Fear of falling (FOF), one of the most common psychological

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1 Effect of Guided Relaxation and Imagery on Falls Self-Efficacy: A Randomized Controlled Trial Bang Hyun Kim, PhD,* Roberta A. Newton, PhD, Michael L. Sachs, PhD, Joseph J. Glutting, PhD, and Karen Glanz, PhD* OBJECTIVES: To examine the effects of guided relaxation and imagery (GRI) on improvement in falls selfefficacy in older adults who report having a fear of falling. DESIGN: Randomized, controlled trial with allocation to GRI or guided relaxation with music of choice. SETTING: General community. PARTICIPANTS: Ninety-one men and women aged 60 to 92. INTERVENTION: Participants were randomized to listen to a GRI audio compact disk (intervention group) or a guided relaxation audio compact disk and music of choice (control group) twice a week for 6 weeks for 10 minutes per session. MEASUREMENTS: Primary outcome measure was the Short Falls Efficacy Scale International (FES-I). Secondary outcome measures were the Leisure Time Exercise Questionnaire (LTEQ) and the Timed Up and Go (TUG) mobility test. RESULTS: GRI participants reported greater improvements on the Short FES-I (P =.002) and LTEQ (P =.001) scores and shorter time on the TUG (P =.002) than the guided relaxation and music-of-choice group. CONCLUSION: GRI was more effective at increasing falls self-efficacy and self-reported leisure time exercise and reducing times on a simple mobility test than was guided relaxation with music of choice. GRI is an effective, simple, low-cost tool for older adults to improve falls selfefficacy and leisure time exercise behaviors. J Am Geriatr Soc 60: , Key words: guided imagery; relaxation; fear of falling; self-efficacy From the * Department of Biostatistics and Epidemiology, University of Pennsylvania, Philadelphia, Pennsylvania; Department of Kinesiology, Temple University, Philadelphia, Pennsylvania; and School of Education, University of Delaware, Newark, Delaware. Address correspondence to Bang Hyun Kim, Department of Biostatistics and Epidemiology, 110 Blockley Hall, 423 Guardian Ave, University of Pennsylvania, Philadelphia, PA bangk@upenn.edu DOI: /j x Fear of falling (FOF), one of the most common psychological problems for older adults, has often been studied within a self-efficacy framework. 1 5 Self-efficacy is defined as one s beliefs in personal capabilities to organize and execute the courses of action required to produce a given outcome and plays a central role in explaining human motivation and behavior. 6 In relation to FOF specifically, it is referred to as a personal belief in one s ability to engage in certain activities of daily living without falling or losing balance. 1,2 Hence, fall-related measures such as the Falls Efficacy Scale (FES) 2 and the Activities Balance Confidence (ABC) Scale 1 have been developed to measure this belief. 1,2 In the past, different concepts such as FOF and falls self-efficacy have been applied to describe and measure the psychological aspects of falling. 4,7 For example, an increase in self-efficacy assessed as balance confidence 1 can act as a mediator to reduce FOF. 5 FOF is also related to performing functional tasks, but the path mediated by falls efficacy is strong. 5 This underscores a need to create effective interventions that can help to modify causal pathways between treatment and the desired outcome (lowering FOF). 3 A simple, low-to-no-cost therapeutic tool that might increase self-efficacious behaviors is guided relaxation and imagery (GRI). 8 Guided imagery involves the use of verbal instructions to create a flow of thoughts that focus the individual s attention on imagined visual, auditory, tactile, or olfactory sensations. It is the third most commonly used mind body therapy in the United States 9 and is designed to alleviate anxiety levels, 10 encourage relaxation, 11 increase self-efficacy, 11 and counteract fear and anxiety. 10 Imagery is also an important tool for encouraging mental states that may ultimately influence cognition (e.g., FOF) and behavior (e.g., exercise) through a direct or indirect relationship. 6 PURPOSE Although there have been numerous studies of GRI, few have been done with older populations. 8,12 Given the benefits of GRI found in previous research, the main purpose of this study was to examine the effects of a 6-week JAGS 60: , , Copyright the Authors Journal compilation 2012, The American Geriatrics Society /12/$15.00

