FibromyalgiaNCT03911609
Cardiovascular Autonomic Function and Endogenous Pain Modulation
A study testing Exercise and Cognitive Task in people with Fibromyalgia and Exercise, run by Marquette University at 1 site in United States.
Trial summary
The study has three aims: 1. To investigate the influence of cardiovascular autonomic function on pain sensitivity at rest in patients with fibromyalgia and age- and sex-matched controls 2. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Fibromyalgia, Exercise, Pain
- What is being tested?
- Exercise and Cognitive Task
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Mar 2019to 30 Dec 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Fibromyalgia
- Healthy Controls without fibromyalgia
- Stable medical management plan for four weeks prior to participation in the study.
- Physical Activity Readiness Questionnaire
- English proficiency
Who cannot join
- Elbow arthritis
- Carpal tunnel syndrome
- Cardiovascular disease
- Cervical surgery
- Cerebrovascular accident / stroke
- Multiple sclerosis
Show all 25Show fewer
- Parkinson's disease
- Any central neurodegenerative disease
- Traumatic brain injury
- Peripheral neuropathy of the upper extremity
- Myocardial infarction
- Chronic obstructive pulmonary disease
- Any unstable medical or psychiatric condition
- Diabetes mellitus
- Active cancer
- Lymphedema of the upper extremity
- Claustrophobia
- Raynaud's phenomenon
- Osteoporosis
- Major depressive disorder
- Bipolar disorder
- Rheumatoid arthritis
- Lupus
- Polymyalgia rheumatica
- Pregnancy
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Marquette University
Milwaukee, Wisconsin, 53233
Marie K Hoeger Bement, PT, PhD, 414-288-6738, mariehoeger.bement@marquette.edu
About this study
Official title: The Influence of Cardiovascular Autonomic Function on Endogenous Pain Modulation Before and After Exercise and Cognitive Task in Fibromyalgia
The study has three aims:
- To investigate the influence of cardiovascular autonomic function on pain sensitivity at rest in patients with fibromyalgia and age- and sex-matched controls
- To investigate the influence of cardiovascular autonomic function at baseline and during exercise on the pain response following submaximal isometric exercise
- To study the relation between the pain response following physical and cognitive tasks (exercise and mental math, respectively).
Read the detailed description
Fibromyalgia (FM) affects 2 -8% of the population with a higher prevalence in women than men. People with FM report widespread pain that impacts their quality of life. Patients may also experience other symptoms besides pain such as depression, anxiety, fatigue, sleep difficulties and others. Exercise is one of the interventions that have been shown to reduce pain in chronic pain populations. The phenomenon by which exercise reduces pain sensitivity is known as exercise-induced hypoalgesia (EIH). Although exercise is strongly recommended by American Pain Society guideline for the treatment of FM, some patients with FM report an increase in pain and worsening symptoms following acute exercise. The worsening of symptoms may impact adherence to exercise training. Why some people with FM report pain exacerbation while others report pain relief following exercise is not known.
This study aims at assessing the influence of the cardiovascular autonomic nervous system on pain sensitivity at rest and following exercise in patients with fibromyalgia and pain-free individuals.
- Conditions
- Fibromyalgia, Exercise, Pain, Autonomic Dysfunction, Physical Activity
- Being tested
- Exercise, Cognitive Task
- Medical subject headings
- Fibromyalgia, Motor Activity, Pain, Primary Dysautonomias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseOther
Subjects will perform isometric (static) handgrip exercise at submaximal intensity for four minutes. The exercise will be performed while the subject is seated, and the elbow bent at around 90° and unsupported. Subjects will be asked to rate their pain using numerical pain rating scale that ranges from 0 (no pain) to 10 (worst pain), perceived exertion (RPE) from 0 (Nothing at all) to 10 (extremely strong), and perceived stress from 0 (not stressed at all) to 10 (extremely stressed). The ratings of pain intensity, RPE and perceived stress will be provided before, at the middle and at the end of the exercise.
