A personalised exercise programme for individuals with lower limb amputation reduces falls and improves gait biomechanics: A block randomised controlled trial

ObjectivesTo determine the feasibility of undertaking a randomised controlled effectiveness trial evaluating the use of a perineural catheter (PNC) after major lower limb amputation with postoperative pain as the primary outcome.DesignRandomised controlled feasibility trial.SettingTwo vascular Centres in South Wales, UK.Participants50 patients scheduled for major lower limb amputation (below or above knee) for complications of peripheral vascular disease.InterventionsThe treatment arm received a PNC placed adjacent to the sciatic or tibial nerve at the time of surgery, with continuous infusion of levobupivacaine hydrochloride 0.125% for up to 5 days. The control arm received neither local anaesthetic nor PNC. Both arms received usual perioperative anaesthesia and postoperative analgesia.Primary and secondary outcome measuresThe primary outcomes were the proportion of eligible patients who were randomised and the proportion of recruited patients who provided primary effectiveness outcome data. Secondary outcomes were: the proportion of recruited patients reaching 2 and 6 month follow-up and supplying pain data; identification of key cost drivers; development of an economic analysis framework for a future effectiveness trial; identification of barriers to recruitment and site set-up; and identification of the best way to measure postoperative pain.ResultsSeventy-six of 103 screened patients were deemed eligible over a 10 month period. Fifty (64.5%) of these patients were randomised, with one excluded in the perioperative period. Forty-five (91.3%) of 49 recruited patients provided enough pain scores on a 4-point verbal rating scale to allow primary effectiveness outcome evaluation. Attrition rates were high; 18 patients supplied data at 6 month follow-up. Costs were dominated by length of hospital stay. Patients and healthcare professionals reported that trial processes were acceptable.ConclusionsRecruitment of patients into a trial comparing PNC use to usual care after major lower limb amputation with postoperative pain measured on a 4-point verbal rating scale is feasible. Evaluation of longer-term symptoms is difficult.Trial registration numberISRCTN: 85 710 690. EudraCT: 2016-003544-37.

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Effectiveness of a self-managed digital exercise programme to prevent falls in older community-dwelling adults: study protocol for the Safe Step randomised controlled trial

BMJ Open ◽

10.1136/bmjopen-2019-036194 ◽

2020 ◽

Vol 10 (5) ◽

pp. e036194 ◽

Cited By ~ 1

Author(s):

Beatrice Pettersson ◽

Lillemor Lundin-Olsson ◽

Dawn A Skelton ◽

Per Liv ◽

Magnus Zingmark ◽

...

Keyword(s):

Randomised Controlled Trial ◽

Exercise Intervention ◽

Controlled Trial ◽

Exercise Programme ◽

Community Dwelling ◽

Falls Prevention ◽

Ethical Review ◽

Exercise Interventions ◽

Educational Videos ◽

Randomised Controlled

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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