Effects of a home-exercise programme in childhood survivors of acute lymphoblastic leukaemia on physical fitness and physical functioning: results of a randomised clinical trial

2019 ◽  
Vol 28 (7) ◽  
pp. 3171-3178 ◽  
Author(s):  
Jahn Dubery Manchola-González ◽  
Caritat Bagur-Calafat ◽  
Montserrat Girabent-Farrés ◽  
Josep Ricard Serra-Grima ◽  
Roser Álvarez Pérez ◽  
...  
2020 ◽  
Vol 6 (1) ◽  
pp. e000707 ◽  
Author(s):  
Marcie Harris-Hayes ◽  
Karen Steger-May ◽  
Allyn M Bove ◽  
Stefanie N Foster ◽  
Michael J Mueller ◽  
...  

Study designPilot, multicentre randomised clinical trial (RCT).ObjectivesAssess viability of performing a definitive RCT and compare preliminary effects of movement pattern training (MoveTrain) and strengthening/flexibility (Standard) to improve function in people with chronic hip-related groin pain (HRGP).BackgroundTo determine the best physical therapist-led intervention for patients with HRGP, we must understand treatment effects of different treatment modes.MethodsForty-six patients (17M:29F; 29±5.3 years; body mass index 25.6±6.3 kg/m2) with HRGP were randomised. MoveTrain included task-specific training to optimise biomechanics during daily tasks. Standard included strengthening/flexibility. Treatment included 10 visits/12 weeks and home exercise programme (HEP). Primary outcomes for feasibility were recruitment, retention, treatment adherence and treatment fidelity. Secondary outcomes were patient-reported function (Hip disability and Osteoarthritis Outcome Score (HOOS)), lower extremity kinematics and hip muscle strength.ResultsWe achieved target recruitment, and retention was excellent (91%). Patient session attendance was high (93%); however, reported HEP adherence (62%) was lower than expected. Physical therapists’ adherence to treatment protocols was high (90%). Patients demonstrated high treatment receipt; 91% of exercises performed were rated independent. Both groups demonstrated clinically important improvements in function (HOOS) and muscle strength; however, there were no between-group differences (HOOS subscales, p≥0.13, strength, p≥0.34). Compared with Standard, MoveTrain demonstrated greater reductions in hip adduction (p=0.016) and pelvic drop (p=0.026) during a single leg squat. No adverse events were noted.ConclusionOur experience in completing this RCT confirmed that a larger, multicentre RCT is feasible and highlighted modifications we will implement to optimise the future RCT.Trial registration numberNCT02913222.


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.


BMJ Open ◽  
2017 ◽  
Vol 7 (10) ◽  
pp. e017052 ◽  
Author(s):  
Rachael Hough ◽  
Sabrina Sandhu ◽  
Maria Khan ◽  
Anthony Moran ◽  
Richard Feltbower ◽  
...  

ObjectiveParticipation rates in clinical trials are low in teenagers and young adults (TYA) with cancer. Whilst the importance of clinical trials in informing best practice is well established, data regarding individual patient benefit are scarce. We have investigated the association between overall survival and trial recruitment in TYA patients with acute lymphoblastic leukaemia (ALL).DesignRetrospective.SettingNational (England) TYA patients treated for ALL.Participants511 patients aged 15–24 years diagnosed with ALL between 2004 and 2010 inclusive, of whom 239 (46.7%) participated in the UKALL2003 trial.Outcome measuresPatients were identified using National Clinical Trial (UKALL2003) and Cancer Registry (National Cancer Data Repository, English National Cancer Online Registration Environment) Databases. Relative survival rates were calculated for trial and non-trial patients and observed differences were modelled using a multiple regression approach. The numbers and percentages of deaths in those patients included in the survival analysis were determined for each 3-month period, p values were calculated using the two-tailed z-test for difference between proportions and 95% CIs for percentage deaths were derived using the binomial distribution based on the Wilson Score method.ResultsPatients treated on the trial had a 17.9% better 2-year survival (85.4% vs 67.5%, p<0.001) and 8.9% better 1-year survival (90.8% vs 81.9%, p=0.004) than those not on the trial. 35 (14.6%) patients recruited to the trial died in the 2 years following diagnosis compared with 86 (32.6%) of those not recruited (p<0.001).ConclusionsTYA patients recruited to the clinical trial UKALL 2003 in England had a lower risk of mortality and a higher overall survival than contemporaneous non-trial patients. These data underline the potential for individual patient benefit in participating in a clinical trial and the importance of international efforts to increase trial participation in the TYA age group.Trial registration numberISRCTN07355119.


