Clinical trial NCT04690400: Telehealth Stretching Exercise Program for Women With Fibromyalgia During the Covid-19 Pandemic
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Fibromyalgia
Fibromyalgia, Primary
Keywords: Stretching exercise
Telehealth
Lead sponsor: Federal University of Pelotas
Sponsor class: OTHER
First posted: 2020-12-30
Enrollment: 28
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a randomized, single-blinded, parallel, superiority, controlled trial. Participants, women with fibromyalgia, will be allocated to two groups, experimental and control, based on randomization sequence. Sequence will be generated by computer, with 1:1 ratio and blocks of random sizes that are not disclosed to ensure concealment. Allocation concealment will be implemented through a central randomization routine conducted by the same investigator that will generate the sequence. The allocation of participants will occur after the completion of baseline outcomes evaluations.
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Changes in the Widespread Pain Index
timeFrame: Zero week, six week, and twelve week
measure: Changes in Sleep Quality
timeFrame: Zero week, six week, and twelve week
Secondary outcomes:
measure: Symptom Severity Scale
timeFrame: Zero week, six week, and twelve week
measure: Impact of fibromyalgia on daily activities
timeFrame: Zero week, six week, and twelve week
measure: Depressive symptoms
timeFrame: Zero week, six week, and twelve week
measure: Physical activity level
timeFrame: Zero week, six week, and twelve week
measure: Functionality / Flexibility
timeFrame: Zero week, six week, and twelve week
measure: Painful intensity at rest and movement
timeFrame: Zero week, six week, and twelve week
measure: Subjective perception of well-being
timeFrame: Twelve week
Other outcomes:
Locations:
city: Pelotas
country: Brazil
facility: Escola Superior de Educação Física
state: RS
Study officials:
affiliation: Federal University of Pelotas
name: Cristine L Alberton, PhD
role: PRINCIPAL_INVESTIGATOR
References: