Protocol summary

Study aim
To evaluate the effects of 8-week mat pilates and electro muscle stimulation exercises on pain, depression, anxiety and strength in sedentary women with fibromyalgia
Design
This study had a randomized controlled, single-blind design. Thirty female subjects with fibromyalgia aged 18-35 years participated in the study. Various scales and tests were administered as a pre-test and then the subjects were randomized into two groups. After 8 weeks of exercise interventions, post-tests were performed. After the tests, intra- and inter-group comparisons were made and the effects of the product were analyzed.
Settings and conduct
This study was conducted at Ondokuz Mayıs University Faculty of Yaşar Doğu Sport Sciences, Samsun, Türkiye. Thirty female subjects aged 18-35 years with fibromyalgia participated in the study. Only the researcher responsible for data analysis was blinded. This researcher did not participate in the tests and interventions, but only performed analyses on the delivered ready-made data file.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Being female, Affected by fibromyalgia, Being at the age of 18-35 years. Exclusion criteria: Oncomitant rheumatoid disease, Unstable hypertension, Serious cardiopulmonary problem, Any psychiatric disorder.
Intervention groups
Invertation group 1: Electro muscle stimulation (n=15). Participants performed the electro muscle stimulation exercise protocol two days a week for 8 weeks. Invertation group 2: Mat Pilates (n=15). Participants practiced a mat Pilates exercise protocol two days a week for 8 weeks.
Main outcome variables
Anxiety, depression and pain scale scores; body circumference measurement results; lower extremity, upper extremity and core area strength test results.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20240411061470N3
Registration date: 2024-05-16, 1403/02/27
Registration timing: retrospective

Last update: 2024-05-16, 1403/02/27
Update count: 0
Registration date
2024-05-16, 1403/02/27
Registrant information
Name
Ali Kerim Yılmaz
Name of organization / entity
Ondokuz Mayıs University, Faculty of Yasar Doğu Sport Sciences
Country
Turkey
Phone
+90 362 457 76 00
Email address
akerim.yilmaz@omu.edu.tr
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-12-18, 1402/09/27
Expected recruitment end date
2023-12-29, 1402/10/08
Actual recruitment start date
2023-12-18, 1402/09/27
Actual recruitment end date
2023-12-29, 1402/10/08
Trial completion date
2024-03-08, 1402/12/18
Scientific title
Effects of electro muscle stimulation and mat pilates exercises on anthropometry, pain, anxiety and strength in sedentary women with fibromyalgia: a randomized control study
Public title
Effects of electro muscle stimulation and mat pilates exercises in sedentary women with fibromyalgia
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Being at the age of 18-35 years Being female Affected by fibromyalgia
Exclusion criteria:
Oncomitant rheumatoid disease Unstable hypertension Serious cardiopulmonary problem affecting participants compliance Any psychiatric disorder Being pregnant
Age
From 18 years old to 35 years old
Gender
Female
Phase
N/A
Groups that have been masked
  • Outcome assessor
Sample size
Target sample size: 45
Actual sample size reached: 30
Randomization (investigator's opinion)
Randomized
Randomization description
After completion of the pre-tests, all participants were assigned a number (1-30). These numbers were randomized into two groups in a 1:1 ratio by means of "Integer Set Generator" in computer-approved software (www.random.org). Participants were divided into groups according to the number groups. After randomization, participants were divided into mat pilates (n=15) and electro muscle stimulation (n=15) groups.
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study, only the researcher responsible for data analysis was blinded throughout. This researcher did not participate in the tests and interventions, but only conducted the analyses on the ready-made data file that was delivered to her.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Gümüşhane University Scientific Research and Publication Ethics Committee
Street address
Gümüşhane University, Gümüşhanevî Campus, Bağlarbaşı Neighborhood, Gümüşhane, Türkiye
City
Gümüşhane
Postal code
29100
Approval date
2023-12-13, 1402/09/22
Ethics committee reference number
E-95674917-108.99-222887

Health conditions studied

1

Description of health condition studied
Fibromyalgia
ICD-10 code
M79.7
ICD-10 code description
Fibromyalgia

Primary outcomes

1

Description
Anxiety Score
Timepoint
Pre-intervention and after 8 weeks of intervention
Method of measurement
Beck Anxiety Inventories (BAI)

2

Description
Depression Score
Timepoint
Pre-intervention and after 8 weeks of intervention
Method of measurement
Beck Depression Inventories (BDI)

3

Description
Pain Score
Timepoint
Pre-intervention and after 8 weeks of intervention
Method of measurement
Fibromyalgia Impact Questionnaire (FIQ)

4

Description
Thigh Circumference
Timepoint
Pre-intervention and after 8 weeks of intervention
Method of measurement
Thigh Circumference Measurement With Tape Measure

5

Description
Lower Extremity Strength
Timepoint
Pre-intervention and after 8 weeks of intervention
Method of measurement
Single Leg Hop Tests (SLHT) and Deep Squat (DSQ)

