Effect of a Falls-prevention Exercise Program on Health-related Quality of Life in Older Fallers Receiving Home Care. A Randomized Controlled Trial
Phase: NA
Conditions: Accidental Falls
Sponsor: Oslo Metropolitan University

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A falls prevention programme to improve quality of life, physical 
function and falls efficacy in older people receiving home help 
services: Study protocol for a randomised controlled trial 
Last updated: 06/23-2017 
 
 
Authors: 
Maria Bjerk (Corresponding author) 
Faculty of Health Sciences 
Oslo and Akershus University College 
PO Box 4 St. Olavs plass 
0130 Oslo, Norway 
 
maria.bjerk@hioa.no 
+47 67 23 66 83 
 
Therese Brovold 
Faculty of Health Sciences 
Oslo and Akershus University College 
therese.brovold@hioa.no 
 
Dawn A Skelton 
Institute of Applied Health Research 
School of Health and Life Sciences,  
Glasgow Caledonian University, UK 
dawn.skelton@gcu.ac.uk 
 
Astrid Bergland   
Faculty of Health Sciences 
Oslo and Akershus University College 
astrid.bergland@hioa.no 
 
 
 
 
 
 
Published under the terms of the CC BY 4.0 licence:  Bjerk M, Brovold T, Skelton DA, Bergland A: A 
falls prevention programme to improve quality of life, physical function and falls efficacy in older 
people receiving home help services: study protocol for a randomised controlled trial. BMC Health 
Services Research 2017, 17(1): 559. DOI: 10.1186/s12913-017-2516-5    
 

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A falls prevention programme to improve quality of life, physical 
function and falls efficacy in older people receiving home help 
services: Study protocol for a randomised controlled trial 
 
Abstract 
 
Background:  
Falls and fall-related injuries in older adults are associated with great burdens, both for the 
individuals, the health care system and the society. Previous research has shown evidence for the 
efficiency of exercise as falls prevention. An understudied group are older adults receiving home help 
services, and the effect of a falls prevention programme on health-related quality of life is unclear. 
The primary aim of this randomised controlled trial is to examine the effect of a falls prevention 
programme on quality of life, physical function and falls efficacy in older adults receiving home help 
services. A secondary aim is to explore the mediating factors between falls prevention and health-
related quality of life.  
Methods:  
The study is a single-blinded randomised controlled trial. Participants are older adults, aged 67 or 
older, receiving home help services, who are able to walk with or without walking aids, who have 
experienced at least one fall during the last twelve months and who have a Mini Mental State 
Examination of 23 or above. The intervention group receives a programme, based on the Otago 
Exercise Programme, lasting twelve weeks including home visits and motivational telephone calls. 
The control group receives usual care. The primary outcome is health-related quality of life (SF-36). 
Secondary outcomes are leg strength, balance, walking speed, walking habits, activities of daily living, 
nutritional status and falls efficacy. All measurements are performed at baseline, following 
intervention at three months and at six months’ follow-up. Sample size, based on the primary 
outcome, is set to 150 participants randomised into the two arms, including an estimated 15-20% 
drop out. Participants are recruited from six municipalities in Norway. 
Discussion:  
This trial will generate new knowledge on the effects of an exercise falls prevention programme 
among older fallers receiving home help services. This knowledge will be useful for clinicians, for 
health managers in the primary health care service and for policy makers.  
 
Trial registration: ClinicalTrials.gov. NCT02374307. First registration, 16/02/2015. 
Keywords: Falls prevention, Home help services, Elderly, Quality of life, Older adults, Exercise, 
Balance, Preventative care 

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Background 
Older adults and health-related quality of life 
Health-related quality of life (HRQOL) is of great interest, both with respect to individuals themselves 
as well as a primary concern of public health administrations and professionals. The remarkable 
increase in life expectancy in the twentieth century implies a need to focus on factors capable of 
promoting a high level of HRQOL into old age. In fact, older adults seem to prefer a high HRQOL more 
than longevity, and researchers have concluded that the key challenge is to preserve a high level of 
HRQOL rather than increase length of life [1, 2]. HRQOL is a subjective, multidimensional concept 
shaped by, but not entirely dependent upon, the effects of disease and treatment [3]. The WHO 
Quality of life (QOL) group defines QOL as “individuals` perception of their position in life in the 
context of the culture and value systems in which they live, and in relation to their goals, 
expectations, standards and concerns” [4]. Public health policies in many European countries are 
therefore primarily concerned with keeping older people living independently in the community with 
a good quality of life [5-7]. The raise in number of older adults implies more people with chronic 
diseases and a greater challenge for the health care system in finding effective and feasible 
interventions to reach this goal [5-8].  
Aiming to enable older people to live at home as long as possible, the municipalities in Norway are 
responsible for providing services in the form of home help for older people [9]. Home help includes 
services that assist instrumental activities of daily living (iADL), such as vacuum cleaning, and 
personal activities of daily living (pADL), such as getting dressed, safety alarm services to provide 
assistance if they fall, and social support. The most important predictor of home care use seems to 
be dependency in IADL and ADL and cognitive impairment [10]. Home help receivers constitute a 
transitional group between independent community living older people, and people living in 
residential care facilities/nursing homes [11]. The combination of the increase of older people and 
the use of the so-called LEON (“lowest most efficient level of care”) principle [6], makes this a 
steadily growing group in society, and can be seen as an especially vulnerable group among the older 
population. Moreover, as economic resources are scarce, there seems to be more focus on post-
acute care instead of health promotion and prevention to maintain older adults at home [12]. To 
date there is no evidence-based practice standard for falls-prevention in Norwegian home care 
services.   

