Use of an ‘adapted Zelen’ design in a randomised controlled trial of a physiotherapist-led exercise intervention in patients with myeloma

IntroductionExercise interventions have a strong evidence base for falls prevention. However, exercise can be challenging to implement and often has limited reach and poor adherence. Digital technology provides opportunities for both increased access to the intervention and support over time. Further knowledge needs to be gained regarding the effectiveness of completely self-managed digital exercise interventions. The main objective of this study is to compare the effectiveness of a self-managed digital exercise programme, Safe Step, in combination with monthly educational videos with educational videos alone, on falls over 1 year in older community-dwelling adults.Methods and analysisA two-arm parallel randomised controlled trial will be conducted with at least 1400 community-living older adults (70+ years) who experience impaired balance. Participants will be recruited throughout Sweden with enrolment through the project website. They will be randomly allocated to either the Safe Step exercise programme with additional monthly educational videos about healthy ageing and fall prevention, or the monthly education videos alone. Participants receiving the exercise intervention will be asked to exercise at home for at least 30 min, 3 times/week with support of the Safe Step application. The primary outcome will be rate of falls (fall per person year). Participants will keep a fall calendar and report falls at the end of each month through a digital questionnaire. Further assessments of secondary outcomes will be made through self-reported questionnaires and a self-test of 30 s chair stand test at baseline and 3, 6, 9 and 12 months after study start. Data will be analysed according to the intention-to-treat principle.Ethics and disseminationEthical approval was obtained by The Regional Ethical Review Board in Umeå (Dnr 2018/433-31). Findings will be disseminated through the project web-site, peer-reviewed journals, national and international conferences and through senior citizen organisations’ newsletters.Trial registration numberNCT03963570.

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Protocol for a feasibility randomised controlled trial of a musculoskeletal exercise intervention versus usual care for children with haemophilia

BMJ Open ◽

10.1136/bmjopen-2019-029474 ◽

2019 ◽

Vol 9 (8) ◽

pp. e029474 ◽

Cited By ~ 2

Author(s):

Ferhana Hashem ◽

Melanie Bladen ◽

Liz Carroll ◽

Charlene Dodd ◽

Wendy I Drechsler ◽

...

Keyword(s):

Randomised Controlled Trial ◽

Muscle Strength ◽

Usual Care ◽

Exercise Intervention ◽

Controlled Trial ◽

Small Scale ◽

Framework Analysis ◽

Muscle Strengthening ◽

Training Requirements ◽

Randomised Controlled

IntroductionHaemophilia is a rare, inherited disorder in which blood does not clot normally, resulting in bleeding into joints and muscles. Long-term consequence is disabling joint pain, stiffness, muscle weakness, atrophy and reduced mobility. The purpose of this proposed feasibility of a randomised controlled trial (RCT) is to test the feasibility of an age-appropriate physiotherapy intervention designed to improve muscle strength, posture and the way boys use their joints during walking and everyday activities.Methods and analysisA small-scale two-centre RCT of a 12-week muscle strengthening exercise intervention versus usual care for young children with haemophilia will be conducted. Primary outcomes will be safety and adherence to the exercise intervention. Secondary outcomes will include recruitment, retention and adverse event rates, clinical data, muscle strength, joint biomechanics and foot loading patterns during walking, 6 min timed walk, timed-up-and-down-stairs, EQ-5D-Y, participants’ perceptions of the study, training requirements and relevant costs. Recruitment, follow-up, safety and adherence rates will be described as percentages. Participant diary and interview data will be analysed using a framework analysis. Demographic and disease variable distributions will be analysed for descriptive purposes and covariant analysis. Estimates of differences between treatment arms (adjusted for baseline) and 75% and 95% CIs will be calculated.Ethics and disseminationThe study has ethical approval from the London—Fulham Research Ethics Committee (17/LO/2043) as well as Health Research Authority approval. As well as informing the design of the definitive trial, results of this study will be presented at local, national and international physiotherapy and haemophilia meetings as well as manuscripts submitted to peer-reviewed journals. We will also share the main findings of the study to all participants and the Haemophilia Society.

