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

NCT04690400 | Unknown

• 1 other identifier: 39305720.9.0000.5313
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

Fibromyalgia; Fibromyalgia, Primary

Keywords

Stretching exercise; Telehealth

Outcome Measures

Primary Outcomes (2)

• Changes in the Widespread Pain Index

  A generalized pain index is a tool used to measure the amplitude of patients' clinical symptoms with fibromyalgia. It is considered a diagnostic scale, presenting 90.8% accuracy about the American College of Rheumatology's first criteria, de1990 and validated by the same institution in 2010 (WOLFE et al., 2010) being recognized by the Brazilian Society of Rheumatology - SBR, in 2017. Comprises the body areas usually affected by the disease, where the patient indicates if he felt pain at that moment in the last seven days (HEYMANN et al., 2017). Scores considered high are higher than 7. It will be checked if there was a change in painful behavior through collections in three periods of time, which will be compared at the end of the treatment.

  Zero week, six week, and twelve week

• Changes in Sleep Quality

  The Pittsburgh Sleep Quality Index Self-Report Questionnaire has been widely used to record sleep for four weeks. It includes 19 self-reported questions, divided into seven domains (HERNÁNDEZ et al., 2020) and five questions to be answered by the roommate, with questions about the noise produced during sleep. The score ranges from 0 to 3, where higher scores indicate worse sleep quality (BERTOLAZI et al., 2011). It was developed in 1989 by Buysse et al. and validated in the Brazilian version in 2011 by Bertolazi et al. (PASSOS et al., 2017). It is hoped to find a change in sleep quality; thus, three collections will be made, at different times of time, which will be compared at the end of the treatment.

  Zero week, six week, and twelve week

Secondary Outcomes (7)

• Symptom Severity Scale

  Zero week, six week, and twelve week

• Impact of fibromyalgia on daily activities

  Zero week, six week, and twelve week

• Depressive symptoms

  Zero week, six week, and twelve week

• Physical activity level

  Zero week, six week, and twelve week

• Functionality / Flexibility

  Zero week, six week, and twelve week

Study Arms (2)

Active care group

EXPERIMENTAL

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.

Other: Experimental: Active care group

Self-care group

ACTIVE COMPARATOR

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.

Other: Active Comparator: Self-care group

Interventions

Experimental: Active care group OTHER

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

Active care group

Active Comparator: Self-care group OTHER

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.

Self-care group

Eligibility Criteria

• Age: 30 Years - 60 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Federal University of Pelotas: lead

Study Sites (1)

Escola Superior de Educação Física

Pelotas, Rio Grande do Sul, 96055-630, Brazil

Location

Related Links

• Therapeutic physical exercise and supplements to treat fibromyalgia.
• Controlled, cross-sectional, multi-center study of physical capacity and associated factors in women with fibromyalgia
• Effectiveness of exercise on fatigue and sleep quality in fibromyalgia: a systematic review and meta-analysis of randomised trials.
• The efficacy of adding group behavioral activation to usual care in patients with fibromyalgia and major depression: design and protocol for a randomized clinical trial.
• Progress towards improved non-pharmacological management of fibromyalgia.
• What happens to muscles in fibromyalgia syndrome

MeSH Terms

Conditions

Fibromyalgia

Condition Hierarchy (Ancestors)

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

Study Officials

• Cristine L Alberton, PhD

  Federal University of Pelotas

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Blinding will be implemented for outcome assessor. The questionnaires and functional tests will be supervised remotely by an investigator blinded to the participant's group. Due to the type of interventions, the investigator conducting exercise sessions as well as participants are not blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Model Details: 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.

Study Record Dates

• First Submitted: December 20, 2020
• First Posted: December 30, 2020
• Study Start: January 15, 2021
• Primary Completion: December 30, 2021
• Study Completion: December 30, 2021
• Last Updated: December 30, 2021

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)