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Older adults and falls 
Falls and fall-related injuries are common in older adults and are associated with substantial 
economic costs that are borne by individuals, the community, and the medical system as a whole [13, 
14]. Up to 40% of all nursing home admissions have been found to relate to falls and instability [15]. 
Important risk factors for falling in the group of older adults are impaired balance and gait, 
polypharmacy and a history of falls [16]. Poor nutritional status has also been associated with an 
increased risk of falling, [17] and malnutrition or being in risk of malnutrition is prevalent in half of 
the older adults receiving home care services [18]. Common consequences of a fall are fear of falling, 
activity restrictions, loss of mobility and loss of independence [19]. Falling, or being at risk of falling 
also has a negative influence on QOL [20]. Hence, it can be argued that HRQOL is an important 
outcome in the assessment of falls-prevention programmes [21].  
After several decades of research on interventions to reduce falls and fall risk factors, there is now 
strong evidence for the effectiveness and cost-efficiency of exercise in reducing the number of falls 
[14, 22-25]. An important, but yet understudied group when it comes to the effect of falls prevention 
programmes are older adults receiving home help services, and especially those who recently have 
experienced a fall [11]. Previous research has shown that falls and fear of falling are common in this 
population and are correlated with the amount of home care needed [11, 26]. Vikman et al. [11] 
concluded that future studies should have a focus on the effects of falls prevention programmes in 
the group of those receiving home help services. Recently it has been shown that home help 
receivers fell more frequently than the independent home-dwelling older population [27]. Low 
functional level and high home care recipient health problems were independently associated with 
risk of falling [27]. Fear of falling is also reported more frequently in the group of older adults 
receiving home help services compared to those who do not receive home care [28]. This suggests 
that the higher level of fear of falling could be due to a higher level of frailty in this group. Finally, it 
has been shown that elderly home help receivers in Sweden have a lower QOL compared to those 
without help and that QOL was negatively correlated with the amount of help needed [29].  
Interventions to improve Quality of life 
Although exercise-based falls prevention programmes have shown a clear effect on falls incidence 
and fall risk factors in the general older population, the evidence is still inconsistent about the effects 
on HRQOL and in particular related to the population of home help receivers [11, 21]. A systematic 
review by Vaapio et al. [21] considered the specific effect of falls prevention programmes on QOL. 
The review looked at twelve RCTs including older adults, but none of the studies were aimed at home 
help receivers. Six of these studies showed a positive effect on QOL. The interventions in these 

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studies ranged from exercise (two studies), information based (one study), to comprehensive 
geriatric assessment (one study). The review concluded that there is a lack of evidence about the 
potential benefits of falls prevention programmes on QOL in older people and that more research is 
needed.  
To the authors’ knowledge, only two RCTs have been examining exercise interventions aimed 
specifically at the population of older home help receivers [30, 31]. The first study tested a home-
exercise programme and found positive results on maximum walking speed, but unfortunately the 
assessors were not blinded to the intervention [31]. The other study explored the effects and costs of 
a multifactorial, interdisciplinary team approach to falls prevention in 109 older home help receivers 
with a risk for falls [30]. Exercise was part of the programme, but the amount and mode of exercise 
varied according to individual needs. At six months, no difference in the mean number of falls 
between groups were found. Subgroup analyses showed that the intervention effectively reduced 
falls in men (75-84 years old) with a fear of falling or negative fall history, but it is unclear whether 
the study had sufficiently power for subgroup analyses [30]. Nevertheless, the secondary outcome of 
QOL significantly improved in the intervention group.  
The effect of exercise interventions on HRQOL in the general older adult population have had mixed 
results, reporting both statistically significant positive effects as well as no significant changes [32-
35]. A meta-analysis found no difference between aerobic and strength training, suggesting that the 
different exercise modes yielded the same effect on self-reported physical function domains of 
HRQOL [34]. Acree et al. [3] concluded that healthy older adults who regularly participated in 
physical activity of at least moderate intensity for more than one hour per week had higher HRQOL 
measures in both physical and mental domains than those who were less physically active. Although 
many intervention trials have found a positive association between exercise and HRQOL, the 
available data from other intervention trials conducted among older adults is inconsistent. 
Additionally, information of the most effective mode of exercise that may influence HRQOL is lacking 
[32-35]. Self-efficacy is a possible psychological mediating factor and physical function is a possible 
physiological mediating factor. Previous research has shown that self-efficacy beliefs can be related 
to well-being following exercise interventions [36, 37] and that self-efficacy can explain adherence to 
exercise programs [38-41]. A central concept of the self-efficacy theory is so-called performance 
accomplishment, i.e. mastery experiences related to certain activities [42], and this points towards 
testing the mediating effect also of physical function. 

