An interventional study of Homebased stretching exercise and app supervision in Fibromyalgia, Pain and Quality of Life, sponsored by University College of Northern Denmark. Completed at 1 site in Denmark. Open to participants aged 18 Years to 55 Years. Per ClinicalTrials.gov, last updated 2024-06-28.
Sponsored by University College of Northern Denmark · Not applicable, Interventional, and Treatment
The study aims to gather knowledge about the patient's acceptance of the intervention and testing procedures, assess the adherence to the intervention, estimate the recruitment rate, and inform the sample size calculation for a subsequent randomized controlled trial.
1,369 studies on the registry are indexed under Fibromyalgia; 272 are open to participants now.
This study's enrollment of 12 is below the median of 60 across 1,056 interventional studies indexed under Fibromyalgia.
Browse Fibromyalgia studies →University College of Northern Denmark is the lead sponsor of 20 studies on the registry; 2 are open to participants now.
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Exclusion Criteria:
Twelve patients aged 18-65, diagnosed with fibromyalgia, will be recruited to participate in a six-week, supervised, home-based stretching program. Exercises are to be performed daily (6 minutes per day) for six weeks. Adherence will be supported, and weekly contact with each participant will be maintained via a mHealth application.
Other: Homebased stretching exercise and app supervision
The intervention group will perform a self-administered, home-based stretching program (a total of 6 minutes per day) and maintain their daily activities as identified at baseline. Exercises are to be performed daily for six weeks. Adherence will be supported, and weekly contact with each participant will be maintained via a mHealth application.
Pressure pain thresholds
Pressure pain thresholds was measures using a handheld pressure algometer
Time frame: Pressure pain thresholds were measured as a baseline before the participants are instructed in the home exercises
Pressure pain thresholds
Pressure pain thresholds was measured using a handheld pressure algometer
Time frame: Pressure pain thresholds were measured six-weeks after the intervention started
Health related Quality of Life
Quality of life measured by the SF-36 Short Form
Time frame: Quality of life was measured as a baseline before the paticipants are instructed in the home exercises
Health related Quality of Life
Quality of life measured by the SF-36 Short Form
Time frame: Quality of life was measured six-weeks after the intervention started
Range of motion
Passive knee extension range of motion measured by the Biodex system 4 pro isokinetic dynamometer
Time frame: Range of motion was measured as a baseline before the participants were instructed in the home exercises
Range of motion
Passive knee extension range of motion measured by the Biodex system 4 pro isokinetic dynamometer
Time frame: Range of motion was measured six-weeks after the intervention started
Fibromyalgia symptoms
Fibromyalgia symptoms were measure using the The Revised Fibromyalgia Impact Questionnaire (FIQR)
Time frame: Fibromyalgia symptoms were measured as a baseline before the paticipants are instructed in the home exercises
Fibromyalgia symptoms
Fibromyalgia symptoms were measure using the The Revised Fibromyalgia Impact Questionnaire (FIQR)
Time frame: Fibromyalgia symptoms was measured six-weeks after the intervention started
Plan to share: Yes — Data is made available upon request.
Supporting information: Study protocol
Time frame: The study protocol will be published.
Access criteria: The study protocol will be published open access
Ran from Feb 2024 to primary completion in May 2024, 3 months.
Of 510 non-industry interventional studies with no phase under Fibromyalgia, half reached primary completion within 13 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 27. This study's 3 months is below that.
Counting every sponsor, half of 522 studies reached it within 13 months; a quarter within 5 and three quarters within 27.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jun 2024. You cannot join it, but the record below documents what was studied.
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University College of Northern Denmark