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Trial registered on ANZCTR


Registration number
ACTRN12617000858392
Ethics application status
Approved
Date submitted
15/06/2016
Date registered
9/06/2017
Date last updated
9/06/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Ageing and Folk Dances from the Basque Country: Functional and neuropsychological changes. A controlled trial.
Scientific title
Folk dances from the Basque Country and habitual physical activity to impove sensorimotor, and neurophsychological performance in a population sample of community living adults over 60 years'
Secondary ID [1] 289387 0
None
Universal Trial Number (UTN)
Trial acronym
EDAN Dantzak
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Prevention of Physical and functional decline in older adults 299031 0
Prevention of cognitive decline in older adults 299086 0
Physiological Fall risk 299140 0
Condition category
Condition code
Physical Medicine / Rehabilitation 299087 299087 0 0
Physiotherapy
Public Health 299088 299088 0 0
Other public health
Physical Medicine / Rehabilitation 299117 299117 0 0
Speech therapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention group participants will be enrolled for the first time in Folk dances from the Basque Country. The lessons will be taken in official schools. They will receive lessons in groups delivered by a licenced experienced dance professor that supervise and control each lesson during the intervention period.
The participants receive one dance lesson of 90 min per week for 32 weeks.
The lessons are performed in stable groups of 12-14 participants per lesson leaded by the same professor.
To monitor adherence a registry of attendance to dance lessons will be used.
To analyse the intensity of dance lessons and obtain heart rate watches and heart rate sensors will be used every 10 classes.
The participants will be encouraged to continue with their habitual routines, and regular activities including physical activities.
Intervention code [1] 294976 0
Prevention
Intervention code [2] 295003 0
Lifestyle
Intervention code [3] 295004 0
Treatment: Other
Comparator / control treatment
The control group are friends or family members from the intervention group (at baseline they should have: similar age, daily-life physical activity and same sex as intervención group). They have ever been involved in a continuous activity related with dances (folk, social, salon...jazz, ball-dance) or exercise with musical accompaniment
After the baseline test, the control group will receive three hours of class over multiple sessions. An exercise physiology or physiyotherapist will be responsible of the lessons. During the first class (on the 1st intervention week) the participants will be taught on the minimum requirements of physical activity for health according to the WHO guide 2010. During the second session (on week 4) they will be given advise on exercise safety: footwear and clothing, hydration and nutrition, on the signs and symtoms to stop exercise and, safety under hot or cold weather conditions.
During the third class (once the program has finished and results of the study analyzed) they will be informed on the effects of dance and folk dances from the basque Country.
They will be advised to preserve their regular routines during the 32 weeks follow up intervention period and also the year after the conclusion of intervention.
Control group
Active