2018 ◽  
Vol 33 (3) ◽  
pp. 473-484 ◽  
Author(s):  
Lorna Paul ◽  
Linda Renfrew ◽  
Jennifer Freeman ◽  
Heather Murray ◽  
Belinda Weller ◽  
...  

Objective: To examine the feasibility of a trial to evaluate web-based physiotherapy compared to a standard home exercise programme in people with multiple sclerosis. Design: Multi-centre, randomized controlled, feasibility study. Setting: Three multiple sclerosis out-patient centres. Participants: A total of 90 people with multiple sclerosis (Expanded Disability Status Scale 4–6.5). Interventions: Participants were randomized to a six-month individualized, home exercise programme delivered via web-based physiotherapy ( n = 45; intervention) or a sheet of exercises ( n = 45; active comparator). Outcome measures: Outcome measures (0, three, six and nine months) included adherence, two-minute walk test, 25 foot walk, Berg Balance Scale, physical activity and healthcare resource use. Interviews were undertaken with 24 participants and 3 physiotherapists. Results: Almost 25% of people approached agreed to take part. No intervention-related adverse events were recorded. Adherence was 40%–63% and 53%–71% in the intervention and comparator groups. There was no difference in the two-minute walk test between groups at baseline (Intervention-80.4(33.91)m, Comparator-70.6(31.20)m) and no change over time (at six-month Intervention-81.6(32.75)m, Comparator-74.8(36.16)m. There were no significant changes over time in other outcome measures except the EuroQol-5 Dimension at six months which decreased in the active comparator group. For a difference of 8(17.4)m in two-minute walk test between groups, 76 participants/group would be required (80% power, P > 0.05) for a future randomized controlled trial. Conclusion: No changes were found in the majority of outcome measures over time. This study was acceptable and feasible by participants and physiotherapists. An adequately powered study needs 160 participants.


Haemophilia ◽  
2010 ◽  
Vol 16 (1) ◽  
pp. 162-169 ◽  
Author(s):  
K. HILL ◽  
M. FEARN ◽  
S. WILLIAMS ◽  
L. MUDGE ◽  
C. WALSH ◽  
...  

2016 ◽  
Vol 31 (8) ◽  
pp. 1068-1077 ◽  
Author(s):  
Kellie B Emmerson ◽  
Katherine E Harding ◽  
Nicholas F Taylor

Objective: To determine whether patients with stroke receiving rehabilitation for upper limb deficits using smart technology (video and reminder functions) demonstrate greater adherence to prescribed home exercise programmes and better functional outcomes when compared with traditional paper-based exercise prescription. Design: Randomized controlled trial comparing upper limb home exercise programmes supported by video and automated reminders on smart technology, with standard paper-based home exercise programmes. Setting: A community rehabilitation programme within a large metropolitan health service. Subjects: Patients with stroke with upper limb deficits, referred for outpatient rehabilitation. Interventions: Participants were randomly assigned to the control (paper-based home exercise programme) or intervention group (home exercise programme filmed on an electronic tablet, with an automated reminder). Both groups completed their prescribed home exercise programme for four weeks. Main measures: The primary outcome was adherence using a self-reported log book. Secondary outcomes were change in upper limb function and patient satisfaction. Results: A total of 62 participants were allocated to the intervention ( n = 30) and control groups ( n = 32). There were no differences between the groups for measures of adherence (mean difference 2%, 95% CI −12 to 17) or change in the Wolf Motor Function Test log transformed time (mean difference 0.02 seconds, 95% CI −0.1 to 0.1). There were no between-group differences in how participants found instructions ( p = 0.452), whether they remembered to do their exercises ( p = 0.485), or whether they enjoyed doing their exercises ( p = 0.864). Conclusions: The use of smart technology was not superior to standard paper-based home exercise programmes for patients recovering from stroke. This trial design was registered prospectively with the Australian and New Zealand Clinical Trials Register, ID: ACTRN 12613000786796. http://www.anzctr.org.au/trialSearch.aspx


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