Clinical trial NCT05659862: Digitally Assisted Behavioral Physical Activity Intervention in Fibromyalgia
Official title: Efficacy of Digitally Assisted Behavioral Physical Activity Intervention in Fibromyalgia Syndrome
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Fibromyalgia
Physical Inactivity
Keywords: fibromyalgia
physical activity
digital health
physical activity intervention
Lead sponsor: Trakya University
Sponsor class: OTHER
First posted: 2022-12-21
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Digital health interventions have the potential to address physical inactivity as they are accessible to a large part of the population and can be delivered with high efficiency at a low cost. By enabling patient education, support for self-management, motivation, follow-up, feedback and communication, it can prevent, cure or treat many chronic conditions. These features can increase patient motivation and encourage compliance with home exercises and physical activity . Digital behavior change interventions use digital technologies (such as websites, mobile apps, Short Message Service or wearable devices) to promote and maintain health and have the potential to overcome many barriers compared to in-person programs by providing cost-effective, effective, and accessible information.

No study has been found in Turkey examining digital interventions or walking programs that include behavior change techniques to increase physical activity in patients with fibromyalgia syndrome. Considering environmental, cultural and economic factors in this patient group in our society, the investigators think that walking, which the investigators think is the most appropriate physical activity method in terms of cost, accessibility and equipment, should be a permanent behavior. The use of technology to increase physical activity in the era of digitalization is important in terms of addressing the increasing inactivity during the Covid19 pandemic period.

The aim of this study is to estimate the effect of digital assisted physical activity intervention combined with patient education compared to patient education alone on physical activity level, functional capacity, quality of life, sleep quality, pain, fatigue, and perspective on exercise of adults with Fibromyalgia Syndrome.


Eligibility criteria: Inclusion Criteria:

* Being between the ages of 18-65
* Having a female gender
* Reporting at least 40 mm in weekly pain intensity from the VAS scored between 0-100 with 'no pain' and 'worst possible pain'
* Using a fixed dose of medication for at least the past 6 months
* Being in the "Inactive" group according to the International Physical Activity Survey (not participating in physical activity to meet the physical activity recommendations of the guides)
* Using / agreeing to use WhatsApp application

Exclusion Criteria:

* Having another disease that affects the physical condition
* Cognitive inability to cooperate
* Being pregnant
* Inability to understand or speak Turkish
* Concurrent autoimmune or inflammatory disease,
* Diseases affecting the central nervous system (eg multiple sclerosis, Parkinson's disease),
* Serious psychiatric conditions that prevent participation (eg, psychotic disorders).
* Participation in a rehabilitation program in the past year,
* Exercising regularly for 6 months

Primary outcomes:
measure: Change from Baseline Step Counts at 2 months
timeFrame: At the baseline and 2 months later
measure: Change from Baseline Physical Activity Level at 2 months
timeFrame: At the baseline and 2 months later
Secondary outcomes:
measure: Change from Baseline Functional Capacity at 2 months
timeFrame: At the baseline and 2 months later
measure: Change from Baseline Quality of Life at 2 months
timeFrame: At the baseline and 2 months later
measure: Change from Baseline Sleep Quality at 2 months
timeFrame: At the baseline and 2 months later
measure: Change from Baseline Pain at 2 months
timeFrame: At the baseline and 2 months later
measure: Change from Baseline Fatigue at 2 months
timeFrame: At the baseline and 2 months later
measure: Change from Baseline Physical Activity Perception at 2 months
timeFrame: At the baseline and 2 months later
measure: Change from Baseline Physical Activity Awareness at 2 months
timeFrame: At the baseline and 2 months later
measure: Activity Diary
timeFrame: At the baseline and 2 months later
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Nimet Sermenli Aydın
Study officials:
References: