Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT02458326 |
| Other study ID # |
37052114.3.0000.5208 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
Phase 1
|
| First received |
May 21, 2015 |
| Last updated |
May 27, 2015 |
| Start date |
April 2015 |
| Est. completion date |
September 2015 |
Study information
| Verified date |
May 2015 |
| Source |
Universidade Federal de Pernambuco |
| Contact |
Manuella MB Barros, Master |
| Phone |
55 81 92562343 |
| Email |
manu_mmbb[@]hotmail.com |
| Is FDA regulated |
No |
| Health authority |
Brazil: National Committee of Ethics in Research |
| Study type |
Interventional
|
Clinical Trial Summary
Fibromyalgia and migraine are diseases with high prevalence in women between the age group
of 30-60 years, which seem to share the same pathophysiological mechanism; both originate
from neuroendocrine disorders of the hypothalamic-pituitary axis in the central nervous
system, and are therefore closely related. In addition to the strong relationship with
migraine, fibromyalgia can also be associated with sleep disorders, chronic fatigue and
psychological disorders. The combination of these factors decreases the quality of life and
contributes to increased sedentary this population. It is known that physical exercise
promotes positive changes in pain pathophysiological pathway to increase the release of
endorphins neuroendógenas, improving the symptoms of fibromyalgia.
The objective of this study is to analyze whether the application of an aerobic exercise
program may result in the reduction of the frequency, duration and intensity of migraine
attacks in women with fibromyalgia. For this, a clinical trial will be conducted randomized
double-blind clinical trial comparing two groups of women diagnosed with fibromyalgia and
migraine. Initially, all answer questionnaires assessing quality of life, impact of
headache, level of depression and anxiety, sleep quality, physical activity level, and; will
be held ergospirometry for research in exercise tolerance. The experimental group will
implement the protocol consists of heating, aerobic exercise according to the heart rate
established for training by spirometry and slowdown; and the control group will hold the
heat on low speed and heart rate will next baseline. Both groups will be followed for 12
weeks, with a frequency of three weekly meetings lasting 30 minutes and re-evaluated every 4
weeks. At the end of the protocol, the groups will have their results were compared and
statistically analyzed.
Description:
This study is classified as a randomized double-blind clinical trial. Will be held in the
Department of Physiotherapy of the university clinic of the Federal University of
Pernambuco, located in University City, Recife-PE. Data for the survey will be collected
during the course of the Masters in Physiotherapy, from April 2015 to September 2015, for
further analysis.
The analyzed groups shall consist of women aged 30-50 years referred to the Department of
Physical Therapy - UFPE, with clinical diagnosis of fibromyalgia and migraine performed by
doctors of Rheumatology clinics and Neurology, Hospital das Clinicas, UFPE. Being invited to
participate and informed about its content, saying their participation by signing a Term of
Consent. Data collection is in accordance with the Declaration of Helsinki, and will begin
after the project was approved by the Ethics Committee for Research on Human beings of the
Federal University Health Sciences Center of Pernambuco, in accordance with Resolution
466/2012 of the National Research Ethics Committee of the Ministry of Health, the body that
regulates research involving human subjects. The study will be registered in the digital
Clinical Trials platform after obtaining the registration number of the Ethics Committee.
Initially there will be a pilot study with 20 women, then the results will be used to
calculate the sample size using the G Power (version 3.1.9.2, Germany), considering a
statistical power (β) of 80% with a significance level (α) of 5%.
Will be excluded those that have some other rheumatologic disease, cardio-respiratory or
cardiovascular that prevents the realization of aerobic exercise protocol; low attendance
during the implementation of the exercise program (over three consecutive absences);
cognitive impairment or neurological disease that compromises the understanding and the
exercises; Body mass index ≥ 30.0 (obesity, according to the World Society of Health);
pregnant women and patients classified as level of active or very active physical activity
by IPAQ (International Physical Activity Questionnaire).
3.1. Randomization
Initially, patients will undergo will a simple randomization through the site
www.randomization.com, resulting in two groups:
1. Aerobic Training: Submitted to a protocol consisting of heating, aerobic training with
adequate heart rate and slowdown;
2. Control Training: Heating Protocol with speed and low intensity (heart rate will next
basal).
