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Trial registered on ANZCTR


Registration number
ACTRN12620000329965
Ethics application status
Approved
Date submitted
29/11/2019
Date registered
10/03/2020
Date last updated
10/03/2020
Date data sharing statement initially provided
10/03/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Cost-effectiveness of "Tele-Square Step Exercise" for falls prevention in fibromyalgia patients
Scientific title
Cost-effectiveness of "Tele-Square Step Exercise" for falls prevention in fibromyalgia patients
Secondary ID [1] 299941 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Fibromyalgia 315389 0
Condition category
Condition code
Public Health 313684 313684 0 0
Health service research
Musculoskeletal 313685 313685 0 0
Other muscular and skeletal disorders
Neurological 313686 313686 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Experimental group will receive Tele-Square Step Exercise training (Tele-SSE), three times per week and during 12 months. Each training session will have a duration close to 50 minutes. They will be given training guidelines through a booklet designed specifically for this study and the session will be tracked through video-conferencing on a mobile phone. The intervention will be administered by a graduate in Physical Activity and Sports Sciences. Two to six patients will simultaneously perform the exercise protocol in the same place, which will be normally a room or dependency yielded by each participating association, including Internet connection via WIFI. The SSE intensity will be given by the movement patterns difficulty, distinguishing three different levels: beginner, intermediate and advanced. There will be a progression in the levels in the proposed intervention. People should not step on the dividing lines of squares. The number of steps patterns and difficulty will increase monthly until achieving the maximum level, which will be maintained until the end of the intervention. A checklist will be used by the study personnel in order to control the participants' adherence to the intervention.
Once the randomized controlled trial has been carried out, and considering its preliminary results, a focus group will be set up around questions previously drawn up by the research group, in order to determine the acceptability of Tele-SSE in the social-sanitary system agents. Key factors will also be identified for its transfer to the public and private social-sanitary system.
Intervention code [1] 316209 0
Treatment: Other
Comparator / control treatment
Control group will continue with the treatment carried out within the public health system ("usual care").
Control group
Active

Outcomes
Primary outcome [1] 322115 0
Incremental cost-effectiveness ratio: Division of the difference between the average costs of both groups by the difference in average Quality Adjusted Life Years (QALYs) gained in both groups. QALYs is calculated multiplying the life years (life expectancy) and participants' quality of life. Health-related quality of life using the EQ-5D-5L questionnaire.
Timepoint [1] 322115 0
One week before the first Tele-SSE session and every 3 months during the 12-month intervention period. In addition, an additional follow-up measure 1 month after the end of the intervention period. The primary timepoint will be 12-month after the beggining of the intervention.
Primary outcome [2] 322116 0
Applicability and safety: Percentage of participants who are able to perform the proposed training and registration of any incidence, injury or problem and origin arising during each session, respectively. A field diary will be used for this purpose.
Timepoint [2] 322116 0
After the 12-month intervention period and an additional follow-up measure 1 month after the end of the intervention period. The primary timepoint will be 12-month after the beggining of the intervention.
Primary outcome [3] 322117 0
Number of falls in the past year and six months: participants will be asked how many falls they have suffered in the last year. It will be adopted the WHO definition of falls: "involuntary events that cause the body to lose balance and find the body on land or another firm surface that stops it.
Timepoint [3] 322117 0
One week before the first Tele-SSE session and every 3 months during the 12-month intervention period. In addition, an additional follow-up measure 1 month after the end of the intervention period. The primary timepoint will be 12-month after the beggining of the intervention.
Secondary outcome [1] 377402 0
Sociodemographic data: questionnaire asking age, income, time of diagnosis of the disease, educational level, marital status.
Timepoint [1] 377402 0
Before the starting of the intervention period.
Secondary outcome [2] 377403 0
Balance: balance will be measured using the 2.40-m, 3-m and 10-m versions of the Timed Up-and-Go test, the one-leg stance test with open and closed eyes, the Four-step Square test (FSST), the Berg Balance Scale (BBS) and the Activity-specific Balance Confidence scale (ABC).
Timepoint [2] 377403 0
At the beginning and every 3 months during the 12-month intervention period. In addition, an additional measure 1 month after the end of the intervention period.
