Abstract
Study Objectives:
Previous research supports exercise as a behavioral approach to manage symptoms of restless legs syndrome (RLS); however, completion rates in exercise studies are low. This study obtained key stakeholder feedback from people with RLS to modify and optimize a 12-week, evidence-based exercise program for RLS.
Methods:
Participants with RLS (n = 513) completed a nationwide survey to provide feedback on the necessity, interest, feasibility, and efficacy of the program as well as perceived barriers and proposed modifications to improve the exercise program.
Results:
Most respondents (67%) expressed the need for an exercise program designed specifically for people with RLS and 64% were interested in the program. Only 6% of participants thought the program would not be well tolerated and 6% responded that it would likely exacerbate symptoms. However, only 58% said they would be likely to participate in the program if it was available to them locally. Key barriers to participation were (1) accessibility, (2) personal factors, (3) trustworthiness, and (4) fear of injury, illness, or symptom exacerbations. Respondents highlighted modification considerations for the individualization of exercise features, adaptations for specific impairments/personal factors, inclusion of flexibility and balance exercises, and flexibility for more home-based activities.
Conclusions:
Interest in the program was driven by the desire to reduce medications and improve overall quality of life. Appropriately educated and trained exercise providers knowledgeable about RLS are integral to buy-in from stakeholders. This study provides an imperative step in clinical research that can increase the success of subsequent implementation efforts and may accelerate the adoption of exercise programs into practice.
Citation:
Cederberg KLJ, Sikes EM, Mignot E. Stakeholder involvement in the optimization of a patient-centered exercise intervention for people with restless legs syndrome. J Clin Sleep Med. 2024;20(4):535–543.
Keywords: restless legs syndrome, exercise, stakeholder, survey
BRIEF SUMMARY
Current Knowledge/Study Rationale: Although exercise programs demonstrate improvement in restless legs syndrome (RLS) symptoms, attrition rates are high and a program that is not perceived as feasible and/or beneficial by the target population will not succeed in the overarching mission of increasing exercise participation. The present study obtained key stakeholder feedback from people with RLS to modify and optimize a 12-week, evidence-based exercise program for adults with RLS.
Study Impact: People with RLS expressed a need for an RLS-specific exercise program designed by informed RLS providers and that appropriately educated and trained exercise providers that are knowledgeable about RLS are integral to buy-in from stakeholders. Results from this study are imperative to increase success of subsequent implementation efforts and will accelerate adoption of any exercise program into practice.
INTRODUCTION
Restless legs syndrome (RLS), or Willis-Ekbom disease, is a sensorimotor sleep disorder that affects approximately 10% of people.1 RLS significantly disrupts sleep2 and increases the risk of cardiovascular disease, hypertension, stroke,3,4 and depression and anxiety,5 and causes overall poorer health1,6 and decreased quality of life.7,8 As 2 key diagnostic features of RLS include the worsening of symptoms at rest and relief by movement,9 there is increasing interest in using exercise to manage symptoms, whereby previous research to date supports exercise as a behavioral approach to manage symptoms of RLS.10–16
The largest randomized controlled trial, to date, examined the effect of exercise on symptoms of RLS using a 12-week, multimodal exercise program.10 Of 41 participants randomized into the exercise program or a nonexercise control condition, 23 participants completed the 12-week study, including 11 in the exercise group and 12 in the control group. The exercise condition was conducted at a hospital-based wellness center and included lower-body resistance training and 30 minutes of aerobic walking 3 days per week. Both groups also received advice on lifestyle interventions (ie, smoking and alcohol cessation, avoidance of caffeine, proper sleep hygiene) to manage symptoms. Both groups had similar RLS severity at baseline and the control group did not change significantly over time. The exercise group demonstrated a 39% reduction in symptoms from baseline to 6 weeks, with no significant change (4% reduction) from week 6 to week 12. The overall reduction in RLS symptoms from baseline to week 12 was 41%, indicating a clinically significant improvement in RLS symptoms for the exercise group. That study supports the use of a multimodal exercise program for managing symptoms of RLS; however, as with any exercise program, there are concerns for attrition. That study only had a completion rate of 53% from enrollment to the 12-week follow up, which is much higher than the average attrition rate for exercise studies, which ranges between 18% and 34%.17 Further, although such exercise programs demonstrate reductions in RLS symptoms and can improve overall health and wellness, there are several challenges in the implementation and overall success of a program outside of the controlled research environment.