Cognitive TaskOther
The mental math task, which is also known as serial subtraction test, will be performed for four minutes. Subjects will be asked to rate their pain intensity and perceived stress before, at the middle and at the end of the mental math task.
| Study group | Role | What they receive |
|---|---|---|
| Isometric (Static) Exercise | Experimental | Subjects will perform isometric (static) handgrip exercise at submaximal intensity for four minutes. The exercise will be performed while the subject is seated, and the elbow bent at around 90° and unsupported. Subjects will be asked to rate their pain using numerical pain rating scale that ranges from 0 (no pain) to 10 (worst pain), perceived exertion (RPE) from 0 (Nothing at all) to 10 (extremely strong), and perceived stress from 0 (not stressed at all) to 10 (extremely stressed). The ratings of pain intensity, RPE and perceived stress will be provided before, at the middle and at the end of the exercise. Receives: Other: Exercise |
| Cognitive Task | Experimental | The mental math task, which is also known as serial subtraction test, will be performed for four minutes. Subjects will be asked to rate their pain intensity and perceived stress before, at the middle and at the end of the mental math task. Receives: Other: Cognitive Task |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline Pressure Pain Threshold to immediately after performance of exercise.
Application of a pressure stimulus to the right forearm and quadriceps muscle at a rate of 50kPa per second until the pressure first becomes painful.
Measured: Before and immediately after exercise at session 2 or 3 which is on day 7 or day 21.
Change from Baseline Pressure Pain Threshold to immediately after cognitive task.
Application of a pressure stimulus to the right forearm muscle and quadriceps muscle at a rate of 50kPa per second until the pressure first becomes painful.
Measured: Before and immediately after cognitive task at session 2 or 3 which is on day 7 or day 21.
Change from Baseline Pressure Pain Threshold to during the submersion of the foot in ice water.
Application of a pressure stimulus to the right forearm muscle and quadriceps muscle at a rate of 50kPa per second until the pressure first becomes painful.
Measured: Before and during the submersion of the foot in ice water on session 2 which is day 7 of data collection
Temporal summation of heat assessment.
Subjects will receive ten heat pulses with ramp and return rate of 8˚C/second to the baseline temperature. The peak stimulus interval 0.6 second and the inter-stimulus interval is 0.3 seconds. The baseline temperature will be 39˚C. Subjects will be asked to rate the first, third, fifth, eighth and tenth stimuli.
Measured: the beginning of session 3 which day 21 of data collection
Heart Rate Variability
Electrocardiogram data will be recorded for ten minutes. Subjects will be instructed to relax. A two-lead configuration method will be utilized with electrodes placed at right clavicle (negative electrode), left lower rib (positive electrode), and left clavicle (ground electrode).
Measured: baseline, session1 which is day 1 of data collection
Change in Heart Rate during Deep Breathing Test
The test is done by asking the participant to perform six breathing cycles with each cycle consists of a five seconds inhalation and 5 seconds exhalation (10 second-cycle). Subjects will perform practice trials until they perform respiratory cycles without sudden inhalation or exhalation or holding the breath. Continuous electrocardiogram data will be collected. The change of heart rate during deep breathing test reflects the cardiovascular parasympathetic function. Reduced heart rate variability during deep breathing test indicates reduced parasympathetic tone.
Measured: baseline, session 1 which is day 1 of data collection
Change in Blood Pressure during Valsalva Maneuver
Subjects will be instructed to perform a forceful expiration at a pressure of 40 mm Hg for 15 seconds. This is done by blowing into a syringe that is connected to a pressure gauge, which will be placed in front of the subjects for visual feedback. In addition, feedback of the time will be provided. Continuous blood pressure will be collected during the test. The recovery time of blood pressure to baseline after Valsalva reflects the cardiovascular sympathetic tone. Greater recovery time indicates reduced sympathetic tone.