Secondary outcome [3] 377404 0
Fear of falling: Fear of falling will be measured using the Falls Efficacy Scale International (FES-I), and the Visual Analogue Scale for Fear of Falling (VAS-FOF).
Timepoint [3] 377404 0
At the beginning and every 3 months during the 12-month intervention period. In addition, an additional measure 1 month after the end of the intervention period.
Secondary outcome [4] 377405 0
Body Composition: A composite of outcomes will be used to assess this variable. Height and weight will be measured using a stadiometer (Seca 22, Hamburg, Germany). The circumference of the waist and hips using an anthropometric tape (Harpenden, Holtain Ltd). The hip circumference (cm) will also be evaluated and a bioimpedanciometer (Tanita) to evaluate body composition.
Timepoint [4] 377405 0
At the beginning and every 3 months during the 12-month intervention period. In addition, an additional measure 1 month after the end of the intervention period.
Secondary outcome [5] 377406 0
6-minute walking test. This test is a submaximal exercise test that entails measurement of distance walked over a span of 6 minutes. The 6 MWT provides information regarding functional capacity, response to therapy and prognosis across a broad range of chronic cardiopulmonary conditions.The test will carry out using dual-task.
Timepoint [5] 377406 0
At the beginning and every 3 months during the 12-month intervention period. In addition, an additional measure 1 month after the end of the intervention period.
Secondary outcome [6] 377407 0
Pain: It will be evaluated by pressure at the different trigger points. This will require an algometer that can evaluate the pressure exerted at these points, such as the Force Ten FDX (Wagner Instrument). The evaluator will have undergone measurement training prior to the initial measurements. In addition, a Visual Analog Pain Scale will be used.
Timepoint [6] 377407 0
At the beginning and every 3 months during the 12-month intervention period. In addition, an additional measure 1 month after the end of the intervention period. Moreover, the Visual Analog Scale of pain will also be used to ask about the level of pain before and after each training session.
Secondary outcome [7] 377408 0
To assess the health-related quality of life (HRQoL), the 15-D questionnaire will be applied: It is a generic instrument for measuring HRQoL among adults. It comprises 15 dimensions: mobility, vision, hearing, breathing, sleeping, eating, speech, elimination, usual activities, mental function, discomfort and symptoms, depression, distress, vitality, and sexual activity. The score can be represented as a single utility score, which ranges from 0 (death) to 1 (full health). This score can be used to perform a cost-effectiveness analysis.
Timepoint [7] 377408 0
At the beginning and every 3 months during the 12-month intervention period. In addition, an additional measure 1 month after the end of the intervention period.
Secondary outcome [8] 377409 0
Impact of fibromyalgia. This will be measured using the Fibromyalgia Impact Questionnaire (FIQ), which is a 10-item, self-administered instrument that covers three domains: function, overall impact and symptoms.
Timepoint [8] 377409 0
At the beginning and every 3 months during the 12-month intervention period. In addition, an additional measure 1 month after the end of the intervention period.
Secondary outcome [9] 377411 0
Depression: It will be assessed using the Geriatric Depression Scale (GDS) has been used on Fibromyalgia research because it is less focus on somatic symptoms than other depression questionnaires and could, therefore, be a more accurate assessment of depressive symptoms in Fibromyalgia patients independently of their health complaints.
Timepoint [9] 377411 0
At the beginning and every 3 months during the 12-month intervention period. In addition, an additional measure 1 month after the end of the intervention period.
Secondary outcome [10] 377412 0
Happiness: It will be assessed by using the General Happiness Scale and the Satisfaction with Life Scale (SWLS).
Timepoint [10] 377412 0
At the beginning and every 3 months during the 12-month intervention period. In addition, an additional measure 1 month after the end of the intervention period.
Secondary outcome [11] 377413 0
Physical activity and sedentary behaviors: A composite of instruments will be used to evaluate this variable.
a) Leisure time physical activity: The questionnaire "Leisure time physical activity instrument" (IAFTL) will be used to evaluate the physical activity carried out by the subjects in their leisure time.
b) Physical Activity at Home and at Work: The "Instrument for Physical Activity at Home and at Work" (IAFCL) questionnaire will be used to assess the physical activity performed by subjects at home and at work.
c) Sedentary Behavior Questionnaire: Evaluates the amount of time spent on 11 behaviors. The 11 elements will be completed separately for weekdays and weekends. Response options are none, 15 minutes or less, 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours, or 6 hours or more. The time spent on each behavior will be converted into hours (e.g., a 15-minute response will be recorded as 0.25 h). For total sedentary behaviour scores, the hours per day for each item will be summed separately for weekdays and weekends. To obtain weekly estimates, working day hours will be multiplied by 5 and weekend hours will be multiplied by 2 and added by total hours/week.
