Digitally Assisted Behavioral Physical Activity Intervention in Fibromyalgia

NCT05659862 | Active Not Recruiting

• 1 other identifier: 09.2022.603
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Fibromyalgia; Physical Inactivity

Keywords

fibromyalgia; physical activity; digital health; physical activity intervention

Outcome Measures

Primary Outcomes (2)

• Change from Baseline Step Counts at 2 months

  The pedometer is an inexpensive, easy-to-use instrument designed to measure the number of steps and walking distance, providing objective measurement. It is usually attached to the lumbar region and includes a lever arm connected to a horizontal spring that bounces off with the vertical acceleration of the hips during walking (up-down motion during cruising). Pedometers designed to detect vertical movement logically determine the number of steps. The output of the device is easily understood as the number of movements representing a step. The pedometer (pedometer) is an easy-to-use device that can be easily carried by people and can approximate the number of steps, the distance walked and the calories consumed.

  At the baseline and 2 months later

• Change from Baseline Physical Activity Level at 2 months

  The purpose of the questionnaire is to obtain data on health-related physical activity. We used the short self-administered version in the present study. The short form International Physical Activity Questionnaire (IPAQ) is a 9-item scale, assessing the amount of minutes spent in vigorous and moderate intense activity and walking during the last 7 days. Also the amount of minutes spending sitting on week days in the past 7 days is assessed. For all categories patients have to define on how many days and how many minutes they spent at a specific activity category. For all categories, the amount of Metabolic Equivalents (METs)-minutes is calculated by multiplying the amount of minutes with 8 (vigorous), 4 (moderate), 3.3 (walking), or 1.3 (sitting). Besides these four subscores, a total score is calculated by counting the METs-minutes of the first 3 categories together.

  At the baseline and 2 months later

Secondary Outcomes (8)

• Change from Baseline Functional Capacity at 2 months

  At the baseline and 2 months later

• Change from Baseline Quality of Life at 2 months

  At the baseline and 2 months later

• Change from Baseline Sleep Quality at 2 months

  At the baseline and 2 months later

• Change from Baseline Pain at 2 months

  At the baseline and 2 months later

• Change from Baseline Fatigue at 2 months

  At the baseline and 2 months later

Study Arms (2)

Digitally assisted behavioral physical activity intervention+Education

EXPERIMENTAL

An activity diary and a pedometer will be given to write down the number of steps per day. After one week, the patient will be asked to send the activity diary as a photo via WhatsApp. Afterwards, a 20-minute phone call will be made to provide patient education. After the patient education, the patient will be consulted about the average number of steps he wants to take at the end of the intervention, and the daily average number of steps will be determined for the first week of the intervention, taking into account the patient's number of steps in the last week and the goal of the number of steps she wants to reach. The person will be added to the WhatsApp patient support group. Patients will receive messages from this group by the researcher twice a week. The target for the number of steps will be renewed every next week and an average of 20 minutes of phone calls including motivational interviews will be held in the light of Social Cognitive Theory.

Behavioral: Digitally assisted behavioral physical activity intervention; Behavioral: Education

Education

ACTIVE COMPARATOR

An activity diary and a pedometer will be given to write down the number of steps per day. After one week, the patient will be asked to send the activity diary as a photo via WhatsApp. Afterwards, a 20-minute phone call will be made to provide patient education. A reminder call will be made to the patient in the 4th week after the training and any questions will be answered. Individuals in the patient education group will be asked to record their steps for one week with a pedometer in the 8th week after the training.

Behavioral: Education

Interventions

Digitally assisted behavioral physical activity intervention BEHAVIORAL

Digitally Assisted Behavioral Physical Activity Intervention Each week, the step count target will be renewed and an average of 20 minutes of phone calls will be made, including motivational interviews guided by Social Cognitive Theory. Motivational interviews will last 8 weeks. Outcome Expectations - Informing about the positive results when the physical activity level is increased and the dose-effect relationship Self Efficacy - Individuals' previous physical activity/exercise experiences will be evaluated and discussed. Social Support - A WhatsApp group will be created. Self Regulation - Self-monitoring ; Goal setting; Feedback, Self-reward

Digitally assisted behavioral physical activity intervention+Education

Education BEHAVIORAL

Patient Education * Definition of fibromyalgia syndrome * Symptoms of fibromyalgia syndrome * Exercise and physical activity * Recommendations to improve the quality of life * Sleep quality and sleep hygiene * Pain management * Fatigue and energy conservation techniques All patient education content will also be available on the website.

Digitally assisted behavioral physical activity intervention+Education; Education

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Trakya University: lead

Study Sites (1)

Nimet Sermenli Aydın

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Fibromyalgia; Sedentary Behavior; Motor Activity

Interventions

Educational Status

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases; Behavior

Intervention Hierarchy (Ancestors)

Socioeconomic Factors; Population Characteristics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant

Study Record Dates

• First Submitted: December 1, 2022
• First Posted: December 21, 2022
• Study Start: September 9, 2022
• Primary Completion: June 1, 2024
• Study Completion: October 1, 2024
• Last Updated: April 26, 2024

Record last verified: 2024-04

Locations

TU (1)