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The effect of Baduanjin Qigong in combination with Transcranial direct current stimulation (tDCS) on physical function, Impact of the Disease and Quality of Sleep in elderly patients with fibromyalgia

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History
# Registration date Revision Id
2 2024-07-17, 1403/04/27 308648
1 2024-02-16, 1402/11/27 294650
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  • Protocol summary

    Determining the effect of Baduan Jin's qigong in combination with transcranial direct electrical stimulation of the brain on the physical performance of the elderly with fibromyalgia.
    Determining the effect of Baduan Jin's qigong in combination with transcranial direct electrical stimulation of the brain on the physical performance , Impact of the Disease and Quality of Sleep of the elderly with fibromyalgia.
    تعیین تاثیر چی‌گونگ بادوان جین در ترکیب با تحریک الکتریکی مستقیم فراجمجمه ای مغز بر عملکرد بدنی سالمندان مبتلا به فیبرو میالژیا
    تعیین تاثیر چی‌گونگ بادوان جین در ترکیب با تحریک الکتریکی مستقیم فراجمجمه ای مغز بر عملکرد بدنیف تأثیر بیماری و کیفیت خواب سالمندان مبتلا به فیبرو میالژیا
    the balance Muscle strength walking speed
    the balance Muscle strength walking speed Impact of the Disease Quality of Sleep
    تعادل قدرت عضلانی سرعت راه رفتن
    تعادل قدرت عضلانی سرعت راه رفتن تأثیر بیماری کیفیت خواب

  • General information

    empty
    Two variables of sleep quality and the impact of the disease were also evaluated, which were not recorded in the outcomes of the study
    empty
    دو متغیر کیفیت خواب و تاثیر بیماری نیز ارزیابی شده است که در پیامدهای مورد مطالعه ثبت نشده است
    The effect of Baduanjin Qigong in combination with Transcranial direct current stimulation (tDCS) on physical function in elderly patients with fibromyalgia
    The effect of Baduanjin Qigong in combination with Transcranial direct current stimulation (tDCS) on physical function, Impact of the Disease and Quality of Sleep in elderly patients with fibromyalgia
    تاثیر چی‌گونگ بادوان جین در ترکیب با تحریک الکتریکی مستقیم فراجمجمه ای مغز بر عملکرد بدنی سالمندان مبتلا به فیبرو میالژیا
    تاثیر چی‌گونگ بادوان جین در ترکیب با تحریک الکتریکی مستقیم فراجمجمه ای مغز بر عملکرد بدنی تأثیر بیماری و کیفیت خواب سالمندان مبتلا به فیبرو میالژیا
    The effect of Baduanjin Qigong in combination with Transcranial direct current stimulation (tDCS) on physical function in elderly patients with fibromyalgia
    The effect of Baduanjin Qigong in combination with Transcranial direct current stimulation (tDCS) on physical function, Impact of the Disease and Quality of Sleep in elderly patients with fibromyalgia
    تاثیر چی‌گونگ بادوان جین در ترکیب با تحریک الکتریکی مستقیم فراجمجمه ای مغز بر عملکرد بدنی سالمندان مبتلا به فیبرو میالژیا
    تاثیر چی‌گونگ بادوان جین در ترکیب با تحریک الکتریکی مستقیم فراجمجمه ای مغز بر عملکرد بدنی، تأثیر بیماری و کیفیت خواب سالمندان مبتلا به فیبرو میالژیا
    Between the ages of 65 and 70 years 6 months through inclusion in the demographic questionnaire
    2. No previous experience of qigong practice.
    3. Consent to participate in the study
    4. Not having regular exercise at least in the last
    5. The presence of widespread pain in different parts of the body on the left and right sides of the body in the last week
    6. Existence of problems such as weakness, tiredness after sleep and disturbance in thinking and remembering things in the last week.
    Between the ages of 65 and 70 years 6 months through inclusion in the demographic questionnaire
    2. No previous experience of qigong practice.
    3. Consent to participate in the study
    4. Not having regular exercise at least in the last
    5. The presence of widespread pain in different parts of the body on the left and right sides of the body in the last week
    6. Existence of problems such as weakness, tiredness after sleep and disturbance in thinking and remembering things in the last week.
    Obtaining a sleep quality score higher than 6 in the Pittsburgh Sleep Quality Index
    1. بین سنین 65تا 70سال.
    2. بدون سابقه قبلی تمرین چیگونگ
    3. رضایت به شرکت در مطالعه
    4. نداشتن ورزش منظم حداقل در 6ماه اخیر از طریق درج در پرسشنامه دموگرافیک
    5. وجود درد منتشردر نقاط مختلف بدن در دو سمت چپ و راست بدن در یک هفته اخیر
    6. وجود مشکلاتی هچون ضعف، خستگی بعد از خواب و اختلال در تفکر و یادآوری مطالب در یک هفته اخیر.
    1. بین سنین 65تا 70سال.
    2. بدون سابقه قبلی تمرین چیگونگ
    3. رضایت به شرکت در مطالعه
    4. نداشتن ورزش منظم حداقل در 6ماه اخیر از طریق درج در پرسشنامه دموگرافیک
    5. وجود درد منتشردر نقاط مختلف بدن در دو سمت چپ و راست بدن در یک هفته اخیر
    6. وجود مشکلاتی هچون ضعف، خستگی بعد از خواب و اختلال در تفکر و یادآوری مطالب در یک هفته اخیر.
    کسب نمره کیفیت خواب بالاتر از 6 در شاخص کیفیت خواب پیتزبورگ