Measured: baseline, session 1 which is day 1 of data collection
Secondary outcomes (14)
Total time spent in sedentary and moderate to vigorous physical activity measured by an Actigraph over the course of 7 days.
An Actigraph is a waist worn device that is used to track the amount and intensity of physical activity performed over the course of seven days. Total time spent in sedentary and moderate to vigorous physical activity is measured in minutes.
Measured: Worn continuously for a 7-day period during study enrollment.
Cortisol Awakening Response (CAR)
CAR represents the increase of cortisol levels after awakening particularly in the first 30-45 minutes post-awakening. CAR is normal circadian phenomenon and the increase of cortisol levels post-awakening can range from 50 -150% in healthy adults. CAR can be assessed by taking three samples following awakening (immediately post-awakening, 30 minutes and 45 post-awakening). Reduced CAR indicates a dysfunction in the hypothalamus-pituitary-adrenal axis and reduction in the ability to respond to acute or chronic physiological or psychological stress.
Measured: samples will be collected at home at any day between day 1 and day 7 of data collection
Six-Minute Walk Test
Subjects will be asked to walk as fast as they can on a straight 30 meters walking course for six minutes. The start and end points will be marked with cones. After each minute, subjects will be informed of the time left and standardized encouragement will be provided. Subjects will be asked at the beginning, middle, and end of the test to rate their pain from 0 (no pain) to 10 (worst pain), and to rate their perceived exertion from 0 (nothing at all) to 10 (extremely strong). At the end of the six minutes, subjects will be asked to stop and the distance walked will be measured.
Measured: time frame: baseline, day 1 of data collection
The Fibromyalgia Impact Questionnaire - Revised
This questionnaire evaluates the severity of fibromyalgia symptoms over the past 7 days. It has three domains: symptoms, overall impact, and function. The total score ranges from a minimum of 0 to maximum of 210 with higher scores indicating worse function and symptoms.
Measured: on session 1, 2 and 3 which are on day 1,7 and 21 of data collection.
The Short-Form McGill Pain Questionnaire
This questionnaire will be used to evaluate the current clinical pain. It evaluates different aspect of pain such as affective, sensory, and cognitive aspects The total score ranges from a minimum of 0 to maximum 45 with higher scores indicating worse symptoms.
Measured: on session 1, 2 and 3 which are on day 1,7 and 21 of data collection
Pain Catastrophizing Scale
This is a 13-item scale that evaluates if the subject has an exaggerated negative mental set towards pain. It has 3 sub-scales which are magnification, rumination, and helplessness. Greater scores indicate greater catastrophizing thinking. Rumination scale ranges from 0 to 16 with higher score indicating higher levels of rumination. Magnification scale ranges from 0 to 12 with higher scores indicating higher levels of magnification. Helplessness scale ranges from 0 to 24 with higher scores indicating higher levels of helplessness. The subscale scores are summed to compute a total score ranging from 0 to 52 with higher scores indicating higher levels of pain catastrophizing.
Measured: on session 1 which is day 1 of data collection.
American College of Rheumatology Diagnostic Criteria for Fibromyalgia
This questionnaire characterizes the symptoms of those with fibromyalgia. The scale is composed of 3 subscales; widespread pain index, symptom severity score A and B. The widespread pain index ranges from 0 to 19 with 19 indicating greater number of body areas in which pain was experienced. The symptom severity score A ranges from 0 to 9 with 9 indicating greater symptom severity. The symptom severity score B ranges from 0 to 3 with 3 indicating greater number of symptoms experienced. The total Symptom Severity Score is calculated by adding symptom severity score A and symptom severity score B with a total range of 0 (no symptoms) to 12 (great deal of symptoms).
Measured: Day 1 of data collection
Baseline Lean Mass
Measurement of lean mass with use of dual energy x-ray absorptiometry testing.
Measured: 7 days after enrollment.
Baseline Fat Mass
Measurement of fat mass with use of dual energy x-ray absorptiometry testing.
Measured: 7 days after enrollment.
