Michael Brach

Feasibility of a multidimensional home-based exercise programme for the elderly with structured support given by the general practitioner's surgery: Study protocol of a single arm trial preparing an RCT (ISRCTN58562962)

BackgroundPhysical activity programmes can help to prevent functional decline in the elderly. Until now, such programmes use to target either on healthy community-dwelling seniors or on elderly living in special residences or care institutions. Sedentary or frail people, however, are difficult to reach when they live in their own homes. The general practitioners (GP) practice offers a unique opportunity to acquire these people for participation in activity programmes. We conceptualised a multidimensional home-based exercise programme that shall be delivered to the target group through cooperation between GPs and exercise therapists. In order to prepare a randomised controlled trial (RCT), a feasibility study is being conducted.MethodsThe study is designed as a single arm interventional trial. We plan to recruit 90 patients aged 70 years and above through their GPs. The intervention lasts 12 weeks and consists of physical activity counselling, a home-exercise programme, and exercise consultations provided by an exercise therapist in the GPs practice and via telephone. The exercise programme consists of two main components: 1. a combination of home-exercises to improve strength, flexibility and balance, 2. walking for exercise to improve aerobic capacity. Primary outcome measures are: appraisal by GP, undesirable events, drop-outs, adherence. Secondary outcome measures are: effects (a. motor tests: timed-up-and-go, chair rising, grip strength, tandem stand, tandem walk, sit-and-reach; b. telephone interview: PRISCUS-Physical Activity Questionnaire, Short Form-8 Health Survey, three month recall of frequency of falls, Falls Efficacy Scale), appraisal by participant, exercise performance, focus group discussion. Data analyses will focus on: 1. decision-making concerning the conduction of a RCT, 2. estimation of the effects of the programme, detection of shortcomings and identification of subgroups with contrary results, 3. feedback to participants and to GPs.ConclusionA new cooperation between GPs and exercise therapists to approach community-dwelling seniors and to deliver a home-exercise programme is object of research with regard to feasibility and acceptance. In case of success, an RCT should examine the effects of the programme. A future implementation within primary medical care may take advantage from the flexibility of the programme.Trial registrationCurrent Controlled Trials ISRCTN58562962.

Studying feasibility and effects of a two-stage nursing staff training in residential geriatric care using a 30 month mixed-methods design [ISRCTN24344776]

BackgroundTransfer techniques and lifting weights often cause back pain and disorders for nurses in geriatric care. The Kinaesthetics care conception claims to be an alternative, yielding benefits for nurses as well as for clients.Starting a multi-step research program on the effects of Kinaesthetics, we assess the feasibility of a two-stage nursing staff training and a pre-post research design. Using quantitative and qualitative success criteria, we address mobilisation from the bed to a chair and backwards, walking with aid and positioning in bed on the staff level as well as on the resident level. In addition, effect estimates should help to decide on and to prepare a controlled trial.Methods/DesignStandard basic and advanced Kinaesthetics courses (each comprising four subsequent days and an additional counselling day during the following four months) are offered to n = 36 out of 60 nurses in a residential geriatric care home, who are in charge of 76 residents. N = 22 residents needing movement support are participating to this study.On the staff level, measurements include focus group discussions, questionnaires, physical strain self-assessment (Borg scale), video recordings and external observation of patient assistance skills using a specialised instrument (SOPMAS). Questionnaires used on the resident level include safety, comfort, pain, and level of own participation during mobilisation. A functional mobility profile is assessed using a specialised test procedure (MOTPA).Measurements will take place at baseline (T0), after basic training (T1), and after the advanced course (T2). Follow-up focus groups will be offered at T1 and 10 months later (T3).DiscussionTen criteria for feasibility success are established before the trial, assigned to resources (missing data), processes (drop-out of nurses and residents) and science (minimum effects) criteria. This will help to make rational decision on entering the next stage of the research program.Trial RegistrationCurrent Controlled Trials ISRCTN24344776.

