Back to results

The Effects of Training and Relaxation on Fibromyalgia.

Primary Purpose

Fibromyalgia

Status

Completed

Phase

Not Applicable

Locations

Sweden

Study Type

Interventional

Intervention

Physcial activity

About this trial

This is an interventional basic science trial for Fibromyalgia focused on measuring Strength exercise, Physical exercise, Physiotheraphy

Eligibility Criteria

20 Years - 65 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria: ACR 1990 criteria for fibromyalgia -

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

Sites / Locations

Sahlgrenska University Hospital
Linkopings University Hospital
Karolinska Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Physcial exercise

Relaxation exercise

Arm Description

15 weeks of progressive resistance group exercise, twice/week supervised by physical therapist

15 weeks of relaxation exercise, twice/week supervised by physical therapist

Outcomes

Primary Outcome Measures

Muscle function

isometric knee-extension force (Steve Strong®)

Secondary Outcome Measures

Fibromyalgia impact questionnaire

Ratings on FIQ, total score

VAS pain

Pain intensity ratings on VAS

Full Information

NCT ID

NCT01226784

First Posted

October 21, 2010

Last Updated

October 23, 2020

Sponsor

Karolinska Institutet

Collaborators

Sahlgrenska University Hospital, Sweden, University Hospital, Linkoeping

1. Study Identification

Unique Protocol Identification Number

NCT01226784

Brief Title

The Effects of Training and Relaxation on Fibromyalgia.

Official Title

The Effects of Training and Relaxation on Fibromyalgia.

Study Type

Interventional

2. Study Status

Record Verification Date

October 2020

Overall Recruitment Status

Completed

Study Start Date

October 2010 (Actual)

Primary Completion Date

May 2015 (Actual)

Study Completion Date

October 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Karolinska Institutet

Collaborators

Sahlgrenska University Hospital, Sweden, University Hospital, Linkoeping

4. Oversight

5. Study Description

Brief Summary

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Fibromyalgia

Keywords

Strength exercise, Physical exercise, Physiotheraphy

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

240 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Physcial exercise

Arm Type

Active Comparator

Arm Description

15 weeks of progressive resistance group exercise, twice/week supervised by physical therapist

Arm Title

Relaxation exercise

Arm Type

Active Comparator

Arm Description

15 weeks of relaxation exercise, twice/week supervised by physical therapist

Intervention Type

Behavioral

Intervention Name(s)

Physcial activity

Intervention Description

Strenght training Relaxation exercise

Primary Outcome Measure Information:

Title

Muscle function

Description

isometric knee-extension force (Steve Strong®)

Time Frame

2010-2013

Secondary Outcome Measure Information:

Title

Fibromyalgia impact questionnaire

Description

Ratings on FIQ, total score

Time Frame

2010-2013

Title

VAS pain

Description

Pain intensity ratings on VAS

Time Frame

2010-2013

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: ACR 1990 criteria for fibromyalgia - Exclusion Criteria: Other dominating pain condition, severe disease preventing from participating in physical exercise -

Facility Information:

Facility Name

Sahlgrenska University Hospital

City

Gothenburg

ZIP/Postal Code

41 345

Country

Sweden

Facility Name

Linkopings University Hospital

City

Linkoping

ZIP/Postal Code

581 85

Country

Sweden

Facility Name

Karolinska Institute

City

Stockholm

ZIP/Postal Code

171 77

Country

Sweden

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

32719459

Citation

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.

Results Reference

background

PubMed Identifier

32168104

Citation

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.

Results Reference

background

PubMed Identifier

31544950

Citation

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.

Results Reference

background

PubMed Identifier

29885369

Citation

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.

Results Reference

background

PubMed Identifier

29673356

Citation

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.

Results Reference

background

PubMed Identifier

29849487

Citation

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.

Results Reference

background

PubMed Identifier

29068036

Citation

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.

Results Reference

background

PubMed Identifier

28282362

Citation

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.

Results Reference

background

PubMed Identifier

28627125

Citation

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.

Results Reference

background

PubMed Identifier

28288611

Citation

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.

Results Reference

background

PubMed Identifier

27695113

Citation

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.

Results Reference

background

PubMed Identifier

27473164

Citation

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.