Timepoint [11] 377413 0
At the beginning and every 3 months during the 12-month intervention period. In addition, an additional measure 1 month after the end of the intervention period.
Secondary outcome [12] 377414 0
Cognitive Aspects: It will be administered the short Brief International Cognitive Assessment for MS (BICAMS), which includes the oral version of the Symbol Digit Modalities Test, the Brief Visuospatial Memory Test (BVMT), and the California Verbal Learning Test (CVLT) will represent cognitive endpoints.
Timepoint [12] 377414 0
At the beginning and every 3 months during the 12-month intervention period. In addition, an additional measure 1 month after the end of the intervention period.
Secondary outcome [13] 377415 0
Clinical Global Impression: Improvement due to interventions will be measured using the Patient Global Impression of Improvement Scale (PGI-I), which uses a Likert scale.
Timepoint [13] 377415 0
At the beginning and every 3 months during the 12-month intervention period. In addition, an additional measure 1 month after the end of the intervention period.
Secondary outcome [14] 378962 0
Lower body strength: It will be measured using the "30-s Chair Stand Test". The test will carry out using dual-task.
Timepoint [14] 378962 0
At the beginning and every 3 months during the 12-month intervention period. In addition, an additional measure 1 month after the end of the intervention period.
Secondary outcome [15] 378963 0
Upper body strength: It will be assessed using the "Arm Curl Test". The test will carry out using dual-task.
Timepoint [15] 378963 0
At the beginning and every 3 months during the 12-month intervention period. In addition, an additional measure 1 month after the end of the intervention period.
Secondary outcome [16] 378964 0
Trunk endurance: It will be assessed by using the method proposed by Ito, Shirado. To evaluate the strength of the flexor muscle of the trunk, participants are asked to lie supine and raise their lower limbs with 90 flexion degrees on hip and knee and; in order to evaluate the resistance of the extensor muscles, patients lie down in pronation. In both cases, participants are asked to move their shoulders away from the ground by bending or extending the trunk. They should hold this position as long as possible, without exceeding 5 min. The test will carry out using dual-task.
Timepoint [16] 378964 0
At the beginning and every 3 months during the 12-month intervention period. In addition, an additional measure 1 month after the end of the intervention period.
Secondary outcome [17] 378965 0
Upper body flexibility: It will be assessed using the "Back Scratch Test". The test will carry out using dual-task.
Timepoint [17] 378965 0
At the beginning and every 3 months during the 12-month intervention period. In addition, an additional measure 1 month after the end of the intervention period.
Secondary outcome [18] 378966 0
Lower body flexibility: It will be measured using the “Chair Sit-and-Reach Test”. The test will carry out using dual-task.
Timepoint [18] 378966 0
At the beginning and every 3 months during the 12-month intervention period. In addition, an additional measure 1 month after the end of the intervention period.
Secondary outcome [19] 378967 0
Velocity: The time needed to walk 10m is recorded in the modified "Brisk Walking Test" as a measure of velocity. The test will carry out using dual-task.
Timepoint [19] 378967 0
At the beginning and every 3 months during the 12-month intervention period. In addition, an additional measure 1 month after the end of the intervention period.
Secondary outcome [20] 378968 0
Functional range: It will be measured using the Functional Reach Test. The test will carry out using dual-task.
Timepoint [20] 378968 0
At the beginning and every 3 months during the 12-month intervention period. In addition, an additional measure 1 month after the end of the intervention period.
Secondary outcome [21] 378969 0
Short Physical Performance Battery (SPPB): battery composed of 3 direct observation tests that are walking speed, balance and time to get up 5 times from a chair. The test will carry out using dual-task.
Timepoint [21] 378969 0
At the beginning and every 3 months during the 12-month intervention period. In addition, an additional measure 1 month after the end of the intervention period.
