FibromyalgiaPhase 4NCT02004405
Heart Rate Variability in Fibromyalgia - Effects of Strengthening Exercises
A Phase 4 study testing strengthening exercise and flexibility exercise in people with Fibromyalgia, run by Federal University of Espirito Santo at 1 site in Brazil.
Trial summary
Abstract Objective: Autonomic dysfunction is an important mechanism that could explain many symptoms observed in fibromyalgia (FM). Exercise is an effective treatment, with benefits potentially mediated through changes in autonomic modulation. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Fibromyalgia
- What is being tested?
- strengthening exercise and flexibility exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteBrazil
- Study dates
- Jul 2010to Sep 2012
- Phase
- Phase 4
- 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
- Classification criteria for Fibromyalgia (ACR 1990)
- Sedentary subjects (without regular physical activity in the last 3 months)
- Women between 18 to 65 years old
Who cannot join
- Cardiovascular and/or respiratory diseases that might limit physical activity (COPD, Pulmonary Fibrosis, asthma moderate to severe, respiratory insufficiency);
- Organ dysfunction (renal, hepatic, coronary, pulmonary insufficiency);
- Arterial hypertension and diabetes mellitus;
- Uncontrolled thyroid disease;
- Autoimmune rheumatic diseases and/or non-autoimmune with symptoms that might limit the movement or physical effort;
- The use of beta blockers, calcium channel blockers and any other anti-hypertensive, anticonvulsants; non tricycles antidepressants; opioid analgesic including tramadol.
Show all 11Show fewer
- cyclobenzaprine >10 mg/day, and amtriptyline > 25 mg/day;
- Performing or have performed exercise within the last 3 months;
- Inability to understand the questionnaires;
- Positive treadmill test for myocardial ischemia;
- Receipt of the social security benefits.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Study of Heart Rate Variability in Patients With Fibromyalgia - Effects of Strengthening Exercises
Abstract Objective: Autonomic dysfunction is an important mechanism that could explain many symptoms observed in fibromyalgia (FM). Exercise is an effective treatment, with benefits potentially mediated through changes in autonomic modulation. Strengthening is one of the less studied exercises in FM, and the acute and chronic effects of strengthening on the autonomic system remain unknown. The objective of this study is to assess the effects of strengthening exercises (STRE) on autonomic modulation, pain perception and the quality of life (QOL) of FM patients. Methods: Sedentary women with FM (ACR 1990) will be randomly selected to STRE or flexibility (FLEX) exercises in a blind controlled trial. The intensity of STRE will be set at 45% of the estimated load of 1 Repetition Maximum (RM) in 12 different exercises. The primary outcomes will be pain measured using the Visual Analog Scale (VAS) and the Heart Rate Variability (HRV) analysis. Other outcomes will be assess: fitness measured by treadmill test, the sit and reach test (Wells and Dillon's Bench), handgrip dynamometry; and quality of life by the Fibromyalgia Impact Questionnaire (FIQ), the Beck and Idate Trait-State Inventory (IDATE), a short-form health survey (SF-36). Statistical analyses and ethical procedures: The visual analog scale (VAS) for pain will be the primary measure used to determine sample size. Statistical significance will be set at 5% and power of 80%. These led to at least 58 participants to be randomized. The main hypothesis is that strengthening exercise is a better treatment than flexibility exercise to improve pain, HRV and quality of life. In all measures tested we will consider the null hypothesis (H0) as being the point of equality between groups tested and H1 the point of difference. Bilateral tests were carried out adopting a 5% level of significance. The normality of the results will be tested using the Shapiro-Wilk test. Student's "t"-test for paired samples will be used to perform intra-group comparisons at different times, when the data were normally distributed, and the nonparametric equivalent of Student's t-test (Wilcoxon test) will be used when the data show an asymmetrical distribution. To compare the data between the STRE and FLEX groups, ANOVA for repeated measures will be used, followed by post-hoc Bonferroni's test.
Read the detailed description
STUDY PROTOCOL: The experimental group (STRE) will receive strengthening training in "Station for lifting weight exercises" (Flex Mega 8, Flex Fitness Equipment Brand) using the recommendations of the American College of Sports Medicine (ACMS, 2010), twice a week, during 45 minutes for 16 weeks. The control group (FLEX) will receive stretching and flexibility exercise training according to the protocol of prescription and previously tested and described in appendix F (Valim et al., 2003), twice a week, during 45 minutes for 16 weeks. The minimum number of patients per group will be 30. The randomization will be by arriving order of the patients at the Clinic, having 2 groups with a distribution at random one by one. There will be an examiner for the selection and unblinded randomization and another for the application of tools that will be blind. Patients will undergo clinical and cardiological evaluation with an exercise stress test (Ergometric test) request in all of them according to ACMS as one more method of evaluation for inclusion and exclusion.
