AzTrials
AzTrials

FibromyalgiaNCT01226784

The Effects of Training and Relaxation on Fibromyalgia.

A study testing Physcial activity in people with Fibromyalgia, run by Karolinska Institutet at 3 sites in Sweden.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Effects of physical training and relaxation exercise on pathophysiological mechanisms and symptoms in finbromyalgia patients. Read more about this study

Who is it for?
Ages 20 to 65 years, women onlyHealthy volunteers can take part
Conditions the study is for
Fibromyalgia
What is being tested?
Physcial activity
Could I receive a placebo?
No, everyone receives an active treatment
How many people
240 participants
Where
3 sitesSweden
Study dates
Oct 2010to Oct 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 65 years
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Exclusion Criteria: Other dominating pain condition, severe disease preventing from participating in physical exercise
  • -

Who cannot join

None listed.

Trial locations and contacts

3 sites in 1 country.

Sweden3 sites

  • Sahlgrenska University Hospital

    Gothenburg, 41 345

  • Linkopings University Hospital

    Linköping, 581 85

  • Karolinska Institute

    Stockholm, 171 77

Other trials in Sweden

About this study

Effects of physical training and relaxation exercise on pathophysiological mechanisms and symptoms in finbromyalgia patients.

Read the detailed description

A multi-center trial examining the effects of progressive resistance group exercise compared with an active control group (relaxation). A person-centred model of exercise was used. The intervention was performed twice a week for 15 weeks and was supervised by experienced physiotherapists.

Secondary aims off this multi-center study was to improve the understanding of pain mechanisms in fibromyalgia and how these are affected by physical exercise. Please see references of published articles for details.

Conditions
Fibromyalgia
Being tested
Physcial activity
Keywords
Strength exercise, Physical exercise, Physiotheraphy
Medical subject headings
Fibromyalgia, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Physcial activityBehavioural

    Strenght training Relaxation exercise

Study groups in NCT01226784
Study groupRoleWhat they receive
Physcial exerciseActive comparator15 weeks of progressive resistance group exercise, twice/week supervised by physical therapist
Receives: Behavioral: Physcial activity
Relaxation exerciseActive comparator15 weeks of relaxation exercise, twice/week supervised by physical therapist
Receives: Behavioral: Physcial activity

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Muscle function

    isometric knee-extension force (Steve Strong®)

    Measured: 2010-2013

Secondary outcomes (2)

  1. Fibromyalgia impact questionnaire

    Ratings on FIQ, total score

    Measured: 2010-2013

  2. VAS pain

    Pain intensity ratings on VAS

    Measured: 2010-2013

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Oct 2010 (estimated)
  2. Study startOct 2010
  3. Primary completionMay 2015
  4. Study completionOct 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
240 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01226784
Sponsor's protocol ID
RF 2010 stud GLS
Status last verified
Oct 2020
First submitted
21 Oct 2010
Last updated
27 Oct 2020
Results posted
No
Individual data sharing
No

Publications

  • Wahlen K, Ernberg M, Kosek E, Mannerkorpi K, Gerdle B, Ghafouri B. Significant correlation between plasma proteome profile and pain intensity, sensitivity, and psychological distress in women with fibromyalgia. Sci Rep. 2020 Jul 27;10(1):12508. doi: 10.1038/s41598-020-69422-z.

    PubMed 32719459

  • Stensson N, Gerdle B, Ernberg M, Mannerkorpi K, Kosek E, Ghafouri B. Increased Anandamide and Decreased Pain and Depression after Exercise in Fibromyalgia. Med Sci Sports Exerc. 2020 Jul;52(7):1617-1628. doi: 10.1249/MSS.0000000000002293.

    PubMed 32168104

  • Jablochkova A, Backryd E, Kosek E, Mannerkorpi K, Ernberg M, Gerdle B, Ghafouri B. Unaltered low nerve growth factor and high brain-derived neurotrophic factor levels in plasma from patients with fibromyalgia after a 15-week progressive resistance exercise. J Rehabil Med. 2019 Oct 29;51(10):779-787. doi: 10.2340/16501977-2593.

    PubMed 31544950

  • Stensson N, Ghafouri N, Ernberg M, Mannerkorpi K, Kosek E, Gerdle B, Ghafouri B. The Relationship of Endocannabinoidome Lipid Mediators With Pain and Psychological Stress in Women With Fibromyalgia: A Case-Control Study. J Pain. 2018 Nov;19(11):1318-1328. doi: 10.1016/j.jpain.2018.05.008. Epub 2018 Jun 7.

    PubMed 29885369

  • Larsson A, Palstam A, Bjersing J, Lofgren M, Ernberg M, Kosek E, Gerdle B, Mannerkorpi K. Controlled, cross-sectional, multi-center study of physical capacity and associated factors in women with fibromyalgia. BMC Musculoskelet Disord. 2018 Apr 19;19(1):121. doi: 10.1186/s12891-018-2047-1.