Composite Autonomic Symptom Score
This is a 31-item questionnaire that evaluates 6 domains of autonomic nervous system which are secretomotor, orthostatic intolerance, vasomotor, bladder function, gastrointestinal, and pupillomotor. The score ranges from 0 to 100 with higher scores indicating worse autonomic function.
Measured: baseline, session1 which is day 1 of data collection
Situational Pain Catastrophizing Scale
A 6-item questionnaire that explores the negative mental set or catastrophizing thinking in reference to a particular experimental pain experience. The scores ranges from 0 to 24 with higher scores indicating greater situational catastrophizing.
Measured: in session 2 and 3 which are day 7 and 21 of data collection
Pain Anxiety Symptom Scale
This is a 20-item scale that evaluates the pain-related fear or anxiety. It has four domains: cognitive anxiety, avoidance, fearful thinking, and physiological anxiety. The scores range from 0 to 100. The higher the score, the greater the pain-related anxiety.
Measured: session 3 which is day 21 of data collection
Depression Anxiety and Stress Scale (DASS21)
The DASS21 is a questionnaire that evaluates the overall psychological distress. It has three main subscales: depression, anxiety and stress subscale, and each subscale has 7 items. The DASS21 has been validated in chronic pain patients and non-clinical sample. In patients with FM, DASS21 is associated with the severity of symptoms measured with FIQR, and it mediates the relation between pain intensity and disability in patients with chronic low back pain. The scale has three subscales which are depression, anxiety and stress. The score of depression subscale ranges from 0 - 27. The score of anxiety ranges from 0 - 21. The score of stress ranges from 0 - 42. The greater the score in all subscales the worse the outcome.
Measured: session 3 which is day 21 of data collection
State Version of State-Trait Anxiety Inventory
This is a 20-item questionnaire that evaluates different feelings the subject may or may not have at the moment. The score ranges from 0 to 80 with higher scores indicating greater state anxiety.
Measured: on session 1, 2 and 3 which are on day 1,7 and 21 of data collection.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2019
- Study start20 Mar 2019
- Primary completion30 Dec 2022 (estimated)
- Study completion30 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FibromyalgiaStudies 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
- Randomised
- Intervention model
- Crossover
- Model description
- All subjects will participate in two randomized sessions (exercise session and cognitive task session). Experimental pain assessment will be performed before after both tasks.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Marquette University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marie Hoeger Bement, PT, PhD, Principal investigator, Marquette University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03911609
- Sponsor's protocol ID
- HR-1812027243
- Status last verified
- Apr 2019
- First submitted
- 3 Apr 2019
- Last updated
- 11 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Cardiovascular Autonomic Function on Endogenous Pain Modulation Before and After Exercise and Cognitive Task in Fibromyalgia
- ClinicalTrials.gov ID
- NCT03911609
- Acronym / sponsor ID
- HR-1812027243
- Conditions
- Fibromyalgia, Exercise, Pain, Autonomic Dysfunction, Physical Activity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Marquette UniversityUniversity, hospital or other
- Study start
- 20 Mar 2019 (actual)
- Primary completion
- 30 Dec 2022 (estimated)
- Study completion
- 30 Dec 2022 (estimated)
- First posted
- 11 Apr 2019 (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.
The study has three aims:
- To investigate the influence of cardiovascular autonomic function on pain sensitivity at rest in patients with fibromyalgia and age- and sex-matched controls
- To investigate the influence of cardiovascular autonomic function at baseline and during exercise on the pain response following submaximal isometric exercise
- To study the relation between the pain response following physical and cognitive tasks (exercise and mental math, respectively).
