scholarly journals Investigating the feasibility and acceptability of the HOLOBalance system compared with standard care in older adults at risk for falls: study protocol for an assessor blinded pilot randomised controlled study

BMJ Open ◽  
2021 ◽  
Vol 11 (2) ◽  
pp. e039254
Author(s):  
Matthew Liston ◽  
Gregory Genna ◽  
Christoph Maurer ◽  
Dimitris Kikidis ◽  
Dimitris Gatsios ◽  
...  

IntroductionApproximately one in three of all older adults fall each year, with wide ranging physical, psychosocial and healthcare-related consequences. Exercise-based interventions are the cornerstone for falls prevention programmes, yet these are not consistently provided, do not routinely address all components of the balance system and are often not well attended. The HOLOBalance system provides an evidence-based balance training programme delivered to patients in their home environment using a novel technological approach including an augmented reality virtual physiotherapist, exergames and a remote monitoring system. The aims of this proof-of-concept study are to (1) determine the safety, acceptability and feasibility of providing HOLOBalance to community dwelling older adults at risk for falls and (2) provide data to support sample size estimates for a future trial.MethodsA single (assessor) blinded pilot randomised controlled proof of concept study. 120 participants will be randomised to receive an 8-week home exercise programme consisting of either: (1) HOLOBalance or (2) The OTAGO Home Exercise Programme. Participants will be required to complete their exercise programme independently under the supervision of a physiotherapist. Participants will have weekly telephone contact with their physiotherapist, and will receive home visits at weeks 0, 3 and 6. Outcome measures of safety, acceptability and feasibility, clinical measures of balance function, disability, balance confidence and cognitive function will be assessed before and immediately after the 8 week intervention. Acceptability and feasibility will be explored using descriptive statistics, and trends for effectiveness will be explored using general linear model analysis of variance.Ethics and disseminationThis study has received institutional ethical approvals in Germany (reference: 265/19), Greece (reference: 9769/24-6-2019) and the UK (reference: 19/LO/1908). Findings from this study will be submitted for peer-reviewed publications.Trial registration numberNCT04053829.Protocol versionV.2, 20 January 2020

2020 ◽  
Author(s):  
Chun Mei Xiao ◽  
Jing Jing LI ◽  
Yong Kang ◽  
Yong Chang Zhuang

Abstract Background Exercise therapy is a key intervention in the management of knee osteoarthritis (KOA) and recommended in international guidelines on KOA management. An effective home-exercise programme for frail older adults with KOA was successful in achieving high adherence. This randomised controlled trial was to compare the adherence to the exercise and lasting effects of follow-up 3 months. Methods Sixty-eight participants in the original Wuqinxi (WQX) exercise study were community dwelling older adults (age = 70.95 ± 9.85 years) with KOA were categorised into 34 controls group, 34 WQX group adherers. The Western Ontario and Mc Master Universities Osteoarthritis Index questionnaire score (WOMAC) pain and Berg Balance Scale, Timed Up and Go Test, 6-min Walk Test, 30-s chair stand test, isokinetic muscle strength testing of knee flexion and extension measured at pre-test and post-test of the intervention period and follow-up for two groups. Results The WQX group maintained or improved in all nine measures from post-test to follow-up, whereas the control group significantly declined in WOMAC pain, Knee extensor strength and Knee flexor strength. Conclusion The WQX programme was an effective home-exercise programme that achieves high adherence in older adults with KOA who lived in these communities.


2020 ◽  
Vol 7 (1) ◽  
Author(s):  
Phenphop Phansuea ◽  
Sookjaroen Tangwongchai ◽  
Thanapoom Rattananupong ◽  
Vitool Lohsoonthorn ◽  
Somrat Lertmaharit

BMJ Open ◽  
2020 ◽  
Vol 10 (12) ◽  
pp. e040108
Author(s):  
Rowan W Johnson ◽  
Sian A Williams ◽  
Daniel F Gucciardi ◽  
Natasha Bear ◽  
Noula Gibson