  • Primary outcomes

    #1
    empty
    Impact of the disease
    empty
    تاثیر بیماری
    empty
    Before and after the intervention
    empty
    قبل و بعد از مداخله
    empty
    The Revised Fibromyalgia Impact Questionnaire (FIQR)
    empty
    پرسشنامه اصلاح شده تاثیر فیبرومیالژیا (FIQR)
    #2
    empty
    Sleep quality
    empty
    کیفیت خواب
    empty
    Before and after the intervention
    empty
    قبل و بعد از مداخله
    empty
    the Pittsburgh Sleep Quality Index (PSQI)
    empty
    شاخص کیفیت خواب پیتزبورگ (PSQI)

  • Sharing plan

    The analysis of information obtained from the results of the interventions on balance, strength and gait speed can be published
    The analysis of information obtained from the results of the interventions on balance, strength and gait speed , Impact of the Disease and Quality of Sleep can be published
    تجزیه و تحلیل اطلاعات به دست آمده از نتایج مداخله ها بر تعادل، قدرت و سرعت راه رفتن قابل انتشار می باشد
    تجزیه و تحلیل اطلاعات به دست آمده از نتایج مداخله ها بر تعادل، قدرت و سرعت راه رفتن،تأثیر بیماری و کیفیت خواب قابل انتشار می باشد

Protocol summary

Study aim
Determining the effect of Baduan Jin's qigong in combination with transcranial direct electrical stimulation of the brain on the physical performance , Impact of the Disease and Quality of Sleep of the elderly with fibromyalgia.
Design
This is a single-blind, randomized clinical trial with a control group and parallel groups, involving 68 participants. Randomization will be conducted using the RAND function in Excel
Settings and conduct
The participants in the study will be diagnosed with fibromyalgia syndrome (FMS) in one of the rheumatology clinics of Urmia city by a rheumatology specialist with extensive experience and based on the criteria of the American College of Rheumatology. A total of 68 participants will be randomly divided into 4 combined TDC groups. S + Baduanjin Qigong BQGT (n=17), combined Baduan Jin Qigong + tDCS Sham group (n=17 BQGS), walking group combined with tDCS Sham (WAS) (n=17, walking group They will be combined with tDCS (WAS) (n=17).
Participants/Inclusion and exclusion criteria
Elderly female fibromyalgia patients of Urmia city
Intervention groups
BQG combined with the tDCS group BQG combined with the sham tDCS group Walking combined with the tDCS group - Walking combined with the sham tDCS
Main outcome variables
the balance Muscle strength walking speed Impact of the Disease Quality of Sleep

General information

Reason for update
Two variables of sleep quality and the impact of the disease were also evaluated, which were not recorded in the outcomes of the study
Acronym
IRCT registration information
IRCT registration number: IRCT20190908044722N3
Registration date: 2024-02-16, 1402/11/27
Registration timing: registered_while_recruiting

