Evaluation of the Frails' Fall Efficacy by Comparing Treatments (EFFECT) on reducing fall and fear of fall in moderately frail older adults: study protocol for a randomised control trial

The Nintendo Wii group intervention is more effective than the gym-based group intervention in improving fall efficacy and self-reported falls in the older adult aged 60 and above.

The Nintendo Wii group intervention is more effective than the gym-based group intervention to improve the secondary outcome measures: knee extension strength, timed up and go (TUG) test, 6-minute walk test (6MWT), narrow corridor walk (NCW) test, gait speed, Short Form -- 36 version 2 (SF-36v2) questionnaire and European Quality of Life -- 5 dimensions (EQ-5D) questionnaire.

This is a parallel prospective single-blind randomised active-control trial. The ratio of subjects in each group is 1:1; refer to Figure 1 for the flow of participants in our study (week 0 to week 13). Each participant who completes the week 13 follow-up will be given a pedometer to track daily physical activity from week 13 to 24 and a final assessment is conducted on week 24. During the first 13 weeks, participants report weekly on incidence of falls to the interventionist. From week 14 to 52, participants record incidence of fall on a falls history sheet kept at home and to report the falls to the Principal Investigator or the outcome assessor immediately. The outcome assessor will contact the participants monthly from week 14 to 52 to update on any fall incidence.

The participants are patients from the Singapore General Hospital (SGH) Specialist Outpatient Centre Geriatric Medicine department, SGH Lifestyle Improvement Fitness Enhancement Centre Osteoporosis and Bone Metabolism unit, SGH Physiotherapy Falls Clinic and public volunteers. The volunteers are approached to participate in the study within the hospital premises. The screening of eligible participants is done by a medical doctor or a physiotherapist during consultation sessions. The abbreviated mental test is used to screen for cognitive impairment [28], while the Short Physical Performance Battery (SPPB) is used to stratify frailty [29]. The scores from the AMT and SPPB include or exclude participants from the study.

The inclusion criteria of this study:

The exclusion criteria of this study:

Participants who are eligible and agree to register for our study will be assessed in the SGH Physiotherapy department for baseline measures by an independent outcome assessor.

This study has been approved by the SingHealth Centralised Institutional Review Board D (Reference: 2010/177/D) in accordance with the International Conference on Harmonisation (ICH)/Singapore Guidelines for Good Clinical Practices (GCP). Written informed consent is obtained from the participant using the forms from the ICH/Singapore Guidelines for GCP. The principal investigator of our study is Boon Chong Kwok, a physiotherapist with Singapore General Hospital.

Participants have the right to withdraw from the study at any time during the trial, but are encouraged to complete the trial after randomisation to minimise drop-out rate. In the event of adverse change of medical condition in the participant deemed unsafe to continue with the study by the principal investigator or co-investigators, the trial for the participant will be terminated.

The interventions are carried out at a satellite clinic to prevent unblinding of the outcome assessor. The two interventions are on separate days to minimise the chance of interaction between the participants from the different groups. The interventions were developed through an evidence-based approach. A physiotherapist with 3 years of clinical experience and American College of Sports Medicine clinical exercise specialist certification conducts the interventions for both groups with adherence to the intervention protocol.

The home exercise programme is equivalent in both groups. Exercise bands for resistance training at different difficulty levels are issued to each participant according to the baseline assessments for the first 6 weeks and the next level of band is issued on the seventh attendance.

One of the unique features of the study is that it has a component of participant specific management in both intervention arms. This enables achievement of the participant's goals in rehabilitation. Every participant may present with different impairments that will need to be addressed with specific strengthening exercises, balance and coordination training, agility training or acute pain management.

Demographics are obtained via the assessor on the first assessment session. Baseline demographics include age, gender, ethnic group, living status (staying alone or with family), history of falls in the past 12 months, number of medications, height, weight, resting heart rate, resting blood pressure, AMT, SPPB score and Physiological Profile Assessment (PPA) fall risk score.

The outcome measures are assessed one week before the first intervention session (week 0), one week after the last intervention session (week 13) and a final reassessment on week 24 by an independent blinded outcome assessor (Table 2). The primary outcome of this study is an improvement in fall efficacy with the Modified Falls Efficacy Scale (MFES). New recent falls after the initiation of intervention will investigate the success of the programme in falls prevention. This is carried out by self report of falls by the participants via telecommunication and on a falls recording sheet. The secondary outcomes of this study are improvement in knee extensor strength, endurance, agility, functional status and quality of life. The global rating of change (GROC) scale is used to assess the participant's perceived change from baseline on each follow-up [32, 33].

