Effectiveness and Cost-effectiveness of Modified Pilates Method Versus Aerobic Exercise in Patients With Fibromyalgia

Universidade Cidade de Sao Paulo

Status: Unknown

Conditions: Fibromyalgia

Treatments: Other: Aerobic; Other: Pilates

Study type: Interventional

Funder types: Other

Identifiers

NCT03050606

UNICID15

Details and patient eligibility

About

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.

Full 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.

Enrollment: 98 estimated patients

Sex: All

Ages: 20 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

98 participants in 2 patient groups

Pilates

Experimental group

Description:

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.

Treatment:

Other: Pilates

Aerobic

Active Comparator group

Description:

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.

Treatment:

Other: Aerobic