Randomization will be performed by an examiner A, not research participant to ensure
allocation concealment (patients and principal investigator will not be aware of which group
are allocated). All women will be evaluated (both groups) through questionnaires and
spirometry before the start and the end of the exercise protocol. Every four weeks, the
patients will be submitted to revaluations through the questionnaires. The evaluation of
these volunteers will be conducted by an examiner B (principal investigator), blinded to
randomization; and the exercise protocol implementation will be the responsibility of the
examiner C, only one will know to which group the patients belong. Corroborating the
double-blinding, the evaluator to perform statistical analysis of the data will not know to
which group belongs the results.
3.2. Evaluation
- Socio-demographic questionnaire Prepared by the researcher to characterize the groups,
which answer questions for identification and history (name, date of valuation,
telephone, address, date of birth, age, weight, height, body mass index / BMI,
profession, education, marital status, physical activity and frequency, use of
medication, type of medication, medication time). One minunciosa history regarding the
use of drugs will be held: types, frequency, duration of treatment.
- Identification of the impact of migraine Will be evaluated by the Migraine Disability
Assessment Test (MIDAS), which contains five items that measure the amount of days lost
in the activities of daily living (ADLs) and professional (AVPs) due to the presence of
migraine in the last three months; the patient declares the amount of days and, from
the result of the sum of the scores, ranks the degree of disability of the individual
(0-5 points: grade I / minimal disability; 6-10 points: grade II / mild disability;
11-20 points: grade III / moderate disability;> 20 points: grade IV / severe
disability).
- Clinical characteristics of the headache Will be filled the journal Headache, based on
criteria established by the International Headache Society (ICHD-III beta version,
2013); assesses the amount and duration of migraine attacks over a period of 30 days,
pain intensity, symptoms associated with headache, medication use.
- Investigation of sleep quality The Pittsburgh Sleep Quality Index (PSQI), used to
measure the subjective quality of sleep; consists of 19 items divided into seven
components that punctuate 0-3 (total score of 0-21 points, the higher the score, the
worse the quality of sleep). Was adapted and validated for the Brazilian population by
Bertolazi and colleagues (2011), with a high reliability (α Cronbach = 0.82).
- Quality of life assessment Measured by the FIQ (Fibromyalgia Impact Questionnaire),
consisting of 19 questions divided into 10 items: the first item has 10 sub-items with
four response options ranging from 0-4 points; the second and third items, the patient
should choose an option on a scale of 0-7; in the other, is given a score of 0-10 in
response (the higher the score, the greater the impact of fibromyalgia on quality of
life). Adapted and validated for the Brazilian population.
- Tracking of symptoms of anxiety and depression The presence of depression will be
assessed by the Beck Depression Inventory (BDI), consisting of 21 questions that add up
to a maximum score of 63 points (level of depression: 0-9 points = No; 10-18 points =
mild depression; 19- 29 points = moderate depression;> 30 points = severe depression).
It is validated and adapted for the Brazilian population, with a Cronbach's alpha of
0.81. The Beck Anxiety (BAI) will be used to identify and classify anxiety; consists of
23 statements that have the maximum score of 63 (0-10 points: minimum Anxiety, 11-19
points: Light Anxiety, points 20-30: moderate anxiety,> 31 points: severe anxiety), is
validated and adapted to Brazilian population.
- Evaluation of the level of physical activity Proposed by the World Health Organization
(1998), the International Physical Activity Questionnaire (IPAQ) aims to measure the
total physical activity level (AFT) from the energy expenditure (METs.min-¹). Will be
used to short IPAQ (version 8), which consists of 4 questions with two sub-items (b) on
activities of daily living, professional life activities and practice of walking; where
the frequency and duration respond if (days and hours / minutes) of activities and its
intensity (moderate or vigorous = 3.3-4 METs = 5.5 to 8 METs) for one week. From the
data obtained, sum up the frequency and duration of activities (walk + moderate +
vigorous intensity) and, from this result, classifies individuals in: sedentary;
irregularly active; active or very active. This questionnaire is validated and adapted
for the Brazilian population, with excellent reproducibility (ICC = 0.79).
