FibromyalgiaNCT05821036
Examining the Effects of Activity Management in Women With Fibromyalgia Syndrome
A study testing Activitiy Management in people with Fibromyalgia, run by Ankara Medipol University at 1 site in Turkey (Türkiye).
Trial summary
Purpose: To determine the effects of activity management training on pain, occupational performance, quality of life, depression, anxiety and occupational balance in women with fibromyalgia syndrome (FMS). Read more about this study
- Who is it for?
- Ages 18 to 64 years, women only
- Conditions the study is for
- Fibromyalgia
- What is being tested?
- Activitiy Management
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 27 Jun 2022to 27 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Having been diagnosed with FMS by a specialist physician,
- Being a woman between the ages of 18-64,
- To be literate,
- Having and actively using a smartphone or a computer
Who cannot join
- Any disease accompanying FMS, the presence of psychiatric illness and endocrine disorders,
- Have previous activity management training,
- Currently and up to 4 weeks on psychotropic medication,
- Breastfeeding and pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Examining the Effects of Activity Management in Women With Fibromyalgia Syndrome :Randomized Controlled Study
Purpose: To determine the effects of activity management training on pain, occupational performance, quality of life, depression, anxiety and occupational balance in women with fibromyalgia syndrome (FMS).
In addition to, reducing pain, which is the main symptom of FMS, by regulating the activity-rest cycle, it is aimed to increase people's participation in daily life and improve their quality of life.
Method: A randomized controlled trial. A total of 10 sessions of individual-internet-based activity management training are applied to women with FMS in the intervention group, 2 sessions a week for 5 weeks, 1st and 10th sessions are pre- and post-training evaluation. Assessments before and after training The Revised Fibromyalgia Impact Questionnaire (FIQR), Canadian Occupational Performance Measure(COPM), Pain-activity patterns scale (Pomp/APPS) ,Nottingham Health Profile,The hospital anxiety and depression scale,The Occupational Balance Questionnaire (OBQ) is applied.Although no intervention is applied to the control group, only preliminary and final evaluations are completed.
- Conditions
- Fibromyalgia
- Being tested
- Activitiy Management
- Keywords
- fibromyalgia, activity management, pain management, occupational balance, occupational performance, occupational therapy
- Medical subject headings
- Fibromyalgia, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Activitiy ManagementBehavioural
Activity Management training will be applied for 5 weeks, 2 sessions per week, and the 1st and 10th sessions will be pre and post-training evaluation, a total of 10 individual, internet-based sessions.
Week 1:Awareness training and ergonomics training including spine anatomy, correct posture use, ergonomic strategies were planned to increase awareness about FMS. Week 2:Focusing on the challenging activities stated by the individuals, it is aimed to change the behavior by arranging the activity resting cycle in daily life. In addition, the management, adaptation and modification of the activities will be provided within the scope of time management training. Week 3: Joint and energy conservation principles training will be given and it is aimed to create body mechanics and proper posture suitable for activities.Week 4: Relaxation training will be provided as a method of coping with pain.Week 5: Re-evaluation/review of the targets set to reduce pain during activities will be provided.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Inclusion criteria:
* Having been diagnosed with FMS by a specialist physician,
* Being a woman between the ages of 18-64,
* To be literate,
* Having and actively using a smartphone or a computer
Exclusion criteria:
* Any disease accompanying FMS, the presence of psychiatric illness and endocrine disorders,
* Have previous activity management training,
* Currently and up to 4 weeks on psychotropic medication,
* Breastfeeding and pregnancy Receives: Behavioral: Activitiy Management |
| Control group | No intervention | Inclusion criteria: * Having been diagnosed with FMS by a specialist physician, * Being a woman between the ages of 18-64, * To be literate, * Having and actively using a smartphone or a computer Exclusion criteria: * Any disease accompanying FMS, the presence of psychiatric illness and endocrine disorders, * Have previous activity management training, * Currently and up to 4 weeks on psychotropic medication, * Breastfeeding and pregnancy |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Revised Fibromyalgia Impact Questionnaire (FIQ/RFEA)
It is a questionnaire that evaluates the limitations and functional impairment in patients with fibromyalgia with a total of 21 questions in three sections: function, general and symptoms. All questions are evaluated on a numerical scale between 0-10. The higher the score obtained from the questionnaire, the higher the disability due to fibromyalgia. Turkish validity and reliability was performed by Ediz et al. on female patients with fibromyalgia. (Cronbach's alpha value is 0.89 for FIQR 1st visit (first assessment) and 0.91 for FIQR 2nd visit (second assessment).)
Measured: 15 minute
Canadian Occupational Performance Measurement (COPM)
It focuses on ocuopational performance in all areas of life, including self-care, leisure, and productivity. It is a person-centered scale created for individuals to analyze and prioritize the factors that limit their participation in ADLs. Turkish cultural adaptation, validity and reliability 2017 (Cronbach Alpha internal consistency coefficient 0.9-1.)
