A Cognitive-Behavioral and Exercise Intervention to Reduce Fear of Falling in Older Adults in Long-Term Care: A Pilot Study

doi:10.21203/rs.3.rs-4860907/v1

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A Cognitive-Behavioral and Exercise Intervention to Reduce Fear of Falling in Older Adults in Long-Term Care: A Pilot Study

https://doi.org/10.21203/rs.3.rs-4860907/v1

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Objective

This pilot study evaluated the feasibility of a Cognitive Behavioral Therapy (CBT) and exercise intervention (AGES) to reduce fear of falling (FoF) in older adults in long-term care (LTC) facilities.

Method

A single-arm, non-randomized pilot study was conducted in three LTC facilities with 19 participants (17 women, 2 men, mean age = 84 years). The intervention consisted of 8 weekly one-hour group sessions led by trained leaders, combining CBT discussions and exercises targeting FoF. Outcome measures included the Falls Efficacy Scale-International (FES-I), the WHO-5 Well-Being Index, and the Timed Up and Go (TUG) test. Gait analysis was performed using a Lidar-based method, developed for this pilot study.

Results

The intervention did not significantly reduce FoF (FES-I: pre = 27.28, post = 25.67, p = 0.411) or improve well-being (WHO-5: p = 0.125). However, significant improvement in mobility was observed (TUG: pre = 14.68, post = 13.40, p = 0.032). Gait analysis showed marginal improvements in gait parameters. Implementation challenges included recruitment and leader engagement.

Discussion

The AGES intervention Pilot trial demonstrated feasibility in LTC settings and improved mobility among participants. The small sample size might have limited the detection of significant changes in FoF and well-being. Future studies should aim for larger sample sizes and address recruitment challenges to validate the intervention's effectiveness. Further refinement of gait analysis methods for participants using walking aids is necessary.

Fear of falling

cognitive behavioral therapy

exercise intervention

long-term care

pilot study

mobility

older adults

We certify that this work is novel and of recent novel clinical research. This intervention adds to the scientific literature by demonstrating the feasibility and potential benefits of a combined cognitive-behavioral therapy and exercise program for reducing fear of falling and improving mobility in older adults residing in long-term care facilities.

Fear of falling (FoF) was first introduced in 1982, by Murphy and Isaac, and defined in 1993, by Tinetti et al, as a lasting concern about falling that leads to an individual avoiding activities that he/she remains capable of performing (1, 2). Often overlooked in favour of somatic causes of reduced mobility, its role in the medical management of the older-adults is significant, due to its prevalence, and associated symptoms, even among those who have not fallen (3). FoF is prevalent in 44% of those over 70 years who have not fallen over the last year, and in up to 86% in those who have fallen more than once (4). Its prevalence in long-term care facilities (LTCs) has been found to be more than 50% (5). Critically, between 30 to 50% of older adults will fall each year (6). In LTCs rates may be as high as 75% (7)). Furthermore, studies have shown an increased prevalence of FoF among those suffering from cognitive impairment (8–10).

FoF results in social sequelae, as well as physical, functional, and psychological symptoms (11). These include avoidance (4), decreased social participation (12), lost self-efficacy (3, 13), reduced ability to perform activities of daily living (ADLs) (3), a decreased quality of life, fear, anxiety, and loss of confidence (14), and a decreased gait speed, stride length, and double support time (15)). These sequelae have been shown to develop into a vicious cycle, where symptoms maintain and reinforce FoF, and its consequences, including increasing the risk of falling (16, 17). Secondary symptoms, such as depression, and general anxiety have also been associated with FoF (18–20).

Reducing risk factors of falls, both physical and psychological, is important. Various treatment modalities have been developed with differing levels of success(21) Systematic reviews of both exercise and cognitive behavioral therapy (CBT) interventions for reducing FoF have shown that they are effective in reducing FoF and falls (22–25). Tennstedt et al’s(26) combined multimodal CBT and exercise intervention A Matter of Balance, appears to be the most widely distributed, having several variants and translations(27–29). To date, however, there do not appear to be any German-language versions or interventions targeted at residents receiving long-term care (21).

Aktiv Gegen Sturzangst (AGES) is a multicomponent CBT-exercise intervention developed by the authors, designed to be implemented in German speaking LTCs in Switzerland. It is inspired by Tennstedt’s A Matter of Balance (AMB), in how the intervention is structured, its duration, and the delivery by laymen who have followed a structured training program. It varies in the CBT having a more significant cognitive component, with CBT daily homework, and an exercise component developed from usual exercise activities currently in LTCs in Switzerland (For a table comparing AMB and AGES, see Supplementary Table S3). There is a need to assess the potential impact of AGES and ensure that it reflects issues of greatest importance to participants (30).