The evaluation will be performed by a blind examiner, an expert physiotherapist in rheumatology and trained for the application of the tools at the beginning, after 30, 60, 90, 120 days from the treatment onset.
The measure for prescription and muscle strength gain will be by the method of maximal repetitions (Lindh et al., 1994; Tritschler, 2003; Brosseau et al., 2008; ACSM, 2010). The evaluations will take place at the beginning, 30, 60, 90, 120 days (final evaluation). Evaluations will be performed by the same blind examiner for the examined group. The training team will be formed by a physiotherapist, physical educator, and experienced doctors at strengthening training and flexibility and stretching exercises and they must follow the following protocol.
PROTOCOL OF EXERCISES The strength training will be performed according to American College of Sports Medicine (ACSM) and will have a mild to moderate intensity representing 45% of the estimated 1RM obtained from the maximal repetition method. Eight major muscle groups will be trained (quadriceps femoris, hamstrings, biceps brachii, triceps brachii, pectoral, calf, deltoid, and latissimus dorsi) in 12 different exercises, with 3 sets of 12 repetitions (leg Press, leg extension, hip flexion, pectoral fly, triceps extension, shoulder flexion, leg curl, calf, pulldown, shoulder abduction, biceps flexion and shoulder extension). Theses 12 different exercises will be distributed in a composed circuit system of 2 sets of exercises: Set A ((leg Press, leg extension, hip flexion, pectoral fly, triceps extension, shoulder flexion) and set B (leg curl, calf, pulldown, shoulder abduction, biceps flexion and shoulder extension). Each set will be applied once a week alternatively. The exercises will be performed twice a week during 16 weeks.
During the training process a load increase will be performed in order to seek progressive muscle strengthening improvement in a controlled way and according to patients' clinical evolution. Blood pressure and heart rate will be monitored as well.
Strength and strengthening training will be performed at the Evaluation, Physical Conditioning and Rehabilitation Laboratory (LACORE) at the University Hospital in in Federal University of Espirito Santo.
We have chosen the frequency of twice a week because it is a frequency (for this kind of study) validated in the literature (Figueroa et al., 2008, Kingsley et al., 2009; 2010).
- Conditions
- Fibromyalgia
- Being tested
- strengthening exercise, flexibility exercise
- Keywords
- autonomic nervous system, fibromyalgia, autonomic dysfunction, strengthening, flexibility, exercise, heart rate variability
- Medical subject headings
- Fibromyalgia, Primary Dysautonomias, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
strengthening exerciseOther
The experimental group (STRE) will receive strengthening training in "Station for lifting weight exercises" (Flex Mega 8, Flex Fitness Equipment Brand) using the recommendations of the American College of Sports Medicine (ACMS, 2010), twice a week, during 45 minutes for 16 weeks.
flexibility exerciseOther
The control group (FLEX) will receive stretching and flexibility exercise training according to the protocol of prescription and previously tested and described in appendix F (Valim et al., 2003), twice a week, during 45 minutes for 16 weeks.
| Study group | Role | What they receive |
|---|---|---|
| strengthening exercise | Experimental | The experimental group (STRE) will receive strengthening training in "Station for lifting weight exercises" (Flex Mega 8, Flex Fitness Equipment Brand) using the recommendations of the American College of Sports Medicine (ACMS, 2010), twice a week, during 45 minutes for 16 weeks. Receives: Other: strengthening exercise |
| Flexibility exercise | Active comparator | The control group (FLEX) will receive stretching and flexibility exercise training according to the protocol of prescription and previously tested and described in appendix F (Valim et al., 2003), twice a week, during 45 minutes for 16 weeks. Receives: Other: flexibility exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain
Visual analogic scale
Measured: 4 weeks
Secondary outcomes (9)
Fibromyalgia Impact Questionnaire
Symptoms
Measured: Initial, 8 weeks, 16 weeks
Short Form Health Survey
Measured: Initial, 8 weeks, 16 weeks
State-Trait Anxiety Inventory (IDATE)
Mood evaluation
Measured: initial, 8 weeks, 16 weeks
BECK Depression Inventory
Mood evaluation
Measured: Initial, 8 weeks, 16 weeks
Treadmill test
cardiorespiratory fitness cardiovascular risk
Measured: initial and 16 weeks
Sit and Reach Test
flexibility
Measured: 4 weeks
dynamometry
global strength
Measured: 4 weeks
Maximal repetition test
muscle strength
Measured: 4 weeks
autonomic modulation
Ratio low frequecy to high frequency in the Heart rate variability
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2013 (estimated)
- Study startJul 2010
- Primary completionSep 2012
- Study completionSep 2012
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.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of Espirito Santo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Valéria Valim, Federal University of Espirito Santo
- Investigators
- Maria Bernadete RO Gavi, Master, Principal investigator, Federal University of Espírito Santo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02004405
- Sponsor's protocol ID
- FUES01
- Status last verified
- Dec 2013
- First submitted
- 26 Nov 2013
- Last updated
- 9 Dec 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Gavi MB, Vassalo DV, Amaral FT, Macedo DC, Gava PL, Dantas EM, Valim V. Strengthening exercises improve symptoms and quality of life but do not change autonomic modulation in fibromyalgia: a randomized clinical trial. PLoS One. 2014 Mar 20;9(3):e90767. doi: 10.1371/journal.pone.0090767. eCollection 2014.
