- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03050606
Effectiveness and Cost-effectiveness of Modified Pilates Method Versus Aerobic Exercise in Patients With Fibromyalgia
Effectiveness and Cost-effectiveness of Modified Pilates Method Versus Aerobic Exercise in the Treatment of Patients With Fibromyalgia: a Randomized Controlled Trial
Study Overview
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Sao Paulo, Brazil, 03071000
- Physical Therapy Outpatient Department
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Patients that meet the criteria for classification of fibromyalgia according to the criteria of the American College of Rheumatology 2010; and
- Pain intensity greater than or equal to 3 points in the Pain Numerical Rating Scale
Exclusion Criteria:
- Contraindications to physical exercise
- Pregnancy
- Uncontrolled systemic diseases (diabetes mellitus, systemic arterial hypertension and thyroid dysfunctions);
- Neurological, cardiorespiratory and musculoskeletal conditions that interfere with treatment such as: paralysis, significant changes in sensitivity, changes in level of consciousness and understanding, advanced joint diseases (severe arthrosis, hip or knee arthroplasty, severe rheumatoid arthritis), cervicalgia with irradiation to the upper limbs, among others;
- Injury or severe pain in the lower limbs that limit the performance of aerobic exercises: meniscus injury, plantar fasciitis, among others;
- Partial or total muscular ruptures;
- Amputations;
- Recent postoperative; and
- Inability to understand the writing and speaking of the Portuguese language.
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: Pilates
This group will perform a modified Pilates exercise program, which will be performed using mat, accessories and studio apparatus, in individual sessions, twice a week, lasting 60 minutes. Both groups will also receive an educational booklet with information on fibromyalgia and self-care strategies for pain management, sleep improvement, depression improvement, stress and fatigue control. |
Exercises performed on the mat and apparatus, following the six principles of the Pilates method.
The exercises will be performed in three levels of difficulty: basic, intermediate and advanced, according to the capacity of the patient.
Other Names:
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Active Comparator: Aerobic
This group will perform aerobic exercise, performed on the treadmill or stationary bike according to the choice of the patient. The training will be performed controlling the heart rate of training. The exercises will be performed individually, twice a week and each session will last 60 minutes. Both groups will also receive an educational booklet with information on fibromyalgia and self-care strategies for pain management, sleep improvement, depression improvement, stress and fatigue control. |
Aerobic exercise will be carried out individually on treadmills or stationary bikes.
The intensity of the training will be mild to moderate (57% to 76% of the maximal heart rate monitored by the frequencymeter).
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Fibromyalgia impact
Time Frame: Eight weeks after randomization
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This outcome will be evaluated by the Fibromyalgia Impact Questionnaire (FIQ) which is composed of 10 items.
Item 1 contains 10 questions related to functionality, each of these issues being evaluated by a 4-point Likert scale, which ranges from 0 (always) to 3 (never).
In items 2 and 3, the patient scores the number of days that felt well and that was unable to work due to fibromyalgia in the last seven days.
Items 4 to 10 are composed of numerical scales that assess difficulty for work, pain, fatigue, morning tiredness, stiffness, anxiety and depression.
The FIQ score ranges from 0 to 100 points and the higher values indicate greater fibromyalgia impact on quality of life.
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Eight weeks after randomization
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Fibromyalgia impact
Time Frame: Six and twelve months after randomization
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This outcome will be evaluated by the Fibromyalgia Impact Questionnaire (FIQ) which is composed of 10 items.
Item 1 contains 10 questions related to functionality, each of these issues being evaluated by a 4-point Likert scale, which ranges from 0 (always) to 3 (never).
In items 2 and 3, the patient scores the number of days that felt well and that was unable to work due to fibromyalgia in the last seven days.
Items 4 to 10 are composed of numerical scales that assess difficulty for work, pain, fatigue, morning tiredness, stiffness, anxiety and depression.
The FIQ score ranges from 0 to 100 points and the higher values indicate greater fibromyalgia impact on quality of life.