Aim of study

The current study is a single-arm non-randomised pilot study primarily aimed at investigating the feasibility of the implementation of AGES, a multicomponent CBT-exercise intervention for reducing fear of falling specifically in LTC facilities. The secondary aims are to assess preliminary estimates of the potential effectiveness of AGES in reducing FoF, in improving mobility and well-being, and to estimate the number of participants required to establish effectiveness in an RCT.

Intervention

The AGES multicomponent CBT-exercise intervention consisted of 8 weekly group sessions of one hour, led by one leader who participated in a training course for the intervention. All sessions were structured and planned, with a homework module in between. Each session started with warm-up exercises, for 15 minutes, followed by a CBT intervention for 20 minutes (see Supplementary Figure S1 and Supplementary Table S1). The session ended with a 15-minute exercise. This dynamic structure was selected to help keep the participants engaged, considering possible beginning cognitive difficulties often seen in the population requiring LTCs. Five minutes were allowed between the exercise and CBT components. Participants received a manual at the first session with descriptions of each session's exercises and CBT content, as well as homework assignments between sessions. The first and last sessions equally had an evaluative component where participants answered questionnaires. These questionnaires were integrated into the CBT component. The CBT component was designed by EL, IP, CS, CK, and SK. CBT is a talking therapy, that is goal-orientated, time-limited, and structured, that helps patients identify and correct negative thought patterns that influence behavior (31).

Exercise interventions are planned, structured, repetitive, and purposeful physical activities to maintain or improve one or more components of physical fitness (32). They likely reduce FoF indirectly by reducing the risk of falling, by improving strength, balance, endurance, and stability (32). It may reduce FoF directly through the positive experience, positive self-evaluation, and social approval of experiencing the exercise (33, 32). The exercise components were designed by PA to suit specifically the LTC structure, and common conditions observed in the Swiss German LTCs. The duration of the 15-minute components took into account the faster fatigability of this population.

Interested LTCs were recruited by sending emails to regional LTCs, with explanations of the project and resources (both structural and personal) necessary. LTCs were invited to nominate staff interested in training to become AGES Course Leaders. The training component for the course leaders consisted of a structured 8 hour theoretical and practical training delivered over one day in groups. Participants received a certification for 8 hours of further education. Participants learned the theoretical background of FoF, including clinical symptoms, using questionnaires to identify it, and various treatment approaches. A theoretical background of CBT was also provided. An overview of AGES was done, with an in-depth look at the first three sessions. Participants practiced physical exercises, as well as CBT interventions.

Participants

Recruitment took place 2 to 3 months prior to the start of intervention. Participants had to be over 65 years old, be thought to have FoF, or requested specifically to participate in a FoF intervention. Participants additionally had to receive some level of care from the LTCs. Participants were excluded if they had a moderate to severe neurocognitive disorder, were psychiatrically unstable (eg. experiencing depression or active substance abuse), or were physically limited (blind, frail, wheelchair-bound, or required assistance for mobilization).

Design

This study was a single-armed pilot study, following the design for pilot and feasibility studies in the CONSORT extension (34, 35). A non-randomised study design was chosen to test whether AGES could be delivered in an LTC setting. This is novel, as previous studies investigating multicomponent CBT-exercise interventions for FoF have been conducted among community-living older-adults (23).

Analysis

The analysis of the study data was conducted using an average-based change approach (ABC), with calculations with SPSS, version 29.0 (36). Descriptive statistics including the mean values, standard deviations, were conducted for age, and FES-I, WHO5, and TUG (see Supplementary Table S2). Since there were less than 50 participants, the normality of the distribution was determined by the Shapiro-Wilk test.

The effectiveness of the intervention was calculated from the difference in the pre-post ordinal (FES-I, WHO5) and continuous (TUG) scores. When the difference scores were normally distributed, effectiveness was calculated using the paired-samples t-test. When data was skewed, the Wilcoxon signed-rank test was used. The symmetric distribution of difference scores was visually confirmed using a boxplot as well as using the non-parametric paired test for difference scores and pre-test scores. Effect sizes, calculated as Cohen's d for normally distributed data, calculated the estimated magnitude of observed changes. Skewed data effect size was calculated from the Wilcoxon signed-rank test Z-score divided by the square root of the number of participants included in the analysis. The confidence interval was calculated by bootstrapping, with bias-corrected accelerated confidence intervals.

The gait analysis first included a description of all gait parameters calculated using Lidar sensors developed and implemented by (37), who describe their algorithm in their publication. Scatterplots were generated to compare stride lengths and speeds between the two methods. Data were reported as descriptive statistics for the Lidar-based method and the IMUs, including box plots for step time, stride time, and cadence.

