Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621001188820
Ethics application status
Approved
Date submitted
15/10/2020
Date registered
3/09/2021
Date last updated
8/08/2022
Date data sharing statement initially provided
3/09/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Square Stepping Exercise training programme for people with Parkinson's disease
Scientific title
Applicability, Safety and Efficacy of the Square Stepping Exercise training programme for people with Parkinson's disease
Secondary ID [1] 302182 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Parkinson's disease 319403 0
Condition category
Condition code
Neurological 317371 317371 0 0
Parkinson's disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The Square Stepping Exercise (SSE) is a training programme that requires physical exertion and cognitive function, namely concentration of attention, memory and executive functions.
The intervention will take place at the Parkinson's Association of Cáceres, will be supervised by an SSE expert and to monitor adherence to the intervention, session attendance checklists will be made.

The experimental group will receive SSE training, 3 times a week for 8 weeks with a duration of 50 minutes in each session.
They will receive the training guidelines in a booklet with the rules to follow and the movement patterns. Between 2 and 6 patients will perform the exercise simultaneously in the same space. The SSE will be performed on a thin carpet measuring 250 x 100cm, this carpet will be divided into 40 smaller squares of 25cm2.
At the end of each face-to-face session, difficulties encountered, incidents or injuries will be followed up and recorded, pointing out the possible cause of the problem. If a participant is unable to execute the intervention, the reason will be recorded.

In the SSE there are 200 different movement patterns that vary in difficulty and are classified into three levels: beginner, intermediate and advanced. The beginner level has two levels, while the intermediate and advanced levels have three levels each. The proposed intervention will follow a progression of levels. It will start with movement patterns similar to those of walking and gradually become more complex patterns requiring not only forward, but also lateral, diagonal and backward movements. People should be prevented from stepping on the dividing lines of the squares. The number of stepping patterns and difficulty will increase weekly until the maximum level is reached, which will be maintained until the end of the intervention.

In all sessions, the ESS expert will call the pair or group of participants to be trained and indicate the training to be performed. Participants will be given a booklet prepared specifically for the intervention, detailing the 200 movement patterns, which they can consult while the SSE expert shows them the sequence to follow in that day's class. The first activity to do before the session begins is to review the last movement pattern performed in the previous class. Once the patients have memorised the pattern, which is expected to be achieved after 4-5 repetitions, they will continue with the session autonomously. At the end of each session, the ESS expert will ask them about the development of the session and give them 2 scales on the level of perceived exertion.
The control group will continue with the treatment carried out within the public health system ("usual care"). Although there is no standard treatment for Parkinson's disease, the usual treatment, depending on the clinical condition of each patient, consists of the prescription of medication, mainly levodopa, and the recommendation of physiotherapy.
Intervention code [1] 320466 0
Treatment: Other
Intervention code [2] 320467 0
Prevention
Comparator / control treatment

30 people with Parkinson's disease will participate in the study:

- Experimental group, 15 people. They will participate in an Esquare Stepping Exercise training programme.

- Control group, 15 persons. The participants will continue with basic life activities and maintain the treatment established by the public health system ("usual care"). Although there is no standard treatment for Parkinson's disease, the usual treatment, depending on the clinical condition of each patient, consists of the prescription of medication, mainly levodopa, and the recommendation of physiotherapy.
Control group
Active

Outcomes
Primary outcome [1] 325408 0
Applicability. and Security
The percentage of patients who complete all training sessions as assessed by auditing session attendance checklists and are able to perform the proposed training.
At each session, difficulties encountered, incidents or injuries should be recorded, noting the possible cause of the problem.
Timepoint [1] 325408 0
Outcomes will be assessed at 8 weeks after the start of the intervention and an additional month of follow-up after the intervention..
Primary outcome [2] 327426 0
Balance.. It will be evaluated by the L-Test, which consists of measuring the time in which participants stand up from a chair, walk 3 m, then turn 90 degrees, walk again 7 m, turn 180 degrees, and finally return to the chair. In addition, the 3 m TUG and the 7 m TUG will be performed..
Timepoint [2] 327426 0
The outcome will be continuously monitored during each training session for the duration of the 8-week study.
Secondary outcome [1] 387837 0
Fear of falling will be measured using the Falls Efficacy Scale International (FES-I) questionnaire.
Timepoint [1] 387837 0
Fear of falling will be assessed at 8 weeks after the start of the intervention and at one month after the intervention.
Secondary outcome [2] 387838 0
Self-perceived fitness shall be assessed using the International Fitness Scale (IFIS).
Timepoint [2] 387838 0
Fear of falling will be assessed at 8 weeks after the start of the intervention and at one month after the intervention.
Secondary outcome [3] 387839 0
Health-related quality of life will be assessed using the Parkinson's Disease Questionnaire (PDQ-8).
Timepoint [3] 387839 0
Fear of falling will be assessed at 8 weeks after the start of the intervention and at one month after the intervention.
Secondary outcome [4] 387840 0
Depression will be assessed using the Beck Depression Inventory-II. (Beck-II)
Timepoint [4] 387840 0

Fear of falling will be assessed at 8 weeks after the start of the intervention and at one month after the intervention.
Secondary outcome [5] 387841 0
Balance will be assessed by the Timed Up and Go test.
Timepoint [5] 387841 0

