search
Back to results

Pilates Exercises In Individuals With Fibromyalgia

Primary Purpose

Fibromyalgia

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Reformer pilates exercises
Home mat pilates exercises
Sponsored by
Berna Cagla Caglayan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fibromyalgia focused on measuring Reformer pilates, Mat pilates, Fibromyalgia, Exercise

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Pamukkale University School of Physical Therapy and Rehabilitation

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Reformer pilates group

Home mat pilates group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
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.
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
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
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.
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
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
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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
December 31, 2019
Last Updated
January 3, 2020
Sponsor
Berna Cagla Caglayan
search

1. Study Identification

Unique Protocol Identification Number
NCT04218630
Brief Title
Pilates Exercises In Individuals With Fibromyalgia
Official Title
Investigation Of Effectiveness Of Reformer Pilates In Individuals With Fibromyalgia: Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
January 14, 2019 (Actual)
Primary Completion Date
September 2, 2019 (Actual)
Study Completion Date
October 11, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Berna Cagla Caglayan

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fibromyalgia
Keywords
Reformer pilates, Mat pilates, Fibromyalgia, Exercise

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
Outcomes Assessor
Masking Description
The physiotherapist performing evaluation was blind to the study.
Allocation
Randomized
Enrollment
39 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Reformer pilates group
Arm Type
Experimental
Arm Description
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.
Arm Title
Home mat pilates group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Reformer pilates exercises
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Home mat pilates exercises
Intervention Description
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.
Primary Outcome Measure Information:
Title
Fibromyalgia Impact Questionnaire
Description
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.
Time Frame
1 year
Title
Pain Location Inventory
Description
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.
Time Frame
1 year
Title
Chair Test
Description
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
Time Frame
1 year
Title
The Timed Up and Go Test
Description
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
Time Frame
1 year
Title
Single Leg Stance Test
Description
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.
Time Frame
1 year
Title
Tampa Kinesiophobia Scale
Description
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
Time Frame
1 year
Title
Fatigue Severity Scale
Description
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
Time Frame
1 year
Title
Pittsburgh Sleep Quality Index
Description
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.
Time Frame
1 year
Title
Cognitive Exercise Therapy Approach- Biopsychosocial Questionnaire
Description
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.
Time Frame
1 year
Title
Short Form-36
Description
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.
Time Frame
1 year

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bilge Basakcı Calık, Assoc.Prof.
Organizational Affiliation
Pamukkale University
Official's Role
Study Director
Facility Information:
Facility Name
Pamukkale University School of Physical Therapy and Rehabilitation
City
Denizli
Country
Turkey

12. IPD Sharing Statement

Citations:
PubMed Identifier
26882533
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.
Results Reference
background
PubMed Identifier
19969158
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.
Results Reference
background
PubMed Identifier
30782866
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.
Results Reference
background
PubMed Identifier
30886990
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.
Results Reference
background

Learn more about this trial

Pilates Exercises In Individuals With Fibromyalgia

We'll reach out to this number within 24 hrs