Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618000923268p
Ethics application status
Not yet submitted
Date submitted
8/06/2017
Date registered
31/05/2018
Date last updated
17/06/2019
Date data sharing statement initially provided
17/06/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Folk dances from the Basque Country in Parkinson's community living participants: sensorimotor and neuropsychological changes.
Scientific title
Folk dances from the Basque Country in Parkinson's community living participants: sensorimotor and neuropsychological changes.
Secondary ID [1] 292150 0
'Nil known
Universal Trial Number (UTN)
Trial acronym
FOLK DANCE PARK
Linked study record

Health condition
Health condition(s) or problem(s) studied:
`Prevention of physical and functional decline in Parkinson's disease 303587 0
Prevention of cognitive decline in Parkinson´s disease 303590 0
Physiological fall risk in Parkinson's disease 303591 0
Condition category
Condition code
Neurological 302997 302997 0 0
Parkinson's disease
Physical Medicine / Rehabilitation 303001 303001 0 0
Physiotherapy
Physical Medicine / Rehabilitation 303002 303002 0 0
Physiotherapy

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. They will receive lessons in groups delivered by a licensed experienced dance professor that supervise and control each lesson during the intervention period.
The participants receive two dance lesson of 90 min per week for 20weeks.
The lessons are performed in stable groups of 12-14 participants per lesson led by the same professor.
To monitor continuity a registry of attendance to dance lessons will be used.
To analyze the intensity of dance lessons and obtain heart rate, watches and heart rate sensors will be used every 10 classes.
They will receive three education lessons on physical activity for health, all of them after baseline test.
The lessons will be in a group and over multiple sessions on a lecture class style. An exercise physiologist or physiotherapist will be responsible for them.
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.
The second class (2nd intervention week) the participants will compare their habitual physical activity to the minimum requirements of exercise for health.
The third class (second week) they will be given advice on exercise safety: footwear and clothing, hydration and nutrition, on the signs and symptoms to stop the exercise and, safety under hot or cold weather conditions.
They will be advised to preserve their regular routines and to do 150min per week of physical activity for the 20 weeks follow-up intervention and the year after the conclusion of the intervention.
Monthly calendars will be given to the participants so that they could register physical activity and sedentary time.
The participants will be encouraged to continue with their habitual routines and regular activities including physical activities.
Previous beginning they will receive 3 educational classes on exercise
Intervention code [1] 298296 0
Lifestyle
Intervention code [2] 298297 0
Treatment: Other
Comparator / control treatment
The control group participants are members of Parkinson's Association (ONG) that accept to participate in the study as controls, similar age, daily-life physical activity and same sex as the intervention group. They will continue with their habitual activity and receive the same education lessons on physical activity for health as the dance group, all of them after baseline test and parallel-time to the dance group.
Monthly calendars will be given to the participants so that they could register physical activity and sedentary time daily.
Control group
Active

Outcomes
Primary outcome [1] 302371 0
The Low-tech Choice Stepping Reaction Time:
One short functional tests that require 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 from step 9 to step 20.
Timepoint [1] 302371 0
Baseline and after 50hr folk dance lesson (20weeks) and one-year post-intervention.
Primary outcome [2] 302372 0
Mini-Balance Evaluation Systems Test (Mini-BESTest)
The Mini BESTest assesses dynamic balance, a unidimensional construct and includes 14 items addressing 4 of the 6 sections of the original BESTest (anticipatory postural adjustments, reactive postural control, sensory orientation, dynamic gait). The Mini BESTest is a 14 item test scored on a 3 level ordinal scale. Total score = 28 points per test directions.
Timepoint [2] 302372 0
Baseline and after 50hr folk dance lesson (20 weeks) and one-year post-intervention period.
Primary outcome [3] 302375 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] 302375 0
Baseline and after 50hr folk dance lesson (20 weeks) and one-year post-intervention.
Secondary outcome [1] 335749 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, and body sway when standing on the medium-density foam rubber mat, which is a measure of balance. PPA QuickScreen (Copyright) test.
Timepoint [1] 335749 0
Baseline and after 50hr folk dance lesson (20 weeks) and one-year post-intervention period.
Secondary outcome [2] 335750 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, semi-tandem and tandem and the test will be performed for a maximum of 30seconds. The time to complete a 4m walk test and to complete 5 sit-to-stand repetitions from a chair will be recorded.
The 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 [2] 335750 0
Baseline and after 50hr folk dance lesson (20 weeks) and one-year post-intervention period.
Secondary outcome [3] 335751 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 organization.
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 [3] 335751 0
Baseline and after 50hr folk dance lesson (20 weeks) and one-year post-intervention period.
Secondary outcome [4] 335752 0
Digit span test is the longest list of items that a person can repeat back in correct order immediately after the 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 [4] 335752 0
Baseline, and after 50hr folk dance lesson (20 weeks) and one-year post-intervention.
Secondary outcome [5] 335753 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 the 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 [5] 335753 0
Baseline, and after 50hr folk dance lesson (20 weeks), and one-year post-intervention
Secondary outcome [6] 335756 0
The IPAQ questionnaire adapted to the Spanish language will be used to calculate the sedentary time (mean minutes per day seated) and Physical Activity (minutes per week) in three different types of intensities (vigorous, moderate and walking). The total physical activity represents the sum time (min·week) of all three intensities.
Timepoint [6] 335756 0
Baseline, and after 50hr folk dance lesson (20 weeks) and one-year post-intervention.
Secondary outcome [7] 335757 0
Fear of falling. The Iconographical Falls Efficacy Scale (ICON-FES) tool will be used 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 scores their fear of falling on a scale from 1 to 4 where 1 is Not at all concerned and 4 very concern.
Timepoint [7] 335757 0
Baseline, and after 50hr folk dance lesson (20 weeks) and one-year post-intervention
Secondary outcome [8] 335758 0
Functional aerobic capacity will be tested with the six-minute walk test. We will use for further analysis the distance covered by the participant.
Timepoint [8] 335758 0
Baseline and after 50hr folk dance lesson (20 weeks) and one-year post-intervention.
Secondary outcome [9] 335759 0
A unified Parkinson's disease rating scale (UPDRS) will be used for neurological examination of Parkinson's disease.
Timepoint [9] 335759 0
Baseline and after 50hr folk dance lesson (20 weeks) and one-year post-intervention
Secondary outcome [10] 335760 0
The Hoehn and Yahr scale will be used to describe symptoms of Parkinson's disease
Timepoint [10] 335760 0
Baseline and after 50hr folk dance lesson (20 weeks) and one-year post-intervention
Secondary outcome [11] 347392 0
The motivation for physical activity and Folk dance activity will be recorded with the Motivation for Physical Activity Measure (MPAM)
Timepoint [11] 347392 0
Baseline and 20 weeks (after 50 hrs folk dance intervention activity)
Secondary outcome [12] 347451 0
Satisfaction with intervention activity will be assessed with the Physical activity enjoyment scale (PACES)
Timepoint [12] 347451 0
20 weeks (50 hrs after folk dance intorvention activity)
Secondary outcome [13] 347452 0
Dance program accomplishment will be recorded with attendance to dance lessons.
Timepoint [13] 347452 0
20 weeks (50 hrs after folk dance intervention activity)
Secondary outcome [14] 347458 0
Adherence to the non-supervised physical activity will be record with brief screening assessment. The participants self report their physical activity by answering if they had met the guidelines for physical activity at baseline time.
Timepoint [14] 347458 0
baseline, every 20 weeks during the intervention period (50 hr dance intervention) and
1 year after dance intervention conclusion.

