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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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.

Brazil1 site
  • Valéria Valim

    Vitória, Espírito Santo, 29055020

Other trials in Brazil

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 groups in NCT02004405
Study groupRoleWhat they receive
strengthening exerciseExperimentalThe 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 exerciseActive comparatorThe 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.

  1. pain

    Visual analogic scale

    Measured: 4 weeks

Secondary outcomes (9)
  1. Fibromyalgia Impact Questionnaire

    Symptoms

    Measured: Initial, 8 weeks, 16 weeks

  2. Short Form Health Survey

    Measured: Initial, 8 weeks, 16 weeks

  3. State-Trait Anxiety Inventory (IDATE)

    Mood evaluation

    Measured: initial, 8 weeks, 16 weeks

  4. BECK Depression Inventory

    Mood evaluation

    Measured: Initial, 8 weeks, 16 weeks

  5. Treadmill test

    cardiorespiratory fitness cardiovascular risk

    Measured: initial and 16 weeks

  6. Sit and Reach Test

    flexibility

    Measured: 4 weeks

  7. dynamometry

    global strength

    Measured: 4 weeks

  8. Maximal repetition test

    muscle strength

    Measured: 4 weeks

  9. 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.

  1. First posted9 Dec 2013 (estimated)
  2. Study startJul 2010
  3. Primary completionSep 2012
  4. Study completionSep 2012

Resources

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)
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

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.

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