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Fall Preventive Exercise With or Without Behavior Change Support for Community-Dwelling Older Adults

A Randomized Controlled Trial With Short-Term Follow-up

Arkkukangas, Marina, PT1; Söderlund, Anne, PT, PhD1; Eriksson, Staffan, PT, PhD2,3,4; Johansson, Ann-Christin, PT, PhD1,5

Journal of Geriatric Physical Therapy: January/March 2019 - Volume 42 - Issue 1 - p 9–17
doi: 10.1519/JPT.0000000000000129
Research Reports

Background and Purpose: In Western countries, falls and fall-related injuries are a well-known threat to health in the aging population. Studies indicate that regular exercise improves strength and balance and can therefore decrease the incidence of falls and fall-related injuries. The challenge, however, is to provide exercise programs that are safe, effective, and attractive to the older population. The aim of this study was to investigate the short-term effect of a home-based exercise program with or without motivational interviewing (MI) compared with standard care on physical performance, fall self-efficacy, balance, activity level, handgrip strength, adherence to the exercise, and fall frequency.

Method: A total of 175 older adults participated in this randomized controlled study. They were randomly allocated for the Otago Exercise Program (OEP) (n = 61), OEP combined with MI (n = 58), or a control group (n = 56). The participants' mean age was 83 years. The recruitment period was from October 2012 to May 2015. Measurements of physical performance, fall self-efficacy, balance, activity level, handgrip strength, adherence to the exercise, and fall frequency were done before and 12 weeks after randomization.

Results and Discussion: A total of 161 participants were followed up, and there were no significant differences between groups after a period of 12 weeks of regular exercise. Within the OEP + MI group, physical performance, fall self-efficacy, physical activity level, and handgrip strength improved significantly; likewise, improved physical performance and fall self-efficacy were found in the control group. A corresponding difference did not occur in the OEP group. Adherence to the exercise was generally high in both exercise groups.

Conclusion: In the short-term perspective, there were no benefits of an exercise program with or without MI regarding physical performance, fall self-efficacy, activity level, handgrip strength, adherence to the exercise, and fall frequency in comparison to a control group. However, some small effects occurred within the OEP + MI group, indicating that there may be some possible value in behavioral change support combined with exercise in older adults that requires further evaluation in both short- and long-term studies.

1School of Health, Care and Social Welfare, Mälardalen University, Västerås, Sweden.

2Centre for Clinical Research Sörmland, Uppsala University, Eskilstuna, Sweden.

3Department of Community Medicine and Rehabilitation, Physiotherapy, Umeå University, Umeå, Sweden.

4Department of Neuroscience, Physiotherapy, Uppsala University, Uppsala, Sweden.

5Centre for Clinical Research, Uppsala University, Västerås, Sweden.

Address Correspondence to: Marina Arkkukangas, PT, School of Health, Care and Social Welfare, Box 883, SE-72123, Mälardalen University, Västerås, Sweden (marina.arkkukangas@mdh.se).

Source of support: The National Swedish Board of Health and Welfare, Grants for the County of Västmanland. Regional Research Fund for Uppsala and Örebro region, Sweden. Research and Development Department in the Community of Eskilstuna, Sweden.

The authors declare no conflict of interest.

Bill Andrews was the Decision Editor.

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INTRODUCTION

The decreased physical functioning that occurs with aging often leads to falls and fall-related injuries, which are a major public health problem globally. Studies indicate that falls and fall-related injuries can be decreased by regular exercise.1 , 2 The challenge, however, is to provide exercise programs that are safe, effective, and attractive to the older population.1 For older adults with incipient transfer disabilities, home-based exercise provides many advantages. The possibility of exercising at home might be important for adherence to prescribed exercise recommendations.1 , 3 , 4 The Otago Exercise Program (OEP) is a strength and balance retraining program suitable for performance at home aimed at preventing falls among older community-dwelling adults.2 The program has been shown to reduce falls and injuries, especially for women older than 80 years. In general, the program is effective for those who adhere to the prescribed exercise recommendations.5 According to the OEP, a training frequency of 3 sessions per week is recommended, although lower levels of adherence also might have favorable effects on health outcomes in the older population.6 The presented effectiveness of the program has been based on a training period of 6 to 12 months.6 The OEP does not include any specified behavioral support. French et al7 highlighted that acceptance of behavior change techniques was an important consideration when physical activity interventions were introduced for older adults.7