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The primary aim of this study is to explore the effects of a falls prevention programme, lasting twelve 
weeks, on HRQOL in older adults receiving home help services. Effects on the secondary outcomes, 
physical function and falls efficacy, will also be explored. A secondary aim of this study is to explore 
the mediating factors between falls prevention and HRQOL.  
Methods 
Study design 
The study is a single-blinded, pragmatic RCT comparing one intervention group with a control group. 
The intervention group will receive an adapted version of the Otago Exercise Programme (OEP) over 
twelve weeks, while the control group receives usual care. Measurements are performed at baseline, 
at three months and at six months. The intervention and assessments will be conducted in the 
participants’ homes. Assessors will be blinded to group participation.   
Study setting and recruitment 
Six municipalities in the Oslo region have agreed to take part in the research project. Participants are 
recruited through consultants in the municipalities coordinating and providing home help services. 
The researcher visits the municipalities on a regular basis to conduct the recruitment. Additionally, 
health workers in the municipalities are informed about the criteria to participate and will alert 
about eligible participants. Eligible participants will be contacted by the researcher by telephone and 
asked to consent to being sent information about the study. After a week, they will be contacted 
again to see if they consent orally to participate. Before baseline testing, the participants must 
provide a written informed consent. Figure 1 presents the planned flow of participants in the study.  
Inclusion and exclusion criteria 
Inclusion criteria are: Individuals who 1) are 67 or older, 2) receive home help services 3) have 
experienced at least one fall during the last twelve months, 4) are able to walk with or without a 
walking aid and 5) understand Norwegian. Exclusion criteria are: 1) medical contraindications to 
exercise, 2) life expectancy below one year, 3) a score below 23 on the Mini Mental State 
Examination (MMSE) and 4) currently participating in other falls prevention programmes or trials. 
Randomisation 
The participants are randomly assigned at a 1:1 ratio to the intervention group and the control 
group. A computer-generated, permuted block randomisation scheme is used to allocate the 
participants. Following randomisation, the participants receive information by telephone on which 
group they are allocated to. See flow chart in Figure 1.  

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In order to optimize the rigor of the RCT and to minimize bias, a number of methodological factors 
have been incorporated into the design of the study. The study participants will be randomly 
allocated to the groups via concealed allocation, as inadequately concealed allocation has been 
associated with bias in RCTs [43]. Due to the nature of the intervention, it is not possible to blind the 
participants or the treating therapists to the allocated groups. However, all assessors are blinded to 
the allocated groups. In further attempts to reduce bias, data will be analysed on an intention-to-
treat basis. This preserves the randomisation process and imitate the real-life situation where the 
possibility exists that not all participants receive the prescribed treatment.  
 
Study intervention 
The intervention performed is based on the OEP, including home visits and motivational phone calls 
[44]. Balance exercises comprise tasks in standing, walking backwards, stair-walking and rising from a 
chair. Strengthening exercises uses ankle weight cuffs to strengthen hip extension and abduction, 
knee flexion and extension and ankle plantar and dorsiflexion. The programme also includes warm-
up exercises as movement of neck and shoulders. The OEP has been described in more detail 
previously [44]. This programme has been shown to be effective in reducing number of falls and 
number of injuries resulting from falls in addition to improving strength and balance, and maintaining 
falls efficacy in home-dwelling older adults [45].  
In previous studies the OEP has been performed over a period of one year [45]. A meta-analysis by 
Sherrington et al. [46], looking at the effect of falls prevention programmes, recommend a dose of at 
least three hours of exercise weekly for six months. This weekly dose is attempted, but the duration 
of three months is shorter than in previous studies. Nevertheless, as in the original OEP, the same 
number of home visits and telephone calls will be made, and the participants will be encouraged to 
do a sufficient amount of exercise between home visits. The rational for the change in duration and 
frequency is both theoretical and pragmatic. Participants included for this study are frail older adults 
who have a fall history and who receive home help services. Previous research has shown that home 
help receivers fall more frequently and have a higher level of fear of falling [27, 47]. Poor health, fear 
of falling, depression and lack of strength are barriers for older adults in order to adhere to exercise 
programmes [48]. The participants in this study are thus likely to have a lower level of observance 
compared to more independent elderly and a duration of one year might be too long. Additionally, 
previous research has shown that falls prevention programmes which were considered too 
demanding by the participants even had a negative impact on QOL [49]. On the other hand, only 
receiving a few visits might not provide sufficient support which in turn could limit adherence. The 

