- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02004405
Heart Rate Variability in Fibromyalgia - Effects of Strengthening Exercises
The Study of Heart Rate Variability in Patients With Fibromyalgia - Effects of Strengthening Exercises
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
Espírito Santo
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Vitória, Espírito Santo, Brazil, 29055020
- Valéria Valim
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Classification criteria for Fibromyalgia (ACR 1990)
- Sedentary subjects (without regular physical activity in the last 3 months)
- Women between 18 to 65 years old
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: strengthening exercise
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 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.
|
Active Comparator: Flexibility exercise
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 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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
pain
Time Frame: 4 weeks
|
Visual analogic scale
|
4 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Fibromyalgia Impact Questionnaire
Time Frame: Initial, 8 weeks, 16 weeks
|
Symptoms
|
Initial, 8 weeks, 16 weeks
|
Short Form Health Survey
Time Frame: Initial, 8 weeks, 16 weeks
|
Initial, 8 weeks, 16 weeks
|
|
State-Trait Anxiety Inventory (IDATE)
Time Frame: initial, 8 weeks, 16 weeks
|
Mood evaluation
|
initial, 8 weeks, 16 weeks
|
BECK Depression Inventory
Time Frame: Initial, 8 weeks, 16 weeks
|
Mood evaluation
|
Initial, 8 weeks, 16 weeks
|
Treadmill test
Time Frame: initial and 16 weeks
|
cardiorespiratory fitness cardiovascular risk
|
initial and 16 weeks
|
Sit and Reach Test
Time Frame: 4 weeks
|
flexibility
|
4 weeks
|
dynamometry
Time Frame: 4 weeks
|
global strength
|
4 weeks
|
Maximal repetition test
Time Frame: 4 weeks
|
muscle strength
|
4 weeks
|
autonomic modulation
Time Frame: 4 weeks
|
Ratio low frequecy to high frequency in the Heart rate variability
|
4 weeks
|
Collaborators and Investigators
Investigators
- Principal Investigator: Maria Bernadete RO Gavi, Master, Federal University of Espirito Santo
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- FUES01
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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