The perceived gains from participating in physical activity interventions vary in different age groups. In general, behavior change techniques are more effective at increasing physical activity in younger and middle-aged adults than in older adults.8 Motivational interviewing (MI) is a communication method that is commonly used to attain behavior change in health care today.9 Features of MI include listening and reinforcing the patient's thoughts to reflect on his/her situation and thus reduce the person's resistance to the behavior change.9 These aspects are important for a person who is beginning or has an intent to maintain a behavioral change process.10 Improvement in self-efficacy and activity limitation when using motivational interventions has been investigated with some positive results in people of working age.11 To the best of our knowledge, the OEP combined with MI has not been studied among older adults who have an increased need for care services or who use walking aids. Hence, the aim of this study was to examine the short-term effect of a home-based exercise program with or without MI compared with standard care in terms of physical performance, fall self-efficacy, balance, activity level, handgrip strength, adherence to the exercise, and fall frequency.

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METHODS

The study was a randomized controlled trial with 2 treatment groups and 1 control group. The Consolidated Standards of Reporting Trials (CONSORT) checklist was used to report the randomized controlled trial.12 The study was registered at clinicaltrials.gov under NCT01778972. In this study, the short-term follow-up (12 weeks) is reported, and future follow-ups will occur at 12 and 24 months. A total of 175 people from 3 communities in central Sweden who lived in their own homes participated in the study (Figure).

Figure

Figure

Care managers, occupational therapists, and physiotherapists (PTs) collaborated to recruit participants who had contacted health centers or the municipality to obtain walking aids or home care. To be eligible, participants were required to be 75 years or older, have the ability to walk independently, and the ability to understand written and oral information in the Swedish language. The exclusion criteria were scoring less than a 25 on the Mini-Mental State Examination (MMSE), ongoing regular physical therapy treatment, or being in terminal care. Patients who were identified and showed interest in participating when they visited the health care centers or home care were contacted by phone and given information about the study by 2 of the researchers. If they were willing to participate in the study, they were contacted by an independent PT for baseline measurements (Table 1). If those participants met the study criteria, informed consent was obtained and they then were randomized into 1 of the 3 groups (Figure).

Table 1

Table 1

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Measurements

The measurements were performed single blinded by 6 independent PTs before randomization and 12 weeks after randomization. All of the PTs had experience working with older people. The setting was in the participant's home or at a health care center. In addition, the participants filled in a fall calendar and exercise diary monthly and received follow-up every month by a PT. Physical performance, fall self-efficacy, balance, activity level, handgrip strength, adherence to the program, and fall frequency were collected using the following measures:

The Short Physical Performance Battery (SPPB) was used to measure physical performance in the lower extremities. The SPPB consists of 3 components: balance, gait speed, and lower body power.13 The SPPB has been reported to be predictive of disability and risk of falls.14 The 3 tasks are graded on a 4-point scale, with a maximum score of 12 points, where the maximum indicates the best physical performance. The test-retest reliability has been reported to be good for the SPPB.13

The Falls Efficacy Scale Swedish version (FES(S)) was used to measure confidence in the participant's ability to perform various daily activities without falling.15 The instrument consists of 13 items that are rated on a 0 to 10 scale, with a maximum score of 130, where 130 represents the highest level of self-efficacy. The internal consistency16 and the test-retest reliability for the FES(S) have been shown to be high.17

The Mini-BESTest was used to measure balance. The test includes 14 different tasks on 4 subscales. All tasks are graded from 0 to 2 points, with a total maximum score of 28 points; in each task, 0 indicates the lowest level of balance and 2 indicates the highest level.18 The test has high reported test-retest reliability and interrater reliability.19

The Frändin/Grimby Activity Scale was used to measure the physical activity level, where activity level is estimated on a 6-point scale. The scale considers activities typically performed during the winter and summer seasons, and the validity has been shown to be good.20

The Jamar hand dynamometer was used to measure handgrip strength. The test is a valid measure for general body strength.21 The test provides an excellent test-retest reliability for grip strength measurement.22

Exercise adherence was monitored by an exercise diary that was filled in by the participants and followed up on every month by a PT. Use of an exercise diary has been shown to be a positive factor for adherence when prescribing regular physical activity for older adults.23 The 36 exercise sessions were prescribed during the study period (3 times per week) according to the original OEP protocol. We set the acceptable amount of exercise adherence to a minimum of 24 sessions (2 times per week). This was considered appropriate because of age and possible upcoming events in the older adults' lives, and it is commonly used as an acceptable measure when prescribing exercise for older adults.24 , 25 Walks were encouraged in between exercise days with an acceptable amount of 24 walks (2 times per week) during the study period, according to the original OEP protocol.25

Fall frequency was reported by a fall calendar during the 12-week study period, in line with current recommendations for reporting falls with follow-up from a practitioner.26

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Interventions

All participants got a pamphlet with general safety recommendations for older adults, including fall prevention recommendations. This was standard care at that time in the 3 communities, and it was the only intervention for the control group.

