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Active@Work - Optimizing Physical Activity at Work.

Primary Purpose

Osteoarthritis, Knee, Osteoarthritis, Hip, Physical Activity

Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
FitBit Flex 2
Sponsored by
Lund University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis, Knee

Eligibility Criteria

18 Years - 67 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Working at least 50 %

Exclusion Criteria:

  • Not being able to do physical activity, non-Swedish speaking

Sites / Locations

  • Vårdcentralen Dalby

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention

Control

Arm Description

Patient education program and the use of an Fitbit where the users can monitore their activity and receive minor feedback regarding physical activity.

Patient education program only.

Outcomes

Primary Outcome Measures

Change in work ability
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.

Secondary Outcome Measures

Change in physical activity
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
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 Scores: Multiply scores by 100 to express in percentages.
Change in quality of life
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
Questionnaire: Hip/Knee disability and Osteoarthritis Outcome Score (HOOS/KOOS). A total sum of 100 indicate no problems and 0 indicate extreme problems.

Full Information

First Posted
November 15, 2017
Last Updated
March 2, 2021
Sponsor
Lund University
Collaborators
Halmstad University
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1. Study Identification

Unique Protocol Identification Number
NCT03354091
Brief Title
Active@Work - Optimizing Physical Activity at Work.
Official Title
Active@Work - Optimizing Physical Activity at Work With Personalized Decision Support Among Individuals With Osteoarthritis.
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
November 16, 2017 (Actual)
Primary Completion Date
May 30, 2020 (Actual)
Study Completion Date
June 15, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Lund University
Collaborators
Halmstad University

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 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?
Detailed Description
Methods Design and setting The project will be performed as a cluster randomized controlled intervention study within primary health care in the region of Skåne and Halland. Sample Patients who are referred to the patient education program for OA in primary health care will be invited to participate in the project. Participants will also be recruited using advertisement on social media. Participants recruited from social media will attend the patient education program for OA arranged by this project. There will be one control group and one intervention group, see details below: A. Patient education program and physical activity monitoring. C. Patient education program (control). Each group within the patient education program for OA will be randomized to either group A or group C. Patients that fulfil the inclusion criteria will then be asked to participate. Digital (BankID or e-legitimation) informed consent will be obtained at the project's website. Recruitment of participants in intervention group A and control group C starts in autumn 2017 and continues through spring 2019 or when sufficient numbers of participants have been included. Interventions Activity monitoring will be performed by giving each participant in group (A) a wearable sensor (Fitbit Flex 2), where the daily physical activity level will be recorded. The monitoring will start at the patient education program within BOA. All activity monitors will be programmed with a daily goal of 7 000 steps. The participants will have the opportunity to follow their physical activity through the fitbit app were they also will receive standardised feedback. The intervention will be performed during three months, with follow-ups online after 3, 6 and 12 months. Measures Patient-reported outcomes Participants will answer the following questionnaires at baseline, after the intervention (3 months) and 6 and 12 months after baseline. Measurements will include: Self-rated work ability (Work ability Index, Ilmarinen,2007) Self-rated work productivity (WPAI-OA, Legget et.al.,2016) Self-rated health-related quality of life (EQ-5D) (http://www.euroqol.org/) Self-rated function in relation to hip and knee arthrosis (HOOS, Nilsdotter 2003, KOOS, Paradowski 2006). Self-rated physical activity (IPAQ, Craig et.al.2003). Questions about the work environment and physical activity. Statistics The investigators will recruit approximately 80 participants/group. With this sample size and 80 % power, effect sizes of about 0.45 SD (significance level 5%) can be identified. In terms of WAI, this corresponds to SD 6, approximately 2,7 points increase/higher score in the intervention group, compared to the control group. Compliance with the intervention will comprise of the activity monitoring device used on at least 50% of the work days. With relatively large group sizes and most data expected to a follow an approximately normal distribution, group differences in the development over time with respect to the different outcome variables will be analyzed by ANOVA models (repeated measures or cross sectional comparison of mean difference scores). Some outcome variables, may likely be skewed and hence appropriate transformations, or non-parametric models, will be applied. Final and exact analytical strategies will be decided once data is available for exploration of final group sizes and distributions/symmetry of numeric outcome variable data.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Knee, Osteoarthritis, Hip, Physical Activity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Cluster-Randomized controlled trial
Masking
Investigator
Masking Description
Masking is performed through sealed envelopes. The investigator has no knowledge of which patients who is randomized to intervention or control
Allocation
Randomized
Enrollment
160 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
Patient education program and the use of an Fitbit where the users can monitore their activity and receive minor feedback regarding physical activity.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Patient education program only.
Intervention Type
Device
Intervention Name(s)
FitBit Flex 2
Intervention Description
Participants in the intervention Group will wear the FitBit Flex 2 for Three months.
Primary Outcome Measure Information:
Title
Change in work ability
Description
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.
Time Frame
Baseline, 3 months, 6 months, 12 months
Secondary Outcome Measure Information:
Title
Change in physical activity
Description
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
Time Frame
Baseline, 3 months, 6 months, 12 months
Title
Change in work productivity
Description
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 Scores: Multiply scores by 100 to express in percentages.
Time Frame
Baseline, 3 months, 6 months, 12 months
Title
Change in quality of life
Description
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.
Time Frame
Baseline, 3 months, 6 months, 12 months
Title
Change in function of Hip or knee
Description
Questionnaire: Hip/Knee disability and Osteoarthritis Outcome Score (HOOS/KOOS). A total sum of 100 indicate no problems and 0 indicate extreme problems.
Time Frame
Baseline, 3 months, 6 months, 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
67 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Working at least 50 % Exclusion Criteria: Not being able to do physical activity, non-Swedish speaking
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Frida Eek, Ass prof
Organizational Affiliation
Lund University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vårdcentralen Dalby
City
Dalby
Country
Sweden

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35114983
Citation
Ostlind E, Eek F, Stigmar K, Sant'Anna A, Hansson EE. Promoting work ability with a wearable activity tracker in working age individuals with hip and/or knee osteoarthritis: a randomized controlled trial. BMC Musculoskelet Disord. 2022 Feb 3;23(1):112. doi: 10.1186/s12891-022-05041-1.
Results Reference
derived

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Active@Work - Optimizing Physical Activity at Work.

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