Fear of falling will be assessed at 8 weeks after the start of the intervention and at one month after the intervention.
Secondary outcome [6] 387842 0
Physical fitness will be assessed by the 2-minute walk test.
Timepoint [6] 387842 0
Fear of falling will be assessed at 8 weeks after the start of the intervention and at one month after the intervention..
Secondary outcome [7] 387843 0
Perceived functional social support will be assessed using the Duke-UNC questionnaire.
Timepoint [7] 387843 0
Fear of falling will be assessed at 8 weeks after the start of the intervention and at one month after the intervention..
Secondary outcome [8] 387844 0
Anticipatory Cognitions will be assessed using Légeron, Riviere and Marboutin's Anticipatory Cognitions Questionnaire (ACQ).
Timepoint [8] 387844 0
Fear of falling will be assessed at 8 weeks after the start of the intervention and at one month after the intervention..
Secondary outcome [9] 398798 0
Fear of falling. Fear of falling will be measured using the Falls Effi-cacy Scale International (FES-I) questionnaire, developed and validated by the Prevention of Falls Network Europe.
Timepoint [9] 398798 0
8 weeks

Eligibility
Key inclusion criteria
Participants must meet the following inclusion criteria:
- Be at least 18 years of age
- Have been diagnosed with PD by a neurologist, in stages I, II or III, according to the Hoehn and Yahr scale .
- Not have any pathology that contraindicates the physical exercise programme (coronary pathologies, thrombosis, bone, kidney, moderate or severe pulmonary pathologies, severe psychiatric illness, etc.). They will be administered the Physical Activity and Fitness Questionnaire (PAR-Q) to find out if they are living with diseases that prevent physical strain.
- Not suffer from moderate (those scoring 12-20) and severe (<12) cognitive impairment, as determined by scores on the Mini-Mental State Examination .
- Must have signed informed consent for the study.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Patients with Parkinson's disease in stages IV and V of the Hoehn & Yahr scale.
- Patients with cognitive impairment and/or severe mental illness.
- Not voluntarily participating in the research study and/or not completing the questionnaires

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)
The randomisation sequence will be produced by a member of the research team with no clinical involvement in the trial. The allocation will be hidden in a password-protected computer file. Participants and the ESS site manager will be aware of their group assignment; however, it will be hidden from the investigators. Data analysts will not be able to know the assignment.
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
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/09/2022
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/09/2022
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment outside Australia
Country [1] 23060 0
Spain
State/province [1] 23060 0

Funding & Sponsors
Funding source category [1] 309590 0
Self funded/Unfunded
Name [1] 309590 0
Country [1] 309590 0
Primary sponsor type
University
Name
Faculty of Medicine
Address
Avenida de Elvas s/n. Campus Universitario 06006 - BADAJOZ.
Country
Spain
Secondary sponsor category [1] 310599 0
None
Name [1] 310599 0
Address [1] 310599 0
Country [1] 310599 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306789 0
Comité de Bioética y Bioseguridad de la Universidad de Extremadura
Ethics committee address [1] 306789 0
Vicerrectorado de Investigación, Transferencia e Innovación, Campus Universitario, Avenida de Elvas, s/n, 06071, Badajoz
Ethics committee country [1] 306789 0
Spain
Date submitted for ethics approval [1] 306789 0
Approval date [1] 306789 0
16/03/2020
Ethics approval number [1] 306789 0
27/2020
Ethics committee name [2] 307103 0
Comité de Ética de la Investigación con medicamentos de Cáceres
Ethics committee address [2] 307103 0
Consejería de Sanidad y Servicios Sociales
Avenida de las Américas, 2
06800 Mérida
Ethics committee country [2] 307103 0
Spain
Date submitted for ethics approval [2] 307103 0
Approval date [2] 307103 0
24/04/2020
Ethics approval number [2] 307103 0
039-2020

Summary
Brief summary
The present study is developed with the aim of providing new rehabilitative therapies that are an alternative to the existing ones and one more resource to treat Parkinson's Disease, whose ultimate goal is to offer a comprehensive care focused on the person, addressing in a holistic way physical and psychological factors, considering that they are closely interrelated and can influence the evolution and/or improvement of PD.

On this basis, the aim is to investigate the effects of applying square step exercise on reducing the number of falls, improving balance, cognitive abilities and psychological well-being in people with PD.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 105030 0
Mrs Mª Asunción Mayoral Moreno
Address 105030 0
University of Extremadura,, Avda. de Elvas, s/n, 06006 Badajoz
Country 105030 0
Spain
Phone 105030 0
+34659400079
Fax 105030 0
Email 105030 0
mmayoralm@unex.es
Contact person for public queries
Name 105031 0
Mrs Mª Asunción Mayoral Moreno
Address 105031 0
University of Extremadura,, Avda. de Elvas, s/n, 06006 Badajoz
Country 105031 0
Spain
Phone 105031 0
+34659400079
Fax 105031 0
Email 105031 0
mmayoralm@unex.es
Contact person for scientific queries
Name 105032 0
Mrs Mª Asunción Mayoral Moreno
Address 105032 0

University of Extremadura,, Avda. de Elvas, s/n, 06006 Badajoz
Country 105032 0
Spain
Phone 105032 0
+34659400079
Fax 105032 0
Email 105032 0
mmayoralm@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?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
9441Ethical approval  mmayoralm@unex.es



Results publications and other study-related documents

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