2 1110 KIM ET AL. JUNE 2012 VOL. 60, NO. 6 JAGS intervention that used GRI techniques to increase falls self-efficacy in community-dwelling adults aged 60 to 92 who reported having a FOF. Secondary aims were to study the effects of GRI techniques on self-reported leisure time exercise levels and on a falls-related mobility test. METHODS Study Design and Participants This study was a repeated measures randomized controlled trial. Data were collected at baseline and 6 weeks (October 2008 March 2009) after enrollment in the study. Temple University s institutional review board approved this protocol. Participants were community-dwelling adults aged 60 to 92 with varying ethnic backgrounds and economic status who were recruited from numerous churches, senior homes, and centers in an urban area. Before recruitment, flyers were posted on location, and the first author (BHK) or a program director made oral announcements. Sign-up sheets were also available for interested individuals to be contacted further about the study. The first author then contacted interested individuals and scheduled a place and time to conduct baseline and follow up assessments. Participants were excluded if they reported no FOF, a history of Parkinson s disease that restricted them from doing activities, a history of stroke or untreated heart disease that restricted them from performing activities, severe rheumatoid arthritis or osteoarthritis that would cause discomfort during walking or stair climbing, a history of fracture due to fall, diagnosis of untreated diabetes mellitus, untreated uncontrolled heart (blood pressure 140/90) or lung (uncontrolled asthma or shortness of breath) disease, a history of Alzheimer s disease, no access to a CD player, and not willing or able to follow procedures specified by the study or instructions of the researcher. Measures Short Falls Efficacy Scale International Version Falls self-efficacy was measured using the 7-item Short (Falls Efficacy Scale International Version) FES-I. 13 The Short FES-I uses a 4-point Likert scale that ranges from 1 (not at all concerned) to 4 (very concerned) to score the level of concern regarding the possibility of falling when performing certain activities of daily living (e.g., taking a bath or shower). Total scores range from 7 (no concern about falling) to 28 (severe concern about falling). The FES-I has been shown to have excellent validity and reliability (Cronbach a = 0.92). 13,14 Leisure Time Exercise Questionnaire The Leisure Time Exercise Questionnaire (LTEQ) is a three-item scale that asks participants to indicate how often they engage in mild (minimal effort), moderate (not exhausting, light sweating), and strenuous (heart beats rapidly) leisure-time exercise during a typical week. 15 Total metabolic equivalents (METs) are scored by weighing intensity levels (3, mild; 5, moderate; 9, strenuous). The LTEQ is a valid and reliable (correlation coefficient (r) = 0.86) measure of self-reported exercise behavior for adults. 16 Timed Up and Go Physical performance was measured using the Timed Up and Go (TUG). 17,18 The TUG measures the time needed for a participant to rise from a chair, walk 3 m, return to the chair, and sit down. Specifically, the researcher placed a chair in a wide open space and placed black tape on the floor 3 m away from the chair. Participants were asked to rise from the chair, walk forward 3 m at their usual walking pace, turn 180, walk back to the chair, turn 180, and sit down. Participants were allowed to practice before testing, and an extra researcher was on standby in the case of an accidental slip or fall. Procedure This study followed procedures similar to those used in a previous study that examined the effects of GRI on selfreported leisure-time exercise behaviors for older adults. 8 The first author administered all of the baseline, study instructions, and follow up assessments. The first author was the only person who administered the whole procedure to ensure consistency in tool administration. In the initial meeting, participants were asked whether they had a FOF. Participants were also asked whether they had access to a CD player at least three times a week. The first author also checked to see whether participants were able to operate a CD player by asking them to insert a CD, play, rewind, fast forward, pause, and stop the CD player provided. If they had access to a CD player, answered yes to FOF, and were able to operate a CD player, they were asked to participate in the study. On agreement, they completed an informed consent and demographics form. Participants then completed two questionnaires (Short FES-I, LTEQ) and were timed (in seconds) performing the TUG. 17,18 Randomization Recruitment was staggered over time. After baseline assessments, participants were randomly assigned to a control or intervention group by a flip of coin. Once all participants were randomly assigned to a control or intervention group, there was no concealment of allocation for the authors. Single-blind randomization was used so that the first author knew where participants were placed, but the participants did not know whether they were placed in the intervention or control group after randomization. All participants had knowledge that they were going to be placed in a group that listened to guided relaxation and music of choice or GRI, but they did not know which group was the control and which the intervention group. GRI Audio CD The intervention group received a GRI audio CD that the researchers created. The GRI audio CD consisted of an introduction track, two guided relaxation tracks, and 11 guided imagery tracks. The first track explained overall

