Clinical trial NCT04218630: Pilates Exercises In Individuals With Fibromyalgia
Official title: Investigation Of Effectiveness Of Reformer Pilates In Individuals With Fibromyalgia: Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fibromyalgia
Keywords: Reformer pilates
Mat pilates
Fibromyalgia
Exercise
Lead sponsor: Pamukkale University
Sponsor class: OTHER
First posted: 2020-01-06
Enrollment: 39
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study is a randomized controlled parallel group model. Participants were randomly divided into two groups as reformer pilates group and home mat pilates group.
Primary purpose: TREATMENT

Brief summary: This study investigated the effects of reformer pilates exercises in Fibromyalgia, which is a chronic musculoskeletal disease characterized by widespread pain in the body, on number of painful regions, disease activity, lower extremity muscle strength, functional mobility, balance, kinesophobia, fatigue, sleep quality, biopsychosocial status and quality of life and compared effects of clinical pilates-based home pilates which is performed on a mat.

Detailed description: In this study, effects of reformer pilates were evaluated by comparing with home mat pilates method. A total of 28 volunteer women who were diagnosed with FM according to the American College of Rheumatology (ACR) 2016 criteria were included in the study. Reformer pilates group had 14 participants, home mat pilates group had 14 participants.

All individuals were evaluated by same physiotherapist according to standardized test protocols and in the same conditions at baseline and at the end of 6th week. Number of painful regions with Pain Location Inventory (PLI), disease activity with Fibromyalgia Impact Questionnaire (FIQ), lower extremity muscle strength with Chair Test, functional mobility with The Timed Up and Go Test (TUG), balance with Single Leg Stance Test, kinesiophobia with Tampa Kinesiophobia Scale, fatigue with Fatigue Severity Scale, sleep quality with Pittsburgh Sleep Quality Index (PSQI), biopsychosocial status with Cognitive Exercise Therapy Approach- Biopsychosocial Questionnaire (BETY-BQ) and quality of life with Short Form-36 (SF-36) were evaluated.

Pilates exercises were performed by a certified and experienced physiotherapist in this field as two different methods (reformer group and home mat group) in 2 times a week for 6 weeks. Before starting treatment program, 5 key elements of clinical pilates exercises, which are breathing, focus, and placement of the rib cage, shoulder, head and neck, were taught to all patients. Participants were encouraged to focus and maintain these 5 key elements during all exercises.

Data were assessed using SPSS (Version 21.0). Continuous variables were stated as average, standard deviation and percentage. When parametric test assumptions were provided the Independent Samples Test was used, when parametric test assumptions were not provided Mann-Whitney U test was used to compare the differences between the independent groups. When parametric test assumptions were provided, the Paired Simple T Test was used, when parametric test assumptions were not provided, Wilcoxon signed-rank test was used to compare the differences between the dependent groups. P value \<0.05 was considered as statistically significant.

Eligibility criteria: Inclusion Criteria:

* having FM diagnosis according to ACR 2016 criteria
* aged 18-65
* being stable in drug use for at least 3 months or more
* being volunteer to participate in this study

Exclusion Criteria:

* doing exercise regularly for the last 3 months
* having orthopaedic and cardiopulmonary diseases which would prevent patients of doing exercise
* neurological disorders
* unstable endocrine system diseases
* malignancy, pregnancy
* severe psychological diseases
* having undergone any surgery in the last 6 months
* having communication problems.

Primary outcomes:
measure: Fibromyalgia Impact Questionnaire
timeFrame: 1 year
measure: Pain Location Inventory
timeFrame: 1 year
measure: Chair Test
timeFrame: 1 year
measure: The Timed Up and Go Test
timeFrame: 1 year
measure: Single Leg Stance Test
timeFrame: 1 year
measure: Tampa Kinesiophobia Scale
timeFrame: 1 year
measure: Fatigue Severity Scale
timeFrame: 1 year
measure: Pittsburgh Sleep Quality Index
timeFrame: 1 year
measure: Cognitive Exercise Therapy Approach- Biopsychosocial Questionnaire
timeFrame: 1 year
measure: Short Form-36
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Denizli
country: Turkey
facility: Pamukkale University School of Physical Therapy and Rehabilitation
Study officials:
affiliation: Pamukkale University
name: Bilge Basakcı Calık, Assoc.Prof.
role: STUDY_DIRECTOR
References:
citation: Ekici G, Unal E, Akbayrak T, Vardar-Yagli N, Yakut Y, Karabulut E. Effects of active/passive interventions on pain, anxiety, and quality of life in women with fibromyalgia: Randomized controlled pilot trial. Women Health. 2017 Jan;57(1):88-107. doi: 10.1080/03630242.2016.1153017. Epub 2016 Feb 16.
citation: Altan L, Korkmaz N, Bingol U, Gunay B. Effect of pilates training on people with fibromyalgia syndrome: a pilot study. Arch Phys Med Rehabil. 2009 Dec;90(12):1983-8. doi: 10.1016/j.apmr.2009.06.021.
citation: Silva HJA, Lins CAA, Nobre TTX, de Sousa VPS, Caldas RTJ, de Souza MC. Mat Pilates and aquatic aerobic exercises for women with fibromyalgia: a protocol for a randomised controlled blind study. BMJ Open. 2019 Feb 19;9(2):e022306. doi: 10.1136/bmjopen-2018-022306.
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.