Assistive technologies at home and in the workplace—a field of research for exercise science and human movement science

Since its existence, the European Review of Aging and Physical Activity (EURAPA) used different forms and contents of editorial articles. Beside referencing and summarizing the current issue, introductory overviews on research subjects are presented, thus drawing attention to fields considered in EURAPA, to stimulate potential research and submission of manuscripts to the journal. Such topics were, e.g. peak exercise [16], socioeconomic perspectives [14], or theory-driven evaluation [4]. The present editorial addresses technical assistance for elderly persons. During the last years, the term “ambient assisted living” (AAL) has been established for this field of research, mostly by national and European Union (EU) funding agencies, including science and technology [1, 19]. This field is of a highly interdisciplinary nature, oriented towards practical solutions, and it includes behavioural and technical aspects. This corresponds to the nature of exercise science and human movement science, which has been described to be “technological” from a theory of science view [3]. In addition, physical activity is an integral part of daily living. Therefore, AAL seems to be an interesting and stimulating field. In the following sections, firstly, the AAL concept is introduced. Secondly, a sketch on concepts to improve and prolong working life is presented, including examples for research questions from a sport and exercise science point of view. Some concluding remarks contain practical information on calls and research frameworks.

Recruiting Hard-to-Reach Subjects for Exercise Interventions: A Multi-Centre and Multi-Stage Approach Targeting General Practitioners and Their Community-Dwelling and Mobility-Limited Patients

The general practitioner (GP)’s practice appears to be an ideal venue for recruiting community-dwelling older adults with limited mobility. This study (Current Controlled Trials ISRCTN17727272) aimed at evaluating the recruiting process used for a multi-centre exercise intervention (HOMEfit). Each of six steps resulted in an absolute number of patients (N1–N6). Sex and age (for N4–N6) and reasons for dropping out were assessed. Patient database screening (N1–N3) at 15 GP practices yielded N1 = 5,990 patients aged 70 and above who had visited their GP within the past 6 months, N2 = 5,467 after exclusion of institutionalised patients, N3 = 1,545 patients eligible. Using a pre-defined limitation algorithm in order to conserve the practices’ resources resulted in N4 = 1,214 patients (80.3 ± 5.6 years, 68% female), who were then officially invited to the final assessment of eligibility at the GP’s practice. N5 = 434 patients (79.5 ± 5.4 years, 69% female) attended the practice screening (n = 13 of whom had not received an official invitation). Finally, N6 = 209 (79.8 ± 5.2 years, 74% female) were randomised after they were judged eligible and had given their written informed consent to participate in the randomised controlled trial (overall recruitment rate: 4.4%). The general strategy of utilising a GP’s practice to recruit the target group proved beneficial. The data and experiences presented here can help planners of future exercise-intervention studies.

Research on exercise programs—an approach of technological science

The European Review on Aging and Physical Activityconcentrates on reviews. Reviews are based on researchpapers. When compiling, reviewing, or just reading reviewson exercise programs, some difficulties arise. They will bediscussed below:& Original research more often aims at general laws thanat technological rules to establish the assumptions underwhich these laws take effect.& Authors omit important information on how interven-tions were executed.& Definitions and background theory may lack clearness,or there are terminological differences in differentscientific traditions.In the present paper, the problem is sketched in thefollowing paragraphs. Below, possible reasons and pro-posals are given. It closes with an appeal to emphasize themethods section in publications. The focus is on originalresearch, which is the base of every review based onoriginal research papers.Reading reviews on physical activity programs, often noclear statement on the effects of certain procedures is given.Sometimes results of collected research seem to be or reallyare contradictory or no meta-analysis is possible, becausethe designs are too heterogeneous. Doing a CochraneReview on home vs center-based exercise, Ashworth andcolleagues expressed this experience [1].This is valid independent of formal quality. Papers oninterventional trials often are not comparable, becauseinformation on how the interventions were done is missing,or the interventions are too different to aggregate results. Inaddition, in physical activity interventions with the elderly,the growing heterogeneity of subjects exacerbates theproblem: Interventions which show effects for one samplemay fail with another sample, in which disorders, socialstatus, motivation, and other aspects are distributed in aslightly different way. For illustration of the differentaspects, three examples are sketched:Example 1: specifications in strength trainingExercise prescriptions in strength training often compriseload magnitude, number of repetitions and sets, rest in-between sets, number of interventions per week, andtraining period. This was reported by Toigo and Boutellier[8]. The authors show, however, that these classicalparameters are insufficient to precisely describe quantitativeand/or qualitative effects on skeletal muscle. Therefore, it isnot surprising that studies containing some sort of strengthtraining lead to contradictive results or are not comparable.Toigo and Boutellier [8] identify new determinants andrecommend to standardize the design and description of allfuture resistance exercise investigations by using a set of 13mechanobiological determinants (classical and new ones),including fractional and temporal distribution of thecontraction modes per repetition, duration of one repetition,rest in-between repetitions, time under tension, muscularfailure, range of motion, recovery time, and anatomicaldefinition.Example 2: designing a new interventionMissing information also aggravates the use ofpublished research for the purpose of designing new

