Osteoarthritis, KneeNCT03354091
Active@Work - Optimizing Physical Activity at Work.
A study testing FitBit Flex 2 in people with Osteoarthritis, Knee and Osteoarthritis, Hip, run by Lund University at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 67 years
- Conditions the study is for
- Osteoarthritis, Knee, Osteoarthritis, Hip, Physical Activity
- What is being tested?
- FitBit Flex 2
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteSweden
- Study dates
- 16 Nov 2017to 15 Jun 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 67 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Working at least 50 %
Who cannot join
- Not being able to do physical activity, non-Swedish speaking
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Active@Work - Optimizing Physical Activity at Work With Personalized Decision Support Among Individuals With Osteoarthritis.
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?
Read the 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:
- 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.
- Conditions
- Osteoarthritis, Knee, Osteoarthritis, Hip, Physical Activity
- Being tested
- FitBit Flex 2
- Medical subject headings
- Osteoarthritis, Knee, Osteoarthritis, Hip, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FitBit Flex 2Device
Participants in the intervention Group will wear the FitBit Flex 2 for Three months.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Patient education program and the use of an Fitbit where the users can monitore their activity and receive minor feedback regarding physical activity. Receives: Device: FitBit Flex 2 |
| Control | No intervention | Patient education program only. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 3 months, 6 months, 12 months
Secondary outcomes (4)
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
Measured: Baseline, 3 months, 6 months, 12 months
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.
Measured: Baseline, 3 months, 6 months, 12 months
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.
Measured: Baseline, 3 months, 6 months, 12 months
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.
Measured: Baseline, 3 months, 6 months, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2017
- Study start16 Nov 2017
- Primary completion30 May 2020
- Study completion15 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Osteoarthritis, KneeStudies of the same condition, open and under way.
- More trials run by Lund UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Cluster-Randomized controlled trial
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lund University
- Sponsor type
- University, hospital or other
- Collaborators
- Halmstad University
- Responsible party
- Sponsor
- Investigators
- Frida Eek, Ass prof, Principal investigator, Lund University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03354091
- Sponsor's protocol ID
- 2016-02327
- Other IDs
- 2016
- Status last verified
- Mar 2021
- First submitted
- 15 Nov 2017
- Last updated
- 4 Mar 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ostlind E, Eek F, Stigmar K, Ekvall Hansson E. Effects of self-monitoring physical activity with wearable activity trackers on perceived joint function and health-related quality of life in people with hip and knee osteoarthritis: a secondary analysis of a cluster-randomised clinical trial. BMC Musculoskelet Disord. 2025 Jan 9;26(1):33. doi: 10.1186/s12891-024-08238-8.
PubMed 39789623Ostlind 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.
PubMed 35114983
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Active@Work - Optimizing Physical Activity at Work With Personalized Decision Support Among Individuals With Osteoarthritis.
- ClinicalTrials.gov ID
- NCT03354091
- Acronym / sponsor ID
- 2016-02327
- Conditions
- Osteoarthritis, Knee, Osteoarthritis, Hip, Physical Activity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Lund UniversityUniversity, hospital or other
- Collaborators
- Halmstad University
- Study start
- 16 Nov 2017 (actual)
- Primary completion
- 30 May 2020 (actual)
- Study completion
- 15 Jun 2020 (actual)
- First posted
- 27 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- Cluster-Randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Device: FitBit Flex 2Patient education program and the use of an Fitbit where the users can monitore their activity and receive minor feedback regarding physical activity. |
| Control | No intervention | –Patient education program only. |
Who may qualify
- Ages
- 18 to 67 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Working at least 50 %
Key exclusion criteria (1 listed)
- Not being able to do physical activity, non-Swedish speaking
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FitBit Flex 2Participants in the intervention Group will wear the FitBit Flex 2 for Three months. | Device | Intervention |
Primary outcome
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.
4 secondary outcomes
Change in physical activity
Time frame: Baseline, 3 months, 6 months, 12 months
Change in work productivity
Time frame: Baseline, 3 months, 6 months, 12 months
Change in quality of life
Time frame: Baseline, 3 months, 6 months, 12 months
Change in function of Hip or knee
Time frame: Baseline, 3 months, 6 months, 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2021.
- Derived from this study: PubMed 39789623Ostlind E, Eek F, Stigmar K, Ekvall Hansson E. Effects of self-monitoring physical activity with wearable activity trackers on perceived joint function and health-related quality of life in people with hip and knee osteoarthritis: a secondary analysis of a cluster-randomised clinical trial. BMC Musculoskelet Disord. 2025 Jan 9;26(1):33. doi: 10.1186/s12891-024-08238-8.
- Derived from this study: PubMed 35114983Ostlind 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Frida Eek, Ass prof principal investigator
Lund University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FitBit Flex 2 in people with Osteoarthritis, Knee and Osteoarthritis, Hip, run by Lund University at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in work ability (time frame: Baseline, 3 months, 6 months, 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03354091, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2021.