NCT03354091

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?

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
160

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 15, 2017

Completed
1 day until next milestone

Study Start

First participant enrolled

November 16, 2017

Completed
11 days until next milestone

First Posted

Study publicly available on registry

November 27, 2017

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2020

Completed
16 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2020

Completed
Last Updated

March 4, 2021

Status Verified

March 1, 2021

Enrollment Period

2.5 years

First QC Date

November 15, 2017

Last Update Submit

March 2, 2021

Conditions

Osteoarthritis, KneeOsteoarthritis, HipPhysical Activity

Outcome Measures

Primary Outcomes (1)

  • 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.

    Baseline, 3 months, 6 months, 12 months

Secondary Outcomes (4)

  • Change in physical activity

    Baseline, 3 months, 6 months, 12 months

  • Change in work productivity

    Baseline, 3 months, 6 months, 12 months

  • Change in quality of life

    Baseline, 3 months, 6 months, 12 months

  • Change in function of Hip or knee

    Baseline, 3 months, 6 months, 12 months

Study Arms (2)

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.

Device: FitBit Flex 2

Control

NO INTERVENTION

Patient education program only.

Interventions

FitBit Flex 2DEVICE

Participants in the intervention Group will wear the FitBit Flex 2 for Three months.

Intervention

Eligibility Criteria

Age18 Years - 67 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Working at least 50 %

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vårdcentralen Dalby

Dalby, Sweden

Location

Related Publications (2)

  • 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.

    PMID: 39789623DERIVED

  • 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.

    PMID: 35114983DERIVED

MeSH Terms

Conditions

Osteoarthritis, KneeOsteoarthritis, HipMotor Activity

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesBehavior

Study Officials

  • Frida Eek, Ass prof

    Lund University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Masking Details
Masking is performed through sealed envelopes. The investigator has no knowledge of which patients who is randomized to intervention or control
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Cluster-Randomized controlled trial
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 15, 2017

First Posted

November 27, 2017

Study Start

November 16, 2017

Primary Completion

May 30, 2020

Study Completion

June 15, 2020

Last Updated

March 4, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share

Locations

SE(1)