Adverse Events in Mobility‐Limited and Chronically Ill Elderly Adults Participating in an Exercise Intervention Study Supported by General Practitioner Practices

To present detailed adverse event (AE) data from a randomized controlled trial (RCT) of a home‐based exercise program delivered to an elderly high‐risk population by an exercise therapist after medical clearance from a general practitioner (GP).

An exercise programme for community-dwelling, mobility-restricted and chronically ill older adults with structured support by the general practitioner's practice (HOMEfit). From feasibility to evaluation.

Programmes containing health-enhancing physical exercise should be evaluated using standards that are just as rigorous as those required for drug development. In contrast to new medicines, exercise programmes are highly complex. This has to be taken into account when designing the research plan. In order to illustrate the development process of a “complex intervention”, we use the example of an exercise programme for community-dwelling, mobility-restricted and chronically ill older adults. Based on a framework for evaluation of complex interventions (Medical Research Council [MRC], UK), a research plan was set up containing the phases: development, feasibility, evaluation, implementation. The development phase resulted in the design of a home-based exercise programme in which the target group is approached and supported via their general practitioner and an exercise therapist. A feasibility study was performed. Three quantitative criteria for feasibility (adoption, safety, continuing participation) were statistically confirmed which permitted the decision to proceed with the research plan. So far, the MRC framework has proved to be valuable for the development of the new programme.ZusammenfassungBewegungstherapeutische Programme sollten nach denselben Standards entwickelt und evaluiert werden wie Medikamente. Im Gegensatz zu neuen Medikamenten sind bewegungstherapeutische Programme allerdings in hohem Maße „komplex“, was bei der Erstellung des Forschungsplans berücksichtigt werden muss. Im vorliegenden Artikel wird der Entwicklungsprozess einer „komplexen Intervention“ anhand eines bewegungstherapeutischen Programms für zu Hause lebende, mobilitätseingeschränkte und chronisch kranke Ältere dargestellt. Basierend auf einem Evaluationsmodell für komplexe Interventionen des Medical Research Council (MRC, UK) wurde ein Forschungsplan aufgestellt, der die Phasen Entwicklung, Machbarkeit, Evaluation und Implementation beinhaltet. Die Entwicklungsphase resultierte in einem Heimübungsprogramm, bei dem die Zielgruppe über eine Kooperation zwischen Hausärzt(inn)en und Bewegungstherapeut(inn)en erreicht und unterstützt wird. In einer Machbarkeitsstudie wurden drei quantitative Machbarkeitskriterien (Annahme, Sicherheit, anhaltende Teilnahme) statistisch bestätigt. Dies erlaubte die Entscheidung, in die nächste Phase des Forschungsplans überzugehen. Bislang hat sich das Modell des MRC als nützlich und wertvoll für den Entwicklungs- und Evaluationsprozess des neuen Programms herausgestellt.

