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

NCT ID: NCT04690400

Last Updated: 2021-12-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-15

Study Completion Date

2021-12-30

Brief Summary

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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.

Detailed Description

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Conditions

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Fibromyalgia Fibromyalgia, Primary

Keywords

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Stretching exercise Telehealth

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
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.

Study Groups

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Active care group

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.

Group Type EXPERIMENTAL

Experimental: Active care group

Intervention Type 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

Self-care group

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.

Group Type ACTIVE_COMPARATOR

Active Comparator: Self-care group

Intervention Type 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.

Interventions

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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

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

30 Years

Maximum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Federal University of Pelotas

OTHER

Sponsor Role lead

Responsible Party

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Cristine Lima Alberton

PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Cristine L Alberton, PhD

Role: PRINCIPAL_INVESTIGATOR

Federal University of Pelotas

Locations

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Escola Superior de Educação Física

Pelotas, Rio Grande do Sul, Brazil

Site Status

Countries

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Brazil

Related Links

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http://doi.org/10.1016/j.apunts.2017.07.001

Therapeutic physical exercise and supplements to treat fibromyalgia.

http://doi.org/10.1186/s12891-018-2047-1

Controlled, cross-sectional, multi-center study of physical capacity and associated factors in women with fibromyalgia

http://doi.org/10.1016/j.apmr.2020.06.019

Effectiveness of exercise on fatigue and sleep quality in fibromyalgia: a systematic review and meta-analysis of randomised trials.

http://doi.org/10.1186/s13063-018-3037-1

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.

http://doi.org/10.1016/j.jbspin.2020.02.005

Progress towards improved non-pharmacological management of fibromyalgia.

http://doi.org/10.1007/s11845-019-02138-w

What happens to muscles in fibromyalgia syndrome

Other Identifiers

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39305720.9.0000.5313

Identifier Type: -

Identifier Source: org_study_id