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pragmatic rationale relates to the organizational structure of physiotherapy services in the primary 
health care. For this group of older adults an intervention of three months is within the time frame of 
what the physiotherapists normally can provide. Finally, previous research has shown that also falls 
prevention programmes with a shorter duration than six months have had a positive effect on QOL 
[21]. 
The physiotherapists visit the participants at home five times during the intervention (week 1, 2, 4, 8 
and 10) for instruction and for guiding the appropriate level and progression of each exercise. This 
includes one additional visit compared to the first twelve weeks of the original OEP intervention [44]. 
Each visit will take about one hour. The first visit may take longer is initial information is given and a 
relationship is established. At this visit advice related to safety when performing exercises is provided 
to the participants, both orally and written. In between supervised sessions, participants will be 
encouraged to continue exercising on their own three times weekly for 30 minutes. Equipment for 
exercising (ankle cuff weights of 1, 1,5, 2 and 2,5 kg) is provided for each participant. The weeks 
between home visits, the physiotherapists call the participants to motivate them to continue 
exercising and to answer possible questions. As a part of the programme, the participants are also 
encouraged to perform at least two or more weekly walks of ≥30 minutes. The participants are 
provided with a written exercise booklet including illustrations. Following the intervention period, 
the participants to keep the exercise equipment and booklets, in order to continue exercising.  
The participants in the control group will receive usual care from the primary health care service. 
Following reassessment, the participants will have opportunity to participate in other falls prevention 
programmes, for example, already existing balance exercise group classes.  
Education of intervention deliverers 
Workshops and meetings will be held to inform the physiotherapists participating in the project. 
Before starting recruitment, one full day workshop on falls prevention and OEP is held for all 
therapists. Following start-up of recruitment and until the end of the project one workshop will be 
held approximately every forth months. These last half a day and include one lecture on a topic 
concerning older people and time for discussion on the development of the project. Additional to the 
workshops, the researcher will have monthly meetings with the physiotherapists in the different 
municipalities. In order to make sure that the intervention is performed as intended, a fidelity 
checklist based on the OEP-manual has been developed. The physiotherapists use the checklist when 
conducting the home visits and phone calls. 

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Outcome measures 
Following recruitment participants are assessed before they are randomised. Assessors are blinded 
to the participants´ group assignment. The time window between baseline assessment and start of 
intervention is aimed to be within two weeks, and the same time window for assessments due at 
three and six months. Measurements and their order are selected to avoid physical and mental 
fatigue of the participants. Outcome measures that are employed have established reliability and 
validity, as recommended by the CONSORT group [50]. In addition to improving measurement quality 
and outcomes, it enables direct comparisons with other studies that investigate HRQOL and can 
possibly contribute to meta-analyses.  
At baseline the Mini Mental Statement Examination (MMSE), a measurement of ”Global cognitive 
function”, is performed and is used as exclusion criteria. The maximum score is 30. A score below 23 
indicates cognitive impairment and these participants are excluded [51]. Sociodemographic 
characteristics, like age and education, are also assessed at baseline. Primary and secondary outcome 
measures will be performed at baseline, at three months and at six months’ follow-up.  
Primary outcome variable  
HRQOL is the primary outcome measured by the Short Form 36 Health Survey (SF-36) [52]. This is a 
generic and validated questionnaire which, translated into Norwegian, is conducted as an interview 
[53]. The 36 items in SF-36 are grouped into eight health status scales: physical functioning, role 
limitations due to physical problems and due to emotional problems, bodily pain, general health 
perception, vitality, social functioning and mental health [52]. 
Secondary outcome variables  
In addition to the SF36, the EQ-5D (1990 EuroQOL EQ-5D) is reported. The EQ-5D is a generic and 
validated questionnaire [54-57]. It describes five dimensions of HRQOL (mobility, self-care, usual 
activities, pain/discomfort, anxiety/depression), each of which can take one of five responses at five 
levels of severity (no problems/slight problems/moderate problems/severe problems/severe 
problems/extreme problems). 
Physical function includes measures of balance, gait speed, muscle strength as well as activities of 
daily living. The Bergs Balance Scale is a 14-item scale, which is applied to assess static and dynamic 
balance in older adults [58]. Gait speed is assessed by measuring usual walking speed over four 
meters [59] and muscle strength is measured by the 30 seconds sit to stand test [60]. Instrumental 
ADL is recorded using the Norwegian Version of the Lawton IADL scale, which is a valid and reliable 
measure of a person’s self-reported ability to perform complex activities of daily living [61].   

