Pilates Exercises In Individuals With Fibromyalgia

Investigation Of Effectiveness Of Reformer Pilates In Individuals With Fibromyalgia: Randomized Controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Fibromyalgia
• Intervention / Treatment: Other: Reformer pilates exercises; Other: Home mat pilates exercises

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.

• Study Type: Interventional
• Enrollment (Actual): 39
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Denizli, Turkey
    • Pamukkale University School of Physical Therapy and Rehabilitation

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 63 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Reformer pilates group; All participants were informed about the reformer machine and the treatment program by the physiotherapist in reformer pilates group. Reformer pilates exercises were applied in the form of general muscle strengthening and flexibility exercises under the supervision of physiotherapist. Exercises were performed in 2 times a week for 6 weeks. The duration of one session was 60 minutes.	Other: Reformer pilates exercises; The program consisted of 10 minutes warm-up exercises, reformer pilates exercises for 40 minutes and 10 minutes cool-down exercises. The exercises were started with 6-8 repetitions, increased to 1-2 repetitions each week and applied to be 12-15 repetitions in the last week. Increasing the resistance of the springs and adding different positions were used for progression of exercises.
Active Comparator: Home mat pilates group; In home mat pilates group, clinical pilates exercises were applied as a home program. Brochures and exercise follow-up forms, which illustrated and written all the exercises in this program, which consisted of clinical pilates-based general muscle strength and flexibility exercises, were given to all participants in this group. Exercises were performed in 2 times a week for 6 weeks at home. Participants marked the follow-up form when they performed exercises. Attendance of participants to exercise was checked by phone calls.	Other: Home mat pilates exercises; The program consisted of 10 minutes warm-up exercises, clinical pilates-based exercises on mat for 40 minutes and 10 minutes cool-down exercises. The exercises were started with 6-8 repetitions, increased to 1-2 repetitions each week, and applied to be 12-15 repetitions in the last week.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fibromyalgia Impact Questionnaire	It is a questionnaire consisting of 10 questions which assess physical health, work status, depression, anxiety, sleep, pain, fatigue, stiffness and well-being in order to evaluate health status and physical functionality of individuals with fibromyalgia.	1 year
Pain Location Inventory	Participants mark the areas in which feel pain in last seven days from the 28 parts of the body. The score is between 0-28. Higher scores indicate having more number of painful body regions.	1 year
Chair Test	In this test, which evaluates lower extremity muscle strength, participants sit and stand up as fast as possible for 30 seconds in a standard chair which is an average height of 44 cm and without back support and arm support. The number of repetitions which are completed were recorded	1 year
The Timed Up and Go Test	In this test, where functional mobility was evaluated, the evaluation was started while the participant was sitting in the chair. It recorded the time that a participant took to rise from a chair, walked three meters, turned around, walked back to the chair, and sat down	1 year
Single Leg Stance Test	This test evaluate participant's balance. The participant must stand unassisted on one leg and is timed in seconds from the time one foot is flexed off the floor to the time when it touches the ground.	1 year
Tampa Kinesiophobia Scale	It is a 17-item scale that assesses fear of movement/ repeat injury. The range of total score are from 17 to 68. High score indicates that the person has high kinesiophobia	1 year
Fatigue Severity Scale	It was developed to evaluate the severity of fatigue in the last week. The range of total score are from 1 to 7. Higher scores indicate more severity of fatigue	1 year
Pittsburgh Sleep Quality Index	It was developed to identify good and poor sleep and to evaluate sleep quality. Scoring of the answers is based on a 0 to 3 scale, whereby 3 reflects the negative extreme on the Likert Scale. A global sum of "5"or greater indicates a "poor" sleeper.	1 year
Cognitive Exercise Therapy Approach- Biopsychosocial Questionnaire	This scale, which was developed in Turkish and consists of 30 items, was used to evaluate the disease-related biopsychosocial process. The range of total score are from 0 to 120. Higher scores indicate bad biopsychosocial status of patients.	1 year
Short Form-36	This scale is one of the most commonly used questionnaires to assess quality of life. "100 points" indicate good health status and "0 points" indicate poor health status.	1 year

Collaborators and Investigators

• Sponsor: Berna Cagla Caglayan
• Investigators: Study Director: Bilge Basakcı Calık, Assoc.Prof., Pamukkale University

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 14, 2019
• Primary Completion (Actual): September 2, 2019
• Study Completion (Actual): October 11, 2019

Study Registration Dates

• First Submitted: December 31, 2019
• First Submitted That Met QC Criteria: January 2, 2020
• First Posted (Actual): January 6, 2020

Study Record Updates

• Last Update Posted (Actual): January 7, 2020
• Last Update Submitted That Met QC Criteria: January 3, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Keywords: Exercise; Fibromyalgia; Reformer pilates; Mat pilates
• Additional Relevant MeSH Terms: Nervous System Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Muscular Diseases; Neuromuscular Diseases; Fibromyalgia; Myofascial Pain Syndromes
• Other Study ID Numbers: 60116787

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No