Secondary outcome [22] 378970 0
Self-perceived physical fitness: International Fitness Scale-IFIS. The test will carry out using dual-task.
Timepoint [22] 378970 0
At the beginning and every 3 months during the 12-month intervention period. In addition, an additional measure 1 month after the end of the intervention period.
Secondary outcome [23] 379875 0
Revised Fibromyalgia Impact Questionnaire (FIQ-R). It has the same three domains but differs in some points. The dimension “function” was reduced from 10 to 9 items and modified. The overall impact domain was completely revised to better reflect the overall impact on functional ability and on the perception of reduced function. Four additional items were added to the dimension “symptoms”: tenderness, memory, balance and environmental sensitivity.
Timepoint [23] 379875 0
At the beginning and every 3 months during the 12-month intervention period. In addition, an additional measure 1 month after the end of the intervention period.
Secondary outcome [24] 379876 0
To assess the health-related quality of life (HRQoL), the SF-12v2: questionnaire will be used. It is a generic instrument for assessing HRQoL covering physical and mental aspects of health. It is an abbreviated version of the SF-36, which consist of 12 items. It comprises 6 dimensions: physical functioning, role limitations, social functioning, pain, mental health, and vitality. A single utility score, specific of the Spanish population, can be calculated for cost-effectiveness analysis from this questionnaire.
Timepoint [24] 379876 0
At the beginning and every 3 months during the 12-month intervention period. In addition, an additional measure 1 month after the end of the intervention period.
Secondary outcome [25] 379877 0
To assess the health-related quality of life (HRQoL), the EQ-5D-5L questionnaire will be applied. It is a generic utility-based instrument for assessing HRQoL. It comprises five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression; and five levels of severity in each dimension. The current health state of the patients (the health state felt the day of the evaluation) is assessed through a Visual Analogue Scale (VAS) from 0 (worst imaginable health status) to 100 (best imaginable health status).
Timepoint [25] 379877 0
At the beginning and every 3 months during the 12-month intervention period. In addition, an additional measure 1 month after the end of the intervention period.
Secondary outcome [26] 379878 0
To assess the health-related quality of life (HRQoL), the Health Utilities Index Mark 3 (HUI3) questionnaire will be used. It is a generic utility-based instrument for assessing HRQoL. It comprises 8 dimensions, including vision, hearing, speech, ambulation, dexterity, emotion, cognition, and pain. These attributes range from five or six levels of health states for each attribute. HUI-3 is capable of identifying 972,000 unique health states. A level 1 response indicates the best possible health state for a given attribute while the highest level indicates the worst possible health state.
Timepoint [26] 379878 0
At the beginning and every 3 months during the 12-month intervention period. In addition, an additional measure 1 month after the end of the intervention period.

Eligibility
Key inclusion criteria
A woman diagnosed with fibromyalgia by a rheumatologist, meet the diagnostic criteria of the American College of Rheumatology, not be physically active as defined by WHO during the previous 3 months, have the ability to walk and communicate on her own, and have access to a telephone in which video-conferencing can be conducted.
Minimum age
18 Years
Maximum age
66 Years
Gender
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Present any pathology that contraindicates the exercise program or requires special attention (coronary pathologies, thrombosis, bone, renal, moderate or severe pulmonary, etc.) or the use of psychotropics or that affects the vestibular system (Parkinson's, etc.).

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Randomization sequence will be prepared by a member of the research team without clinical participation in the trial. The assignment will be hidden in a password-protected computer file.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?

The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis
Sample calculation: To carry out the sample calculation, version 7.12 of the GRANMO sample size calculator has been used (https://www.imim.es/ofertadeserveis/software-public/granmo/).