Detailed description
Fibromyalgia (FM) affects 2 -8% of the population with a higher prevalence in women than men. People with FM report widespread pain that impacts their quality of life. Patients may also experience other symptoms besides pain such as depression, anxiety, fatigue, sleep difficulties and others. Exercise is one of the interventions that have been shown to reduce pain in chronic pain populations. The phenomenon by which exercise reduces pain sensitivity is known as exercise-induced hypoalgesia (EIH). Although exercise is strongly recommended by American Pain Society guideline for the treatment of FM, some patients with FM report an increase in pain and worsening symptoms following acute exercise. The worsening of symptoms may impact adherence to exercise training. Why some people with FM report pain exacerbation while others report pain relief following exercise is not known.
This study aims at assessing the influence of the cardiovascular autonomic nervous system on pain sensitivity at rest and following exercise in patients with fibromyalgia and pain-free individuals.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- All subjects will participate in two randomized sessions (exercise session and cognitive task session). Experimental pain assessment will be performed before after both tasks.
| Arm | Type | Receives |
|---|---|---|
| Isometric (Static) Exercise | Experimental | Other: ExerciseSubjects will perform isometric (static) handgrip exercise at submaximal intensity for four minutes. The exercise will be performed while the subject is seated, and the elbow bent at around 90° and unsupported. Subjects will be asked to rate their pain using numerical pain rating scale that ranges from 0 (no pain) to 10 (worst pain), perceived exertion (RPE) from 0 (Nothing at all) to 10 (extremely strong), and perceived stress from 0 (not stressed at all) to 10 (extremely stressed). The ratings of pain intensity, RPE and perceived stress will be provided before, at the middle and at the end of the exercise. |
| Cognitive Task | Experimental | Other: Cognitive TaskThe mental math task, which is also known as serial subtraction test, will be performed for four minutes. Subjects will be asked to rate their pain intensity and perceived stress before, at the middle and at the end of the mental math task. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Fibromyalgia
- Healthy Controls without fibromyalgia
- Stable medical management plan for four weeks prior to participation in the study.
- Physical Activity Readiness Questionnaire
- English proficiency
Key exclusion criteria (25 listed)
- Elbow arthritis
- Carpal tunnel syndrome
- Cardiovascular disease
- Cervical surgery
- Cerebrovascular accident / stroke
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 |
|---|---|---|
| ExerciseSubjects will perform isometric (static) handgrip exercise at submaximal intensity for four minutes. The exercise will be performed while the subject is seated, and the elbow bent at around 90° and unsupported. Subjects will be asked to rate their pain using numerical pain rating scale that ranges from 0 (no pain) to 10 (worst pain), perceived exertion (RPE) from 0 (Nothing at all) to 10 (extremely strong), and perceived stress from 0 (not stressed at all) to 10 (extremely stressed). The ratings of pain intensity, RPE and perceived stress will be provided before, at the middle and at the end of the exercise. | Other | Isometric (Static) Exercise |
| Cognitive TaskThe mental math task, which is also known as serial subtraction test, will be performed for four minutes. Subjects will be asked to rate their pain intensity and perceived stress before, at the middle and at the end of the mental math task. | Other | Cognitive Task |
Primary outcome
Change from Baseline Pressure Pain Threshold to immediately after performance of exercise.
Time frame: Before and immediately after exercise at session 2 or 3 which is on day 7 or day 21.
Application of a pressure stimulus to the right forearm and quadriceps muscle at a rate of 50kPa per second until the pressure first becomes painful.
Change from Baseline Pressure Pain Threshold to immediately after cognitive task.
Time frame: Before and immediately after cognitive task at session 2 or 3 which is on day 7 or day 21.
Application of a pressure stimulus to the right forearm muscle and quadriceps muscle at a rate of 50kPa per second until the pressure first becomes painful.
Change from Baseline Pressure Pain Threshold to during the submersion of the foot in ice water.
Time frame: Before and during the submersion of the foot in ice water on session 2 which is day 7 of data collection
Application of a pressure stimulus to the right forearm muscle and quadriceps muscle at a rate of 50kPa per second until the pressure first becomes painful.
Temporal summation of heat assessment.
