Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05739422 |
| Other study ID # |
ONPRCT |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
November 16, 2022 |
| Est. completion date |
May 24, 2023 |
Study information
| Verified date |
September 2023 |
| Source |
Institute of Technology, Sligo |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
This study is being undertaken as part of a PhD qualification at ATU Sligo by the principal
researcher Eimear Cronin. It will investigate the feasibility, safety and efficacy of a 6
week, online, remotely supervised neuropilates programme in post stroke participants as
compared to a 6 week, online, remotely supervised generalised exercise programme and a 6 week
unsupervised home exercise programme
Description:
Stroke survivors often demonstrate balance and mobility deficits and low physical activity
levels. They experience barriers to physical exercise including embarrassment, low
self-efficacy and a shortage of tailored community exercise programmes. Access to physical
activity programmes for stroke survivors could be improved by providing tailored, online
programmes, although little is known about the safety and feasibility of online exercise
classes for stroke survivors. One such programme of exercise which has received little
attention in the literature is neuropilates. Neuropilates is the practice of a modified
pilates programme in those with neurological conditions, is theorised to have beneficial
effects on strength, balance and proprioception in stroke survivors. No randomised controlled
trial has previously been conducted to investigate online, remotely supervised neuropilates
exercise classes in the stroke survivors.
The proposed randomised controlled feasibility study will begin to address some of the afore
mentioned gaps in the literature base and determine whether the intervention should be
recommended for efficacy testing in line with the standards set for feasibility trials by
Bowen et al, 2009. The aim of the study is to conduct a randomised controlled feasibility
study to examine the feasibility and clinical outcomes on stroke survivors of a live, online,
once weekly, six-week neuropilates exercise class when compared to two control groups. The
first control group will be participating in a live, online, once weekly, supervised,
six-week generalised exercise class. The second control group will be given a home exercise
programme to carry out unsupervised.
Research Design and Methods:
Study Design The design of the trial is a single (assessor) blinded, randomised controlled
feasibility study. Due to the nature of the intervention, neither the instructing therapist
nor the participant can be blinded to group allocation. An independent assessor, who is
blinded to the treatment assignment, will perform all clinical outcome assessments.
Participants were asked not to discuss their allocation with their assessors on post
assessment. Participants will undergo stratified random sampling, following an initial phone
screening conversation. The sampling frame will be 20 - 25 potential participants. The age of
the participants and functional status will be the strata considered during this
randomisation process to ensure a representative sample in each group with factors that could
influence outcome accounted for. In terms of functional ability, higher functionally
independent participants will be considered to be those who can walk without an assistive
device and lower functionally independent participants will be those who need an assistive
device to walk. There will then be four strata from which random sampling will extract from;
1) Less than 65 years, lower functioning, 2) Greater than 65 years, lower functioning, 3)
Less than 65 years, higher functioning, 4) Greater than 65 years, higher functioning.
Participants from stratum 1 will be divided into intervention and control groups by the
following method; all names will be placed into envelopes, shuffled and divided as evenly as
possible into intervention and control groups by an independent researcher. This process will
be repeated for the rest of the strata. This should result in an even, random spread from
each stratum across all groups.
Study Setting:
Participants' will be exercising at home, with some connecting virtually to live, supervised
classes. All clinical outcome assessments will take place face-to-face at the Physiotherapy
Department at St. John's Hospital, Sligo, Ireland.
Participants / sample size:
We will aim to recruit 20 - 25 adults with a diagnosis of stroke who meet the inclusion
criteria detailed below. The sample size chosen is based upon previous randomised control
trials carried out in this field as well as current pilot trial research recommendations. The
sample size chosen should be practical within this single centre trial to allow completion
within a timely manner and should provide valuable preliminary information on practicalities
of the intervention, feasibility, recruitment, uptake and attrition.
Participants will be recruited from outpatient physiotherapy clinics throughout Sligo,
occupational therapy departments and also from geriatrician clinics. Community
Physiotherapists, Occupational therapists and Geriatricians will act as gate keepers,
identifying potential participants. They will provide potential participants with information
sheets regarding the trial and ask potential participants to sign a consent to contact form.
