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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00643006
Other study ID # GAU2
Secondary ID
Status Completed
Phase N/A
First received March 19, 2008
Last updated September 28, 2012
Start date January 2008
Est. completion date June 2009

Study information

Verified date September 2012
Source Göteborg University
Contact n/a
Is FDA regulated No
Health authority Sweden: Regional Ethical Review Board
Study type Interventional

Clinical Trial Summary

The study aims to compare low-intensive and high-intensive physical exercise and its impact on physical function, pain and signs of inflammation.


Recruitment information / eligibility

Status Completed
Enrollment 67
Est. completion date June 2009
Est. primary completion date May 2009
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 60 Years
Eligibility Inclusion Criteria:

- Women with Fibromyalgia, interested in exercise twice a week

Exclusion Criteria:

- Other severe diseases

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment


Intervention

Behavioral:
Physical exercise
Supervised walks with poles twice a week at moderate-high intensity
Active comparator: low intensive exercise
Supervised walks once a week at low-intensity.

Locations

Country Name City State
Sweden Alingsås Primary Health Care Alingsås
Sweden Sahlgrenska University Hospital, Dept of Physical Therapy Göteborg
Sweden Uddevalla Primary Health Care Uddevalla

Sponsors (4)

Lead Sponsor Collaborator
Göteborg University Reumatikerförbundet, Sahlgren´s University Hospital, Västra Götalands Forskningsfond

Country where clinical trial is conducted

Sweden, 

Outcome

Type Measure Description Time frame Safety issue
Primary Six-minute Walk Test Patient is instructed to walk as fast as she can. The distance covered during 6 minutes is documented. 15 weeks No
Primary Change of Pain Level From Baseline. Pain was measured by The Fibromyalgia Impact Questionnaire (FIQ) subscale for Pain, which is a self-rated pain on visual analogue scale, 0-100 mm. The higher value, the worse pain. 15 weeks Yes
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