Clinical Trials Logo

Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04690400
Other study ID # 39305720.9.0000.5313
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date January 15, 2021
Est. completion date December 30, 2021

Study information

Verified date December 2021
Source Federal University of Pelotas
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 28
Est. completion date December 30, 2021
Est. primary completion date December 30, 2021
Accepts healthy volunteers No
Gender Female
Age group 30 Years to 60 Years
Eligibility 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.

Study Design


Intervention

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
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.

Locations

Country Name City State
Brazil Escola Superior de Educação Física Pelotas RS

Sponsors (1)

Lead Sponsor Collaborator
Federal University of Pelotas

Country where clinical trial is conducted

Brazil, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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 Symptom Severity Scale Symptom Severity, based on analyzing the primary symptoms reported in fibromyalgia, such as fatigue, sleep, and cognition, is considered a diagnostic criterion, with a sensitivity of 90.9% and specificity of 85.9% (HEYMANN et al., 2017). It comprises four domains, with scores ranging from 0 to 3, and scores above five are considered relevant. Validated by the American College of Rheumatology in 2010 (WOLFE et al., 2010) and recognized by the Brazilian Society of Rheumatology - SBR, 2017. Zero week, six week, and twelve week
Secondary Impact of fibromyalgia on daily activities Fibromyalgia Impact Questionnaire (FIQ) is a survey that looks at the severity of the pathology on the individual's functional capacity and the perception of the quality of life. Their scores range from 0 to 100, where higher values indicate a more significant disease impact. Scores are expressed as follows: from 0 to 38 mild effect, from 39 to 58 moderate effect, and from 59 to 100 severe impact (UMAY et al., 2019) and validated in 1991 by Burckhardt et al., Translated and adapted for the Brazilian version in 2006, by Marques et al. (MARQUES et al., 2006). Zero week, six week, and twelve week
Secondary Depressive symptoms Beck's Depression Inventory (BDI) is a tool whose purpose is to analyze the perception of depressive symptoms, developed and revised in 1996 by Becket al., And validated in the Brazilian version in 2012, by Gomes-Oliveira et al. (GOMES- OLIVEIRA et al., 2012). It includes 21 items, with scores ranging from 0 to 3, where the maximum score is 63, indicating severity. Values between 0 and 13 show minimal symptoms, 14 to 19 medium symptoms, 20 to 28 moderate, and 29 or more indicate severe depression (ALVENTOSA et al., 2020). Among the issues investigated there are feelings of sadness, failure, dissatisfaction, pessimism, self-judgment, distorted body vision, tiredness, lack of appetite, constant concerns, difficulty in work activities, and loss of libido (ANDRADE et al., 2020). Zero week, six week, and twelve week
Secondary Physical activity level The participants' physical activity levels will be measured using the International Physical Activity Questionnaire - IPAQ-C, in its short version, including eight self-administered questions, in different domains such as work, leisure, domestic activities, and physical exercise. The data expressed in minutes, with the metabolic equivalent calculated (1 MET: 3.5 ml/kg/min). As with other questionnaires, we will apply it in electronic format, already tested and proven by previous studies (PIRES et al., 2014). Proposed and validated by the World Health Organization in 1998, it had its Brazilian version in 2001, through the study by Pardini et al. (PARDINIA et al., 2001). Zero week, six week, and twelve week
Secondary Functionality / Flexibility Flexiteste is a tool developed by Araújo and Pavel in 1986 to analyze the flexibility of twenty articular movements of the human body (SALVADOR et al., 2010). Passively performed, with the examiner's aid up to the maximum joint amplitude, will adapt it for the online format, done in an active-assisted way, where the examined person assists the top angle, with the help of the opposite upper limb, with scores from 0 to 4. Higher values indicate increased mobility (ARAÚJO, 1986). The investigator masked will guide the patient's position remotely throughout the test. Zero week, six week, and twelve week
Secondary Painful intensity at rest and movement Pain intensity will be analyzed using the Visual Analog Pain Scale - VAS, which comprises values from 0 to 10, where 0 corresponds to "no pain" and 10 "means the greatest pain imaginable" (HERNÁNDEZ et al., 2019). Being a unidirectional scale allows measuring the pain felt at the test's exact moment (MARTINEZ et al., 2011). The project will be used to check the pain at rest and right after the execution of a movement, aiming to understand the pain behavior before the proposed activity, in three moments: week 0, week six, and week 13. The associated test will elevate the upper limbs, with the hands splayed upwards and the fingers intertwined, using three sustained series of ten seconds, to be performed, together with the examiner's online presence. The EVA will be shown to the participant before the exercise and immediately after. Zero week, six week, and twelve week
Secondary Subjective perception of well-being Will analyze the subjective perception of well-being through a simple question, "in your opinion, how much did participation in the project improve your feeling of general well-being," with structured responses based on the 5-point Likert Scale, varying from "dissatisfied" to "very satisfied." The same will be applied to the two groups in the same format as the questionnaires previously mentioned, through Google Docs, with a link to be made available on a scheduled date and time, through the WhatsApp application. Twelve week
See also
  Status Clinical Trial Phase
Active, not recruiting NCT05659862 - Digitally Assisted Behavioral Physical Activity Intervention in Fibromyalgia N/A
Recruiting NCT03207828 - Testing Interventions for Patients With Fibromyalgia and Depression N/A
Completed NCT03042728 - Impact of Inclusion of a Therapy Dog Visit as Part of the Fibromyalgia Treatment Program N/A
Recruiting NCT06097091 - Effects and Mechanisms of Pain Neuroscience Education in Patients With Fibromyalgia N/A
Recruiting NCT04554784 - Effectiveness of Bowen Therapy for Pain Management in Patients With Fibromyalgia N/A
Completed NCT03300635 - Metabolism, Muscle Function and Psychological Factors in Fibromyalgia N/A
Recruiting NCT06166563 - Exercise, Irritable Bowel Syndrome and Fibromyalgia N/A
Completed NCT03166995 - Postural Exercises in Women With Fibromyalgia N/A
Completed NCT03227952 - Sensory Stimulation in Fibromyalgia N/A
Recruiting NCT06237595 - Vagus Nerve Stimulation in Fibromyalgia N/A
Completed NCT01888640 - Fibromyalgia Activity Study With Transcutaneous Electrical Nerve Stimulation (FAST) N/A
Completed NCT03641495 - Pain Education and Therapeutic Exercise for Fibromyalgia N/A
Recruiting NCT05581628 - FREQUENCY OF FIBROMYALGIA IN PATIENTS WITH CELIAC DISEASE
Active, not recruiting NCT05128162 - Open-label Study to Assess the Safety and Efficacy of Psilocybin With Psychotherapy in Adult Participants With Fibromyalgia Phase 2
Completed NCT04674878 - Comparison of Muscle Energy Techniques and Breathing Exercises for Functional Improvement in Fibromyalgia N/A
Active, not recruiting NCT04084795 - Augmentation of EMDR With tDCS in the Treatment of Fibromyalgia N/A
Completed NCT03129906 - Impact of the Restriction of Sources of Gluten in Fibromyalgia Patients N/A
Completed NCT05058911 - Exposure-based Cognitive Behavior Therapy vs Traditional Cognitive Behavior Therapy for Fibromyalgia N/A
Recruiting NCT04571853 - New Educational Tool for FM N/A
Recruiting NCT04571528 - Effectiveness of VIRTUAL FIBROWALK STUDY N/A