3 JAGS JUNE 2012 VOL. 60, NO. 6 FALLS SELF-EFFICACY AND GUIDED EXERCISE IMAGERY 1111 directions on how to use the CD. Track two consisted of an imagery controllability and vividness exercise to familiarize the participant with imagery. The final tracks consisted of two guided relaxation exercises: Progressive Muscle Relaxation (PMR, Track 3) 19 and deep breathing (Track 4). The 11 guided imagery scenarios were based on previous literature on FOF 1,13,14,20,21 and a GRI audio CD created for older adults to promote physical activity. 8 Each track was 4 to 6 minutes long and was narrated by the first author or another research assistant trained in relaxation and guided imagery. An important feature of this CD was that, as tracks progressed, the activities became more difficult. For example, earlier tracks consisted of simple activities around the house, but in later tracks, activities became more challenging, such as walking on an icy road. The rationale for this was that, after participants became familiar with imagery, they would be confident performing the difficult tasks on later tracks without having a FOF. The control group audio CD consisted of an introductory track and two of the same guided relaxation tracks listed above. Right after listening to a relaxation track, participants were asked to listen to music of their choice for 5 minutes. Intervention Procedures The intervention group was asked to listen to the GRI audio CD and the control group to the relaxation tracks and songs of their choice twice a week for 6 weeks for 10 to 15 minutes a session. The time and day of the week were their choice; but participants were asked to keep the schedule consistent throughout the 6 weeks. Participants in both groups were given an instruction booklet with a schedule of tracks to listen to on certain days and a checklist to monitor their progress during the 6 weeks. For consistency, the researcher emphasized listening only to the set of tracks on each chosen listening day as specified in the instruction booklet. To encourage adherence to these instructions, participants were asked to sign a trust agreement letter stating that they would listen only to the given track on the day listed in the instruction booklet. After 6 weeks, participants were retested using the same questionnaires and mobility test used at baseline. The first author facilitated all self-reported baseline and follow-up measures and conducted the TUG. Data Analysis Power was estimated to determine the number of participants needed for each outcome measure (Short FES-I, TUG, and the LTEQ) over a 6-week period. The overall power was set to 0.80, and equal sample sizes were assumed. A sample size needed of at least 45 participants per group was determined using a multivariate method 22 with a mean effect size of After calculating mean scores and times, a traditional repeated-measures analysis of variance 22 was completed for each outcome measure (Short FES-I, TUG, and LTEQ). Pre- and posttest change scores and times for the outcome measures and their 95% confidence intervals were computed to examine the intervention effects. A two-tailed alpha level was set to.05. Effect sizes were also interpreted as a standardized measure of the size of the treatment effect independent of the sample size. According to previously used guidelines for partial-eta square (g 2 ), g 2 of 0.01 represents small effect sizes, g 2 of 0.06 represents medium effects, and g 2 greater than 0.14 represents large effects. 23 All data analyses were performed using PASW software version 18 (IBM, Chicago, IL). RESULTS Figure 1 shows a flow summary of recruitment, randomization, and retention of participants. One hundred eightyfour participants were recruited for this study. During enrollment, 65 were excluded according to health criteria, withdrawals, and other problems (health and personal). Of the 184 recruited, 119 (76.5%) met the criteria and were assessed and randomized: 59 to the control group and 60 to the intervention group. During the allocation phase, six individuals (four control, two intervention) did not receive the allocated intervention because of being noncommittal (two each control and intervention) and poor health conditions (two intervention). During follow-up, 19 participants (9 control, 10 intervention) were not included in the analysis because of loss of contact, being noncommittal, relocation, and death. Finally, three participants (one control, two intervention) were not included in the analysis because they did not provide follow up data. In summary, 91 (45 control, 46 intervention) of 119 participants completed the study; despite dropping 28 participants after allocation, the power