PubMed 24651512
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Study of Heart Rate Variability in Patients With Fibromyalgia - Effects of Strengthening Exercises
- ClinicalTrials.gov ID
- NCT02004405
- Acronym / sponsor ID
- FUES01
- Conditions
- Fibromyalgia
- Keywords
- autonomic nervous system, fibromyalgia, autonomic dysfunction, strengthening, flexibility, exercise, heart rate variability
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Federal University of Espirito SantoUniversity, hospital or other
- Study start
- Jul 2010
- Primary completion
- Sep 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 9 Dec 2013 (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.
Abstract Objective: Autonomic dysfunction is an important mechanism that could explain many symptoms observed in fibromyalgia (FM). Exercise is an effective treatment, with benefits potentially mediated through changes in autonomic modulation. Strengthening is one of the less studied exercises in FM, and the acute and chronic effects of strengthening on the autonomic system remain unknown. The objective of this study is to assess the effects of strengthening exercises (STRE) on autonomic modulation, pain perception and the quality of life (QOL) of FM patients. Methods: Sedentary women with FM (ACR 1990) will be randomly selected to STRE or flexibility (FLEX) exercises in a blind controlled trial. The intensity of STRE will be set at 45% of the estimated load of 1 Repetition Maximum (RM) in 12 different exercises. The primary outcomes will be pain measured using the Visual Analog Scale (VAS) and the Heart Rate Variability (HRV) analysis. Other outcomes will be assess: fitness measured by treadmill test, the sit and reach test (Wells and Dillon's Bench), handgrip dynamometry; and quality of life by the Fibromyalgia Impact Questionnaire (FIQ), the Beck and Idate Trait-State Inventory (IDATE), a short-form health survey (SF-36). Statistical analyses and ethical procedures: The visual analog scale (VAS) for pain will be the primary measure used to determine sample size. Statistical significance will be set at 5% and power of 80%. These led to at least 58 participants to be randomized. The main hypothesis is that strengthening exercise is a better treatment than flexibility exercise to improve pain, HRV and quality of life. In all measures tested we will consider the null hypothesis (H0) as being the point of equality between groups tested and H1 the point of difference. Bilateral tests were carried out adopting a 5% level of significance. The normality of the results will be tested using the Shapiro-Wilk test. Student's "t"-test for paired samples will be used to perform intra-group comparisons at different times, when the data were normally distributed, and the nonparametric equivalent of Student's t-test (Wilcoxon test) will be used when the data show an asymmetrical distribution. To compare the data between the STRE and FLEX groups, ANOVA for repeated measures will be used, followed by post-hoc Bonferroni's test.
Detailed description
STUDY PROTOCOL: The experimental group (STRE) will receive strengthening training in "Station for lifting weight exercises" (Flex Mega 8, Flex Fitness Equipment Brand) using the recommendations of the American College of Sports Medicine (ACMS, 2010), twice a week, during 45 minutes for 16 weeks. The control group (FLEX) will receive stretching and flexibility exercise training according to the protocol of prescription and previously tested and described in appendix F (Valim et al., 2003), twice a week, during 45 minutes for 16 weeks. The minimum number of patients per group will be 30. The randomization will be by arriving order of the patients at the Clinic, having 2 groups with a distribution at random one by one. There will be an examiner for the selection and unblinded randomization and another for the application of tools that will be blind. Patients will undergo clinical and cardiological evaluation with an exercise stress test (Ergometric test) request in all of them according to ACMS as one more method of evaluation for inclusion and exclusion.
The evaluation will be performed by a blind examiner, an expert physiotherapist in rheumatology and trained for the application of the tools at the beginning, after 30, 60, 90, 120 days from the treatment onset.
The measure for prescription and muscle strength gain will be by the method of maximal repetitions (Lindh et al., 1994; Tritschler, 2003; Brosseau et al., 2008; ACSM, 2010). The evaluations will take place at the beginning, 30, 60, 90, 120 days (final evaluation). Evaluations will be performed by the same blind examiner for the examined group. The training team will be formed by a physiotherapist, physical educator, and experienced doctors at strengthening training and flexibility and stretching exercises and they must follow the following protocol.