6

Description
Upper Extremity Strength
Timepoint
Pre-intervention and after 8 weeks of intervention
Method of measurement
Modified Push Up (MPU), Handgrip Strength (HGS) and Bent-Arm Hang (BA)

7

Description
Core Area Strength
Timepoint
Pre-intervention and after 8 weeks of intervention
Method of measurement
V-Sit Flexor (Trunk Flexor) Test, Sit-Up Test and Biering Sorensen (Rear Extensor) Test

8

Description
Arm Circumference
Timepoint
Pre-intervention and after 8 weeks of intervention
Method of measurement
Arm Circumference Measurement With Tape Measure

9

Description
Thorax Circumference
Timepoint
Pre-intervention and after 8 weeks of intervention
Method of measurement
Thorax Circumference Measurement With Tape Measure

10

Description
Abdomen Circumference
Timepoint
Pre-intervention and after 8 weeks of intervention
Method of measurement
Abdomen Circumference Measurement With Tape Measure

11

Description
Lower Abdomen Circumference
Timepoint
Pre-intervention and after 8 weeks of intervention
Method of measurement
Lower Abdomen Circumference Measurement With Tape Measure

12

Description
Hip Circumference
Timepoint
Pre-intervention and after 8 weeks of intervention
Method of measurement
Hip Circumference Measurement With Tape Measure

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group 1: Participants performed electro muscle stimulation exercise protocol two days a week for 8 weeks. Electrical muscle stimulation (EMS) is a type of exercise that involves using electrical impulses to stimulate muscle contractions. It's often used for rehabilitation purposes, but it's also gaining popularity as a supplement to traditional exercise routines for strength training.
Category
Treatment - Other

2

Description
Intervention group 2: Participants performed a mat pilates exercise protocol two days a week for 8 weeks. Mat Pilates is a form of exercise that focuses on strengthening and toning the body's core muscles (abdominals, lower back, hips, and buttocks) while also improving flexibility, posture, and overall body alignment. Unlike traditional Pilates, which often involves the use of specialized equipment like reformers, Cadillac, or chairs, Mat Pilates utilizes exercises performed on a mat or a padded surface.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Ondokuz Mayıs University
Full name of responsible person
Ali Kerim Yılmaz
Street address
Ondokuz Mayıs University, Samsun, Türkiye
City
Samsun
Postal code
55070
Phone
+90 542 495 37 37
Email
akerim.yilmaz@omu.edu.tr

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Ondokuz Mayıs University
Full name of responsible person
Ali Kerim Yılmaz
Street address
Ondokuz Mayıs University, Samsun, Türkiye
City
Samsun
Postal code
55070
Phone
+90 542 495 37 37
Email
akerim.yilmaz@omu.edu.tr
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ondokuz Mayıs University
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Ondokuz Mayıs University, Faculty of Yasar Doğu Sport Sciences
Full name of responsible person
Ali Kerim Yılmaz
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Sport Medicine
Street address
Ondokuz Mayıs University, Faculty of Yasar Doğu Sport Sciences, Samsun 55270, Türkiye
City
Samsun
Province
Samsun
Postal code
55070
Phone
+90 362 457 76 00
Fax
Email
akerim.yilmaz@omu.edu.tr

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ondokuz Mayıs University, Faculty of Yasar Doğu Sport Sciences
Full name of responsible person
Ali Kerim Yılmaz
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Sport Medicine
Street address
Ondokuz Mayıs University, Faculty of Yasar Doğu Sport Sciences, Samsun 55270, Türkiye
City
Samsun
Province
Samsun
Postal code
55070
Phone
+90 362 457 76 00
Fax
Email
akerim.yilmaz@omu.edu.tr

Person responsible for updating data

Contact
Name of organization / entity
Ondokuz Mayıs University, Faculty of Yasar Doğu Sport Sciences
Full name of responsible person
Ali Kerim Yılmaz
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Sport Medicine
Street address
Ondokuz Mayıs University, Faculty of Yasar Doğu Sport Sciences, Samsun 55270, Türkiye
City
Samsun
Province
Samsun
Postal code
55070
Phone
+90 362 457 76 00
Fax
Email
akerim.yilmaz@omu.edu.tr

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
To share the data and documents of this research, only the information related to the main outcome will be shared. Also, files that can be published and do not violate people's privacy will be published.
When the data will become available and for how long
The access period will start 6 months after the results are published.
To whom data/document is available
Our data will only be available to researchers working in academic and scientific institutions.
Under which criteria data/document could be used
If there are conditions, all our data will be shared except personal information of people. The use of our data will only be allowed for similar research and review of our data by other researchers. All those who work in universities and scientific centers and decide to conduct similar research or check the accuracy of our data can access our data.
From where data/document is obtainable
In order to receive information, all eligible people can collect data by referring to the person in charge of the project. The contact method is the email address akerim.yilmaz@omu.edu.tr.
What processes are involved for a request to access data/document
To receive information after sending the request, the requests will be reviewed within 10 days. If the above conditions are met, the information will be sent to the provided email within 30 days at most.
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