Once participant consent has been gained, participant information can then be passed on to
the principal researcher. The principal researcher will then phone the participants to
provide further information regarding the trial, carry out initial screening and provide a
date for an initial face to face assessment. Informed consent will be sought from
participants by the principal researcher at the initial assessment.
An independent assessor, a CORU registered Physiotherapist with experience assessing stroke
survivors, will carry out the clinical standardised outcome measurements as detailed below.
Intervention The intervention described below has been completed in line with the TIDieR
checklist
Intervention title:
Neuropilates remotely supervised online class for stroke survivors.
Materials and Procedures:
Participants will be asked to participate in exercises remotely but in an online group
setting with the other participants visible on screen and targeted at improving their
posture, core stability, flexibility, abdominal and pelvic strength and balance. These
exercises will be pitched at a beginner level focused on the core elements of neuropilates
and progressing week on week as appropriate. The only materials required for the participants
will be a chair, a theraband and a tablet electronic device, all of which will be provided at
assessment. The instructor will require a laptop, wireless headphones with a microphone and a
professional Zoom © account. The neuropilates class will include a warm up, cool down and
neuropilates exercises in line with the teaching of APPI ® (the Australian Physiotherapy and
Pilates Institute). In order to be adept at instructing neuropilates exercises such as these
highlighted above, it is recommended that any interested Physiotherapist completes a
qualification in Pilates instruction with APPI and then completes the "neuropilates" CPD
module, available here: https://appihealthgroup.com/buy/neuro-Pilates/
Who will provide the intervention A chartered Physiotherapist who holds a Pilates
qualification from APPI © with 11 years' experience in stroke rehabilitation and 10 years'
experience in Pilates instruction will conduct the online classes. The instructor has also
undergone APPI © modules in "neuropilates" and "3d standing Pilates". In order to ensure
fidelity, another investigator will log onto a number of the classes with video and sound off
to confirm the intervention is being carried out as per protocol.
How and where will the intervention take place The intervention group will attend a remotely
supervised, live, online, neuropilates group exercise class from their homes via the online
platform Zoom ®. There will be an average of 4 participants per group.
When and how much:
The intervention and CG1 exercise classes will be delivered once a week over six weeks.
Classes will be recorded and participants will be asked to complete the same class on their
own twice more during the week. Classes will last one hour. Initially, exercises will be
pitched at a beginner level but exercises will get more challenging with higher repetitions,
longer holds or less support in standing positions as the weeks progress. Six weeks was
chosen as the length of intervention as previous studies investigating Pilates in various
clinical conditions have indicated that Pilates interventions have proven effective if
completed two to three times a week from periods of four weeks up to 12 weeks. Once a week
supervised with two more sessions unsupervised over six weeks was chosen as a timeframe that
was deemed replicable in a busy rehabilitation "real-world" setting with budgetary, staffing
and time constraints that may also prove effective in research settings, thus improving the
replicability of the intervention.
Tailoring and modifications The Physiotherapist will use their clinical judgement throughout
to tailor and modify the exercises to meet the needs of the individual participant. These
modifications may include altering starting positions, recommended range of motion and level
of support in standing to name a few.
Adherence Reminder texts will be sent out to each participant the morning of each class.
After each class, the recording of the class will be emailed to each participant or their
designated technological support person with a reminder to complete the recorded class twice
during the week.
Control Groups There will be two control groups. Control group 1 will attend a live, remotely
supervised, online, once weekly 60-minute generalised exercise class from their homes over
six weeks, facilitated via the online platform Zoom ® by the principal investigator. The
exercises will consist of a specific set of generalised exercises based on clinical
experience as well as previous literature examining exercise classes in stroke patients [46].
Bottles of water will be used for arm weights. The instructing physiotherapist may correct
improper exercise technique as necessary to prevent injury but no specific cues should be
given about posture, core activation or visual imagery for form. Progressions should be made
by including longer holds or more repetitions as the weeks progress. For weaker upper limbs,
short levers can be used by keeping the elbow bent for shoulder exercises, or bilateral
exercises can be performed without the weight by using the non-stroke side to assist the
stroke side. For very weak upper limbs with little to no active movement or limited by pain,
additional sets of exercises on the non-stroke side can be performed. Warm up and cool down
should consist of head, neck, trunk, upper and lower limb gentle active range of movements
and chair marching.
