Heart Rate Variability in Fibromyalgia - Effects of Strengthening Exercises

NCT02004405 | Completed Phase 4 DMC

• 1 other identifier: FUES01
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Fibromyalgia

Keywords

autonomic nervous system; fibromyalgia; autonomic dysfunction; strengthening; flexibility; exercise; heart rate variability

Outcome Measures

Primary Outcomes (1)

• pain

  Visual analogic scale

  4 weeks

Secondary Outcomes (9)

• Fibromyalgia Impact Questionnaire

  Initial, 8 weeks, 16 weeks

• Short Form Health Survey

  Initial, 8 weeks, 16 weeks

• State-Trait Anxiety Inventory (IDATE)

  initial, 8 weeks, 16 weeks

• BECK Depression Inventory

  Initial, 8 weeks, 16 weeks

• Treadmill test

  initial and 16 weeks

Study Arms (2)

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.

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.

Other: flexibility exercise

Interventions

strengthening exercise OTHER

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.

strengthening exercise

flexibility exercise OTHER

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.

Flexibility exercise

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Classification criteria for Fibromyalgia (ACR 1990)
• Sedentary subjects (without regular physical activity in the last 3 months)
• Women between 18 to 65 years old

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Federal University of Espirito Santo: lead

Study Sites (1)

Valéria Valim

Vitória, Espírito Santo, 29055020, Brazil

Location

Related Publications (1)

• 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.

  PMID: 24651512 DERIVED

MeSH Terms

Conditions

Fibromyalgia; Primary Dysautonomias; Motor Activity

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases; Autonomic Nervous System Diseases; Behavior

Study Officials

• Maria Bernadete RO Gavi, Master

  Federal University of Espírito Santo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD, MD Valéria Valim

Study Record Dates

• First Submitted: November 26, 2013
• First Posted: December 9, 2013
• Study Start: July 1, 2010
• Primary Completion: September 1, 2012
• Study Completion: September 1, 2012
• Last Updated: December 9, 2013

Record last verified: 2013-12

Locations

BR (1)