ObjectiveDetermine the adherence to and effectiveness of an 8-week home exercise programme for children with disabilities delivered using Physitrack, an online exercise prescription tool, compared with traditional paper-based methods.DesignSingle-blinded, parallel-groups, randomised controlled trial (RCT).SettingIntervention took place in participants’ homes in Western Australia.ParticipantsChildren aged 6 to 17 years, with neurodevelopmental disabilities including cerebral palsy (CP), receiving community therapy services.InterventionAll participants completed an individualised home exercise programme, which was delivered to the intervention group using Physitrack and conventional paper-based methods for the control group.Primary outcome measuresAdherence to exercise programme, goal achievement and exercise performance.Secondary outcome measuresEnjoyment, confidence and usability of Physitrack.ResultsFifty-four participants with CP (n=37) or other neurodevelopmental disabilities (n=17) were recruited. Fifty-three were randomised after one early withdrawal. Forty-six completed the 8-week programme, with 24 in the intervention group and 22 in the control group. There was no difference between the two groups for percentage of exercises completed (intervention (n=22): 62.8% (SD 27.7), control (n=22): 55.8% (SD 19.4), between group mean difference −7.0% (95% CI: −21.6 to 7.5, p=0.34)). Both groups showed significant improvement in their self-rated performance of individualised goal activities, however there was no statistically significant difference between groups for goal achievement, quality of exercise performance, enjoyment, confidence or preferred method of delivery. There were no adverse events.ConclusionPhysitrack provides a therapist with a new means of providing an exercise programme with online tools such as exercise videos, but our preliminary findings indicate that it may be no better than a traditional paper-based method for improving exercise adherence or the other outcomes measured. Exercise programmes remain an intervention supported by evidence, but a larger RCT is required to fully evaluate online delivery methods.Trial registration detailsAustralian New Zealand Clinical Trials Registry; ACTRN12616000743460.


2019 ◽  
Vol 48 (Supplement_4) ◽  
pp. iv18-iv27
Author(s):  
Sasiporn Ounjaichon ◽  
Chris Todd ◽  
Emma Stanmore ◽  
Elisabeth Boulton

Abstract Introduction Falls are the leading cause of injuries in older Thai adults. There is a need to develop a fall prevention exercise programme to encourage participation and adherence. The adapted Lifestyle-integrated Functional Exercise (aLiFE) programme may be suitable by integrating exercise into daily routines as opposed to attending an exercise class. This study aimed to explore the acceptability and feasibility of the aLiFE programme in Thai context (TLiFE) among older Thai adults. Methods Based on the findings of a prior qualitative study, a feasibility randomised controlled trial (RCT) of TLiFE was conducted among community-dwelling older adults, comparing the TLiFE intervention group with a usual care control group. Outcome measures were analysed at baseline, 3 months, and after 6 months of the intervention. Results We recruited a total of 72 older adults into the RCT, randomised to TLiFE (n=36) and control (n=36). The retention rate at 6 months was 91.7%. Attendance in the intervention group (3 home visits and 4 follow-up calls) was 82.9%. There were no differences in fall incidence between the groups. The acceptability survey reveals TLiFE is easy to perform in daily life, safe, and useful. No adverse events were reported. Conclusion The TLiFE programme appears to be acceptable and feasible to deliver to community-dwelling older Thai adults. This feasibility study was not powered to detect a difference between groups. A further fully powered definitive randomised controlled trial of TLiFE is needed to evaluate long-term outcomes and cost-effectiveness before it is integrated within the healthcare system in Thailand.


2020 ◽  
Vol 8 (4) ◽  
pp. 99-107
Author(s):  
Anastasia Shvedko

Study objective. The aim of this study was to examine the feasibility of a Physical Activity Intervention for Loneliness (PAIL) in community-dwelling older adults at risk of loneliness. Methods. Study design was a 12-week randomized controlled feasibility trial (RCT). Participants were 25 (mean age 68.5(8.05) years, range 60-92) healthy, inactive, community-dwelling older adults at risk for loneliness. The intervention consisted of group outdoor walking sessions with health education workshops once weekly, with a wait-list control condition. Estimation of recruitment, retention and adherence were feasibility outcomes. Body mass index, blood pressure, physical activity, and psychosocial variables were secondary outcomes. Results. Forty-eight participants were recruited over 4 months with a recruitment rate of 52.1% (25/48); 52% (25/48) met the inclusion criteria and 100% (25/25) were randomized into the intervention (N=12) and wait-listed (WL) control groups (N=13). At 12 weeks, 10/12 (83.3%; 95% CI 55.20 to 95.30) intervention and 10/13 (76.9%; 95% CI 49.74 to 91.82) control participants completed final assessments. The average attendance rate was 69.2% for the intervention group (range 25% – 91.7%) and 55% (range 25% – 91.7%) among controls. The a priori recruitment criteria for progression was not met. The retention rate satisfied the criteria of the study. No serious adverse events occurred. Conclusions. Community-dwelling older adults at risk of loneliness can safely participate in physical activity intervention for loneliness. However, to progress into a large-scale RCT, the design and methodology would need to be changed.