Outcomes
Primary outcome [1] 298554 0
The Low-tech Choice Stepping Reaction Time:
One short functional tests that requires the subject to perform quick, correctly targeted steps in response to verbal cues. Errors and Time will be recorded.
We will look at mean step time and SD mean step time, both them form step 9 to step 20.
Timepoint [1] 298554 0
Baseline and after 50hr folk dance lesson (32 weeks) and one year post intervention
Primary outcome [2] 298556 0
Functional aerobic capacity will be tested with the six minute walk test.
The test will be developed indoor on a quiete place on a flat, hard and firm sufrace. The walkway round (30m).
Timepoint [2] 298556 0
Baseline and after 50hr folk dance lesson (32 weeks) and one year post intervention
Primary outcome [3] 298636 0
Cognitive function - Trail Making Test A and B
Time to complete the Trail Making Test (TMT, part A and B) will be assessed. The TMT A and B is an executive functioning tests. Part A measures processing speed and involves participants connecting consecutive numbers (e.g., 1-2-3), and Part B is a measure of executive function and involves participants connecting alternating letters and numbers (e.g.,1-A-2-B). The difference in time between the two parts will be calculated to isolate the executive component of this test.
Timepoint [3] 298636 0
Baseline and fter 50hr folk dance lesson (32 weeks) and one year post intervention
Secondary outcome [1] 324576 0
Mobility Walking adaptability
Gait adaptability will be registered with Gaitrite. The participant will be tested under different conditions while walking: habitual and maximum gait speed (temporal demand), steping over an obstacle (obstacle negociation), with horizontal head turns (postural transitions demands) a test adapted from the dynamic gait index.
Step and stride spatial (length, with) and temporal (time) and gait simetry parameters will be obtained to analyze intraindividual variability.
Timepoint [1] 324576 0
Baseline and after 50hr folk dance lesson (32 weeks) and one year post intervention period.
Secondary outcome [2] 324577 0
Physiological Profile Assessment (PPA)
The PPA comprises of five tests which provide a multifactorial falls risk score: Vision (edge contrast sensitivity), peripheral sensation (proprioception), lower extremity strength (knee extension), simple reaction time using figure press as the response, and body sway when standing on the medium-density foam rubber mat, which is a measure of balance.
PPA QuickScreen (Copyright) test
Timepoint [2] 324577 0
Baseline and after 50hr folk dance lesson (32 weeks) and one year post intervention period.
Secondary outcome [3] 324578 0
The *Short Physical Performance Battery" (SPPB). The battery compromises functional performance: balance, mobility and strength test. The participants are required to keep balance for 10sc in different positions side by side, semitandem and tandem and the test will be perform for a maximum of 30 seconds. The time to complete a 4m walk test and to complete 5 sit-to-stand repetitions from a chair will be record.
Posturographic analysis will be obtained for balance test with Force Plates (Bertec). Gait analysis will be registered with gaitrite and sit to stand test will be registered with force Plates (Bertec)
Timepoint [3] 324578 0
Baseline and after 50hr folk dance lesson (32 weeks) and one year post intervention period.
Secondary outcome [4] 324820 0
Rey Auditory Verbal Learning test (RAVLT). The test evaluates verbal learning and memory, including proactive inhibition, retroactive inhibition, retention, encoding versus retrieval, and subjective organisation. The test starts with a list of 15 words, which an examiner reads aloud at the rate of one per second. The participant's task is to repeat all the words he or she can remember, in any order. This procedure is carried out a total of five times. Then the examiner presents a second list of 15 words, allowing the participant only one attempt at recall. Immediately following this, the patient is asked to remember as many words as possible from the first list
Timepoint [4] 324820 0
Baseline and after 50hours of folk dance lessons and one year post intervention
Secondary outcome [5] 324821 0
Muscle synergy will be tested across the leg and trunk mucles. Neuromuscular changes will be tests with special attention to muscle synergies multi-muscle coordination patterns across the leg and trunk will be tested in musculus gastrocnemius, anterior tibialis y long peroneus, tensor of the fascia lata, vastus medialis, vastus lateralis paravertebral muscles, musculatura paravertebral, Sternocleidomastoid with wireless electromyography (EMG) MYON 320 with 16 channels in order to determine postural strategies to regain balance, stepping or walking.
Timepoint [5] 324821 0
Baseline and after 50hours of folk dance lessons and one year post intervention.
Secondary outcome [6] 324822 0
Dygit span test: is the longest list of items that a person can repeat back in correct order immediately after presentation on 50% of all trials. Items may include words, numbers, or letters. The task is known as digit span when numbers are used. And we will also use the Backward memory span wich is a more challenging variation which involves recalling items in reverse order.
Timepoint [6] 324822 0
Baseline, and after 50hr folk dance lesson (32 weeks) and one year post intervention.
Secondary outcome [7] 324826 0
The quick screen is a multifactorial assessment tool that consists of the following measures:
1) previous falls The participant is asked about the number of falls during the year previous,
2) medication usage: the participant is asked about the number o medications and the use of medications that affect the nervous system like Sleeping tablet or anti-depressant or Major tranquilisers
3) Visual acuity is measured using a chart with low-contrast (10%) letters (similar to a Snellen scale). The client must be able to correctly identify all of the letters on each
4) Sensation (Tactile sensitivity test involves the use of a pressure aesthesiometer placed on the lateral malleolus of the ankle of the dominant side) ,
5)lower limb strength (5 rep sit-to-stand),
6). balance and co-ordination and requires to test the alternate step (8-repetitions)and the near tandem for 10sc.
The assessment allows for the identification of people who are at a high risk of falling, in addition to its ability to determine which specific factors contribute to that risk
Timepoint [7] 324826 0
Baseline, and after 50hr folk dance lesson (32 weeks) and one year post intervention.
Secondary outcome [8] 324827 0
The Geriatric Depression Scale (GDS) long form is a brief, 30-item questionnaire in which
participants are asked to respond by answering yes or no in reference to how they felt over the past week. The GDS may be used with healthy, medically ill and mild to moderately cognitively impaired older adults. It has been extensively used in community, acute and long-term care settings. Scores of 0-4 are considered normal, depending on
age, education, and complaints; 5-8 indicate mild depression; 9-11 indicate moderate depression; and 12-15 indicate severe depression
Timepoint [8] 324827 0
Baseline, and after 50hr folk dance lesson (32 weeks) and one year post intervention.
Secondary outcome [9] 324828 0
Fear of falling. The Iconogrphyical Falls Efficacy Scale (ICON-FES) tool will be usted to Concern about falling on 30 daily activities (Including indoor, outdoor, social, risky ADL) and using pictures as visual cues will be tested. The participant score their fear of falling on a scale from 1 to 4 where 1 is Not at all concerned and 4 very concern.
Timepoint [9] 324828 0
Baseline, and after 50hr folk dance lesson (32 weeks) and one year post intervention.
Secondary outcome [10] 334777 0
The Time up and go is a simple test used to assess a person's mobility. It measures the time taken to rise from a chair, walk three metres, turn around, walk back to the chair, and sit down.
Timepoint [10] 334777 0
Baseline, and after 50hr folk dance lesson (32 weeks) and one year post intervention.
Secondary outcome [11] 334778 0
Depression and anxiety:
The Goldberg Depression and Anxiety Scales give scores of 0 to 9 for the number of symptoms of depression and of anxiety. Each item is answered with a 'yes/no' response. Items are scored 0 (no) or 1 (yes) and summed
Timepoint [11] 334778 0
Baseline, and after 50hr folk dance lesson (32 weeks) and one year post intervention.
Secondary outcome [12] 334779 0
Falls
The number of falls, time to first fall and consequences associated to falls will be recorded with monthly calendars.
Timepoint [12] 334779 0
During the intervention period and one year post intervention.
Secondary outcome [13] 334780 0
The IPAQ questionnaire adapted to the Spanish language will be used to calculate sedentary time (mean minutes per day seated) and Physical Activity (minutes per week) in three different types of intensities (vigorous, moderate and walking). Total physical activity represents the sum time (min·week) of all three intensities
Timepoint [13] 334780 0
Baseline, and after 50hr folk dance lesson (32 weeks) and one year post intervention.