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The influence of a home-based exercise intervention on human health indices in individuals with chronic spinal cord injury (HOMEX-SCI): study protocol for a randomised controlled trial

Trials ◽

10.1186/s13063-016-1396-z ◽

2016 ◽

Vol 17 (1) ◽

Cited By ~ 6

Author(s):

Tom E. Nightingale ◽

Jean-Philippe Walhin ◽

James E. Turner ◽

Dylan Thompson ◽

James L. J. Bilzon

Keyword(s):

Spinal Cord ◽

Spinal Cord Injury ◽

Randomised Controlled Trial ◽

Exercise Intervention ◽

Controlled Trial ◽

Chronic Spinal Cord Injury ◽

Health Indices ◽

Home Based ◽

Cord Injury ◽

Randomised Controlled

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The CanMoRe trial – evaluating the effects of an exercise intervention after robotic-assisted radical cystectomy for urinary bladder cancer: the study protocol of a randomised controlled trial

BMC Cancer ◽

10.1186/s12885-020-07140-5 ◽

2020 ◽

Vol 20 (1) ◽

Author(s):

Andrea Porserud ◽

Patrik Karlsson ◽

Elisabeth Rydwik ◽

Markus Aly ◽

Lars Henningsohn ◽

...

Keyword(s):

Bladder Cancer ◽

Randomised Controlled Trial ◽

Urinary Bladder ◽

Radical Cystectomy ◽

Study Protocol ◽

Exercise Intervention ◽

Controlled Trial ◽

Urinary Bladder Cancer ◽

Robotic Assisted ◽

Randomised Controlled

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PERCEPT myeloma: a protocol for a pilot randomised controlled trial of exercise prehabilitation before and during autologous stem cell transplantation in patients with multiple myeloma

BMJ Open ◽

10.1136/bmjopen-2019-033176 ◽

2020 ◽

Vol 10 (1) ◽

pp. e033176

Author(s):

Orla McCourt ◽

Abigail Fisher ◽

Gita Ramdharry ◽

Anna L Roberts ◽

Joanne Land ◽

...

Keyword(s):

Stem Cell ◽

Randomised Controlled Trial ◽

Stem Cell Transplantation ◽

Usual Care ◽

Cell Transplantation ◽

Autologous Stem Cell Transplantation ◽

Exercise Intervention ◽

Controlled Trial ◽

Pilot Randomised Controlled Trial ◽

Randomised Controlled

IntroductionMyeloma, a blood cancer originating from plasma cells, is the most common indication for autologous stem cell transplantation (SCT). Patients with myeloma undergoing autologous SCT (ASCT) experience treatment-related morbidity and reduction in function and well-being for many months post-treatment. Interventions targeting physical functioning delivered prior to and during SCT have shown promising results in mixed haematological populations and may offer a non-pharmacological solution to physically optimising and preparing patients for SCT. The aim of this study is to investigate the feasibility of a physiotherapist-led exercise intervention as an integral part of the myeloma ASCT pathway at a UK tertiary centre.Methods and analysisPERCEPT is a single-site, pilot randomised controlled trial of an exercise intervention embedded within the myeloma ASCT pathway, compared with usual care. The primary study end points will be feasibility measures of study and intervention delivery including recruitment rates, acceptability of intervention, study completion rate and any adverse events. Secondary end points will evaluate differences between the exercise intervention group and the usual care control group in cancer-related fatigue, quality of life, functional capacity (6 min walk test; handheld dynamometry; a timed sit-to-stand test) and objective and self-reported physical activity. Outcomes will be assessed at four time points, approximately 6–8 weeks prior to SCT, on/around day of SCT, on discharge from SCT hospital admission and 12 weeks post-discharge. The exercise intervention comprises of partly supervised physiotherapist-led aerobic and resistance exercise including behaviour change techniques to promote change in exercise behaviour. The primary outcomes from the trial will be summarised as percentages or mean values with 95% CIs. Group differences for secondary outcomes at each time point will be analysed using appropriate statistical models.Ethics and disseminationThis study has NHS REC approval (Camden and Kings Cross, 19/LO/0204). Results will be disseminated through publication and presentations at haematology and rehabilitation-related meetings.Trial registration numberISRCTN15875290.

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