Pilates Exercises In Individuals With Fibromyalgia

NCT04218630 | Completed

• 1 other identifier: 60116787
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

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.

Conditions

Fibromyalgia

Keywords

Reformer pilates; Mat pilates; Fibromyalgia; Exercise

Outcome Measures

Primary Outcomes (10)

• 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

Study Arms (2)

Reformer pilates group

EXPERIMENTAL

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

Home mat pilates group

ACTIVE COMPARATOR

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

Interventions

Reformer pilates exercises OTHER

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.

Reformer pilates group

Home mat pilates exercises OTHER

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.

Home mat pilates group

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Berna Cagla Caglayan: lead

Study Sites (1)

Pamukkale University School of Physical Therapy and Rehabilitation

Denizli, Turkey (Türkiye)

Location

Related Publications (5)

• 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.

  PMID: 26882533 BACKGROUND

• 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.

  PMID: 19969158 BACKGROUND

• 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.

  PMID: 30782866 BACKGROUND

• 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 BACKGROUND

• Caglayan BC, Basakci Calik B, Gur Kabul E, Karasu U. Investigation of effectiveness of reformer pilates in individuals with fibromyalgia: A randomized controlled trial. Reumatol Clin (Engl Ed). 2023 Jan;19(1):18-25. doi: 10.1016/j.reumae.2022.01.003.

  PMID: 36603963 DERIVED

MeSH Terms

Conditions

Fibromyalgia; Motor Activity

Condition Hierarchy (Ancestors)

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

Study Officials

• Bilge Basakcı Calık, Assoc.Prof.

  Pamukkale University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The physiotherapist performing evaluation was blind to the study.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: December 31, 2019
• First Posted: January 6, 2020
• Study Start: January 14, 2019
• Primary Completion: September 2, 2019
• Study Completion: October 11, 2019
• Last Updated: January 7, 2020

Record last verified: 2020-01

Locations

TU (1)