Pilates Exercises In Individuals With Fibromyalgia

Fibromyalgia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04218630
• Other study ID #: 60116787
• Status: Completed
• Phase: N/A
• Start date: January 14, 2019
• Est. completion date: October 11, 2019

Study information

• Verified date: January 2020
• Source: Pamukkale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: October 11, 2019
• Est. primary completion date: September 2, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Fibromyalgia
• Myofascial Pain Syndromes

Intervention

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.
• 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.

Locations

Country	Name	City	State
Turkey	Pamukkale University School of Physical Therapy and Rehabilitation	Denizli

Sponsors (1)

Lead Sponsor	Collaborator
Berna Cagla Caglayan

Country where clinical trial is conducted

Turkey, 

References & Publications (4)

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. — View 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. Epub 2016 Feb 16. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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