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

NCT ID: NCT03050606

Last Updated: 2020-03-26

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 98 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-02-15
• Study Completion Date: 2020-12-22

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.

Conditions

Fibromyalgia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Pilates

Intervention Type: OTHER

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.

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.

Group Type: ACTIVE_COMPARATOR

Aerobic

Intervention Type: OTHER

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).

Interventions

Pilates

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.

Intervention Type: OTHER

Aerobic

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).

Intervention Type: OTHER

Other Intervention Names

Modified Pilates method exercises

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universidade Cidade de Sao Paulo

OTHER

Sponsor Role: lead

Responsible Party

Cristina Maria Nunes Cabral

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Cristina MN Cabral, PhD

Role: PRINCIPAL_INVESTIGATOR

Universidade Cidade de São Paulo

Locations

Physical Therapy Outpatient Department

São Paulo, , Brazil

Countries

Brazil

References

Franco KFM, Miyamoto GC, Franco YRDS, Salvador EMES, do Nascimento BCB, Menten LA, Cabral CMN. Is Pilates more effective and cost-effective than aerobic exercise in the treatment of patients with fibromyalgia syndrome? A randomized controlled trial with economic evaluation. Eur J Pain. 2023 Jan;27(1):54-71. doi: 10.1002/ejp.2039. Epub 2022 Sep 23.

Reference Type: DERIVED

PMID: 36097826 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 30886990 (View on PubMed)

Other Identifiers

UNICID15

Identifier Type: -

Identifier Source: org_study_id