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Six and twelve months after randomization
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Pain intensity
Time Frame: Eight weeks, six and twelve months after randomization
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This outcome will be evaluated by an 11-point scale ranging from 0 to 10, in which 0 represents "no pain" and 10 represents "pain as bad as it could be."
The participant will classify his average pain in the last 7days.
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Eight weeks, six and twelve months after randomization
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Pain intensity
Time Frame: Eigth weeks, before and after each intervention session
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This outcome will be evaluated by an 11-point scale ranging from 0 to 10, in which 0 represents "no pain" and 10 represents "pain as bad as it could be."
The participant will classify his average pain before and after each treatment session .
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Eigth weeks, before and after each intervention session
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Functional capacity
Time Frame: Eight weeks after randomization
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This outcome will be assessed using the 6-Minute Walk Test.
Two cones will be used, which will mark the starting point and 30 meters, where the patient will turn around and continue walking without hesitation.
The area of the test will also have markings every 3 meters.
The patient should walk for 6 minutes, as fast as he can, without running, while the evaluator will control the time (for 6 minutes) and count how many laps the patient performs (each turn corresponds to 60 meters).
When the stopwatch is stopped, the evaluator will say "stop" and mark the point where the patient stopped with a tape.
After the test, the evaluator will request that the patient answer to the Borg's range of effort perception.
The measurement of the walked distance will be made by the number of laps added to the meters walked until the patient stops.
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Eight weeks after randomization
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Kinesiophobia
Time Frame: Eight weeks, six and twelve months after randomization
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This outcome will be evaluated by a 17-item questionnaire.
The score of each question varies from 1 ("strongly disagree") to 4 ("strongly agree") points.
For the total score, the scores of the questions 4, 8, 12, and 16 should be inverted.
The final score can vary from 17 to 68 points, and the higher the score, the greater the degree of kinesiophobia.
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Eight weeks, six and twelve months after randomization
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Quality of sleep
Time Frame: Eight weeks, six and twelve months after randomization
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This outcome will be evaluated by the Pittsburgh Sleep Quality Index, where the patient will report sleep quality in the last month.
The questionnaire consists of 19 self-evaluation questions.
The 19 questions are classified into seven components (subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, sleeping medication use and daytime dysfunction), which are rated at a score ranging from 0 to 3 (0 = none in the last month, 1 = less than 1 time/week, 2 = 1 or 2 times/week, 3 = 3 or more times/week).
The sum of the scores for these 7 components ranges from 0 to 21, where the highest score indicates poorer sleep quality.
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Eight weeks, six and twelve months after randomization
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Specific disability
Time Frame: Eight weeks, six and twelve months after randomization
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This outcome will be evaluated using the Patient-Specific Functional Scale.
The participants will identify 3 significant activities that are difficult or that are unable to perform because of fibromyalgia.
Next, the participants will rate how able they feel to perform these activities on an 11-point scale (0 to 10), with 0 representing "unable to perform activity" and 10 "able to perform the activity at preinjury level."
The final score is the mean of the 3 ratings, and the higher the score, the greater the specific ability.
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Eight weeks, six and twelve months after randomization
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Health-related quality of life using the EQ-5D-3L
Time Frame: Eight weeks, six and twelve months after randomization
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This outcome will be evaluated by the Euroqol 5 dimensions (EQ-5D-3L).
The EQ-5D-3L questionnaire is a generic measure that assesses health-related quality of life through five dimensions, and each dimension with three levels.
Health states are labeled with a five-digit numeric code that represents the severity level in each dimension.
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Eight weeks, six and twelve months after randomization
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Health-related quality of life using the SF-6D
Time Frame: Eight weeks, six and twelve months after randomization
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This outcome will be evaluated by the Short-Form 6 dimensions (SF-6D).
The SF-6D questionnaire also measures health-related quality of life, through six domains: functional capacity, global limitation, social aspects, pain, mental health and vitality.
The SF-6D score represents the strength of an individual's preference for a particular health condition, ranging from zero to one, where zero corresponds to the worst health condition and one corresponds to the best health status.
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Eight weeks, six and twelve months after randomization
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Cristina MN Cabral, PhD, Universidade Cidade de Sao Paulo
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- UNICID15
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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