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Physical activity is measured using the “Walking habits questionnaire”, a valid questionnaire for 
walking habits and physical activity for frailer older people [62]. This questionnaire assesses general 
behaviour of walking, regarding how often and for how long. The following questions are asked: “Do 
you take a daily walk?” (yes/no) or “If you do not take a daily walk how many times per week do you 
take a walk?” (never/almost never/1-2 days/3-4 days/ almost daily) and ”How long does you walk 
generally last? (0-15 mins/15-30mins/30-60mins/ 1h-2h/>2h)”. Walking time in minutes per week is 
calculated by taking the lowest level of days multiplied by lowest level of minutes for each response 
alternative [62]. 
Nutritional status is measured using the Mini Nutritional Assessment (MNA- elderly, Société des 
Produits Nestlé, S.A., Vevey, Switzerland) form. The first screening part of six questions is used which 
includes measurement of weight and height for calculation of BMI [63-65].  
Falls efficacy is assessed using the Falls Efficacy Scale International (FES-I). This scale has shown good 
reliability and validity assessing concerns about falling in older adults, and is recommended for 
clinical trials and practise [66, 67]. It is a self-reported questionnaire, containing 16 items on different 
activities of daily living. Level of concern is measured on a four-point scale ranging from 1, which is 
not at all concerned, to 4 which is very concerned [68].  
Adherence to the programme is documented through an activity diary completed by the participants 
and a form checked by the physiotherapists during home visits and calls. Additionally, the 
participants have a falls calendar where they report adverse events. Adverse events are registered in 
the following four categories: falls, cardiovascular events, musculoskeletal injuries and health care 
utilization and will be documented as “due to the intervention” or “not due to the intervention” [69]. 
Sample size estimation  
The sample size is estimated from the primary outcome, HRQOL (SF-36). A treatment difference of 10 
points between the two groups in one of the domains in SF-36 is regarded to be of statistical and 
clinical significance. The associated standard deviation is assumed to be around 20 points. This 
implies a moderate effect size [70], which can be expected as previous OEP studies have shown 
substantial effects on physical outcomes [45]. Moreover, a similar Norwegian study, which included 
older adults performing exercise following discharge from hospital, estimated the required sample 
size identically [71]. Given a power of 80% and level α=0.05, we aim at including 150 participants, 
allowing for a 15-20% dropout, to detect a difference of 10 points between groups (see Figure 1).  

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Statistical procedures 
Statistical analysis is performed using SPSS or a similar statistical package. Descriptive data are 
reported for variables of interest. The data will be analysed following the intention to treat principle 
[72]. Prospective differences in primary and secondary outcomes and baseline characteristics 
between the intervention group and the control group will be assessed by t-tests for continuous and 
normal distributed variables and with non-parametric tests for categorical variables. Multiple linear 
regression modelling are used to control for confounding of between-group differences [73]. 
Hypotheses about mediating factors are tested through correlations, multiple regressions and 
bootstrapping methods exploring the correlations and explained variance of the chosen mediating 
factors and the changes in QOL [74]. Bootstrapping is a non-parametric method and is considered 
favourable with dichotomous variables (group 1 and 2) and small samples (n < 250) [74].  
Discussion  
The main purpose of the study is to evaluate the impact of OEP on HRQOL in older adults receiving 
home help services. We anticipate that the intervention described in this protocol will have a positive 
impact on the HRQOL. The tailored intervention will have a potential to promote evidence-based 
decision-making and empower older people receiving home help services to remain to a greater 
extent in charge of their own lives. We rely on a systematic approach, which corresponds with the 
guidance on developing and evaluating RCTs [75].  Only a few studies have included HRQOL when 
measuring the effect of a falls prevention programme, and most of these studies include it as a 
secondary outcome [21, 76]. Outcomes examining HRQOL are selected based on literature 
identifying a standard set of measurements in falls prevention programmes [77, 78]. SF-36 is chosen 
due to its good validity, reliability and responsiveness when assessing older adults [79]. This outcome 
is detailed and broad, but it might be putting a burden on the participants due to its length and 
sensitive questions. Nevertheless, estimating HRQOL is important to determine whether the effect of 
a falls prevention programme is significant enough to achieve clinical relevant changes and thus to 
justify the implementation.  
Several studies have looked at the effect of exercise on HRQOL, but to the authors’ knowledge, none 
of them have specifically focused on older adults who receive home help services and who have a fall 
history. Studying the relationship between exercise and HRQOL is interesting due to the potential 
influence of exercise on both health and wellness through improvement of HRQOL [3, 80]. However, 
results from previous clinical exercise trials have reported mixed effects on HRQOL following exercise 
[32-35, 81]. Although many studies have found a positive association between exercise and HRQOL, 