was still sufficient for analysis. Both groups had similar characteristics, and there were no statistically significant differences in baseline scores on the dependent variables. Table 1 shows demographic characteristics and group comparisons for the outcome measures at baseline. Short FES-I Table 2 shows Short FES-I scores from baseline to followup for both groups. Overall, both groups had significant improvements in scores after 6 weeks [F(1, 89) = 48.12, P =.001], but the GRI group had better improvement on their scores than those in the guided relaxation and musicof-choice group [F(1, 89) = 22.95, degrees of freedom (1, 89), P =.002]. The observed effect for time (g 2 = 0.35) and group by time (g 2 = 0.29) represented a large effect size. Leisure Time Exercise Questionnaire The GRI group had better improvements [F(1, 89) = 50.75, P =.002] on their LTEQ scores after 6 weeks (Table 2). The observed effect for time (g 2 = 0.36) represented a large effect size, and the group-by-time interaction represented a medium to large effect size (g 2 = 0.10). Timed Up and Go Both groups had a significant decrease in TUG time [F(1, 89) = 50.75, P =.001] after 6 weeks (Table 2), but the GRI group had better improvements [F(1, 89) = 9.80,

4 1112 KIM ET AL. JUNE 2012 VOL. 60, NO. 6 JAGS Figure 1. Randomization, participant flow, and retention throughout the study. Table 1. Comparison of Characteristics and Preliminary Scores of Outcome Measures According to Randomization Group Characteristic Control Group (n = 45) Intervention Group (n = 46) Female, n (%) 27 (60.0) 29 (64.4) Age, mean ± standard ± 8.2 (60 91) ± 8.5 (61 92) deviation (range) Ethnicity, n (%) African American 13 (28.8) 19 (41.3) Asian 17 (37.8) 12 (26.1) Caucasian 14 (31.1) 13 (28.2) Latino 1 (2.2) 2 (4.3) Household income < 32 (71.1) 29 (63.0) $35,000, n (%) Had 1 falls, n (%) Past 1 month 19 (42.2) 16 (34.8) Past 3 months 21 (46.7) 17 (40.0) Assisted device, n (%) 17 (37.8) 25 (54.3) Being treated for heart 36 (80) 37 (80.4) condition, n (%) Being treated for 16 (35.6) 14 (30.4) osteoporosis, n (%) Balance problem, n (%) 27 (60.0) 32 (69.6) Hearing problem, n (%) 33 (73.3) 29 (63.0) >4 medications, n (%) 24 (53.3) 26 (56.5) P =.002]. The observed effect for time (g 2 = 0.36) represented a large effect size, and the group-by-time interaction represented a medium to large effect size (g 2 = 0.10). DISCUSSION The main purpose of this study was to examine the effects of a GRI audio CD to increase falls self-efficacy in older adults who reported having a FOF. Results revealed that the GRI group had better improvements on efficacious behaviors than the group using guided relaxation with music of choice. Both groups had improvements on their Short FES-I scores at follow-up, but there was greater improvement in the GRI group (30% decrease in average scores, meaning higher falls self-efficacy) than the control group (10.1% decrease in average scores). Secondary outcomes also showed greater reductions in times for the TUG and greater increases in reported leisure-time activity scores for the GRI group after 6 weeks. The current study supports previous research that found that GRI might be an effective therapeutic tool for behaviors and problems such as fear of animals and reduction of pain in cancer treatment. 10,24 This study also extends previous literature in successfully increasing falls self-efficacy and self-reported leisure-time exercise behaviors 8 using an intervention. The GRI audio CD was specifically made so that participants could visualize (imagine) certain daily activities (e.g., go to bathroom, walk around supermarket) without having a FOF. With significant improvements in falls self-efficacy, self-reported leisure-time exercise behaviors, and the TUG, GRI might be a practical tool for those who are unable to perform certain physical activities simply because they have a FOF. Guided relaxation along with music of choice (control

5 JAGS JUNE 2012 VOL. 60, NO. 6 FALLS SELF-EFFICACY AND GUIDED EXERCISE IMAGERY 1113 Table 2. Comparison of Scores on Primary and Secondary Outcome Measures According to Intervention Group Control Group (n = 45) Intervention Group (n = 46) Baseline 6 Weeks Difference Baseline 6 Weeks Difference Mean Difference (95% Confidence Interval) a Outcome P-Value Mean ± Standard Deviation (Range) 20.6 ± 3.2 (13 26) 18.5 ± 3.3 (11 25) 2.09 ± ± 1.7 (21 27) 16.6 ± 3.5 (12 26) 7.10 ± ( 8.24 to 0.871).002 Short Falls Efficacy Scale International 18.6 ± 13.8 (3 66) 23.6 ± 9.6 (5 49) 4.93 ± ± 12.9 (3 49) 24.8 ± 9.9 (5 49) 5.81 ± ( ).001 Leisure Time Exercise Questionnaire (metabolic equivalent) score 15.4 ± 4.6 (7 24) 13.6 ± 3.2 (8 22) 1.78 ± ± 4.5 (7 24) 11.6 ± 3.3 (7 22) 4.57 ± ( 5.82 to 0.49).002 Timed Up and Go time, seconds a Between-group differences in change scores. group) also significantly improved falls self-efficacy and the TUG, but these changes were not as dramatic as in the intervention group. Both groups