Generalised exercises for CG1:
Strengthening upper body: Biceps curls, Shoulder press, Shoulder flexion and abduction, Wrist
extension and flexion, Punching Stretching upper body: Pectoralis major stretch, Deltoid
stretch, Biceps / triceps stretches Wrist stretch into flexion / extension, Trunk rotation
Strengthening lower body: Knee extensions in sitting, Hip flexion in sitting, Sit to stand,
Hip flexion, abduction and extension in standing holding support if necessary, Squats, Calf
raises, Knee curls Stretching lower body: Calf stretch, Hamstring stretch, Ankle AROM
Modifications will be made to the exercises as necessary including encouragement regarding
appropriate range of motion or active assisted range of motion alternatives when needed.
There will be an average of four participants per class. The participants will need a chair,
a water bottle as a weight and a tablet device which they may receive on loan from the
research team. The class will be instructed by a chartered Physiotherapist with 11 years'
experience in stroke rehabilitation. This comparator was chosen to assess the superiority, if
any, of neuropilates exercises over general exercises in post stroke patients.
Control Group 2 will be instructed in a tailored home exercise programme based on deficits
found at assessment stage and will be asked to carry out these exercises at home,
unsupervised, for six weeks. A paper copy of their exercises and if they possess a smart
phone or laptop, a video copy of their exercises will be sent to them. They will be given a
follow up phone call at week three to address any issues they may be having. This comparator
was chosen to represent a "standard care" group
Statistics We will analyse feasibility outcomes using descriptive statistics. Adverse events
will be recorded and rates compared between groups. Adherence rates will be expressed as a
percentage of the total number of sessions for the intervention group and CG1. Recruitment
rates will be expressed as a percentage of those screened and contacted. Attrition rates will
also be expressed as a percentage of the total. Descriptive statistics will be used to
summarise the age, gender and functional independence of the participants in each group.
Outcomes from clinical assessments will be completed using excel and paired T tests will be
used to compare before and after data in each group. Anova tests will define if there are
differences in the mean improvement or change in outcome scores between the three groups.
Data Storage:
All individual data will be identifiable during initial screenings, assessments and training
sessions. Upon all assessment completion, data will be irrevocably anonymised. All data will
also be coded to enable statistical analysis to take place. All data will be securely stored
on the ATU Sligo campus, with access limited to the principal researcher and supervisor
alone. Hard copy data will be stored in a secure locked filing cabinet and electronic data
will be stored on a secure encrypted computer, in a password protected file.
Safety measures for remotely supervised exercising in intervention and control groups:
At the initial assessment stage, those participants that need one will be given an electronic
tablet device on loan for the duration of the classes. The principal investigator will give
the participant a tutorial on the use of the tablet at this stage. A detailed information
sheet will also be given to all participants in the intervention group and control group 1
with instructions about how to log into the class, class schedule, exercise information and
information regarding monitoring their own symptoms prior to attending classes and seeking
medical advice when appropriate. Participants will also be given advice regarding exercising
safely at home and when to stop exercising if they experience any pain, dizziness or
shortness of breath. Participants will be given a safe home exercise checklist to reinforce
this verbal advice and a disclaimer. These forms are based upon the recommended forms from
the Irish guidance document for virtual pulmonary rehabilitation. They must read these and
return a written agreement to the terms and conditions before commencement of the classes.
During the first class, the class instructor may individually cue the participants regarding
their set up at home if it is suboptimal, or may phone the patient after the class to discuss
modifications to the set up, e.g, holding onto a solid chair during standing or creating more
space around them, if necessary.
Additionally, as recommended by the authors of the Irish guidelines for virtual pulmonary
rehabilitation, if a patient scores less than 67% on the Activities Specific Balance
Confidence Scale, they will be advised to have another person present in the house during the
online exercise class. Patients exercising on their own will be asked to supply an emergency
contact number which will be held on file by the principal researcher. Any adverse events
that do occur will be reported in line with HSE open disclosure guidelines.
Ethics:
Ethical approval (#872 July 2022) has been gained from both the Sligo University Hospital and
ATU Sligo Ethics Committees.
Dissemination:
Individual participant results will be posted to them. Results of the trial will be written
up and published in a peer review journal and presented at relevant conferences during the
following year.
