FibromyalgiaNCT01278641
Men With Fibromyalgia or Chronic Widespread Pain - Effect of Exercise on Symptoms and Body Functions
A study testing Graded strength resistance training program and Temperate pool exercise program in people with Fibromyalgia and Pain, run by Göteborg University at 1 site in Sweden.
Trial summary
A controlled randomised trial (CRT). 60 men who fulfil the ACR-criteria for Fibromyalgia or Chronic Widespread Pain (Wolfe 1990) participate in the study. The main objective of the study is to compare the effect of a graded strength training program and a low intensive pool exercise program. Read more about this study
- Who is it for?
- Ages 18 to 60 years, men only
- Conditions the study is for
- Fibromyalgia, Pain
- What is being tested?
- Graded strength resistance training program and Temperate pool exercise program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteSweden
- Study dates
- Jan 2008to Nov 2009
- 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 18 to 60 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- Male patients with Fibromyalgia or Chronic Widespread pain
Who cannot join
- Other severe physical or psychiatric disorders.
Trial locations and contacts
1 site in 1 country.
About this study
A controlled randomised trial (CRT). 60 men who fulfil the ACR-criteria for Fibromyalgia or Chronic Widespread Pain (Wolfe 1990) participate in the study.
The main objective of the study is to compare the effect of a graded strength training program and a low intensive pool exercise program.
Read the detailed description
A controlled randomised trial (CRT). 60 men who fulfil the ACR-criteria for Fibromyalgia or Chronic Widespread Pain (Wolfe 1990) participate in the study.
40 patients (in the city Uddevalla) are randomised into two groups; low intensive temperate pool exercise program, and graded strength training program. The study period is 12 weeks.
20 patients (in the city Alingsås) make a reference group who is asked to continue their normal activities during the study period.
Primary outcomes are fatigue (using the Multidimensional fatigue inventory and VAS for global fatigue)and muscle strength (using Steve Strong, Isobex and the Grippit). Several other self-administered instruments was used.
- Conditions
- Fibromyalgia, Pain
- Being tested
- Graded strength resistance training program, Temperate pool exercise program
- Keywords
- Fibromyalgia, Widespread pain, Fatigue, Physical exercise
- Medical subject headings
- Fibromyalgia, Pain, Fatigue, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Graded strength resistance training programBehavioural
Graded strength resistance training, 75 minutes, twice a week for 12 weeks.
Temperate pool exercise programBehavioural
Temperate pool low intensive exercise, 50 minutes, twice a week for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Intervention i arm 1 comprises graded strength resistance training, 75 minutes twice a week for 12 weeks. Receives: Behavioral: Graded strength resistance training program |
| 2 | Experimental | Intervention in arm 2 comprises low intensive temperate pool exercise 50 minutes, twice a week for 12 weeks. Receives: Behavioral: Temperate pool exercise program |
| 3 | No intervention | Reference group, continues with normal activities during the study period of 12 weeks. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The multidimensional Fatigue Inventory (MFI-20)
Measured: 12 weeks
Secondary outcomes (2)
The Hospital Anxiety and Depression Scale (HADS)
Measured: 12 weeks
Muscle strength (measured with Isobex and Steve Strong)
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2011 (estimated)
- Study startJan 2008
- Primary completionMar 2009
- Study completionNov 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for FibromyalgiaStudies of the same condition, open and under way.
- More trials run by Göteborg UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Göteborg University
- Sponsor type
- University, hospital or other
- Investigators
- Kaisa E Mannerkorpi, Ass Prof, Principal investigator, Göteborg University, Dept of Rheumatology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01278641
- Sponsor's protocol ID
- 082-07
- Status last verified
- Apr 2008
- First submitted
- 18 Jan 2011
- Last updated
- 19 Jan 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Ericsson A, Bremell T, Cider A, Mannerkorpi K. Effects of exercise on fatigue and physical capacity in men with chronic widespread pain - a pilot study. BMC Sports Sci Med Rehabil. 2016 Sep 6;8(1):29. doi: 10.1186/s13102-016-0054-9. eCollection 2016.
PubMed 27602228
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Men With Fibromyalgia or Chronic Widespread Pain - Effect of Exercise on Symptoms and Body Functions
- ClinicalTrials.gov ID
- NCT01278641
- Acronym / sponsor ID
- 082-07
- Conditions
- Fibromyalgia, Pain
- Keywords
- Fibromyalgia, Widespread pain, Fatigue, Physical exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Göteborg UniversityUniversity, hospital or other
- Study start
- Jan 2008
- Primary completion
- Mar 2009 (actual)
- Study completion
- Nov 2009 (actual)
- First posted
- 19 Jan 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A controlled randomised trial (CRT). 60 men who fulfil the ACR-criteria for Fibromyalgia or Chronic Widespread Pain (Wolfe 1990) participate in the study.
The main objective of the study is to compare the effect of a graded strength training program and a low intensive pool exercise program.
Detailed description
A controlled randomised trial (CRT). 60 men who fulfil the ACR-criteria for Fibromyalgia or Chronic Widespread Pain (Wolfe 1990) participate in the study.
40 patients (in the city Uddevalla) are randomised into two groups; low intensive temperate pool exercise program, and graded strength training program. The study period is 12 weeks.
20 patients (in the city Alingsås) make a reference group who is asked to continue their normal activities during the study period.
Primary outcomes are fatigue (using the Multidimensional fatigue inventory and VAS for global fatigue)and muscle strength (using Steve Strong, Isobex and the Grippit). Several other self-administered instruments was used.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: Graded strength resistance training programIntervention i arm 1 comprises graded strength resistance training, 75 minutes twice a week for 12 weeks. |
| 2 | Experimental | Behavioral: Temperate pool exercise programIntervention in arm 2 comprises low intensive temperate pool exercise 50 minutes, twice a week for 12 weeks. |
| 3 | No intervention | –Reference group, continues with normal activities during the study period of 12 weeks. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Male patients with Fibromyalgia or Chronic Widespread pain
Key exclusion criteria (1 listed)
- Other severe physical or psychiatric disorders.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Graded strength resistance training programGraded strength resistance training, 75 minutes, twice a week for 12 weeks. | Behavioural | 1 |
| Temperate pool exercise programTemperate pool low intensive exercise, 50 minutes, twice a week for 12 weeks. | Behavioural | 2 |
Primary outcome
The multidimensional Fatigue Inventory (MFI-20)
Time frame: 12 weeks
2 secondary outcomes
The Hospital Anxiety and Depression Scale (HADS)
Time frame: 12 weeks
Muscle strength (measured with Isobex and Steve Strong)
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2011.
- Derived from this study: PubMed 27602228Ericsson A, Bremell T, Cider A, Mannerkorpi K. Effects of exercise on fatigue and physical capacity in men with chronic widespread pain - a pilot study. BMC Sports Sci Med Rehabil. 2016 Sep 6;8(1):29. doi: 10.1186/s13102-016-0054-9. eCollection 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kaisa E Mannerkorpi, Ass Prof principal investigator
Göteborg University, Dept of Rheumatology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Graded strength resistance training program and Temperate pool exercise program in people with Fibromyalgia and Pain, run by Göteborg University at 1 site 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 1 inclusion and 1 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 19 Jan 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The multidimensional Fatigue Inventory (MFI-20) (time frame: 12 weeks). 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 NCT01278641, which also lists 1 linked publication.
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 19 Jan 2011.