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

Federal University of Pelotas

Status: Unknown

Conditions: Fibromyalgia; Fibromyalgia, Primary

Treatments: Other: Active Comparator: Self-care group; Other: Experimental: Active care group

Study type: Interventional

Funder types: Other

Identifiers

NCT04690400

39305720.9.0000.5313

Details and patient eligibility

About

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.

Enrollment: 28 patients

Sex: Female

Ages: 30 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Women between 30 and 60 years of age;
• Diagnosis of fibromyalgia (according medical confirmation) at least three months before eligibility;
• Inactive for at least three months;
• Inability or unwillingness to give informed consent for participation and to complete the questionnaires;
• Consent to participate in the study regardless of the allocation group.

Exclusion criteria

• Presence of another associated rheumatic pathology (secondary fibromyalgia);
• Uncontrolled systemic disease;
• Being under physiotherapeutic treatment;
• Lack of internet access.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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28 participants in 2 patient groups

Active care group

Experimental group

Description:

Participants will practice stretching exercises twice a week, at a distance and under the supervision of a professional, for 12 weeks. In addition, the experimental group will receive the same written guide and video of the comparator group.

Treatment:

Other: Experimental: Active care group

Self-care group

Active Comparator group

Description:

Participants will receive stretching advice by written guide and video with stretching exercises, to be performed individually, without distance supervision, for 12 weeks. Participants will be able to resolve questions about the protocol at any time, via telephone.

Treatment:

Other: Active Comparator: Self-care group