BMJ Open ◽  
2021 ◽  
Vol 11 (5) ◽  
pp. e041242
Author(s):  
Hannah G Withers ◽  
Joanne V Glinsky ◽  
Jackie Chu ◽  
Matthew D Jennings ◽  
Alison J Hayes ◽  
...  

IntroductionExercise, support and advice are considered core components of management for most musculoskeletal conditions and are typically provided by physiotherapists through regular face-to-face treatments. However, exercise can be provided remotely as part of a home exercise programme, while support and advice can be provided over the telephone. There is initial evidence from trials and systematic reviews to suggest that remotely provided physiotherapy can be used to manage a variety of musculoskeletal conditions safely and effectively.Methods and analysisThe aim of this single-blind randomised controlled non-inferiority trial is to determine whether a supported home exercise programme is as good as or better than face-to-face physiotherapy for the treatment of musculoskeletal conditions. Two hundred and ten participants will be recruited from five public hospitals in Sydney, Australia. Participants will be randomised to either the supported home exercise group or the face-to-face physiotherapy group. Participants allocated to the supported home exercise group will initially receive one face-to-face session with the trial physiotherapist and will then be managed remotely for the next 6 weeks. Participants allocated to the face-to-face physiotherapy group will receive a course of physiotherapy as typically provided in Sydney government hospitals. The primary outcome is function measured by the Patient Specific Functional Scale at 6 weeks. There will be nine secondary outcomes measured at 6 and 26 weeks. Separate analyses will be conducted on each outcome, and all analyses will be conducted on an intention-to-treat basis. A health economic evaluation will be conducted from a health funder plus patient perspective.Ethics and disseminationEthical approval was obtained on the 17 March 2017 from the Northern Sydney Local Health District HREC, trial number HREC/16HAWKE/431-RESP/16/287. The results of this study will be submitted for publication to peer-reviewed journals and be presented at national and international conferences. Recruitment commenced in March 2019, and it is anticipated that the trial will be completed by December 2021. This trial will investigate two different models of physiotherapy care for people with musculoskeletal conditions.Trial registration numberCPMP/ICH-135/95.Protocol versionThe most recent version of the protocol is V.1.2 dated November 2019.


2021 ◽  
Author(s):  
Ruth McLaren ◽  
Paul F. Smith ◽  
Sue Lord ◽  
Preet Kamal Kaur ◽  
Yiwen Zheng ◽  
...  

UNSTRUCTURED Background: Reduced mobility and falls are common in older adults. Balance retraining programmes are effective in reducing falls and improving balance and mobility. Noisy galvanic stimulation (nGVS) is a low level electrical stimulation used to reduce the threshold for firing of vestibular neurons via a mechanism of stochastic resonance. We hypothesise that nGVS will enhance the effects of balance retraining in older adults at risk of falls. Methods: This 3- armed randomised controlled trial assesses the feasibility of augmenting balance retraining with nGVS. Community dwelling older adults at risk of falling will be randomly assigned to either an nGVS plus balance programme (nGVS group), sham plus balance programme (sham group) or a no treatment group (Control). Participants will attend the exercise group twice a week for 8 weeks with assessment of balance and gait pre-treatment, post-treatment and at 3-months post-intervention. Primary outcome measures include postural sway, measured by Centre of Pressure (COP) velocity, area and root mean square and gait parameters of speed, step width, step variability and double support time. Spatial memory will also be measured using the Triangle Completion and 4 Mountains Tests. Discussion: This study will evaluate the feasibility of using nGVS alongside balance retraining in older adults at risk of falls and will inform the design of a fully powered randomised controlled trial. Trial registration: This trial has been prospectively registered with the Australia New Zealand Clinical Trials Registry (ACTRN12620001172998) and has a UTN of U1111-1241-2231.


Sign in / Sign up

Export Citation Format

Share Document