Eligibility
Key inclusion criteria
Community living men and women, over 50 years with independence to walk continuously for 6 minutes without walking aids, and able to cover 300m.
Walk 8m test over or equal to 0.8m per second velocity
Participants have to score between 1 and two in Hoehn and Yahr scale.
Less than 4 risk factors determined by the Quick screen (copyright).
All participants must have high physical performance (score 6 or more in the Short Physical
Performance Battery).
Previous the beginning of the intervention, neither participants in control group nor the participants in the intervention group, could have been involved during the previous year in any continuous (weekly) activity related with dances or with music accompaniment.
Minimum age
50 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants in both groups will be excluded if they score less than 1 in Hoehn and Yahr scale or more than two.
Have high fall risk determined by quick screen (5 or more fall risk factors),
Have cognitive impairment determined by MMSE <24,
Terminal disease
Unstable medical conditions involving neuromuscular, skeletal or cardiovascular system
Other known neurodegenerative disease apart from Parkinson's
Absolute or relative contraindications for exercise,
Participants enrolled previously in dance activities, or with music involvement (i.e. Aerobic, step,...), also those in the control group that become participants of dance activities during intervention period or follow-up.

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)
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
1/10/2019
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment outside Australia
Country [1] 8957 0
Spain
State/province [1] 8957 0
Basque Country and Navarre

Funding & Sponsors
Funding source category [1] 296685 0
University
Name [1] 296685 0
Basque Country Universiy
Country [1] 296685 0
Spain
Primary sponsor type
University
Name
The Basque Country University
Address
Barrio Sarriena s/n Leioa-Erandio 48049, Biscay
Country
Spain
Secondary sponsor category [1] 295644 0
None
Name [1] 295644 0
Address [1] 295644 0
Country [1] 295644 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 297911 0
Ethics committee of the Public University of Navarre
Ethics committee address [1] 297911 0
Ethics committee country [1] 297911 0
Spain
Date submitted for ethics approval [1] 297911 0
18/06/2018
Approval date [1] 297911 0
Ethics approval number [1] 297911 0

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

Contacts
Principal investigator
Name 75438 0
Dr Mirian Aranzazu Garrues-Irisarri
Address 75438 0
Medicine and Nursery Faculty
Department of Physiology
University of the Basque Country
Barrio Sarriena s/n
Leioa-Erandio
48049 Bizkaia/Spain
Spain
Country 75438 0
Spain
Phone 75438 0
+34 667615026
Fax 75438 0
Email 75438 0
[email protected]
Contact person for public queries
Name 75439 0
Mirian Aranzazu Garrués-Irisarri
Address 75439 0
Medicine and Nursery Faculty
Department of Physiology
University of the Basque Country
Barrio Sarriena s/n
Leioa-Erandio
48049 Bizkaia/Spain
Spain
Country 75439 0
Spain
Phone 75439 0
+34 667615026
Fax 75439 0
Email 75439 0
[email protected]
Contact person for scientific queries
Name 75440 0
Mirian Aranzazu Garrués-Irisarri
Address 75440 0
Medicine and Nursery Faculty
Department of Physiology
University of the Basque Country
Barrio Sarriena s/n
Leioa-Erandio
48049 Spain
Country 75440 0
Spain
Phone 75440 0
+34 667615026
Fax 75440 0
Email 75440 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.