Eligibility
Key inclusion criteria
Community living men and women, over 60 years with independence to walk continuously for 6 minutes without walking aids.
Less than 4 risk factors determined by Quick screen (copyright)
Physically active (150min physical activity per week)
All participants must have high physical performance (score 9 or more in the Short Physical Performance Battery).
The control group must be family or friends of the participant, aged 60 and over.
Previous the begining of the intervention, neither participants in control grupo nor the participants in the intervention group, could have been involved during the previous year in any continuos (weekly) activity related with dances or with music accompaniment.
Minimum age
60 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Participants in both groups will be excluded if they can not
Be able to cover 6min walk test without Aaids,
Walk 8m test over or equal to 1m per second velocity
Have high fall risk determined by quick screen (4 or more fall risk factors),
Have cognitve impairment determined by MMSE <24,
Terminal disease
Unestable medical conditions involving neuromuscular skeletal or cardiovascular system
Neurodegenerative disease
Absolute or relative contraindicaciones for exercise,
Participants enrolled previously in dance activities, or with music involvement (i.e. Aerobic, step,...), also those in the control group that become participats of dance activities during intervention period or follow up.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
For continuous variables with skewed distributions, data will be transformed and analyses will be performed with the normalized data. Independent t-tests (for continuous data), Chi square or Mann Whitney tests (for categorical data or ordinal variables) will be used to determine differences between the intervention and control groups at baseline.
Analysis of covariance (ANCOVA) will be used to compare the effect of the intervention on outcome measures at follow-up adjusting for baseline values. Possible dose-response relationships were explored using paired t-tests and Analysis of variance for repeated measures (ANOVA). The alpha level will be set at 5%. Analyses will be performed with SPSS (for Windows, IBM Corp)

