Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000169741
Ethics application status
Approved
Date submitted
9/11/2021
Date registered
2/02/2022
Date last updated
5/05/2022
Date data sharing statement initially provided
2/02/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Effect of a targeted exercise intervention in post-stroke older people.
Scientific title
Effect of a targeted exercise intervention on independent mobility and motor functioning in post-stroke older people
Secondary ID [1] 305664 0
none
Universal Trial Number (UTN)
Trial acronym
IN-PostStroke
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stroke Ischaemic 324135 0
Stroke Haemorrhagic 324136 0
Condition category
Condition code
Stroke 321608 321608 0 0
Haemorrhagic
Stroke 321609 321609 0 0
Ischaemic
Physical Medicine / Rehabilitation 321610 321610 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Arm1: Target intervention programme combines a repertory of standardized exercises that have been previously described in scientific literature to improve balance and are: 1) biomechanical restrictions, 2) limits of stability and verticality, 3) anticipatory responses, 4) postural responses, 5) sensory orientation, and 6) gait stability. Exercises or tasks selected will be individually adjusted to 1) patients needs, that is based on their altered or limitation identified with functional test and 2) perceived difficulty of task. The last one will be used as well for exercise progression.
The rehabilitation exercises are oriented as well towards the patient's choice of recovery of functional mobility.
For the choice of activities, the patient is provided with the images with activities included in the ICON-FES30 and arrange them hierarchically a final question is added asking if there is any activity not contemplated that you want to add.
Difficulty progression of the exercises includes (work position, activity time, amount of base of support, stability of base of support, speed of execution requested, number of displacements: direction, sense and magnitude of the displacement, present-limited-altered balance sensory systems, presence or absence of dual tasks and their modality).
Patients will perform 15 different exercises or tasks per session. Each proposed exercise will have an approximate duration of 15 seconds, it will be repeated 2-3 times and the execution conditions will be altered to guarantee the alteration of the stimuli in the therapy. The intensity of the proposals will be adjusted to subjective perception of difficulty, that will have to be 3 or 4 on a scale of difficulty from 0 to 5, with 0 being no difficulty and 5 very difficult.
E.g. When a patient has problems-difficulty in the sitting posture, an exercise is included, for this purpose. The indication would be: I would like you to stay seated on this chair as upright and aligned as possible. You must place the chin in line with the ear lobe, the head without inclination. The shoulders must be aligned horizontally and positioned also aligned with the hips vertically, you should perceive that the weight of the body is distributed over the chair is homogeneous over both buttocks. The trunk should be stand still, not lean forward or behind or towards either side. Please place ech arm over the arm rest of the chair. When the patient performs this exercise correctly and evaluates it between 2 or less in difficulty on a scale of 0-5, 5 being very difficult or unable to perform it, progress would be made towards an exercise of greater difficulty and vice versa. For example fold your arms across the chest. On the contrary ff the difficulty is 5=extreme, or unable to do it correctly, the difficulty will be lowered, for example, allowing support on the back of the chair. In both conditions the criteria use to adjust difficulty inolves the number of support surfaces used. Initially the partient will obtain concurrent feedback using a mirror, then without it only with indications-corrections from the physiotherapist.
Intervention will commence within 1 week post-stroke. Therapeutic intervention will be conducted in Hospital and delivered by a physiotherapist specialized in neurological rehabilitation who supervise and control each therapeutic session during the intervention period.

