An interventional study of FitBit Flex 2 in Osteoarthritis, Knee, Osteoarthritis, Hip and Physical Activity, sponsored by Lund University. Completed at 1 site in Sweden. Open to participants aged 18 Years to 67 Years. Per ClinicalTrials.gov, last updated 2021-03-04.
Sponsored by Lund University · Not applicable, Interventional, and Treatment
Among 54 studies in Osteoarthritis, Knee with a site in Sweden — 12 open to participants now, 19 under way, none of them phase 3. Osteoarthritis, Knee · Sweden.
Among the 54 studies in Osteoarthritis, Knee with a site in Sweden, this one is the 20th largest by enrollment of the 38 interventional ones that give a count, is one of 2 that started in 2017, is one of 23 with no phase, and was the 23rd registered.
3,292 studies on the registry are indexed under Osteoarthritis, Knee; 623 are open to participants now.
Browse Osteoarthritis, Knee studies →12 of the 54 studies in Osteoarthritis, Knee with a site in Sweden are open now. Recruiting first, the newest first:
Vastra Gotaland Region · Sites in Sweden
Vastra Gotaland Region · Sites in Sweden
Uppsala University · Sites in Sweden
Region Skane · Sites in Sweden
Danderyd Hospital · Sites in Sweden
A study can be open while its sites in Sweden have not opened yet or have stopped. Only those recruiting at a site in Sweden →
Of the 382 Osteoarthritis, Knee studies recruiting now, 176 (46%) set no upper age limit and 113 (30%) stop at 75 or younger; 19 take children under 18; 39 take healthy volunteers.
This study: 18 Years to 67 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
54 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 3 · Phase 2 6 · Phase 3 7
First in 2005; this study’s year is marked. 2 started in 2017.
This study's enrollment of 160 is above the median of 68 across 2,714 interventional studies indexed under Osteoarthritis, Knee.
Median enrollment 175 across the 38 interventional studies, 246 across the 16 observational. Of the 30 that completed or were terminated, 8 (27%) have results posted.
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18 of 54 have an industry lead sponsor. The 10 most frequent:
Lund University is the lead sponsor of 234 studies on the registry; 36 are open to participants now.
Lund University has 8 studies filed under Osteoarthritis, Knee — fewer than ten, so there is no comparison to draw.
5 of the studies in Osteoarthritis, Knee with a site in Sweden that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05584410Vastra Gotaland RegionDigitalization of Osteoarthritis Care | 2026-12-31 |
| NCT07212920Vastra Gotaland RegionValidity and Reliability of Video-Based Functional Physiotherapy Assessment of Subacute Knee Injuries | 2026-12-31 |
| NCT06459700Lund UniversityEffect of Probiotic Supplements on Osteoarthritis Outcomes | 2027-04-30 |
| NCT07875647Mälardalen UniversityPerson-Centred Digital Rehabilitation for Knee Osteoarthritis | 2027-09 |
| NCT07383740Vastra Gotaland RegionTest-Retest Reliability of a Submaximal Exercise Test in Patients With Hip and Knee Osteoarthritis | 2027-09-01 |
Among the 54 studies in Osteoarthritis, Knee with a site in Sweden, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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:
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:
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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
Patient education program only.
Participants in the intervention Group will wear the FitBit Flex 2 for Three months.
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.
Time frame: Baseline, 3 months, 6 months, 12 months
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
Time frame: 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: 1. = currently employed 2. 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
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.
Time frame: 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.
Time frame: Baseline, 3 months, 6 months, 12 months
Plan to share: No
Ran from Nov 2017 to primary completion in May 2020, 30 months.
Of 1,111 non-industry interventional studies with no phase under Osteoarthritis, Knee, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 36. This study's 30 months is above that.
Counting every sponsor, half of 1,251 studies reached it within 18 months; a quarter within 8 and three quarters within 36.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Mar 2021. You cannot join it, but the record below documents what was studied.
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