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Clinical Trial Details — Status: Completed

Administrative data

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

Study information

Verified date August 2018
Source Frederiksberg University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

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.

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Motivational SMS text message
Motivational text messages delivered to the participants' mobile phones. The text messages contain motivational text and advice on physical activity.

Locations

Country Name City State
Denmark The Parker Institute, Bispebjerg and Frederiksberg University Hospitals Copenhagen

Sponsors (1)

Lead Sponsor Collaborator
Marius Henriksen

Country where clinical trial is conducted

Denmark, 

Outcome

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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