The maximum duration of therapeutic intervention for the purpose of the study will be 90 days after stroke, however could be less if the patients achieve independent mobility walking 15 meters at a speed of 1 meter per second or over.
Two treatment phases will be identified, differentiated by hospital care modality 1) acute hospital post-stroke and 2) sub-acute. The transition form acute to sub-acute phase will be determined by the assigned physician to the patient, neurologist, neurosurgeon or rehabilitator at time of discharge from acute stroke ward and admission to sub-acute hospital rehabilitation unit. The transition form sub-acute phase to community living individual will be determined as well by the asigned physician to the patient, at time of discharge from sub-acute hospital rehabilitation unit. In the first phase all patients will receive 4 and a half hour (270 minutes) of weekly physiotherapy, which will be distributed in sessions of 45 minutes, 5 sessions per week from Monday to Friday. In the subacute phase, they will receive 135 minutes of weekly physical therapy in sessions, separated between them for at least 24 hours (3 sessions of 46 minutes) or (two sessions of 70 minutes). All therapy sessions will be individual (not in group).
Adherence will be measured as number of days attending treatment.
Intervention code [1] 322061 0
Rehabilitation
Intervention code [2] 322520 0
Treatment: Other
Comparator / control treatment
Arm2: Conventional Physiotherapy involving active and passive movements, gait reeducation and balance for maximum 90 days after stroke. Intervention length could be less if the patients achieve independent mobility walking 15 meters at a speed of 1 meter per second or over.
Intervention will commence within 1 week post-stroke. Therapeutic intervention will be conducted in Hospital and delivered by a physiotherapist specialized in neurological rehabilitation who supervise and control each therapeutic session during the intervention period.
Two treatment phases will be identified, differentiated by hospital care modality 1) acute hospital post-stroke and 2) sub-acute. The transition form acute to sub-acute phase will be determined by the assigned physician to the patient, neurologist, neurosurgeon or rehabilitator at time of discharge from acute stroke ward and admission to sub-acute hospital rehabilitation unit. The transition form sub-acute phase to community living individual will be determined as well by the asigned physician to the patient, at time of discharge from sub-acute hospital rehabilitation unit. In the first phase all patients will receive 4 and a half hour (270 minutes) of weekly physiotherapy, which will be distributed in sessions of 45 minutes, 5 sessions per week from Monday to Friday. In the subacute phase, they will receive 135 minutes of weekly physical therapy in sessions, separated between them for at least 24 hours (3 sessions of 46 minutes) or (two sessions of 70 minutes). Patients will perform 15 different exercises or tasks per session.
All therapy sessions will be individual (not in group). Adherence will be measured as number of days attending treatment.
Control group
Active