12 
 
 
available data from other trials is inconsistent and lacks information on the most effective mode of 
exercise that may influence HRQOL [32, 33, 71, 81]. This study can provide insight into the effect of 
falls preventative exercise and its applicability to home-dwelling older fallers with dependency of 
help from the primary health care service.  
There are two ways an intervention mechanism can influence HRQOL, it can be a mediator or a 
moderator [82]. A mediating factor is defined as an intervening causal factor that may provide 
information concerning why the intervention increases HRQOL. Moderator mechanisms help us to 
understand for whom an intervention works [38] and can be classified as either characteristic of the 
person/group i.e. baseline characteristics or characteristics of the exercise protocol [38, 83]. 
Mediating mechanisms between HRQOL and falls-prevention programs may be both physiological, 
such as increased balance and strength, and psychological, such as self-efficacy [38]. A recent study 
provide evidence that fear is related to falls and concluded that falls self-efficacy plays a mediation 
role on the relationship between fear of falls and falls [84]. They recommend that any falls 
prevention should consider psychological covariates of falls, especially subjects’ self-efficacy to 
reduce falls, alongside other risk factors and covariates of falls. More theoretically driven research on 
these mechanisms behind treatment effects have been recommended [85-87]. 
It is widely accepted that falls and subsequent injuries are likely to result in a substantial reduction in 
quality of life for the persons affected as well a substantial economic burden to the healthcare 
system [88]. This provision of OEP in this setting could potentially be a beneficial and cost-effective 
intervention for this group of frail older adults, just as it is for community-dwelling older adults. 
Several studies have performed analysis on cost-effectiveness of exercise programmes which have 
shown that it can reduce healthcare costs [14, 89]. Due to its large sample size and theoretically 
based intervention the present study has the potential to generate new knowledge that may 
improve the design of future activity programmes for older fallers receiving home help services. 
Since both outcome measures as well as the intervention are carried out in a clinical setting, 
relevance and application of study findings to clinicians is enhanced. Results from this study will be 
primarily of interest to, and could be used by, health care managers and clinicians. Particularly, the 
results will be useful in decision making to set priorities relating to prevention measures in the 
community, to appropriately allocate resources and to assess costs and benefits of a falls prevention 
programme. Finally, the results can be useful for policy makers, in order to put preventative 
healthcare for this group of frail older adults on the agenda.  

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To conclude, older people receiving home help services represent a growing and diverse group as 
part of the population of community-dwelling older adults. The appropriate assessment of HRQOL, 
the mechanisms behind the relationship between fall prevention and HRQOL, the most effective 
mode of exercise, as well as the clinical relevance of the results, are challenging issues which are 
important to address.  
 
 

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List of abbreviations 
ADL 
 
Activities of Daily Living  
 
BMI 
 
Body Mass Index 
 
 
EQ-5D  
European Quality of Life - 5 Dimensions 
HRQOL  
Health-related Quality of Life 
iADL 
 
instrumental Activities of Daily Living 
LEON  
lowest most efficient level of care 
MMSE  
Mini Mental State Examination 
MNA 
 
Mini Nutritional Assessment 
OEP 
 
Otago Exercise Programme 
pADL 
 
personal Activities of Daily Living 
QOL 
 
Quality of Life 
RCT 
 
Randomised Controlled Trial 
SF-36  
Short Form 36 Health Survey 
 
 
WHO 
 
World Health Organization 
 
 

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Declarations 
Ethics approval and consent to participate 
The project proposal has been approved by The Regional Committee for Medical Research Ethics in 
South Norway (Ref. 2014/2051). Informed consent is obtained from all participants included in the 
analyses, and the project is conducted according to the WMA Declaration of Helsinki.  
Consent for publication 
Not applicable 
Availability of data and materials 
The datasets generated and/or analysed during the proposed study are only available to the 
participating researchers due to data protection laws. Subsets or aggregation of these data will not 
include information that could compromise research participants’ privacy. Consent can be made 
available from the corresponding author on reasonable request. 
Competing interests 
DAS is a Director of Later Life Training Ltd, a UK based non-profit organisation providing training to 
therapists in the effective delivery of the OEP to older adults. 
Funding  
This study has received no external funding. It is internally funded by the Oslo and Akershus 
University College. 
Authors’ contributions 
MB and AB were involved in choosing falls prevention programme as well as outcome measures. AB 
was responsible for the internal grant application for this trial. MB and AB contributed to the design 
of the study. MB administrates the data collection and coordination of conducting the fall prevention 
programme. MB and AB wrote the first draft of the manuscript. TB and DAS critically revised and 
approved the final version of this manuscript. 
Acknowledgements 
Thanks to all physiotherapists and consultants working in the municipalities contributing with 
information on practical issues on recruitment and management of the intervention.  
 