Statistical analysis: The baseline characteristics of the study participants will be presented as mean (standard deviation) for continuous variables and proportions for categorical variables. Two types of analysis will be performed: 1) an intention-to-treat analysis with all participants and 2) a "per-protocol" analysis with only those who complete the study.
a) Intention to treat analysis: this analysis will include all participants randomly assigned to the analysis. Multiple imputations will be used to impute lost data. The effects of the intervention on the main variable and the secondary variables will be evaluated through analysis of repeated measures of covariance adjusted for age and initial values. The results shall include the effect size (95% confidence interval) and statistical significance for each measure of the study with respect to time and its interaction effects (group × time). The statistical significance shall be established at the conventional level of p < 0,05. In sensitivity analyses, the imputation of the data will be made from the baseline patient data and from those who completed the study, in order to avoid estimation biases.
b) Analysis by protocol: Analyses similar to those described above will be carried out, but only in those participants who have attended at least 75% of the sessions.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 22151 0
Spain
State/province [1] 22151 0

Funding & Sponsors
Funding source category [1] 304404 0
Government body
Name [1] 304404 0
European Commission
Address [1] 304404 0
European Commission,DG Employment, Social Affairs & Inclusion, European Social Fund, B-1049 Brussels.
Country [1] 304404 0
Belgium
Funding source category [2] 304408 0
Government body
Name [2] 304408 0
Secretaría General de Ciencia, Tecnología e Innovación
Address [2] 304408 0
Paseo de Roma, s/n, Módulo A, 3ª PLANTA, 06800 Mérida, Badajoz.
Country [2] 304408 0
Spain
Primary sponsor type
University
Name
Health, Economy, Motricity and Education (HEME), Faculty of Sport Sciences, University of Extremadura
Address
Avda. de la universidad s/n - 10003 Caceres.
Country
Spain
Secondary sponsor category [1] 304663 0
None
Name [1] 304663 0
Address [1] 304663 0
Country [1] 304663 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304841 0
Comité de Bioética y Bioseguridad de la Universidad de Extremadura
Ethics committee address [1] 304841 0
Vicerrectorado de Investigación, Transferencia e Innovación, Campus Universitario, Avenida de Elvas, s/n, 06071, Badajoz
Ethics committee country [1] 304841 0
Spain
Date submitted for ethics approval [1] 304841 0
Approval date [1] 304841 0
06/07/2018
Ethics approval number [1] 304841 0
79/2018

Summary
Brief summary
The aims of this project are to investigate the applicability, safety, falls incidence, and incremental cost-effectiveness ratio of a prevention of falls program through Tele-SSE in women with fibromyalgia. A randomized controlled trial with experimental (Tele-SSE) and control (usual treatment) groups will be carried out. A focus group will include agents to identify key points to transfer the findings to the public and private sectors in Extremadura. The hypothesis is that this project will improve the efficiency and equity of physical therapy services based on tele-exercise in preventing falls in people with fibromyalgia and will reduce the expenses in the health system by an increase in the cost-effectiveness of the treatment used.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 98378 0
Dr José Carmelo Adsuar Sala
Address 98378 0
Health, Economy, Motricity and Education (HEME)
Faculty of Sport Sciences
University of Extremadura
Avda. de la Universidad s/n - 10003 Caceres
Country 98378 0
Spain
Phone 98378 0
+34 927 257460
Fax 98378 0
Email 98378 0
jadssal@unex.es
Contact person for public queries
Name 98379 0
Dr Jorge Carlos Vivas
Address 98379 0
Health, Economy, Motricity and Education (HEME)
Faculty of Sport Sciences
University of Extremadura
Avda. de la Universidad s/n - 10003 Caceres
Country 98379 0
Spain
Phone 98379 0
+34 927 257460
Fax 98379 0
Email 98379 0
jorgecv@unex.es
Contact person for scientific queries
Name 98380 0
Dr Jorge Carlos Vivas
Address 98380 0
Health, Economy, Motricity and Education (HEME)
Faculty of Sport Sciences
University of Extremadura
Avda. de la Universidad s/n - 10003 Caceres
Country 98380 0
Spain
Phone 98380 0
+34 927 257460
Fax 98380 0
Email 98380 0
jorgecv@unex.es

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Ensure the exclusive use of data by the research group.
What supporting documents are/will be available?
Study protocol
Ethical approval
How or where can supporting documents be obtained?
Type [1] 5919 0
Study protocol
Citation [1] 5919 0
Link [1] 5919 0
Email [1] 5919 0
jorgecv@unex.es
Other [1] 5919 0
Attachment [1] 5919 0
Type [2] 5921 0
Ethical approval
Citation [2] 5921 0
Link [2] 5921 0
Email [2] 5921 0
jorgecv@unex.es
Other [2] 5921 0
Attachment [2] 5921 0
Summary results
No Results