An exercise programme for community-dwelling, mobility-restricted and chronically ill older adults with structured support by the general practitioner’s practice (HOMEfit)

Programmes containing health-enhancing physical exercise should be evaluated using standards that are just as rigorous as those required for drug development. In contrast to new medicines, exercise programmes are highly complex. This has to be taken into account when designing the research plan. In order to illustrate the development process of a “complex intervention”, we use the example of an exercise programme for community-dwelling, mobility-restricted and chronically ill older adults. Based on a framework for evaluation of complex interventions (Medical Research Council [MRC], UK), a research plan was set up containing the phases: development, feasibility, evaluation, implementation. The development phase resulted in the design of a home-based exercise programme in which the target group is approached and supported via their general practitioner and an exercise therapist. A feasibility study was performed. Three quantitative criteria for feasibility (adoption, safety, continuing participation) were statistically confirmed which permitted the decision to proceed with the research plan. So far, the MRC framework has proved to be valuable for the development of the new programme.ZusammenfassungBewegungstherapeutische Programme sollten nach denselben Standards entwickelt und evaluiert werden wie Medikamente. Im Gegensatz zu neuen Medikamenten sind bewegungstherapeutische Programme allerdings in hohem Maße „komplex“, was bei der Erstellung des Forschungsplans berücksichtigt werden muss. Im vorliegenden Artikel wird der Entwicklungsprozess einer „komplexen Intervention“ anhand eines bewegungstherapeutischen Programms für zu Hause lebende, mobilitätseingeschränkte und chronisch kranke Ältere dargestellt. Basierend auf einem Evaluationsmodell für komplexe Interventionen des Medical Research Council (MRC, UK) wurde ein Forschungsplan aufgestellt, der die Phasen Entwicklung, Machbarkeit, Evaluation und Implementation beinhaltet. Die Entwicklungsphase resultierte in einem Heimübungsprogramm, bei dem die Zielgruppe über eine Kooperation zwischen Hausärzt(inn)en und Bewegungstherapeut(inn)en erreicht und unterstützt wird. In einer Machbarkeitsstudie wurden drei quantitative Machbarkeitskriterien (Annahme, Sicherheit, anhaltende Teilnahme) statistisch bestätigt. Dies erlaubte die Entscheidung, in die nächste Phase des Forschungsplans überzugehen. Bislang hat sich das Modell des MRC als nützlich und wertvoll für den Entwicklungs- und Evaluationsprozess des neuen Programms herausgestellt.

Theory-driven evaluation of exercise programs: often recommended but still only a few hits in literature databases

Among the papers submitted to and published by the European Review of Aging and Physical Activity, there are usually some dealing with exercise programs. In this editorial, some thoughts on the evaluation of such programs are shared. The editorial closes with some news regarding the journal. Research-based activities in order to develop, to design or to change some real-world object or aspect (e.g., by an exercise program), are considered technological science, as expanded on in a recent editorial of this journal [1]. The outcome of this kind of research should and usually is in fact assessed and rated (evaluation). Researchers, funders, representatives of the target group, and other individuals being affected by such a program (stakeholders) increasingly call for evaluation. Often, the term evaluation is used as a synonym for assessment of effectivity. Compared with that, theory-driven evaluation includes also planning and implementation of a program. Theory-driven evaluation is a framework (in fact, there are several frameworks) with rising acceptance during the last 20 years—and seems to be helpful for health-oriented exercise programs. In the following sections, the reader will find

Standardisation for Mobility-Related Assisted Living Solutions: From Problem Analysis to a Generic Mobility Model

DKE, the German Commission for Electrical, Electronic & Information Technologies, established an AAL (ambient assisted living) standardisation roadmap and a mobility group working on a standardisation document for DIN and IEC committees. Problems in mobility support, i.e. changing body positions and locomotion, are, among others, (a) individual need changes on different time scales, (b) AAL usage as resource of both increase and decrease in activity and (c) barriers between indoor and outdoor mobility. Experts from science, technology and industry (human movement, transportation, telecommunication, computing, electrical engineering) developed (1) a common theoretical base, using existing European projects in the field of AAL, DIN ISO standards, (2) user stories on different target groups and mobility devices, (3) example use cases for the UCMR (Use Case Management Repository), (4) a generic mobility model using UML (unified modeling language). The resulting model combines action theory (situation with person, task and environment) and the resource-based view (internal and external resources) in order to distinguish mobility as room for action. Thus, standardising mobility-related AAL means to assess resources the product will offer to but also demand from the user. This holds especially when different products are combined in mobility chains.