The OEP and OEP + MI groups were supervised and supported on 5 occasions during the 12 weeks by a PT for exercise and MI treatment. The treatment was given by 11 PTs, all of whom had experience working with older people.

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OEP group

The OEP is a home-based exercise program designed to improve strength, balance, and endurance. With the support of the PT, the level of difficulty of the individually tailored exercise program was increased successively during the 12 weeks. To ensure the safety and intensity of the program, the PT increased and supervised the exercise closely during the 5 home visits. The exercise was estimated to take 30 minutes and was prescribed at a frequency of 3 times weekly. Ankle cuff weights were used according to the OEP protocol.6 Walks were recommended for the days between the exercise days. Exercise and walks were reported in the exercise diary by the participant. Each session with the PT was estimated to take 1 hour.

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OEP + MI group

MI was combined with the OEP to follow the participant's motivation to change regarding exercise. Unlike the OEP group, the PT in the OEP + MI group strived to enhance the person's own motivation for and commitment to change. The session began with MI, open-ended questions, affirmations, reflective listening and summaries (OARS),27 a collaborative conversation to strengthen and mobilize the participants' inner resources. The session then proceeded to discussion and a decision of the individual setup regarding the OEP. Throughout each session, the underlying principles of MI were present. The sessions aimed to keep a flexible intervention tailored to the participant's needs and at the same time keeping the standardized structure of the OEP. Each session was calculated to last approximately 1 hour, equal to the OEP group.

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Treatment Fidelity

Treatment fidelity was considered in both exercise groups and consisted of meetings for all of the PTs who delivered the OEP and OEP + MI treatments before the study began and during the study period. Minor adjustments to the OEP were made with the agreement of all the PTs involved, and a consensus was reached regarding how the program was administered and delivered. The PTs in both intervention groups followed the study protocol and registered the exercise during the home visits.

All of the PTs who performed the MI had received education in MI, and they were all experienced and familiar with the MI method. In addition, the PTs who worked with the participants in the OEP + MI group received a 3-day educational training in MI before the study started with 2 Motivational Interviewing Network of Trainers (MINT) instructors and 3 booster sessions during the study period. Control coding during the study was performed at the Motivational Interviewing Coding Laboratory (MIC lab) in Sweden; the average was 3.8 for the PTs, which was interpreted as an acceptable score rated on a 5-point Likert scale, where 0 is a low MI spirit and 5 is high.28

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Ethics

We followed the 1964 Helsinki Declaration, which concerns human rights, informed consent, and correct procedures concerning treatment in research involving human participants. The participants received no compensation for their participation, and the study was approved by the regional ethics committee in Uppsala, Dnr. 2012/147.

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Randomization

The participants were randomly allocated in variable block sizes of 3, 6, 9, and 12 participants to 1 of 3 groups. The randomization was stratified by the 3 communities. A statistician independent from the research group generated the random allocation. The random allocation sequences were transferred to consecutively numbered envelopes that were handled by 2 researchers who did not participate in the data collection or in the intervention.

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Statistics

A power calculation based on the SPPB, the main outcome variable, was performed before the study started. An estimated small meaningful change was set to 0.5, with a standard deviation (SD) of 1.5 in the SPPB.29 , 30 This resulted in the need for 45 participants in each group, with a significance level of 5% and power of 80%. A 15% dropout rate was estimated, resulting in a total of 52 participants for each group or a grand total of 155. We had access to 175 participants, and therefore they were all included in the study. A 1-way analysis of variance power analysis was performed with PASS version 13.0.8. Baseline characteristics were measured with Kruskal-Wallis and Fisher exact tests, and the χ2 test was used for categorical data. Between-group effects were analyzed with 1-way analysis of variance and post hoc analysis using the Scheffé test. The intention-to-treat analysis was complemented with a per-protocol analysis where dropouts and nonadherent participants were excluded. Levene's test was used for homogeneity of the variance test and skewness and kurtosis for the distribution of data. Within-group effects were analyzed with the paired t test. We used an α level of 0.05 for all of the statistical tests. The data analysis was performed using IBM SPSS statistics 20.

