability, health related quality of life or work productivity among individuals with hip and/or knee osteoarthritis. This will be performed by evaluating the use of mobile technology and activity monitoring to support physical activity in individuals with OA in a cluster randomized controlled trial. The investigators research questions are:
• Can an intervention, comprised of the above mentioned technology, have any effect on physical activity level, function, work ability, quality of life or work productivity among individuals with OA?
|Condition or disease||Intervention/treatment||Phase|
|Osteoarthritis, Knee Osteoarthritis, Hip Physical Activity||Device: FitBit Flex 2||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||160 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Cluster-Randomized controlled trial|
|Masking Description:||Masking is performed through sealed envelopes. The investigator has no knowledge of which patients who is randomized to intervention or control|
|Official Title:||Active@Work - Optimizing Physical Activity at Work With Personalized Decision Support Among Individuals With Osteoarthritis.|
|Actual Study Start Date :||November 16, 2017|
|Actual Primary Completion Date :||May 30, 2020|
|Actual Study Completion Date :||June 15, 2020|
Patient education program and the use of an Fitbit where the users can monitore their activity and receive minor feedback regarding physical activity.
Device: FitBit Flex 2
Participants in the intervention Group will wear the FitBit Flex 2 for Three months.
No Intervention: Control
Patient education program only.
- Change in work ability [ Time Frame: Baseline, 3 months, 6 months, 12 months ]Questionnaire Work ability index (WAI) 7-49 points. 7-27 points (bad) - restore work ability. 28-36 points (moderate) - improve work ability. 37-43 points (good) - support work ability. 44-49 points (very good) - support work ability.
- Change in physical activity [ Time Frame: Baseline, 3 months, 6 months, 12 months ]
Questionnaire: International physical activity questionnaire (IPAQ). Three levels of physical activity; Category 1: Low. This is the lowest level of physical activity. Those individuals who not meet criteria for categories 2 or 3 are considered low/inactive.
Category 2: Moderate. Any one of the following 3 criteria:
- 3 or more days of vigorous activity of at least 20 minutes per day OR
- 5 or more days of moderate-intensity activity or walking of at least 30 minutes per day OR
- 5 or more days of any combination of walking, moderate-intensity or vigorous intensity activities achieving a minimum of at least 600 MET-min/week.
Category 3: High. Any one of the following 2 criteria:
- Vigorous-intensity activity on at least 3 days and accumulating at least 1500 MET-minutes/ week OR
- 7 or more days of any combination of walking, moderate-intensity or vigorous intensity activities achieving a minimum of at least 3000 MET-minutes/week
- Change in work productivity [ Time Frame: Baseline, 3 months, 6 months, 12 months ]
Questionnaire: Work Productivity and Activity Impairment Questionnaire - osteoarthritis (WPAI - OA) WPAI outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity, i.e., worse outcomes, as follows: Questions:
- = currently employed
- a = hours missed due to specified problem
2b = hours missed due to other health problems 2c = hours missed other reasons 3 = hours actually worked 4a = degree problem affected productivity while working 4b = degree other health problems affected productivity while working 5a = degree problem affected regular activities 5b = degree other health problems affected regular activities
Multiply scores by 100 to express in percentages.
- Change in quality of life [ Time Frame: Baseline, 3 months, 6 months, 12 months ]Questionnaire EQ5D. EuroQol. The EQ5D consists of a scale from 0-100 where 0 is the worst Health and 100 is the best. There is also an additional five questions from where a Health-index is calculated with a mathematic formula. The Health-index ranges from 1 to -0,594. 1 is best.
- Change in function of Hip or knee [ Time Frame: Baseline, 3 months, 6 months, 12 months ]Questionnaire: Hip/Knee disability and Osteoarthritis Outcome Score (HOOS/KOOS). A total sum of 100 indicate no problems and 0 indicate extreme problems.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03354091
|Principal Investigator:||Frida Eek, Ass prof||Lund University|