Protocol summary
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Study aim
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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.
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Design
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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
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Settings and conduct
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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).
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Participants/Inclusion and exclusion criteria
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Elderly female fibromyalgia patients of Urmia city
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Intervention groups
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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
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Main outcome variables
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the balance
Muscle strength
walking speed
Impact of the Disease
Quality of Sleep
General information
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Reason for update
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Two variables of sleep quality and the impact of the disease were also evaluated, which were not recorded in the outcomes of the study
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Acronym
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IRCT registration information
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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
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Registration date
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2024-02-16, 1402/11/27
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2024-01-21, 1402/11/01
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Expected recruitment end date
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2024-03-20, 1403/01/01
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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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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Public title
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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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Purpose
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Supportive
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Inclusion/Exclusion criteria
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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)
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Age
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From 60 years old to 70 years old
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Gender
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Both
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Phase
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N/A
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Groups that have been masked
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Sample size
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Target sample size:
68
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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The sequence of random grouping of the participants in this study will be done by the software (Random allocation software version 1.0.0).
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Blinding (investigator's opinion)
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Single blinded
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Blinding description
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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.
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2024-01-06, 1402/10/16
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Ethics committee reference number
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IR.URMIA.REC.1402.026
Health conditions studied
1
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Description of health condition studied
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Fibromyalgia
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ICD-10 code
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M79.7
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ICD-10 code description
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Fibromyalgia
Primary outcomes
1
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Description
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Strenght
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Timepoint
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Before and after the intervention
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Method of measurement
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Digital dynamometer
2
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Description
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Balance
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Timepoint
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Before and after the intervention
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Method of measurement
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Berg Balance Scale
3
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Description
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Walk
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Timepoint
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Before and after the intervention
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Method of measurement
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the six-minute walk test (6MWT)
4
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Description
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Impact of the disease
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Timepoint
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Before and after the intervention
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Method of measurement
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The Revised Fibromyalgia Impact Questionnaire (FIQR)
5
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Description
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Sleep quality
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Timepoint
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Before and after the intervention
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Method of measurement
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the Pittsburgh Sleep Quality Index (PSQI)
Intervention groups
1
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Description
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Intervention group: BQG combined with the tDCS group
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Category
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Rehabilitation
2
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Description
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Intervention group: BQG combined with the sham tDCS group
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Category
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Rehabilitation
3
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Description
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Intervention group: Walking combined with the tDCS group
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Category
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Rehabilitation
4
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Description
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Intervention group: Walking combined with the sham tDCS
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Category
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Rehabilitation
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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The university of urmia
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Proportion provided by this source
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1
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Public or private sector
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Private
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Other
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Not applicable
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Informed Consent Form
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No - There is not a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Not applicable
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Data Dictionary
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Not applicable
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Title and more details about the data/document
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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
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When the data will become available and for how long
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From the time the article was published until a year later
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To whom data/document is available
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All researchers
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Under which criteria data/document could be used
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Provided Someone wants to do a similar research project
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From where data/document is obtainable
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r.khanmohamadi65@yahoo.com
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What processes are involved for a request to access data/document
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Send request by email
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Comments
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