Measured: 20 minute
Patterns of Activity Measure" (POAM-P)
It analyzes the altered activity patterns of individuals with chronic pain while creating their activities. The questionnaire consists of 30 questions and all questions are evaluated on a numerical scale between 0-4. Its Turkish adaptation, validity and reliability were performed by Emine Tunç Süygün on patients with chronic low back/neck pain in 2019. (Cronbach's alpha coefficient is 0.941 for avoidance, 0.917 for overdoing, and 0.940 for regulation.)
Measured: 15 minute
Nottingham Health Profile (NSP)
It consists of 38 questions examining the effects of health problems on different areas of quality of life and 6 sections including physical activity, pain, sleep, social isolation, emotional reactions and energy level. These parameters are; pain (8 items), physical activity (8 items), energy (3 items), sleep (5 items), social isolation (5 items), emotional reactions (9 items). Each sub-parameter is scored between 0-100. 0 indicates best health, 100 indicates worst health. Turkish validity and reliability of the questionnaire Küçükdeveci, McKenna, Kutlay et al. (2002) by
Measured: 15 minute
Hospital anxiety depression scale (HADS)
Hospital anxiety depression scale (HADS) was developed by Zigmoid and Snaith to examine anxiety and depression in individuals with physical illness. 7 questions of the 14-item scale question anxiety and 7 questions about depression symptoms. assessed on a four-point Likert scale.
The answers given to the questions are scored between 0-3. The sum of the scores of the odd questions gives the anxiety subscale (HAD-A) score, and the sum of the scores of the even questions gives the depression subscale (HAD-D) score. The lowest score that patients can get from both subscales is 0, and the highest score is 21. The Turkish validity and reliability study of the scale was performed by Aydemir in 1997. (Cronbach's alpha coefficient 0.8525 for anxiety, 0.7784 for depression)
Measured: 15 minute
Ocupational Balance Questionnaire (OB-Quest)
Occupational balance, which is considered to be an important component of health and well-being, is a very important concept in occupational therapy.The concept of 'ocupational balance' is the right amount of the perception that it has the oculation and that it has the right variety between ocuations.Opations and roles in the life cycle, personal factors and ıt has a dynamic structure that changes with external factors. There is a constant transition between ocupational imbalance and balance.The Ocupational Balance Questionnaire (OB-Task) is designed as a standard tool to assess a person's ocupational balance. The questionnaire consists of 10 closed-ended questions. The Turkish validity and reliability were evaluated by Bahadır et al. in 2021. The alpha score of the Turkish OB-Quest Cronbach is 0.645 and it has questionable internal consistency.
Measured: 15 minute
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2023
- Study start27 Jun 2022
- Primary completion27 Dec 2023 (estimated)
- Study completion27 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FibromyalgiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- A randomized controlled trial.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ankara Medipol University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sena Albay, Ankara Medipol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05821036
- Sponsor's protocol ID
- SAlbay
- Status last verified
- Apr 2023
- First submitted
- 20 Mar 2023
- Last updated
- 20 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examining the Effects of Activity Management in Women With Fibromyalgia Syndrome :Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT05821036
- Acronym / sponsor ID
- SAlbay
- Conditions
- Fibromyalgia
- Keywords
- fibromyalgia, activity management, pain management, occupational balance, occupational performance, occupational therapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Ankara Medipol UniversityUniversity, hospital or other
- Study start
- 27 Jun 2022 (actual)
- Primary completion
- 27 Dec 2023 (estimated)
- Study completion
- 27 Dec 2023 (estimated)
- First posted
- 20 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Purpose: To determine the effects of activity management training on pain, occupational performance, quality of life, depression, anxiety and occupational balance in women with fibromyalgia syndrome (FMS).
In addition to, reducing pain, which is the main symptom of FMS, by regulating the activity-rest cycle, it is aimed to increase people's participation in daily life and improve their quality of life.
Method: A randomized controlled trial. A total of 10 sessions of individual-internet-based activity management training are applied to women with FMS in the intervention group, 2 sessions a week for 5 weeks, 1st and 10th sessions are pre- and post-training evaluation. Assessments before and after training The Revised Fibromyalgia Impact Questionnaire (FIQR), Canadian Occupational Performance Measure(COPM), Pain-activity patterns scale (Pomp/APPS) ,Nottingham Health Profile,The hospital anxiety and depression scale,The Occupational Balance Questionnaire (OBQ) is applied.Although no intervention is applied to the control group, only preliminary and final evaluations are completed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- A randomized controlled trial.