Results Reference

background

PubMed Identifier

27448744

Citation

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.

Results Reference

background

PubMed Identifier

27296860

Citation

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.

Results Reference

background

PubMed Identifier

27209068

Citation

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.

Results Reference

background

PubMed Identifier

26624891

Citation

Christidis N, Ghafouri B, Larsson A, Palstam A, Mannerkorpi K, Bileviciute-Ljungar I, Lofgren M, Bjersing J, Kosek E, Gerdle B, Ernberg M. Comparison of the Levels of Pro-Inflammatory Cytokines Released in the Vastus Lateralis Muscle of Patients with Fibromyalgia and Healthy Controls during Contractions of the Quadriceps Muscle--A Microdialysis Study. PLoS One. 2015 Dec 1;10(12):e0143856. doi: 10.1371/journal.pone.0143856. eCollection 2015.

Results Reference

background

PubMed Identifier

26413476

Citation

Flodin P, Martinsen S, Mannerkorpi K, Lofgren M, Bileviciute-Ljungar I, Kosek E, Fransson P. Normalization of aberrant resting state functional connectivity in fibromyalgia patients following a three month physical exercise therapy. Neuroimage Clin. 2015 Aug 18;9:134-9. doi: 10.1016/j.nicl.2015.08.004. eCollection 2015.

Results Reference

background

PubMed Identifier

26084281

Citation

Larsson A, Palstam A, Lofgren M, Ernberg M, Bjersing J, Bileviciute-Ljungar I, Gerdle B, Kosek E, Mannerkorpi K. Resistance exercise improves muscle strength, health status and pain intensity in fibromyalgia--a randomized controlled trial. Arthritis Res Ther. 2015 Jun 18;17(1):161. doi: 10.1186/s13075-015-0679-1.

Results Reference

background

PubMed Identifier

25275449

Citation

Martinsen S, Flodin P, Berrebi J, Lofgren M, Bileviciute-Ljungar I, Ingvar M, Fransson P, Kosek E. Fibromyalgia patients had normal distraction related pain inhibition but cognitive impairment reflected in caudate nucleus and hippocampus during the Stroop Color Word Test. PLoS One. 2014 Oct 2;9(9):e108637. doi: 10.1371/journal.pone.0108637. eCollection 2014.

Results Reference

background

PubMed Identifier

25074026

Citation

Palstam A, Larsson A, Bjersing J, Lofgren M, Ernberg M, Bileviciute-Ljungar I, Ghafouri B, Sjors A, Larsson B, Gerdle B, Kosek E, Mannerkorpi K. Perceived exertion at work in women with fibromyalgia: explanatory factors and comparison with healthy women. J Rehabil Med. 2014 Sep;46(8):773-80. doi: 10.2340/16501977-1843.

Results Reference

background

PubMed Identifier

24998297

Citation

Flodin P, Martinsen S, Lofgren M, Bileviciute-Ljungar I, Kosek E, Fransson P. Fibromyalgia is associated with decreased connectivity between pain- and sensorimotor brain areas. Brain Connect. 2014 Oct;4(8):587-94. doi: 10.1089/brain.2014.0274. Epub 2014 Aug 7.

Results Reference

background

PubMed Identifier

35029590

Citation

Wahlen K, Yan H, Welinder C, Ernberg M, Kosek E, Mannerkorpi K, Gerdle B, Ghafouri B. Proteomic Investigation in Plasma from Women with Fibromyalgia in Response to a 15-wk Resistance Exercise Intervention. Med Sci Sports Exerc. 2022 Feb 1;54(2):232-246. doi: 10.1249/MSS.0000000000002790.

Results Reference

derived

PubMed Identifier

34224497

Citation

Sandstrom A, Ellerbrock I, Lofgren M, Altawil R, Bileviciute-Ljungar I, Lampa J, Kosek E. Distinct aberrations in cerebral pain processing differentiating patients with fibromyalgia from patients with rheumatoid arthritis. Pain. 2022 Mar 1;163(3):538-547. doi: 10.1097/j.pain.0000000000002387.

Results Reference

derived

Learn more about this trial

The Effects of Training and Relaxation on Fibromyalgia.

We'll reach out to this number within 24 hrs