This site became the new ClinicalTrials.gov on June 19th. Learn more.
Show more
ClinicalTrials.gov Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu
Give us feedback

Physical Exercise and Its Impact on Signs of Inflammation in Fibromyalgia

This study has been completed.
Sponsor:
Collaborators:
Sahlgren´s University Hospital
Västra Götalands Forskningsfond
Reumatikerförbundet
Information provided by (Responsible Party):
Göteborg University
ClinicalTrials.gov Identifier:
NCT00643006
First received: March 19, 2008
Last updated: September 28, 2012
Last verified: September 2012
Results First Received: May 3, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Exercise Therapy
Pain
Interventions: Behavioral: Physical exercise
Behavioral: Active comparator: low intensive exercise

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
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

Participant Flow:   Overall Study
    A. High Intensive Exercise   B. Low-intensive Exercise
STARTED   34   33 
COMPLETED   29   29 
NOT COMPLETED   5   4 
Lost to Follow-up                5                4 



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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
Total Total of all reporting groups

Baseline Measures
   A. High Intensive Exercise   B. Low-intensive Exercise   Total 
Overall Participants Analyzed 
[Units: Participants]
 34   33   67 
Age 
[Units: Participants]
     
<=18 years   0   0   0 
Between 18 and 65 years   34   33   67 
>=65 years   0   0   0 
Age 
[Units: Years]
Mean (Standard Deviation)
 48  (7.8)   50  (7.6)   49  (7.7) 
Gender 
[Units: Participants]
     
Female   34   33   67 
Male   0   0   0 
Region of Enrollment 
[Units: Participants]
     
Sweden   34   33   67 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Six-minute Walk Test   [ Time Frame: 15 weeks ]

2.  Primary:   Change of Pain Level From Baseline.   [ Time Frame: 15 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information