Knee Osteoarthritis Clinical Trial
Official title:
Effectiveness of Text Messages for Decreasing Inactive Behavior in Patients With Knee Osteoarthritis: a Pilot Randomised Controlled Study
NCT number | NCT03339011 |
Other study ID # | CB_IV |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | November 14, 2017 |
Est. completion date | July 29, 2018 |
Verified date | August 2018 |
Source | Frederiksberg University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Physical inactivity is a major risk behaviour with a potential for causing premature death,
particularly among people with mobility limitations, such as knee osteoarthritis.
Digital motivational interventions (such as SMS) can motive to a healthy behaviour including
increased physical activity.
The purpose of this study is to investigate if motivational text messages following an
exercise intervention to improve mobility limitations will change the physical activity level
in patients with knee osteoarthritis.
This study is designed as pilot randomized controlled trial, with equal randomization (1:1).
Eligible participants will be randomised into one of two groups (intervention or control)
after completing their baseline measurements. The intervention group will receive weekly
motivational text messages and the control group will not receive any attention from the
study.
Status | Completed |
Enrollment | 38 |
Est. completion date | July 29, 2018 |
Est. primary completion date | July 29, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Age =18 - Diagnosed with knee osteoarthritis - Owner of a smart phone or tablet - Have just finished an exercise program for knee osteoarthritis Exclusion Criteria: - Not able to read and understand Danish - Any condition, which in the opinion of the investigator would put the subject at increased safety risk by participation, or otherwise make the subject unsuitable for this study. |
Country | Name | City | State |
---|---|---|---|
Denmark | The Parker Institute, Bispebjerg and Frederiksberg University Hospitals | Copenhagen |
Lead Sponsor | Collaborator |
---|---|
Marius Henriksen |
Denmark,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change from baseline in physical inactivity | Physical inactivity is measured using an accelerometer based activity monitor. Physical activity is defined as time (in minutes) spent inactive, i.e. lying, sitting, standing during a day. | 6 weeks | |
Secondary | Change form baseline in the Knee Injury and Osteoarthritis Outcome Score (KOOS) | The Knee injury and Osteoarthritis Outcome Score (KOOS) questionnaire is used to assess patient reported outcomes on pain, function, and quality of life. | 6 weeks | |
Secondary | Transition questionnaire (TRANS-Q) of perceived change in knee symptoms | To investigate if participants experience a change in their osteoarthritis symptoms over time, they will be asked: "Pleas answer if you feel that your osteoarthritis symptoms have change for either the better, worse or no changes compared to before you entered this study" at the follow-up visit. The Participants can then check a box say: not change, a change for the worse or change for the better | 6 weeks | |
Secondary | Self-reported change in physical inactivity | At the follow-up visit participants will be asked "Have you changed your physical activity behaviour after completing the motivational intervention". This question will be asked at the end of the intervention period to investigate if the objective measurement of sedentary behaviour is related to the participants own perceived behaviour. | 6 weeks |
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