    PubMed 29673356

  • Ernberg M, Christidis N, Ghafouri B, Bileviciute-Ljungar I, Lofgren M, Bjersing J, Palstam A, Larsson A, Mannerkorpi K, Gerdle B, Kosek E. Plasma Cytokine Levels in Fibromyalgia and Their Response to 15 Weeks of Progressive Resistance Exercise or Relaxation Therapy. Mediators Inflamm. 2018 Apr 18;2018:3985154. doi: 10.1155/2018/3985154. eCollection 2018.

    PubMed 29849487

  • Larsson A, Palstam A, Lofgren M, Ernberg M, Bjersing J, Bileviciute-Ljungar I, Gerdle B, Kosek E, Mannerkorpi K. Pain and fear avoidance partially mediate change in muscle strength during resistance exercise in women with fibromyalgia. J Rehabil Med. 2017 Nov 21;49(9):744-750. doi: 10.2340/16501977-2278.

    PubMed 29068036

  • Tour J, Lofgren M, Mannerkorpi K, Gerdle B, Larsson A, Palstam A, Bileviciute-Ljungar I, Bjersing J, Martin I, Ernberg M, Schalling M, Kosek E. Gene-to-gene interactions regulate endogenous pain modulation in fibromyalgia patients and healthy controls-antagonistic effects between opioid and serotonin-related genes. Pain. 2017 Jul;158(7):1194-1203. doi: 10.1097/j.pain.0000000000000896.

    PubMed 28282362

  • Martinsen S, Flodin P, Berrebi J, Lofgren M, Bileviciute-Ljungar I, Mannerkorpi K, Ingvar M, Fransson P, Kosek E. The role of long-term physical exercise on performance and brain activation during the Stroop colour word task in fibromyalgia patients. Clin Physiol Funct Imaging. 2018 May;38(3):508-516. doi: 10.1111/cpf.12449. Epub 2017 Jun 18.

    PubMed 28627125

  • Bjersing JL, Larsson A, Palstam A, Ernberg M, Bileviciute-Ljungar I, Lofgren M, Gerdle B, Kosek E, Mannerkorpi K. Benefits of resistance exercise in lean women with fibromyalgia: involvement of IGF-1 and leptin. BMC Musculoskelet Disord. 2017 Mar 14;18(1):106. doi: 10.1186/s12891-017-1477-5.

    PubMed 28288611

  • Gerdle B, Ernberg M, Mannerkorpi K, Larsson B, Kosek E, Christidis N, Ghafouri B. Increased Interstitial Concentrations of Glutamate and Pyruvate in Vastus Lateralis of Women with Fibromyalgia Syndrome Are Normalized after an Exercise Intervention - A Case-Control Study. PLoS One. 2016 Oct 3;11(10):e0162010. doi: 10.1371/journal.pone.0162010. eCollection 2016.

    PubMed 27695113

  • Ericsson A, Palstam A, Larsson A, Lofgren M, Bileviciute-Ljungar I, Bjersing J, Gerdle B, Kosek E, Mannerkorpi K. Resistance exercise improves physical fatigue in women with fibromyalgia: a randomized controlled trial. Arthritis Res Ther. 2016 Jul 30;18:176. doi: 10.1186/s13075-016-1073-3.

    PubMed 27473164

  • Kosek E, Martinsen S, Gerdle B, Mannerkorpi K, Lofgren M, Bileviciute-Ljungar I, Fransson P, Schalling M, Ingvar M, Ernberg M, Jensen KB. The translocator protein gene is associated with symptom severity and cerebral pain processing in fibromyalgia. Brain Behav Immun. 2016 Nov;58:218-227. doi: 10.1016/j.bbi.2016.07.150. Epub 2016 Jul 20.

    PubMed 27448744

  • Ernberg M, Christidis N, Ghafouri B, Bileviciute-Ljungar I, Lofgren M, Larsson A, Palstam A, Bjersing J, Mannerkorpi K, Kosek E, Gerdle B. Effects of 15 weeks of resistance exercise on pro-inflammatory cytokine levels in the vastus lateralis muscle of patients with fibromyalgia. Arthritis Res Ther. 2016 Jun 13;18(1):137. doi: 10.1186/s13075-016-1041-y.

    PubMed 27296860

  • Palstam A, Larsson A, Lofgren M, Ernberg M, Bjersing J, Bileviciute-Ljungar I, Gerdle B, Kosek E, Mannerkorpi K. Decrease of fear avoidance beliefs following person-centered progressive resistance exercise contributes to reduced pain disability in women with fibromyalgia: secondary exploratory analyses from a randomized controlled trial. Arthritis Res Ther. 2016 May 21;18(1):116. doi: 10.1186/s13075-016-1007-0.

    PubMed 27209068

Questions about this trial

What is this clinical trial studying?

A study testing Physcial activity in people with Fibromyalgia, run by Karolinska Institutet at 3 sites in Sweden.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Muscle function (time frame: 2010-2013). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01226784, which also lists 23 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2020.

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