NCT04690400

Telehealth Stretching Exercise Program for Women With Fibromyalgia During the Covid-19 Pandemic

Adaptations From a Telehealth Stretching Exercise Program on Painful Conditions, Depression, Sleep and Functionality of Women With Fibromyalgia During the Covid-19 Pandemic: a Randomized Clinical Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: Federal University of Pelotas · Academic / Other
• Sex: Female
• Age: 30 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

This study is a randomized, single-blinded, parallel, superiority, controlled trial. The main objective is to verify the effects of a telehealth stretching exercise program on pain, depression, sleep parameters and functionality of women with fibromyalgia, during the Covid-19 pandemic. Participants will be women with primary fibromyalgia, seen at public and private health services, in the city of Pelotas (south of Brazil). Participants will be recruited through social networks, newspapers and support from the National Association of Fibromyalgia and Correlated Diseases (Anfibro). Eligible participants will be randomized, stratified by age (30 to 45; 46 to 60), and allocated to one of the two groups, experimental or control. The experimental group will receive a telehealth stretching exercise program twice a week (guided by a professional) and counseling guide to stretching exercises with explanatory video regarding the execution of the protocol proposed by the guide. The total duration of exercise program will be 40 minutes (will be 12 exercise, 3 sets of each stretching for 10 seconds, carried out individually by a video call application - WhatsApp). The control group will receive only counseling guide to stretching exercises with explanatory video regarding the execution of the protocol. Both interventions will last 12 weeks, with outcomes evaluations in three moments: baseline (week 0), midpoint (week 6) and after the intervention (week 13). The following outcomes will be evaluated: generalized index of pain, fatigue and severity of symptoms, depression, level of physical activity, functionality, quality of life and sleep. All outcomes will be evaluated by questionnaires self-completed, that will be answered on Google Docs by video call, with exception of functional test that will be applied by video call. The study's hypothesis consists of improving outcomes for both groups, but with superiority for the experimental group.

Conditions

• Fibromyalgia
• Fibromyalgia, Primary

Interventions

Type	Name	Description
OTHER	Experimental: Active care group	Stretching exercise program remotely supervised. Total of approximately 40 minutes per session by WhatsApp, individually and supervised by a professional (physiotherapist or physical education teacher). As recommended for flexibility improving, 30 seconds of stretching in each exercise will be perform fractionated (3 series of 10 seconds of static position at the point of moderate discomfort, with 10 seconds interval between series). There will be two stretching protocol models with exercises variations, but for the same muscle groups, intensity, volume, and duration. The position at the point of moderate discomfort will be self-adjusted by subjective perception over 12 weeks of intervention. The protocol model will change after seven weeks. In order to make the interventions more similar, the guide and videos of control group will be also sent to experimental group
OTHER	Active Comparator: Self-care group	The participants will receive counseling to stretching by guide and explanatory video that will be send by WhatsApp. The stretching exercise protocols will be the same performed by the experimental group. In addition, participants will receive recommendation to perform the protocol with the same weekly frequency, intensity, volume, and duration perform by the experimental group After the guide and explanatory video are sent, participants will receive a call for clarification. As well as in the experimental group, the protocol model will change after seven weeks; so, other guide and explanatory video will be sent for participants.

Timeline

• Start date: 2021-01-15
• Primary completion: 2021-12-30
• Completion: 2021-12-30
• First posted: 2020-12-30
• Last updated: 2021-12-30

Locations

1 site across 1 country: Brazil