Regarding the 6MWT the distance covered will be used while the participant maintain the same objective intensity of exercise (determined with whole blood lactate and heart rate) and subjective perceived fatigue (Borg Scale). To confirm the absolute perceived and physiologic absolute intensity some control variables will be obtained. 1) Whole blood lactate will be obtained from the ear lobe (only 0.3µl required) at the begining and at the end of the test. 2) Heart rate will be obtained with heart rate stopwatch and sensors (RS300X) Polar at the begining and at the end of the test. 3) Borg dyspnea and fatigue will be obtained at the begining and end of the test.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
19/06/2017
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment outside Australia
Country [1] 7942 0
Spain
State/province [1] 7942 0
Basque Country and Navarre

Funding & Sponsors
Funding source category [1] 296448 0
University
Name [1] 296448 0
Basque Country University
Country [1] 296448 0
Spain
Primary sponsor type
University
Name
Basque Country University
Address
Barrio Sarriena s/n Leioa-Erandio 48049, Bizkaia
Country
Spain
Secondary sponsor category [1] 295400 0
None
Name [1] 295400 0
Address [1] 295400 0
Country [1] 295400 0
Other collaborator category [1] 279037 0
Government body
Name [1] 279037 0
Bilbao Musika (Local Independent Body dependent from the Council of Bilbao)
Address [1] 279037 0
Calle Sorkunde, 8, 48006 Bilbao, Bizkaia
Country [1] 279037 0
Spain
Other collaborator category [2] 279038 0
Charities/Societies/Foundations
Name [2] 279038 0
EFEI (Ejercicio Físico y Entrenamiento Individualizado) NGO
Address [2] 279038 0
Fuente del Hierro 4, 8B, Pamplona, Navarra
Country [2] 279038 0
Spain

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295250 0
Ethics committee of the Public University of Navarre
Ethics committee address [1] 295250 0
Ethics committee country [1] 295250 0
Spain
Date submitted for ethics approval [1] 295250 0
28/01/2016
Approval date [1] 295250 0
10/02/2016
Ethics approval number [1] 295250 0
PI001/16 Envejecimiento y actividad física: Adaptaciones sensoriomotrices

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 66494 0
Dr Mirian Aranzazu Garrues-Irisarri
Address 66494 0
Medicine and Nursery Faculty
Department of Physiology
University of the Basque Country
Barrio Sarriena s/n
Leioa-Erandio
48049 Bizkaia/Spain
Country 66494 0
Spain
Phone 66494 0
+34 667615026
Fax 66494 0
Email 66494 0
magarruesi@hotmail.com
Contact person for public queries
Name 66495 0
Mirian Aranzazu Garrues-Irisarri
Address 66495 0
Medicine and Nursery Faculty
Department of Physiology
University of the Basque Country
Barrio Sarriena s/n
Leioa-Erandio
48049 Bizkaia/Spain
Country 66495 0
Spain
Phone 66495 0
+34 667615026
Fax 66495 0
Email 66495 0
mirianaranzazu.garrues@ehu.es
Contact person for scientific queries
Name 66496 0
Mirian Aranzazu Garrues-Irisarri
Address 66496 0
Medicine and Nursery Faculty
Department of Physiology
University of the Basque Country
Barrio Sarriena s/n
Leioa-Erandio
48049 Bizkaia/Spain
Country 66496 0
Spain
Phone 66496 0
+34 667615026
Fax 66496 0
Email 66496 0
mirianaranzazu.garrues@ehu.es

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