- Assessment of exercise tolerance Ergospirometry or cardio-pulmonary function test
assesses precisely, the cardio-respiratory capacity and metabolic by direct measurement
of maximum oxygen consumption and determining the maximum ventilatory thresholds. He is
currently considered the gold standard for evaluation of exercise tolerance by
providing non-invasive and very precise exercise intensities featuring aerobic or
anaerobic metabolism (anaerobic threshold - LA). It is the most appropriate test for
prescription of aerobic exercise intensity in sedentary individuals or with regular
physical activity. Oxygen consumption (VO2 max) appears to be the most accurate
indicator of exercise capacity. The test will be performed on a treadmill, coupled with
a spirometer and a computer system in a climatically standardized environment. To
minimize air leakage, will be employed the use of face masks with tiny dead-space. The
main parameters obtained in the test are the ventilatory thresholds: anaerobic
threshold (AT) and respiratory compensation point, which will characterize the aerobic
and anaerobic workouts. The variables obtained during the test, with clinical relevance
are: maximal oxygen uptake (VO2 max), carbon dioxide release (VCO 2), rate of gas
exchange (R), estimated lactate threshold, expired minute volume (VE) , ventilatory
reserve (RVE), ventilatory equivalents, end-expiratory pressures (PEF), ventilatory
pattern, arterial gas tensions / oxyhemoglobin saturation, physiological dead space,
electrocardiograms, heart rate, peripheral O2 saturation (SpO2) and blood pressure (BP
).
The responses to the cardiopulmonary exercise testing (CPX) are obtained by means of an
incremental protocol, which consists in progressive load increases at predetermined time
periods. A typical incremental protocol should provide: a resting phase (2-3 minutes or
more), in which we observe a lack of hyperventilation before starting the test; a heating
period with zero charge (2-3 minutes); incrementing a time (8-12 minutes) and an active
period of recovery with no load (3-6 minutes if possible). For the intervention protocol,
heart rate obtained just below the anaerobic threshold, recommended for proper intensity to
gain fitness with greater security and compliance will be used. Generally, oxygen
consumption levels in the anaerobic threshold are lower in these patients.
-Re-Reviews Initially, will be held the evaluation of patients through questionnaires and
cardiopulmonary stress test to investigate exercise tolerance before the start of exercise
protocol (review 1). Every 4 weeks, the patients of both groups will be reassessed by the
re-application of all questionnaires: 4 weeks - review 2; 8 weeks: evaluation 3. At the end
of the 12 weeks of training, the review 4 will be held, with repetition of the
questionnaires and cardiopulmonary exercise testing.
3.3. Intervention protocol The intervention protocol will be made by the examiner C, one who
is not blind to the research. After randomization and evaluation, patients will be allocated
to one of the groups: experimental or control. After the evaluation of cardiorespiratory
capacity of patients, will be established starting parameters appropriate to the level of
physical activity each based on heart rate obtained just below the anaerobic threshold
(ensuring aerobic work).
The experimental group will follow the following protocol: performing heating for 5 minutes
at low speed on a treadmill; after heating, the speed is increased gradually until the
patient reaches the proper heart rate for aerobic training obtained during cardiopulmonary
exercise testing, maintaining the same for 20 minutes to perform the aerobic workout;
completed, the velocity will be decreased to regain speed heating maintained for 5 minutes
and finishing training. It is envisaged that in practice using the FC to ensure proper
aerobic exercise for 20-60 minutes at a frequency of 3-5 times per week are effective in
increasing the functional capacity of individuals with low fitness (American College of
Sports Medicine - ACSM, 2006). In the control group, these women will be guided to perform
10 minutes of heating on the treadmill with a low speed that does not cause patient effort
(monitored by the Borg scale and FC close to the basement).
Both groups will be followed for 12 weeks, with a driving frequency of 3 times per week.
Heart rate and saturation of peripheral oxygen (SpO2) will be continuously monitored through
the use of finger pulse oximeter during the course of all practices of all the volunteers of
research to ensure that HR is within the established for each group