Time frame: the beginning of session 3 which day 21 of data collection
Subjects will receive ten heat pulses with ramp and return rate of 8˚C/second to the baseline temperature. The peak stimulus interval 0.6 second and the inter-stimulus interval is 0.3 seconds. The baseline temperature will be 39˚C. Subjects will be asked to rate the first, third, fifth, eighth and tenth stimuli.
Heart Rate Variability
Time frame: baseline, session1 which is day 1 of data collection
Electrocardiogram data will be recorded for ten minutes. Subjects will be instructed to relax. A two-lead configuration method will be utilized with electrodes placed at right clavicle (negative electrode), left lower rib (positive electrode), and left clavicle (ground electrode).
Change in Heart Rate during Deep Breathing Test
Time frame: baseline, session 1 which is day 1 of data collection
The test is done by asking the participant to perform six breathing cycles with each cycle consists of a five seconds inhalation and 5 seconds exhalation (10 second-cycle). Subjects will perform practice trials until they perform respiratory cycles without sudden inhalation or exhalation or holding the breath. Continuous electrocardiogram data will be collected. The change of heart rate during deep breathing test reflects the cardiovascular parasympathetic function. Reduced heart rate variability during deep breathing test indicates reduced parasympathetic tone.
Change in Blood Pressure during Valsalva Maneuver
Time frame: baseline, session 1 which is day 1 of data collection
Subjects will be instructed to perform a forceful expiration at a pressure of 40 mm Hg for 15 seconds. This is done by blowing into a syringe that is connected to a pressure gauge, which will be placed in front of the subjects for visual feedback. In addition, feedback of the time will be provided. Continuous blood pressure will be collected during the test. The recovery time of blood pressure to baseline after Valsalva reflects the cardiovascular sympathetic tone. Greater recovery time indicates reduced sympathetic tone.
14 secondary outcomes
Total time spent in sedentary and moderate to vigorous physical activity measured by an Actigraph over the course of 7 days.
Time frame: Worn continuously for a 7-day period during study enrollment.
Cortisol Awakening Response (CAR)
Time frame: samples will be collected at home at any day between day 1 and day 7 of data collection
Six-Minute Walk Test
Time frame: time frame: baseline, day 1 of data collection
The Fibromyalgia Impact Questionnaire - Revised
Time frame: on session 1, 2 and 3 which are on day 1,7 and 21 of data collection.
The Short-Form McGill Pain Questionnaire
Time frame: on session 1, 2 and 3 which are on day 1,7 and 21 of data collection
Pain Catastrophizing Scale
Time frame: on session 1 which is day 1 of data collection.
American College of Rheumatology Diagnostic Criteria for Fibromyalgia
Time frame: Day 1 of data collection
Baseline Lean Mass
Time frame: 7 days after enrollment.
Baseline Fat Mass
Time frame: 7 days after enrollment.
Composite Autonomic Symptom Score
Time frame: baseline, session1 which is day 1 of data collection
Situational Pain Catastrophizing Scale
Time frame: in session 2 and 3 which are day 7 and 21 of data collection
Pain Anxiety Symptom Scale
Time frame: session 3 which is day 21 of data collection
Depression Anxiety and Stress Scale (DASS21)
Time frame: session 3 which is day 21 of data collection
State Version of State-Trait Anxiety Inventory
Time frame: on session 1, 2 and 3 which are on day 1,7 and 21 of data collection.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2019.
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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.
Marie Hoeger Bement, PT, PhD principal investigator
Marquette University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise and Cognitive Task in people with Fibromyalgia and Exercise, run by Marquette University at 1 site in United States.
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 5 inclusion and 25 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: status not confirmed, as of the sponsor's last update on 11 Apr 2019. 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 United States. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marie K Hoeger Bement, PT, PhD (414-288-6738, mariehoeger.bement@marquette.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline Pressure Pain Threshold to immediately after performance of exercise. (time frame: Before and immediately after exercise at session 2 or 3 which is on day 7 or day 21.). The study lists 7 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 11 Apr 2019.