PROTOCOL OF EXERCISES The strength training will be performed according to American College of Sports Medicine (ACSM) and will have a mild to moderate intensity representing 45% of the estimated 1RM obtained from the maximal repetition method. Eight major muscle groups will be trained (quadriceps femoris, hamstrings, biceps brachii, triceps brachii, pectoral, calf, deltoid, and latissimus dorsi) in 12 different exercises, with 3 sets of 12 repetitions (leg Press, leg extension, hip flexion, pectoral fly, triceps extension, shoulder flexion, leg curl, calf, pulldown, shoulder abduction, biceps flexion and shoulder extension). Theses 12 different exercises will be distributed in a composed circuit system of 2 sets of exercises: Set A ((leg Press, leg extension, hip flexion, pectoral fly, triceps extension, shoulder flexion) and set B (leg curl, calf, pulldown, shoulder abduction, biceps flexion and shoulder extension). Each set will be applied once a week alternatively. The exercises will be performed twice a week during 16 weeks.
During the training process a load increase will be performed in order to seek progressive muscle strengthening improvement in a controlled way and according to patients' clinical evolution. Blood pressure and heart rate will be monitored as well.
Strength and strengthening training will be performed at the Evaluation, Physical Conditioning and Rehabilitation Laboratory (LACORE) at the University Hospital in in Federal University of Espirito Santo.
We have chosen the frequency of twice a week because it is a frequency (for this kind of study) validated in the literature (Figueroa et al., 2008, Kingsley et al., 2009; 2010).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| strengthening exercise | Experimental | Other: strengthening exerciseThe experimental group (STRE) will receive strengthening training in "Station for lifting weight exercises" (Flex Mega 8, Flex Fitness Equipment Brand) using the recommendations of the American College of Sports Medicine (ACMS, 2010), twice a week, during 45 minutes for 16 weeks. |
| Flexibility exercise | Active comparator | Other: flexibility exerciseThe control group (FLEX) will receive stretching and flexibility exercise training according to the protocol of prescription and previously tested and described in appendix F (Valim et al., 2003), twice a week, during 45 minutes for 16 weeks. |
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)
- Classification criteria for Fibromyalgia (ACR 1990)
- Sedentary subjects (without regular physical activity in the last 3 months)
- Women between 18 to 65 years old
Key exclusion criteria (11 listed)
- Cardiovascular and/or respiratory diseases that might limit physical activity (COPD, Pulmonary Fibrosis, asthma moderate to severe, respiratory insufficiency);
- Organ dysfunction (renal, hepatic, coronary, pulmonary insufficiency);
- Arterial hypertension and diabetes mellitus;
- Uncontrolled thyroid disease;
- Autoimmune rheumatic diseases and/or non-autoimmune with symptoms that might limit the movement or physical effort;
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 |
|---|---|---|
| strengthening exerciseThe experimental group (STRE) will receive strengthening training in "Station for lifting weight exercises" (Flex Mega 8, Flex Fitness Equipment Brand) using the recommendations of the American College of Sports Medicine (ACMS, 2010), twice a week, during 45 minutes for 16 weeks. | Other | strengthening exercise |
| flexibility exerciseThe control group (FLEX) will receive stretching and flexibility exercise training according to the protocol of prescription and previously tested and described in appendix F (Valim et al., 2003), twice a week, during 45 minutes for 16 weeks. | Other | Flexibility exercise |
Primary outcome
pain
Time frame: 4 weeks
Visual analogic scale
9 secondary outcomes
Fibromyalgia Impact Questionnaire
Time frame: Initial, 8 weeks, 16 weeks
Short Form Health Survey
Time frame: Initial, 8 weeks, 16 weeks
State-Trait Anxiety Inventory (IDATE)
Time frame: initial, 8 weeks, 16 weeks
BECK Depression Inventory
Time frame: Initial, 8 weeks, 16 weeks
Treadmill test
Time frame: initial and 16 weeks
Sit and Reach Test
Time frame: 4 weeks
dynamometry
Time frame: 4 weeks
Maximal repetition test
Time frame: 4 weeks
autonomic modulation
Time frame: 4 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 9 Dec 2013.
- Derived from this study: PubMed 24651512Gavi MB, Vassalo DV, Amaral FT, Macedo DC, Gava PL, Dantas EM, Valim V. Strengthening exercises improve symptoms and quality of life but do not change autonomic modulation in fibromyalgia: a randomized clinical trial. PLoS One. 2014 Mar 20;9(3):e90767. doi: 10.1371/journal.pone.0090767. eCollection 2014.
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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.
Maria Bernadete RO Gavi, Master principal investigator
Federal University of Espírito Santo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing strengthening exercise and flexibility exercise in people with Fibromyalgia, run by Federal University of Espirito Santo at 1 site in Brazil.
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 11 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 9 Dec 2013. 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 Brazil. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 (time frame: 4 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 NCT02004405, 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 9 Dec 2013.