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RESULTS

The study was conducted from October 2012 to May 2015. Among the 335 eligible older people, 8 participants scored less than 25 on the MMSE and 152 participants declined participation for various reasons. The remaining 175 participants were randomized as follows: 61 individuals in the OEP group, 58 individuals in the OEP + MI group, and 56 individuals in the control group (Figure). No significant baseline differences were observed between the 3 groups (Table 1). The mean age for the entire group was 83 years (Table 1). No significant values were detected with Levene's test, and the data were considered to be normally distributed, as the values for skewness and kurtosis fell within ±1 for all the outcome variables. A total of 161 participants were followed up at 12 weeks: 54 individuals in the OEP group, 52 individuals in the OEP + MI group, and 55 individuals in the control group (Figure). The 14 dropouts during the study period were mostly due to participants' health-related problems. Of the remaining 161 participants, a total of 15 persons were nonadherent to the exercise and were excluded according to the set limit of acceptable adherence to the exercise in a per-protocol analysis with a total of 146 participants: 43 individuals in the OEP group, 48 individuals in the OEP + MI group, and 55 individuals in the control group (Figure). The per-protocol analysis revealed similar results as the intention-to-treat analysis (Tables 2 and 3). At least 1 accidental fall was reported during the study by 45 participants (29%), with a total of 74 falls. There were 19 falls in the OEP group reported by 15 persons (31%), 38 falls in the OEP + MI group reported by 18 persons (33%), of whom 3 individuals fell more than 5 times, and 17 falls in the control group reported by 12 persons (22%). According to the fall calendars, no falls occurred during the exercise.

Table 2

Table 2

Table 3

Table 3

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Physical Performance

No significant differences between the groups were observed over time regarding physical performance measured by the SPPB (Table 2). Within groups, the OEP + MI group (P = .04) (per-protocol analysis, P = 0.03; Table 3) and the control group (P = .03) showed significant improvements in physical performance. The difference in the OEP group was not significant for the SPPB (Table 2).

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Falls Efficacy Scale

No significant differences between the groups were observed over time for the results in the FES (Table 2). Within groups, the OEP + MI group (P = .02) (per-protocol analysis, P = .05; Table 3) and the control group (P = .03) improved significantly. The difference was not significant in the OEP group (Table 2).

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Balance

The Mini-BESTest showed no significant differences in balance between the groups or within any of the 3 groups over time (Table 2).

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Physical Activity Level

No significant differences between the groups were observed over time regarding the Frändin/Grimby Activity Scale (Table 2). Within groups, the OEP + MI group significantly improved (P = .02). The differences in the OEP and control groups regarding the Frändin/Grimby Activity Scale were not significant (Table 2).

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Jamar Handgrip

No significant differences between the groups were observed over time in the Jamar handgrip (Table 2). Within groups, the OEP + MI group significantly improved (P = .03) in (per-protocol analysis, P = .02; Table 3) the Jamar handgrip on the left side (Table 2). The differences in the OEP and control groups regarding the Jamar Handgrip were not significant (Table 2).

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Adherence to Exercise

No significant differences were detected between the OEP and OEP + MI groups in adherence. In total, 42% of the participants adhered to the recommendation of 3 times per week; adherence was 42% in the OEP group and likewise 42% in the OEP + MI group. The exercise was accomplished 2 times weekly by 81% of the participants: by 77% in the OEP and by 84% in the OEP + MI group.

The walking frequency of 2 times weekly was accomplished by 67% of the participants, and the proportions within groups were 70% in the OEP group and 64% in the OEP + MI group. In total, 25% of the participants had a walking frequency of 4 times per week; this was 21% in the OEP group and 28% in the OEP + MI group.

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DISCUSSION

We were unable to confirm the hypothesis that exercise (OEP) in combination with MI increases physical functioning after 12 weeks of exercise compared with regular exercise (OEP) and a control group. No significant differences were found between the 3 study groups in this short-term follow-up. Over time, effects in physical performance, fall self-efficacy, physical activity level, and handgrip strength after the exercise period were achieved in the OEP + MI group, and such effects in physical performance and fall self-efficacy were also achieved in the control group. These changes did not occur in the OEP group. Adherence in exercise was high in both the OEP and OEP + MI groups.