Outcomes
Primary outcome [1] 329372 0
Time taken (in days) to achieve independent gait (at a speed of 1 metre per second or over) assessed using 15m walking test without assistive devices'
Timepoint [1] 329372 0
Baseline and immediately after achieving independent mobility (gait, at a speed of 1 metre per second or over assessed using 15m walking test without assistive devices) and/or changing patients status (acute, and/or post acute) and/or 90 days post stroke at time of intervention completion (3 moths)
Primary outcome [2] 329375 0
Gait speed assessed using 15m walking test without assistive devices
Timepoint [2] 329375 0
Baseline and immediately after achieving independent mobility (gait, at a speed of 1 metre per second or over assessed using 15m walking test without assistive devices) and/or changing patients status (acute, and/or post acute) and/or 90 days post stroke at time of intervention completion (3 moths)
Secondary outcome [1] 402379 0
Physiotherapist-related feasibility: adequacy and acceptation of testing methods by physiotherapist will be assessed with a short questionnaire including 5 questions that will be answered with a 5 level likert scale
Timepoint [1] 402379 0
At the time of intervention completion
Secondary outcome [2] 402380 0
Physiotherapist-related feasibility: adequacy and acceptation of intervention method will be assessed with a short questionnaire including 5 questions that will be answered with a 5 level likert scale.
Timepoint [2] 402380 0
At the time of intervention completion. Immediately after intervention is completed (the patient achevie independent mobility walking (independent gait, at a speed of 1 metre per second or over assessed using 15m walking test without assistive devices) or maximum 3moths after stroke).
Secondary outcome [3] 402381 0
Functional Performance change. The Short Physical performance Battery is a group of measures that combines the results of the gait speed, chair stand and balance tests (Guralnik et al., 2000). It has been used as a predictive tool for possible disability and can aid in the monitoring of physical function in older people. The scores range from 0 (worst performance) to 12 (best performance). The SPPB has been shown to have predictive validity showing a gradient of risk for mortality, nursing home admission, and disability.
Timepoint [3] 402381 0
Baseline and immediately after achieving independent mobility (gait, at a speed of 1 metre per second or over assessed using 15m walking test without assistive devices) and/or changing patients status (acute, and/or post acute) and/or 90 days pos-stroke at the time of intervention completion (3 moths)
Secondary outcome [4] 402384 0
Balance. The Balance Evaluation Systems Test (BESTest) is a quantitative assessment tool that aims to identify the disordered systems underlying the postural control responsible for poor functional balance. By identifying the disordered systems underlying balance control, therapists can direct specific types of intervention for different types of balance problems
Timepoint [4] 402384 0
Baseline and immediately after achieving independent mobility (gait, at a speed of 1 metre per second or over assessed using 15m walking test without assistive devices) and/or changing patients status (acute, and/or post acute) and/or 90 days pos-stroke at the time of intervention completion (3 moths)
Secondary outcome [5] 402781 0
Balance. The Mini Balance Evaluation Systems Test (MiniBESTest) is a quantitative assessment tool shorter than the BESTest that aims to identify the disordered systems underlying the postural control responsible for poor functional balance. By identifying the disordered systems underlying balance control, therapists can direct specific types of intervention for different types of balance problems and a shortened version could be more suitable for clinical use.
Timepoint [5] 402781 0
Baseline and immediately after achieving independent mobility (gait, at a speed of 1 metre per second or over assessed using 15m walking test without assistive devices) and/or changing patients status (acute, and/or post acute) and/or 90 days pos-stroke at the time of intervention completion (3 moths)
Secondary outcome [6] 404534 0
Patient-related feasibility: adequacy and acceptation of testing methods by physiotherapist will be assessed with a short questionnaire including 5 questions that will be answered with a 5 level likert scale
Timepoint [6] 404534 0
At the time of intervention completion
Secondary outcome [7] 404535 0
Patient-related feasibility: adequacy and acceptation of intervention method will be assessed with a short questionnaire including 5 questions that will be answered with a 5 level likert scale.
Timepoint [7] 404535 0
At the time of intervention completion. Immediately after intervention is completed (the patient achevie independent mobility walking or maximum 3moths after stroke)
Secondary outcome [8] 409362 0
The IPAQ questionnaire adapted to the Spanish language will be used to calculate the sedentary time (mean minutes per day seated)
Timepoint [8] 409362 0
Baseline and immediately after achieving independent mobility (gait, at a speed of 1 meter per second or over assessed using 15m walking test without assistive devices) and/or changing patients status (acute, and/or post acute) and/or 90 days post stroke at time of intervention completion (3 moths)
Secondary outcome [9] 409363 0
The iconographical Falls Efficacy Scale assesses concerns about falling during 30 common activities of daily life. The scale uses pictures to describe the activities and situations. Each item is scored on a 4-point scale with 1 = not at all concerned to 4 = very concerned along with facial expression icons
Timepoint [9] 409363 0
Baseline and immediately after achieving independent mobility (gait, at a speed of 1 metre per second or over assessed using 15m walking test without assistive devices) and/or changing patients status (acute, and/or post acute) and/or 90 days pos-stroke at the time of intervention completion (3 moths)
Secondary outcome [10] 409364 0
number of Falls. A weekely calendar will be used to registry falls during the intervention period. The physiotherapist will ask the patient at the end of the week.
Timepoint [10] 409364 0
weekly untill the patient achieve independent mobility (gait, at a speed of 1 metre per second or over assessed using 15m walking test without assistive devices) and/or changing patients status (acute, and/or post acute) and/or 90 days pos-stroke at the time of intervention completion (3 moths)
Secondary outcome [11] 409365 0
Pictures included in the iconographical Falls Efficacy Scale with activities of daily life will be used to decide on which activities 5 patients would like to focus on in their therapy sessions.
Timepoint [11] 409365 0
Baseline and at the beginin of post acute stage.

Eligibility
Key inclusion criteria
- Community living independent living individuals before the stroke, who are acutely hospitalized due to being diagnosed after having suffered their first stroke at the Royo Villanova (HRV) or the Provincial Nuestra Señora de Gracia de Zaragoza (HNSG) and the Cruces Hospital in Bizkaia ( HC)
- Cognitive status preserved and
- Able to follow the instructions, both during testing and intervention.
- Ability to maintain a sitting position on a chair without assisstance with a back
Minimum age
60 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Severe heart disease or severe bronchopathies
- Other types of medical conditions that prevent the treatment from being implemented
- Cognitive impairment
- Inability to understand the instructions during the test or intervention.
- Unstable orthopedic injuries such as unconsolidated fractures or with unstable osteosynthesis systems,
- Inability to maintain a sitting position on a chair without assisstance with a back

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)
sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated simple randomisation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving 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
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
16/05/2022
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
80
Accrual to date
Final
Recruitment outside Australia
Country [1] 24252 0
Spain
State/province [1] 24252 0
Basque Country
Country [2] 24253 0
Spain
State/province [2] 24253 0
Aragón