Last update: 2024-07-20, 1403/04/30
Update count: 1
Registration date
2024-02-16, 1402/11/27
Registrant information
Name
Razieh Khanmohamadi
Name of organization / entity
The university of Urmia
Country
Iran (Islamic Republic of)
Phone
+98 86 3221 4311
Email address
r.khanmohamadi@ut.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-01-21, 1402/11/01
Expected recruitment end date
2024-03-20, 1403/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Baduanjin Qigong in combination with Transcranial direct current stimulation (tDCS) on physical function, Impact of the Disease and Quality of Sleep in elderly patients with fibromyalgia
Public title
The effect of Baduanjin Qigong in combination with Transcranial direct current stimulation (tDCS) on physical function, Impact of the Disease and Quality of Sleep in elderly patients with fibromyalgia
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Between the ages of 65 and 70 years 6 months through inclusion in the demographic questionnaire 2. No previous experience of qigong practice. 3. Consent to participate in the study 4. Not having regular exercise at least in the last 5. The presence of widespread pain in different parts of the body on the left and right sides of the body in the last week 6. Existence of problems such as weakness, tiredness after sleep and disturbance in thinking and remembering things in the last week. Obtaining a sleep quality score higher than 6 in the Pittsburgh Sleep Quality Index
Exclusion criteria:
Patient with diabetes - thyroid disorder - neuropathies - Lyme hepatitis disease 2. Uncontrolled psychiatric illness Uncontrolled psychiatric illness Absence more than 3 times in the intervention meetings Unwillingness to continue participating in the study during the plan A score of less than 23 in the cognitive state test (MMSE)
Age
From 60 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Outcome assessor
Sample size
Target sample size: 68
Randomization (investigator's opinion)
Randomized
Randomization description
The sequence of random grouping of the participants in this study will be done by the software (Random allocation software version 1.0.0).
Blinding (investigator's opinion)
Single blinded
Blinding description
This study will be blinded, so the evaluators will not know which patients are in the intervention group and which are in the control group.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Urmia University
Street address
Urmia University, Kilometer 11 of Cypress Road, Urmia, West Azarbaijan Province
City
Urmia
Province
West Azarbaijan
Postal code
5756151818
Approval date
2024-01-06, 1402/10/16
Ethics committee reference number
IR.URMIA.REC.1402.026

Health conditions studied

1

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

Primary outcomes

1

Description
Strenght
Timepoint
Before and after the intervention
Method of measurement
Digital dynamometer

2

Description
Balance
Timepoint
Before and after the intervention
Method of measurement
Berg Balance Scale

3

Description
Walk
Timepoint
Before and after the intervention
Method of measurement
the six-minute walk test (6MWT)

4

Description
Impact of the disease
Timepoint
Before and after the intervention
Method of measurement
The Revised Fibromyalgia Impact Questionnaire (FIQR)

5

Description
Sleep quality
Timepoint
Before and after the intervention
Method of measurement
the Pittsburgh Sleep Quality Index (PSQI)

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: BQG combined with the tDCS group
Category
Rehabilitation

2

Description
Intervention group: BQG combined with the sham tDCS group
Category
Rehabilitation

3

Description
Intervention group: Walking combined with the tDCS group
Category
Rehabilitation

4

Description
Intervention group: Walking combined with the sham tDCS
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
One of the rheumatology clinics in Urmia
Full name of responsible person
Razieh Khanmohammadi
Street address
Urmia University, Kilometer 11 of Cypress Road, Urmia, West Azarbaijan Province
City
Urmia
Province
West Azarbaijan
Postal code
5756151818
Phone
+98 918 624 2003
Email
r.khanmohamadi65@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
The university of urmia
Full name of responsible person
Razieh Khanmohammadi
Street address
Urmia University, Kilometer 11 of Cypress Road, Urmia, West Azarbaijan Province
City
Urmia
Province
West Azarbaijan
Postal code
5756151818
Phone
+98 918 624 2003
Email
r.khanmohamadi65@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
The university of urmia
Proportion provided by this source
1
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Other

Person responsible for general inquiries

Contact
Name of organization / entity
The university of urmia
Full name of responsible person
Razieh Khanmohammadi
Position
assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
motor behavior
Street address
Urmia University, Kilometer 11 of Cypress Road, Urmia, West Azarbaijan Province
City
Urmia
Province
West Azarbaijan
Postal code
5756151818
Phone
0098-044-43-32752741-
Email
r.khanmohamadi65@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
The university of urmia
Full name of responsible person
Razieh Khanmohammadi
Position
assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
motor behavior
Street address
Urmia University, Kilometer 11 of Cypress Road, Urmia, West Azarbaijan Province
City
Urmia
Province
West Azarbaijan
Postal code
5756151818
Phone
0098 044 43-32752741-
Email
r.khanmohamadi65@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
The university of urmia
Full name of responsible person
Razieh Khanmohammadi
Position
assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
motor behavior
Street address
Urmia University, Kilometer 11 of Cypress Road, Urmia, West Azarbaijan Province
City
Urmia
Province
West Azarbaijan
Postal code
43-32752741-044
Phone
0098 044 43-32752741
Email
r.khanmohamadi65@yahoo.com

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
Not applicable
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
The analysis of information obtained from the results of the interventions on balance, strength and gait speed , Impact of the Disease and Quality of Sleep can be published
When the data will become available and for how long
From the time the article was published until a year later
To whom data/document is available
All researchers
Under which criteria data/document could be used
Provided Someone wants to do a similar research project
From where data/document is obtainable
r.khanmohamadi65@yahoo.com
What processes are involved for a request to access data/document
Send request by email
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