Clinical trial NCT03050606: Effectiveness and Cost-effectiveness of Modified Pilates Method Versus Aerobic Exercise in Patients With Fibromyalgia
Official title: Effectiveness and Cost-effectiveness of Modified Pilates Method Versus Aerobic Exercise in the Treatment of Patients With Fibromyalgia: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Fibromyalgia
Keywords: Exercise Therapy
Exercise Movement Techniques
Pilates-Based Exercises
Cost-effectiveness
Lead sponsor: Universidade Cidade de Sao Paulo
Sponsor class: OTHER
First posted: 2017-02-13
Enrollment: 98
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Fibromyalgia is a rheumatologic disease characterized by generalized chronic pain, hyperalgesia and allodynia. Physical exercises are recommended as the first choice of non-pharmacological therapy. Thus, the purpose of this study is to evaluate the effectiveness and cost-effectiveness of modified Pilates method exercises compared to aerobic exercises in the treatment of patients with fibromyalgia. The hypothesis is that Pilates exercises will be as effective as aerobic exercise in the improvement of clinical outcomes, and that this improvement will be maintained over the medium to long term. It is also expected that aerobic exercises will be more cost-effective.

Detailed description: Fibromyalgia is a rheumatologic disease characterized by generalized chronic pain, hyperalgesia and allodynia. Physical exercises are recommended as the first choice of non-pharmacological therapy. Thus, the purpose of this study is to evaluate the effectiveness and cost-effectiveness of modified Pilates method exercises compared to aerobic exercise in the treatment of patients with fibromyalgia. For this, the following outcomes of 98 patients will be evaluated by a blinded evaluator at baseline, 8 weeks, 6 and 12 months after randomization: fibromyalgia impact assessed by the Fibromyalgia Impact Questionnaire, pain intensity assessed by the Pain Numerical Rating Scale, kinesiophobia assessed by the Tampa Scale for Kinesiophobia, specific disability assessed by the Patient-Specific Functional Scale, functional capacity assessed by the 6-minute Walk Test, quality of sleep assessed by the Pittsburgh Sleep Quality Index, and health-related quality of life assessed by the EQ-5D-3L and SF-6D questionnaires. Participants will be randomly divided into Aerobic Group, who will perform aerobic exercises on treadmills and/or stationary bikes, and Pilates Group, which will perform exercises of the modified Pilates method. Both groups will be treated for eight weeks, twice a week. The hypothesis is that Pilates exercises will be as effective as aerobic exercise in the improvement of clinical outcomes, and that this improvement will be maintained over the medium to long term. It is also expected that aerobic exercises will be more cost-effective.

Eligibility criteria: 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.

Primary outcomes:
measure: Fibromyalgia impact
timeFrame: Eight weeks after randomization
Secondary outcomes:
measure: Fibromyalgia impact
timeFrame: Six and twelve months after randomization
measure: Pain intensity
timeFrame: Eight weeks, six and twelve months after randomization
measure: Pain intensity
timeFrame: Eigth weeks, before and after each intervention session
measure: Functional capacity
timeFrame: Eight weeks after randomization
measure: Kinesiophobia
timeFrame: Eight weeks, six and twelve months after randomization
measure: Quality of sleep
timeFrame: Eight weeks, six and twelve months after randomization
measure: Specific disability
timeFrame: Eight weeks, six and twelve months after randomization
measure: Health-related quality of life using the EQ-5D-3L
timeFrame: Eight weeks, six and twelve months after randomization
measure: Health-related quality of life using the SF-6D
timeFrame: Eight weeks, six and twelve months after randomization
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Physical Therapy Outpatient Department
Study officials:
affiliation: Universidade Cidade de São Paulo
name: Cristina MN Cabral, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Franco KFM, Franco YRDS, Salvador EMES, do Nascimento BCB, Miyamoto GC, Cabral CMN. Effectiveness and cost-effectiveness of the modified Pilates method versus aerobic exercise in the treatment of patients with fibromyalgia: protocol for a randomized controlled trial. BMC Rheumatol. 2019 Jan 18;3:2. doi: 10.1186/s41927-018-0051-6. eCollection 2019.