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

NCT03050606 | Unknown DMC

• 1 other identifier: UNICID15
• Study Type: interventional
• Target: 98
• Locations: 1 country
• Sites: 1

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.

Conditions

Fibromyalgia

Keywords

Exercise Therapy; Exercise Movement Techniques; Pilates-Based Exercises; Cost-effectiveness

Outcome Measures

Primary Outcomes (1)

• Fibromyalgia impact

  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.

  Eight weeks after randomization

Secondary Outcomes (9)

• Fibromyalgia impact

  Six and twelve months after randomization

• Pain intensity

  Eight weeks, six and twelve months after randomization

• Pain intensity

  Eigth weeks, before and after each intervention session

• Functional capacity

  Eight weeks after randomization

• Kinesiophobia

  Eight weeks, six and twelve months after randomization

Study Arms (2)

Pilates

EXPERIMENTAL

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.

Other: Pilates

Aerobic

ACTIVE COMPARATOR

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.

Other: Aerobic

Interventions

Pilates 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.

Also known as: Modified Pilates method exercises

Pilates

Aerobic 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).

Aerobic

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidade Cidade de Sao Paulo: lead

Study Sites (1)

Physical Therapy Outpatient Department

São Paulo, 03071000, Brazil

Location

Related Publications (2)

• 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.

  PMID: 36097826 DERIVED

• 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.

  PMID: 30886990 DERIVED

MeSH Terms

Conditions

Fibromyalgia

Interventions

Exercise Movement Techniques

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Physical Therapy Modalities; Therapeutics

Study Officials

• Cristina MN Cabral, PhD

  Universidade Cidade de São Paulo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 3, 2017
• First Posted: February 13, 2017
• Study Start: February 15, 2017
• Primary Completion: December 22, 2018
• Study Completion: December 22, 2020
• Last Updated: March 26, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)