had longer average times on the TUG 17 at baseline (control, seconds, intervention, seconds) than the high falls risk cutoff time of 14 seconds or longer, 18 but after 6 weeks, both groups significantly lowered their times (control, seconds, intervention, seconds), indicating that a guided relaxation CD with music of choice or the GRI audio CD might have a significant effect on reducing participants risk of falls. In future studies, it might be interesting to expand upon this by examining the effects of GRI with actual fall rates for older adults. GRI had a significant effect on higher self-reported leisure time exercise levels. Because one of the best ways to prevent FOF and falling is to exercise, 29 it might be interesting in future studies to use GRI techniques to build exercise programs or interventions for sedentary older adults and to examine whether they have an effect on actual exercise levels (e.g., step count). Limitations Despite its innovativeness, this study had a number of limitations. First, because of the small sample size and most participants being relatively healthy with no history of falls, results may not be generalizable to a broader population, although this study adds to current knowledge about minority elderly adults, because most of the participants were low-income African-American and Asian older adults (70.3%). Second, some participants reported not enjoying listening to the GRI audio CD simply because it was not personable. The GRI audio CD was created through a review of general concepts and ideas in the research on healthy aging, FOF, and imagery. A suggestion for future researchers interested in using guided imagery might be to create customized imagery scripts that focus on target behaviors, such as decreasing FOF or increasing exercise levels. Third, it was a challenge to monitor and identify whether participants listened to their audio CDs during the intervention phase. The authors asked participants to sign a trust agreement letter stating that they would follow listening directions, but a future recommendation might be to create a more reliable and modernized method for monitoring (e.g., on-line accounts). Fourth, the first author was aware of the randomization for each participant, which might have created a potential source of bias, especially with the facilitated outcome measure (TUG). In efforts to reduce investigator bias and for consistency, the first author was the only person who conducted the baseline and follow up measures, and there were no indications of group assignment in the data collection tools. For future studies, a recommendation might be to have a blinded team member conduct data collection to reduce investigator bias. Last, self-reported data for the questionnaires may have been misinterpreted, and responses may have reflected inaccurate recall or limited detail. Future studies might consider using more-objective measures such as heart monitors or accelerometers in addition to self-reported questionnaires to examine the effects of GRI further.

6 1114 KIM ET AL. JUNE 2012 VOL. 60, NO. 6 JAGS CONCLUSION In conclusion, this study revealed that GRI was effective in increasing falls self-efficacy and self-reported leisure-time behaviors and reducing times on a simple mobility test for older adults with a FOF. More importantly, GRI might be a helpful tool for those who cannot perform the physical activities that previous FOF intervention studies have recommended, such as home-based exercises 20,21 and tai chi. 30 More research is needed to find ways to apply and disseminate this helpful tool by creating more-innovative and -efficient methods such as creating customized and digitalized guided imagery applications. ACKNOWLEDGMENTS The authors would like to thank Dr. Elizabeth Loughren and David S. Lee for their help creating the GRI audio CD. The authors would like to thank Drs. Nicole Gabler, Stephen Lepore, Joseph DuCette, and Karyn Tappe for their expert advice. This paper was presented as a poster presentation at the 31st Annual Meeting and Scientific Sessions of the Society of Behavioral Medicine, Seattle, Washington, Conflict of Interest: The editor in chief has reviewed the conflict of interest checklist provided by the authors and has determined that the authors have no financial or any other kind of personal conflicts with this paper. Author Contributions: Drs. Kim, Newton, Sachs, and Glutting had full access to all of the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis. Study concept and design: Kim, Newton, Sachs. Acquisition of data: Kim, Newton, Sachs. Analysis and interpretation of data: Kim, Sachs, Newton, Glutting, Glanz. Drafting of manuscript: Kim, Sachs, Newton, Glanz. Critical revision of manuscript for important intellectual content: Glanz, Newton, Sachs. Statistical analysis: Glutting, Kim, Sachs. Administrative, technical, or material support: Kim, Sachs. 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