Therapeutic ExerciseNCT04817605
Effects of Therapeutic Exercise in Patients With Fibromyalgia
A study testing Therapeutic Exercise in people with Therapeutic Exercise and Chronic Pain, run by Universidad de Zaragoza at 1 site in Spain.
Trial summary
Fibromyalgia syndrome is characterized by chronic generalized musculoskeletal pain associated with fatigue, sleep disturbances and some biochemical markers. The European League Againts Rheumatism (EULAR) described an algorithm how to treat step by step these patients. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Therapeutic Exercise, Chronic Pain
- What is being tested?
- Therapeutic Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSpain
- Study dates
- 10 Mar 2021to 20 Jun 2022
- 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 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed medically with Fibromyalgia
- Diagnosed according to the American College of Rheumatology criteria
- Agreement to attend to treatment sessions
Who cannot join
- Any kind of contraindications for physical activity
- Other kind of diseases that could limit the intervention
- Previous surgery last year
- Medication modifications in the last 3 months
Trial locations and contacts
1 site in 1 country.
About this study
Fibromyalgia syndrome is characterized by chronic generalized musculoskeletal pain associated with fatigue, sleep disturbances and some biochemical markers. The European League Againts Rheumatism (EULAR) described an algorithm how to treat step by step these patients.
The objective of this trial is to evaluate if therapeutic exercise is effective on fatigue, pain threshold, quality of life, quality of sleep, pain coping and biochemical and genetic markers.
Read more
For this purpose, the investigators conduct a randomized controlled trial double-blind (patient and examiner). The investigators included patients diagnosed of fibromyalgia according to the American College of Rheumatology (ACR).
Patients included one group receiving exercise therapy consisting of 3 treatment sessions a week over 10 weeks.
The variables are measured at the beginning and end of treatment.
- Conditions
- Therapeutic Exercise, Chronic Pain
- Being tested
- Therapeutic Exercise
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Therapeutic ExerciseOther
Exercise therapy based primarily in aerobic exercise according clinical guidelines last recommendations.To perform different whole body aerobic exercises with a mild to moderate intensity according to Borg scale and maximum heart rate.
| Study group | Role | What they receive |
|---|---|---|
| Exercise Therapy | Experimental | Not described Receives: Other: Therapeutic Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity
VAS
Measured: Baseline
Pain intensity
VAS
Measured: through study completion, an average 10 weeks
Quality of Sleep
The investigators measure the quality of sleep with Pittsburg Sleeping Questionnaire Index (PSQI) at baseline
Measured: Baseline
Quality of Sleep
The investigators measure the quality of sleep with Pittsburg Sleeping Questionnaire Index (PSQI) at baseline
Measured: through study completion, an average 10 weeks
Secondary outcomes (6)
Pressure pain threshold
The investigators measure the pressure pain threshold of the 18 points described initially by the American College of rheumatology with a digital algometer at baseline
Measured: Baseline
Pressure pain threshold
The investigators measure the pressure pain threshold of the 18 points described initially by the American College of rheumatology with a digital algometer at the end of treatment
Measured: through study completion, an average 10 weeks
Central sensitization
The investigators measure the central sensitization with Chronic Pain Self-Efficacy Scale (CPSS) at baseline
Measured: Baseline
Central sensitization
The investigators measure the central sensitization with Chronic Pain Self-Efficacy Scale (CPSS)
Measured: through study completion, an average 10 weeks
Analysis of tryptophan metabolites
The investigators measure the tryptophan metabolites with blood test analysis at baseline
Measured: Baseline
Analysis of tryptophan metabolites
The investigators measure the tryptophan metabolites with blood test analysis at baseline
Measured: through study completion, an average 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2021
- Study start10 Mar 2021
- Primary completion10 Jun 2022
- Study completion20 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Therapeutic ExerciseStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad de Zaragoza
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sandra Jiménez, Universidad de Zaragoza
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04817605
- Sponsor's protocol ID
- UVa
- Status last verified
- May 2023
- First submitted
- 23 Mar 2021
- Last updated
- 18 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Therapeutic Exercise in Patients With Fibromyalgia
- ClinicalTrials.gov ID
- NCT04817605
- Acronym / sponsor ID
- UVa
- Conditions
- Therapeutic Exercise, Chronic Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Universidad de ZaragozaUniversity, hospital or other
- Study start
- 10 Mar 2021 (actual)
- Primary completion
- 10 Jun 2022 (actual)
- Study completion
- 20 Jun 2022 (actual)
- First posted
- 26 Mar 2021 (actual)
- 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.
Fibromyalgia syndrome is characterized by chronic generalized musculoskeletal pain associated with fatigue, sleep disturbances and some biochemical markers. The European League Againts Rheumatism (EULAR) described an algorithm how to treat step by step these patients.
The objective of this trial is to evaluate if therapeutic exercise is effective on fatigue, pain threshold, quality of life, quality of sleep, pain coping and biochemical and genetic markers.
For this purpose, the investigators conduct a randomized controlled trial double-blind (patient and examiner). The investigators included patients diagnosed of fibromyalgia according to the American College of Rheumatology (ACR).
Patients included one group receiving exercise therapy consisting of 3 treatment sessions a week over 10 weeks.
The variables are measured at the beginning and end of treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Exercise Therapy | Experimental | Other: Therapeutic Exercise |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosed medically with Fibromyalgia
- Diagnosed according to the American College of Rheumatology criteria
- Agreement to attend to treatment sessions
Key exclusion criteria (4 listed)
- Any kind of contraindications for physical activity
- Other kind of diseases that could limit the intervention
- Previous surgery last year
- Medication modifications in the last 3 months
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 |
|---|---|---|
| Therapeutic ExerciseExercise therapy based primarily in aerobic exercise according clinical guidelines last recommendations.To perform different whole body aerobic exercises with a mild to moderate intensity according to Borg scale and maximum heart rate. | Other | Exercise Therapy |
Primary outcome
Pain intensity
Time frame: Baseline
VAS
Pain intensity
Time frame: through study completion, an average 10 weeks
VAS
Quality of Sleep
Time frame: Baseline
The investigators measure the quality of sleep with Pittsburg Sleeping Questionnaire Index (PSQI) at baseline
Quality of Sleep
Time frame: through study completion, an average 10 weeks
The investigators measure the quality of sleep with Pittsburg Sleeping Questionnaire Index (PSQI) at baseline
6 secondary outcomes
Pressure pain threshold
Time frame: Baseline
Pressure pain threshold
Time frame: through study completion, an average 10 weeks
Central sensitization
Time frame: Baseline
Central sensitization
Time frame: through study completion, an average 10 weeks
Analysis of tryptophan metabolites
Time frame: Baseline
Analysis of tryptophan metabolites
Time frame: through study completion, an average 10 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 18 May 2023.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Therapeutic Exercise in people with Therapeutic Exercise and Chronic Pain, run by Universidad de Zaragoza at 1 site in Spain.
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 3 inclusion and 4 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 18 May 2023. 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 Spain. 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?
Pain intensity (time frame: Baseline). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 May 2023.