Missing data were considered missing at random and therefore unrelated to study outcomes. Missing data were thus excluded from the analysis. All statistical analyses were performed at a 95% confidence level (α = 0.05).

To calculate the minimum number of participants necessary to achieve significant findings for the FES, WHO-5, and TUG outcomes, a power analysis was conducted. This analysis determines the sample size required to detect a statistically significant effect, considering the effect size, significance level (alpha = 0.50), and power (1-beta = 0.80). The sample sizes were then calculated using the G*Power statistical software (38).

The evaluation was conducted from September to December 2022 across three LTC facilities. Nineteen older adults (17 women and 2 men) participated in the study. Participants were predominantly LTC residents, with three individuals from the community, who benefited from the outreach programs for their local LTC. Seven participants had fallen in the past year, and 11 expressed FoF. Walking aids were used by 6 participants. No participant withdrew from the study. Two participants did not report their age.

Table 1

Participant characteristics
Mean age (SD)	Female, %	Used Walking aides (n.)	Fall in previous year	Answered yes to: “Are you afraid of falling?”	FES-I (mean, SD)	WHO-5 (mean, SD)	TUG (mean, SD)
84 (6.2)	89	6	7	11	27.3 (6.2)	16.9 (5.4)	14.7 (5.2)

Leader training occurred in groups of 6 participants in two locations on 22.06 and 01.07.2022. Only four participants lead courses (two activation therapists, one occupational therapist, and one without a specific health-care related degree). Only four leaders lead the interventions, as there were only three intervention groups formed. Leaders managed to adhere entirely to course protocols.

The paired-samples t-test for the FES-I scores showed no significant difference between pre- and post-intervention means (M_pre = 27.28, M_post = 25.67), with a mean difference of 1.61 (t(17) = 0.844, p = 0.411). This suggests that the intervention did not significantly reduce fear of falling among participants. In contrast, the TUG test results indicated a significant improvement in mobility, with the mean score decreasing from 14.68 to 13.40 (mean difference = 1.28, t(17) = 2.338, p = 0.032). The high correlation between pre- and post-intervention TUG scores (r = 0.902, p < 0.001) further supports this finding. A Wilcoxon Signed-Rank Test conducted to evaluate the impact of the intervention on WHO-5 scores was skewed. The results indicated no significant difference between the pre- and post-intervention scores (Z = 1.534, p = 0.125). This suggests that the intervention did not significantly affect the well-being of the participants as measured by the WHO-5 index.

Table 2

Effect of AGES on FES-I, WHO, and TUG
	Pre-Intervention Mean (SD)	Post-Intervention Mean (SD)	Mean Difference (SD)	t/Z Value	p-Value	Correlation (r)	Correlation p-Value	Effect size	Recommended sample size
FES-I	27.28 (6.27)	25.67 (8.04)	1.61 (8.10)	0.844	0.411	0.379	0.121	0.199 (-0.27, 0.663)	199
TUG	14.68 (5.15)	13.40 (3.97)	1.28 (2.32)	2.338	0.032	0.902	< 0.001	0.552 (0.047, 1.041)	27
WHO-5 (Wilcoxon Test)	-	-	-	1.534	0.125	-	-	0.362^*	43

Gait analysis:

The algorithm developed by (37) successfully tracked the legs of walking individuals, see Fig. 1. However, participants using walking aids were excluded from the analysis due to the complexity in tracking leg movements accurately with the current algorithms. The step extraction algorithm effectively separated the static background from moving objects, allowing for the clear identification and tracking of left and right legs in participants walking naturally without aids. A pre-test post-test change in gait and velocity could be observed. The device was easily set-up in each LTC facility.

This pilot study aimed to evaluate the implementation of the AGES intervention in reducing fear of falling (FoF) among older adults in LTC facilities, with the overarching goal of identifying areas for improvement prior to a multi-centered RCT. The study’s secondary objectives of assessing preliminary estimates of potential effectiveness could not find evidence of an effect on FoF, as measured by the FES-I, or well-being, as measured by the WHO-5, however, notes a general trend in decreasing FoF and improving well-being. The TUG score changes, despite the low number of participants, did indicate there could be improvement. This suggests that the intervention may have the greatest impact by enhancing physical mobility. This is important, as LTF residents have been found to suffer from reduced mobility (39). In searching for means of improving mobility, qualitative studies have shown that mobility is dependent on a schedule or routine, which can potentially be offered by the AGES intervention which encourages participants engagement in regular activities between sessions and offers a schedule to plan specific exercises, which may equate to improved independence and confidence in the future (40).