Funding & Sponsors
Funding source category [1] 310013 0
Self funded/Unfunded
Name [1] 310013 0
Mirian A. Garrués Irisarri
Country [1] 310013 0
Spain
Funding source category [2] 310025 0
Self funded/Unfunded
Name [2] 310025 0
Mª Pilar Dominguez Oliván
Country [2] 310025 0
Spain
Funding source category [3] 310026 0
Self funded/Unfunded
Name [3] 310026 0
Raul Zaballa Fernandez
Country [3] 310026 0
Spain
Funding source category [4] 310029 0
Self funded/Unfunded
Name [4] 310029 0
Asunción Campos Sanz
Country [4] 310029 0
Spain
Funding source category [5] 310030 0
Self funded/Unfunded
Name [5] 310030 0
Ana Bengoechea Arrese
Country [5] 310030 0
Belgium
Primary sponsor type
University
Name
University of the Basque Country/Universidad del Pais Vasco-Euskal Herriko Univertsitatea
Address
Medicine and Nursery Faculty
Physiology Department
Barrio Sarriena s/n Leioa-Erandio
48049, Biscay
Spain
Country
Spain
Secondary sponsor category [1] 311067 0
University
Name [1] 311067 0
Zaragoza's University/Universidad de Zaragoza
Address [1] 311067 0
Zaragoza's University
Facultad de Ciencias de la Salud
Departamento de Fisiatría y Enfermería
Área de Fisioterapia
C/Domingo Miral, s/n
50009 Zaragoza
Spain
Country [1] 311067 0
Spain
Secondary sponsor category [2] 311083 0
Hospital
Name [2] 311083 0
Cruces hospital/Hospital de Cruces
Address [2] 311083 0
BioCruces Bizkaia,
Instituto de Investigación Sanitaria
Cruces Plaza,
48903 Barakaldo, Bizkaia
Country [2] 311083 0
Spain
Other collaborator category [1] 282033 0
Hospital
Name [1] 282033 0
Hospital Provincial Nuestra Señora de Gracia
Address [1] 282033 0
Hospital Provincial Nuestra Señora de Gracia
Ramón y Cajal , 68 -
50004 Zaragoza
Country [1] 282033 0
Spain
Other collaborator category [2] 282035 0
University
Name [2] 282035 0
Université libre de Bruxelles
Address [2] 282035 0
Faculté des Sciences de la Motricité Campus Erasme
CP 640. Route de Lennik, 808 1070
Bruxels
Belgium
Country [2] 282035 0
Belgium

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309720 0
Comité de Ética de la Investigación de la Comunidad Autónoma de Aragón: CEICA
Ethics committee address [1] 309720 0
Ethics committee country [1] 309720 0
Spain
Date submitted for ethics approval [1] 309720 0
08/10/2021
Approval date [1] 309720 0
20/10/2021
Ethics approval number [1] 309720 0
PI21-406

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

Contacts
Principal investigator
Name 115158 0
Dr Mirian Aranzazu Garrués Irisarri
Address 115158 0
Department of Physiology
Faculty of Medicine and Nursery
University of the Basque Country
Barrio Sarriena, s/n
Leioa | 48940
Country 115158 0
Spain
Phone 115158 0
+34946015085
Fax 115158 0
Email 115158 0
[email protected]
Contact person for public queries
Name 115159 0
Maider Guenetxea Arrinda
Address 115159 0
Hospital Universitario de Cruces
BioCruces Institute
Cruces Plaza, 48903 Barakaldo, Bizkaia
AND
Department of Physiology
Faculty of Medicine and Nursery
University of the Basque Country
Barrio Sarriena, s/n
Leioa | 48940
Country 115159 0
Spain
Phone 115159 0
+34946015085
Fax 115159 0
Email 115159 0
[email protected]
Contact person for scientific queries
Name 115160 0
Mª Pilar Domínguez Oliván
Address 115160 0
Universidad de Zaragoza
Departamento de Fisiatría y Enfermería
Área de Fisioterapia
Facultad de Ciencias de la Salud
C/Domingo Miral, s/n
50009 Zaragoza
Country 115160 0
Spain
Phone 115160 0
+34876554461
Fax 115160 0
Email 115160 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.