With knowledge of the benefits of the OEP for community-dwelling older adults, we were interested to see whether the OEP could have an effect on this sample of older adults with light disabilities, needing walking aids or home care. Follow-up was done after 12 weeks because most of the support provided by the PT was given at this time point. Because adherence to exercise programs for older adults is generally low,31 we found it interesting to evaluate whether MI would increase adherence and therefore also have an impact on the effects of exercise. The OEP + MI group improved significantly in all of the outcome variables except for balance performance measured by the Mini-BESTest. In contrast, the OEP group showed no significant changes in any of the outcome variables. However, because these changes not were significant when compared between groups, these findings are not grounds for further conclusions.

MI as a complement to traditional physical therapy was studied in a systematic review by McGrane et al,32 where it was shown to have some positive effects on long-term exercise behavior.32 However, several different study populations were included in the review, and therefore no specific conclusion could be drawn regarding its effects in an older population. Observed changes within the OEP + MI group in our study imply a need for further studies on MI as a complement to exercise for this age group.

The high adherence in both exercise groups could also be linked to the transtheoretical stages of change.33 The participants in this study had accepted participation and, thus, the motivation to exercise was considered to be present from the study start, regardless of the allocated group. The stages of change consist of 5 stages: precontemplation, contemplation, preparation, action, and maintenance. The PTs supported and guided the participants to proceed through the stages of change. Prochaska et al33 argued that behavior changes during the first month in a treatment intervention are the most important in the process of moving forward toward behavior change actions.33

Existing guidelines suggest that general exercise should be undertaken for at least 2 hours per week for older adults,4 and we considered the minimum of exercise 2 times per week in combination with walks performed at least 2 times per week to meet this guideline. A total of 81% of the participants performed the exercise 2 times per week, and 67% of the participants walked 2 times per week in both treatment groups. Gardner et al25 showed that exercise performed 2 times per week during 12 months was highly associated with physical benefits for older adults older than 65 years.25 Regarding the OEP + MI group, our results offer some support to the conclusions drawn by Gardner that physical improvement can be achieved when exercise is performed 2 times per week after a relatively short period of training. To reach the desired effect, the exercise has to be challenging but also done within a safe and comfortable margin.34 We judged the safety margin to be high in our study, which might explain the absence of improvement.

Over time, the exercises performed in this study were intended to prevent falls, but the limited study sample and the short follow-up time did not allow for conclusions regarding the effect on falls. In total, 29% of the 175 participants reported falls; this was composed of 31% from the OEP group, 33% from the OEP + MI group, and 22% from the control group. Home-based exercise including a walking program may cause an increased risk of falls if not carefully prescribed. However, none of the participants reported fall accidents during exercising in the present study.

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Limitations and Strength

A 12-week follow-up may have been too short to detect differences between the groups. Nevertheless, we were interested to see whether this program, which was submaximal and done within a safe margin, possibly had any short-term effects. The sample size could also have been underpowered, because we had a higher dispersion in the SPPB variable (SD, 2.6) compared with the SD we used in the power calculation (SD, 1.5). The similarities of the exercise programs and the unexpected improvement in the control group were likely limitations of this study, as these factors contributed to difficulties in detecting differences between the groups.

The control group did not keep exercise diaries, so it is unknown whether this group exercised on their own. A diary for the control group, however, could have been interpreted as a reminder or request for regular exercise, which was a reason for not including one.

The balance performance was the only outcome variable that did not change in any of the groups. Perhaps the Mini-BESTest was not sensitive enough to detect possible changes; a more sensitive test might have been preferable for this study sample.

The control of treatment fidelity was a strength in this study along with thoroughly followed protocols and several meetings for the involved PTs to attain standardization of the OEP and MI interventions. In addition, the PTs who performed the measurements were blinded to group allocation, and the randomization was performed by 2 researchers who did not participate in the intervention or measurements.

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CONCLUSION

A short-term follow-up of a home-based exercise program with or without MI compared with standard care showed no significant differences between the groups in terms of physical performance, fall self-efficacy, balance, activity level, handgrip strength, adherence to the exercise, and fall frequency. Some small effects occurred within the OEP + MI group regarding physical performance, fall self-efficacy, activity level, and handgrip strength. Behavioral change supports for older adults who are recommended to exercise need to be further developed and evaluated not only in the short-term perspective but also in the long-term perspective.

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Keywords:

behavior; exercise; older adults

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