Fear of fall (self efficacy): MFES is a validated 14-item questionnaire of fall efficacy of the older person in various ADLs and community activities [11]. It is administered by an interviewer approach in our study to prevent misinterpretation by the participant and to maintain consistent and accurate responses from the participant. The Short Fall Efficacy Scale -- International questionnaire takes a shorter time to administer with 7-item on indoor and outdoor activities [13]. The questionnaires have no risk of recall bias as they require the participants to rate their perceived confidence based on the day of assessment.

Strength (impairment): Knee extension strength measurement with the PPA is a maximum isometric contraction on a spring gauge [34]. The test is conducted 3 times with a rest interval of 30 seconds. Another strength measurement is the weight lifted for 10 repetitive maximum knee extension of 0 to 90°.

Endurance (functional limitation): 6MWT is one of the most commonly conducted field tests and is utilised in numerous research trials for the evaluation of aerobic capacity [35]. The test is carried out on a clear and quiet 10-metre corridor marked with a cone at each end. Instructions are given prior to the test and the time left to the end of the test is announced by the assessor at interval of 1 minute.

Functional status (functional limitation): TUG is an established test of agility in the older population and is used in this study for agility changes [36‐38]. Subject is to rise from the chair and walk 3 metres, marked by a cone, and return to the seat. Higher functional task is assessed in our study using the NCW test -- a test of dynamic balance that comprises of a 6-metre walk within the width of 0.2-metre throughout the entire course [39]. Gait speed is calculated from 4-metre walk test of SPPB [15, 29], which is potentially a sixth vital sign [40].

Quality of life (disability): Quality of Life will be measured with the SF-36v2 [41] and EQ-5D questionnaires [42].

On the 13^th week, each participant undergoes an outcome assessment. After the assessment, the participant will be issued a pedometer (HJ-109 Omron Healthcare, Japan) for daily quantifying of physical activity via number of steps taken for the day [43]. Participants in both groups will continue with the home exercises after the last supervised exercise session. The pedometer is used to gauge and encourage physical activity of the participants. A follow-up monitoring of change on the 24^th week will assess changes in self efficacy, impairments, functional changes and quality of life. Monthly from week 14 to 52, the participants will be contacted for any events of fall. The pedometer reading will be correlated with the change in outcome measures from week 13 to 24.

Our primary endpoint is a change in MFES scores immediately post-intervention. There was no literature of MFES investigated in the moderately frail population. We estimated the minimum clinically important difference (MCID) to be detected between the novel intervention programme and the traditional supervised exercise programme and derived a change in 1.5 MFES units. Previous randomised controlled trial showed no change in MFES scores post intervention because healthy volunteers were recruited in their study [25]. The use of healthy volunteers resulted in a ceiling effect in that trial. In the absence of trials assessing MFES in the moderately frail older adults, we assumed a common between-participant standard deviation of 2 units for MFES [25]. This translates to a standardized effect size of interest (Cohen's d) of 0.75. Accordingly, the required sample is 30 participants per group for a two-tailed comparison of the groups when d is 0.75, power is 0.8 and type I error is 0.05. Considering a 15% drop-out rate, 80 participants will be recruited.

Block randomisation will be generated by an independent investigator who is not involved in the outcome assessments and interventions and concealed in sealed envelopes marked 1 to 80. Participants will be randomised after completion of the initial assessment independently by an investigator who is not involved in the outcome assessments.

Due to the particular nature of our study, only the outcome assessor is blinded. Participants are not blinded in the study.

Reliability of the MFES [11], Short FES-I [13], PPA knee extension [34], TUG [44], 6MWT [45], SF-36v2 [46] and EQ-5D [47] have been established. However, we find no literature on the reliability of NCW test and decided to carry out a reliability assessment.

Test-retest reliability was then established between the outcome assessors, Intraclass Correlation Coefficient 0.972, from the analysis of 10 repeated timed walk of the NCW test.

The trend of rising healthcare cost is a concern to the population. Evaluation of the cost-effectiveness of the programme will determine the feasibility of implementing the programme as a fall prevention programme. The cost-effectiveness of the intervention programmes will be analysed at the end of one year follow-up. We will analyse the cost of programme, EQ-5D, fall history and incurred opportunity cost. The EQ-5D will provide the study with Quality-Adjusted Life Years. Fall history and accompanying opportunity cost will be obtained from telecommunication interview with the participant. Opportunity cost of a fall is equivalent to the total cost of treatment and management for the fall. The limit for overall cost per fall prevented is set at S$20,000 to evaluate the programme cost effectiveness.

The study time-line is monitored by the study principal investigator. Table 3 reflects the milestones of the study.