The Lidar-assessment of gait showed that the measurement device could be effectively deployed in LTC environments. Pre-post test findings showed slight change in gait and velocity, representing improvements in gait following the intervention. This is consistent with findings from (15). Difficulties in the gait analysis, however, formed when participants used walking aids. There may additionally be an observation bias effect, where participants transiently adapt their gait. These limitations indicate a need for further investigation beyond the scope of this publication. Future research will aim to improve the step extraction algorithm to allow gait analysis for participants with walking aids.

Caution should be given to intervention effect scores, as this study is a non-randomised pilot study, whose goal was not to establish effectiveness of intervention. Outcomes were expected not to be insignificant, due to the small number of participants, and reflects the importance of establishing a large enough population for a high level of confidence in the results. To detect significant changes in FES, TUG, and WHO-5 outcomes, future studies should aim for sample sizes of approximately 199, 27, and 43 participants, respectively. These estimated numbers would provide robust and reliable results by ensuring adequate power to detect true effects.

A larger sample size of approximately 200 participants per group is recommended to provide more robust data and enhance the statistical power of the findings, in particular for the FES-I outcomes. However, if investigating only functional and well-being outcomes, groups of 50 will suffice (Eldridge et al., 2016). Considering that each LTC had groups that could theoretically accommodate more participants, novel patient recruitment strategies could be tried (such as incorporating the program permanently in the therapeutic routine of the facilities). In addition, the current approach to recruiting participants did not adequately represent the male population, which, like women, suffers from FoF. Sufficient training and deployment across multiple facilities will be crucial for the scalability and success of the intervention.

The pilot study also revealed challenges to adoption: not all trained leaders could be engaged with an AGES group. This represents the limitations that LTC facilities may have, possibly due to workload saturation of staff, facilities within the structure required for administrating the intervention, and limited participant interest in an intervention that may be seen as unnecessary. These limitations underscore the need for careful planning and support to ensure that sufficient resources are available to deliver the intervention without overwhelming individual LTC facilities. Nevertheless, we did not find evidence for poor adherence to the AGES protocols. This is likely represented in the thorough training program established for the leaders. This observation follows a trend in similar layman-lead interventions, such as the A Matter of Balance by (26) where intervention leaders receive up to 20 hours of training, and regular recertification, with an emphasis on maintaining fidelity to intervention protocols (41).

This pilot study has provided important insights into the limitations of conducting a multicenter RCT of the AGES intervention and potential preliminary efficacy. While an improved mobility was observed, FoF and well-being trends suggested potential effectiveness despite an insufficient participant sample size to confirm this. Planning for a future RCT should focus on refining the intervention, optimizing recruitment processes, and ensuring the acceptability and feasibility of outcome measures, as well as adequate participant sizes. Addressing these factors will be essential for a comprehensive evaluation of the AGES intervention's effectiveness in a larger, more diverse population of older adults in LTC settings.

Ethics approval and consent to participate

This study was approved by the local ethics committee (Kantonale Ethikkommission Bern): ID Req-2021-01366. All participants provided written informed consent. No participants received monetary compensation.

Consent for publication

No individual personal data, such as images or personal details, have been used in this study.

Availability of data and materials

Data supporting the findings of this study are not openly available due to reasons of sensitivity and are available from the corresponding author upon reasonable request. Data are located in controlled access data storage at the Department of Old Age Psychiatry and Psychotherapy, University Hospital of Psychiatry, Bern (UPD, Bern).

Competing interests

The authors declare that they have no competing interests

Funding

Funding for this project was provided by the Age-Stiftung, Switzerland, project ID 849

Authors' contributions

EL : Conceptualization, intervention design, methodology, project administration, analysis, and writing of manuscript. Prepared all Tables and Figure S1.

AB : Conceptualization, implementation, analysis, and writing of manuscript

LB : Data curation, developed Lidar for gait analysis, writing – review and editing. Prepared Figure 1.

IP : Conceptualization, intervention design, intervention design, writing – review and editing.

CS : Intervention design, writing – review and editing

CK : Intervention design, writing - review and editing

PA : Intervention design, implementation, methodology, administration, writing – review and editing

SK : Supervision, conceptualization, intervention design, methodology, writing – review and editing.

All authors prepared the manuscript

Acknowledgements

We would like to extend a special thanks to the staff and management of the LTCs associated with this study: Senevita Beaulieu, in particular Jose Dos Santos and Beatrice Imberdorf, EMS Buttenberg, and the EMS Spitalackerpark. We would like to thank Mr Michael Single for sharing his statistical expertise. We acknowledge Ms Karin Weiss from the Age Stiftung, and the funding provided by the Age Stiftung that supported this project.

Conflict of interest

None of the authors are affiliated with any organization or institution that has any financial interest in this publication. No author has any conflicts of interest to declare.

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No competing interests reported.

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A Cognitive-Behavioral and Exercise Intervention to Reduce Fear of Falling in Older Adults in Long-Term Care: A Pilot Study

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