Trial Outcomes & Findings for Physical Exercise and Its Impact on Signs of Inflammation in Fibromyalgia (NCT NCT00643006)

NCT ID: NCT00643006

Last Updated: 2012-10-30

Results Overview

Patient is instructed to walk as fast as she can. The distance covered during 6 minutes is documented.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 67 participants
• Primary outcome timeframe: 15 weeks
• Results posted on: 2012-10-30

Participant Flow

Participant milestones

Measure	A. High Intensive Exercise High intensive exercise by means of Nordic walking twice a week for 45 minutes during 15 weeks	B. Low-intensive Exercise Low-to-moderate intensive supervised walks twice a week for 45 minutes during 15 weeks
Overall Study STARTED	34	33
Overall Study COMPLETED	29	29
Overall Study NOT COMPLETED	5	4

Reasons for withdrawal

Measure	A. High Intensive Exercise High intensive exercise by means of Nordic walking twice a week for 45 minutes during 15 weeks	B. Low-intensive Exercise Low-to-moderate intensive supervised walks twice a week for 45 minutes during 15 weeks
Overall Study Lost to Follow-up	5	4

Baseline Characteristics

Physical Exercise and Its Impact on Signs of Inflammation in Fibromyalgia

Baseline characteristics by cohort

Measure	A. High Intensive Exercise n=34 Participants High intensive exercise by means of Nordic walking twice a week for 45 minutes during 15 weeks	B. Low-intensive Exercise n=33 Participants Low-to-moderate intensive supervised walks twice a week for 45 minutes during 15 weeks	Total n=67 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	34 Participants n=5 Participants	33 Participants n=7 Participants	67 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age Continuous	48 years STANDARD_DEVIATION 7.8 • n=5 Participants	50 years STANDARD_DEVIATION 7.6 • n=7 Participants	49 years STANDARD_DEVIATION 7.7 • n=5 Participants
Sex: Female, Male Female	34 Participants n=5 Participants	33 Participants n=7 Participants	67 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment Sweden	34 participants n=5 Participants	33 participants n=7 Participants	67 participants n=5 Participants

PRIMARY outcome

Timeframe: 15 weeks

Patient is instructed to walk as fast as she can. The distance covered during 6 minutes is documented.

Outcome measures

Measure	Arm A. Exercise n=29 Participants The intervention group participated in Nordic walking	Arm B. Active Comparator n=29 Participants The active comparison group participated in low-intensive walks.
Six-minute Walk Test	37.7 meter Standard Deviation 41.8	8.6 meter Standard Deviation 42.2

PRIMARY outcome

Timeframe: 15 weeks

Population: Patients attending at post-test

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.

Outcome measures

Measure	Arm A. Exercise n=29 Participants The intervention group participated in Nordic walking	Arm B. Active Comparator n=29 Participants The active comparison group participated in low-intensive walks.
Change of Pain Level From Baseline.	-4.0 mm Standard Deviation 14.5	-5.3 mm Standard Deviation 16.3

Adverse Events

A. High Intensive Exercise

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

B. Low-intensive Exercise

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. K Mannerkorpi

Gothenburg University

Phone: 046-31-24220

Email: kaisa.mannerkorpi@rheuma.gu.se

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place