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: Activitiy ManagementInclusion criteria: * Having been diagnosed with FMS by a specialist physician, * Being a woman between the ages of 18-64, * To be literate, * Having and actively using a smartphone or a computer Exclusion criteria: * Any disease accompanying FMS, the presence of psychiatric illness and endocrine disorders, * Have previous activity management training, * Currently and up to 4 weeks on psychotropic medication, * Breastfeeding and pregnancy |
| Control group | No intervention | –Inclusion criteria: * Having been diagnosed with FMS by a specialist physician, * Being a woman between the ages of 18-64, * To be literate, * Having and actively using a smartphone or a computer Exclusion criteria: * Any disease accompanying FMS, the presence of psychiatric illness and endocrine disorders, * Have previous activity management training, * Currently and up to 4 weeks on psychotropic medication, * Breastfeeding and pregnancy |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Having been diagnosed with FMS by a specialist physician,
- Being a woman between the ages of 18-64,
- To be literate,
- Having and actively using a smartphone or a computer
Key exclusion criteria (4 listed)
- Any disease accompanying FMS, the presence of psychiatric illness and endocrine disorders,
- Have previous activity management training,
- Currently and up to 4 weeks on psychotropic medication,
- Breastfeeding and pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Activitiy ManagementActivity Management training will be applied for 5 weeks, 2 sessions per week, and the 1st and 10th sessions will be pre and post-training evaluation, a total of 10 individual, internet-based sessions. Week 1:Awareness training and ergonomics training including spine anatomy, correct posture use, ergonomic strategies were planned to increase awareness about FMS. Week 2:Focusing on the challenging activities stated by the individuals, it is aimed to change the behavior by arranging the activity resting cycle in daily life. In addition, the management, adaptation and modification of the activities will be provided within the scope of time management training. Week 3: Joint and energy conservation principles training will be given and it is aimed to create body mechanics and proper posture suitable for activities.Week 4: Relaxation training will be provided as a method of coping with pain.Week 5: Re-evaluation/review of the targets set to reduce pain during activities will be provided. | Behavioural | Intervention group |
Primary outcome
The Revised Fibromyalgia Impact Questionnaire (FIQ/RFEA)
Time frame: 15 minute
It is a questionnaire that evaluates the limitations and functional impairment in patients with fibromyalgia with a total of 21 questions in three sections: function, general and symptoms. All questions are evaluated on a numerical scale between 0-10. The higher the score obtained from the questionnaire, the higher the disability due to fibromyalgia. Turkish validity and reliability was performed by Ediz et al. on female patients with fibromyalgia. (Cronbach's alpha value is 0.89 for FIQR 1st visit (first assessment) and 0.91 for FIQR 2nd visit (second assessment).)
Canadian Occupational Performance Measurement (COPM)
Time frame: 20 minute
It focuses on ocuopational performance in all areas of life, including self-care, leisure, and productivity. It is a person-centered scale created for individuals to analyze and prioritize the factors that limit their participation in ADLs. Turkish cultural adaptation, validity and reliability 2017 (Cronbach Alpha internal consistency coefficient 0.9-1.)
Patterns of Activity Measure" (POAM-P)
Time frame: 15 minute
It analyzes the altered activity patterns of individuals with chronic pain while creating their activities. The questionnaire consists of 30 questions and all questions are evaluated on a numerical scale between 0-4. Its Turkish adaptation, validity and reliability were performed by Emine Tunç Süygün on patients with chronic low back/neck pain in 2019. (Cronbach's alpha coefficient is 0.941 for avoidance, 0.917 for overdoing, and 0.940 for regulation.)
Nottingham Health Profile (NSP)
Time frame: 15 minute
It consists of 38 questions examining the effects of health problems on different areas of quality of life and 6 sections including physical activity, pain, sleep, social isolation, emotional reactions and energy level. These parameters are; pain (8 items), physical activity (8 items), energy (3 items), sleep (5 items), social isolation (5 items), emotional reactions (9 items). Each sub-parameter is scored between 0-100. 0 indicates best health, 100 indicates worst health. Turkish validity and reliability of the questionnaire Küçükdeveci, McKenna, Kutlay et al. (2002) by
Hospital anxiety depression scale (HADS)
Time frame: 15 minute
Hospital anxiety depression scale (HADS) was developed by Zigmoid and Snaith to examine anxiety and depression in individuals with physical illness. 7 questions of the 14-item scale question anxiety and 7 questions about depression symptoms. assessed on a four-point Likert scale. The answers given to the questions are scored between 0-3. The sum of the scores of the odd questions gives the anxiety subscale (HAD-A) score, and the sum of the scores of the even questions gives the depression subscale (HAD-D) score. The lowest score that patients can get from both subscales is 0, and the highest score is 21. The Turkish validity and reliability study of the scale was performed by Aydemir in 1997. (Cronbach's alpha coefficient 0.8525 for anxiety, 0.7784 for depression)
Ocupational Balance Questionnaire (OB-Quest)
Time frame: 15 minute
Occupational balance, which is considered to be an important component of health and well-being, is a very important concept in occupational therapy.The concept of 'ocupational balance' is the right amount of the perception that it has the oculation and that it has the right variety between ocuations.Opations and roles in the life cycle, personal factors and ıt has a dynamic structure that changes with external factors. There is a constant transition between ocupational imbalance and balance.The Ocupational Balance Questionnaire (OB-Task) is designed as a standard tool to assess a person's ocupational balance. The questionnaire consists of 10 closed-ended questions. The Turkish validity and reliability were evaluated by Bahadır et al. in 2021. The alpha score of the Turkish OB-Quest Cronbach is 0.645 and it has questionable internal consistency.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Activitiy Management in people with Fibromyalgia, run by Ankara Medipol University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Revised Fibromyalgia Impact Questionnaire (FIQ/RFEA) (time frame: 15 minute). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2023.