 

16 
 
 
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17 
 
 
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21 
 
 
 
Figure 1: Planned flow of participants in the study. 

22 
 
 
 
 
 
 
SPIRIT 2013 Checklist: Recommended items to address in a clinical trial protocol and related documents* 
Section/item 
Item 
No 
Description 
Addressed on 
page number 
Administrative information 
 
Title 
1 
Descriptive title identifying the study design, population, interventions, and, if applicable, trial acronym 
1, 2 
Trial registration 
2a 
Trial identifier and registry name. If not yet registered, name of intended registry 
2 
2b 
All items from the World Health Organization Trial Registration Data Set 
2  
Protocol version 
3 
Date and version identifier 
 
Funding 
4 
Sources and types of financial, material, and other support 
14 
Roles and 
responsibilities 
5a 
Names, affiliations, and roles of protocol contributors 
1, 14 
5b 
Name and contact information for the trial sponsor 
14 
 
5c 
Role of study sponsor and funders, if any, in study design; collection, management, analysis, and 
interpretation of data; writing of the report; and the decision to submit the report for publication, including 
whether they will have ultimate authority over any of these activities 
14 
 
5d 
Composition, roles, and responsibilities of the coordinating centre, steering committee, endpoint 
adjudication committee, data management team, and other individuals or groups overseeing the trial, if 
applicable (see Item 21a for data monitoring committee) 
14 
Introduction 
 
 
 

23 
Background and 
rationale 
6a 
Description of research question and justification for undertaking the trial, including summary of relevant 
studies (published and unpublished) examining benefits and harms for each intervention 
3-5 
 
6b 
Explanation for choice of comparators 
6 
Objectives 
7 
Specific objectives or hypotheses 
5, 10-11 
Trial design 
8 
Description of trial design including type of trial (eg, parallel group, crossover, factorial, single group), 
allocation ratio, and framework (eg, superiority, equivalence, noninferiority, exploratory) 
6 
Methods: Participants, interventions, and outcomes 
 
Study setting 
9 
Description of study settings (eg, community clinic, academic hospital) and list of countries where data will 
be collected. Reference to where list of study sites can be obtained 
6 
Eligibility criteria 
10 
Inclusion and exclusion criteria for participants. If applicable, eligibility criteria for study centres and 
individuals who will perform the interventions (eg, surgeons, psychotherapists) 
6 
Interventions 
11a 
Interventions for each group with sufficient detail to allow replication, including how and when they will be 
administered 
7-8 
11b 
Criteria for discontinuing or modifying allocated interventions for a given trial participant (eg, drug dose 
change in response to harms, participant request, or improving/worsening disease) 
 
11c 
Strategies to improve adherence to intervention protocols, and any procedures for monitoring adherence 
(eg, drug tablet return, laboratory tests) 
8, 10  
11d 
Relevant concomitant care and interventions that are permitted or prohibited during the trial 
6 
Outcomes 
12 
Primary, secondary, and other outcomes, including the specific measurement variable (eg, systolic blood 
pressure), analysis metric (eg, change from baseline, final value, time to event), method of aggregation 
(eg, median, proportion), and time point for each outcome. Explanation of the clinical relevance of chosen 
efficacy and harm outcomes is strongly recommended 
8-10 
Participant timeline 
13 
Time schedule of enrolment, interventions (including any run-ins and washouts), assessments, and visits 
for participants. A schematic diagram is highly recommended (see Figure) 
6-7, 9, Figure 1 

24 
Sample size 
14 
Estimated number of participants needed to achieve study objectives and how it was determined, including 
clinical and statistical assumptions supporting any sample size calculations 
10 
Recruitment 
15 
Strategies for achieving adequate participant enrolment to reach target sample size 
6 
Methods: Assignment of interventions (for controlled trials) 
 
Allocation: 
 
 
 
Sequence 
generation 
16a 
Method of generating the allocation sequence (eg, computer-generated random numbers), and list of any 
factors for stratification. To reduce predictability of a random sequence, details of any planned restriction 
(eg, blocking) should be provided in a separate document that is unavailable to those who enrol 
participants or assign interventions 
6-7 
Allocation 
concealment 
mechanism 
16b 
Mechanism of implementing the allocation sequence (eg, central telephone; sequentially numbered, 
opaque, sealed envelopes), describing any steps to conceal the sequence until interventions are assigned 
6-7,  
Implementation 
16c 
Who will generate the allocation sequence, who will enrol participants, and who will assign participants to 
interventions 
6 
Blinding (masking) 
17a 
Who will be blinded after assignment to interventions (eg, trial participants, care providers, outcome 
assessors, data analysts), and how 
7-9 
 
17b 
If blinded, circumstances under which unblinding is permissible, and procedure for revealing a participant’s 
allocated intervention during the trial 
6 
Methods: Data collection, management, and analysis 
 
Data collection 
methods 
18a 
Plans for assessment and collection of outcome, baseline, and other trial data, including any related 
processes to promote data quality (eg, duplicate measurements, training of assessors) and a description of 
study instruments (eg, questionnaires, laboratory tests) along with their reliability and validity, if known. 
Reference to where data collection forms can be found, if not in the protocol 
8-10 
 
18b 
Plans to promote participant retention and complete follow-up, including list of any outcome data to be 
collected for participants who discontinue or deviate from intervention protocols 
7 

25 
Data management 
19 
Plans for data entry, coding, security, and storage, including any related processes to promote data quality 
(eg, double data entry; range checks for data values). Reference to where details of data management 
procedures can be found, if not in the protocol 
Included in ethical 
approval, p.14 
Statistical methods 
20a 
Statistical methods for analysing primary and secondary outcomes. Reference to where other details of the 
statistical analysis plan can be found, if not in the protocol 
10 
 
20b 
Methods for any additional analyses (eg, subgroup and adjusted analyses) 
10 
 
20c 
Definition of analysis population relating to protocol non-adherence (eg, as randomised analysis), and any 
statistical methods to handle missing data (eg, multiple imputation) 
6-7 
Methods: Monitoring 
 
Data monitoring 
21a 
Composition of data monitoring committee (DMC); summary of its role and reporting structure; statement of 
whether it is independent from the sponsor and competing interests; and reference to where further details 
about its charter can be found, if not in the protocol. Alternatively, an explanation of why a DMC is not 
needed 
14 
 
21b 
Description of any interim analyses and stopping guidelines, including who will have access to these 
interim results and make the final decision to terminate the trial 
10, 14 
Harms 
22 
Plans for collecting, assessing, reporting, and managing solicited and spontaneously reported adverse 
events and other unintended effects of trial interventions or trial conduct 
10 
Auditing 
23 
Frequency and procedures for auditing trial conduct, if any, and whether the process will be independent 
from investigators and the sponsor 
NA 
Ethics and dissemination 
 
Research ethics 
approval 
24 
Plans for seeking research ethics committee/institutional review board (REC/IRB) approval 
14 
Protocol 
amendments 
25 
Plans for communicating important protocol modifications (eg, changes to eligibility criteria, outcomes, 
analyses) to relevant parties (eg, investigators, REC/IRBs, trial participants, trial registries, journals, 
regulators) 
14 

26 
Consent or assent 
26a 
Who will obtain informed consent or assent from potential trial participants or authorised surrogates, and 
how (see Item 32) 
6, 14 
 
26b 
Additional consent provisions for collection and use of participant data and biological specimens in ancillary 
studies, if applicable 
NA 
Confidentiality 
27 
How personal information about potential and enrolled participants will be collected, shared, and 
maintained in order to protect confidentiality before, during, and after the trial 
Included in ethical 
approval, p.14 
Declaration of 
interests 
28 
Financial and other competing interests for principal investigators for the overall trial and each study site 
14 
Access to data 
29 
Statement of who will have access to the final trial dataset, and disclosure of contractual agreements that 
limit such access for investigators 
14 
Ancillary and post-
trial care 
30 
Provisions, if any, for ancillary and post-trial care, and for compensation to those who suffer harm from trial 
participation 
8 
Dissemination policy 31a 
Plans for investigators and sponsor to communicate trial results to participants, healthcare professionals, 
the public, and other relevant groups (eg, via publication, reporting in results databases, or other data 
sharing arrangements), including any publication restrictions 
14 
 
31b 
Authorship eligibility guidelines and any intended use of professional writers 
 
 
31c 
Plans, if any, for granting public access to the full protocol, participant-level dataset, and statistical code 
14 
Appendices 
 
 
 
Informed consent 
materials 
32 
Model consent form and other related documentation given to participants and authorised surrogates 
Included in ethical 
approval 
Biological 
specimens 
33 
Plans for collection, laboratory evaluation, and storage of biological specimens for genetic or molecular 
analysis in the current trial and for future use in ancillary studies, if applicable 
 
*It is strongly recommended that this checklist be read in conjunction with the SPIRIT 2013 Explanation & Elaboration for important clarification on the items. 
Amendments to the protocol should be tracked and dated. The SPIRIT checklist is copyrighted by the SPIRIT Group under the Creative Commons 
“Attribution-NonCommercial-NoDerivs 3.0 Unported” license.