A program that is not perceived as feasible and/or beneficial by the target population will not succeed in the overarching mission of increasing exercise participation. Therefore, including the target population as key stakeholders in the development of the exercise program is imperative to increase the success of subsequent implementation efforts.18 Further, stakeholder involvement may improve the relevance of research questions and accelerate adoption of programs into practice.19 The present study obtained key stakeholder feedback from people with RLS to modify and optimize a 12-week, evidence-based exercise program for adults with RLS.10 We used a mixed-methods, nationwide survey with quantitative questions to examine the perceived necessity, interest, feasibility, and efficacy of the proposed program as well as open-ended responses to address barriers and inquire about key modifications that could optimize the feasibility and efficacy of the exercise program. Such results will incorporate valuable feedback from people with RLS that will improve the feasibility of an RLS-specific exercise program to optimize subsequent clinical research that can improve health, reduce risk of disease and comorbidities, and manage RLS symptoms.
METHODS
Participants and procedure
The procedure was approved by Stanford’s Institutional Review Board. The Restless Legs Syndrome Foundation distributed the survey to 3,644 registered members with RLS via an email advertisement in October 2021. Persons interested in participating were instructed to proceed to the internet-based survey by clicking on the survey link provided in the email. A Restless Legs Syndrome Foundation member who completed the survey also shared the survey link to the “RLS SUCKS! Restless Legs Syndrome–Willis-Ekbom Support Group” Facebook group, which included approximately 1,804 members at the time of sharing. Upon entry into the survey, all participants were provided a detailed description of the survey and all participants provided electronic informed consent followed by the completion of the questionnaire. All questionnaires were checked for completeness; however, the survey was conducted completely anonymously. Therefore, a survey missing data for relevant study outcomes was considered incomplete and excluded from formal analyses. The survey was closed to participants in June 2022, at which time 1,935 (53%) of the 3,644 emails sent by the Restless Legs Syndrome Foundation were opened, with 727 (38%) recorded unique clicks to proceed to the survey. We were unable to track the number of individuals in the Facebook group who completed the survey. In total, there were 587 survey responses with 513 people (87%) who completed all relevant outcomes for the present study.
Mixed-methods survey
The survey was designed in collaboration with the Northern California Restless Legs Syndrome Support Group. The first author (K.L.J.C.) pretested the proposed survey items to 20 members of the group in June 2021, whereby members engaged in an active discussion and provided feedback and suggestions regarding survey items perceived to be important to address for people with RLS. The final, distributed version of the mixed-methods survey included items assessing RLS diagnosis, RLS severity, demographic and clinical characteristics, and questions regarding a proposed, evidence-based exercise program.
RLS diagnosis
The Cambridge-Hopkins Restless Legs Syndrome Short Form Diagnostic Questionnaire (RLS-SFDQ13)20 was used to assess a positive screen for RLS. A positive screen for RLS requires that participants present with the following criteria: (1) the desire to move the legs in association with uncomfortable sensations, (2) the need to move the legs in response to these sensations, (3) the worsening of sensations at rest, (4) the partial or complete relief of the urge with movement, and (5) the sensations occurring most frequently during the evening or early part of the night. All participants either had a positive screen for RLS or a self-reported previous diagnosis of RLS from a medical professional.
RLS severity
The Self-Administered version of the International Restless Legs Syndrome Study Group Scale (sIRLS) is a validated 10-question survey that provides a global score regarding the severity and frequency of symptoms over the previous week.21 Overall symptom severity scores range between 0 and 40 and are determined by summing item scores, with higher scores indicating a greater severity of symptoms. Severity scores can further be categorized as no symptoms (0) and mild (scores 1–10), moderate (scores 10–20), severe (scores 20–30), and very severe (scores 30–40) symptoms.
Perception of exercise programs for RLS
Participants were provided a brief description of the proposed evidence-based exercise program in a bulleted list with a figure of an example week for ease of identification (Figure 1). The exercise program was informed by exercise guidelines outlined by the American College of Sports Medicine,22 the American Heart Association, and the Centers for Disease Control and Prevention23 as well as the exercise program utilized in the largest randomized controlled trial to-date in people with RLS.10 The program includes 3 sessions per week for 12 weeks, including 2 sessions in person with an exercise specialist and at least 1 cardiovascular session at home on their own. The program includes cardiovascular exercise (eg, walking/jogging, bicycling) for 30 minutes per day on at least 3 days per week at a moderate-to-vigorous intensity as well as strength training on 2 nonconsecutive days per week targeting major muscle groups for approximately 30 minutes. The intensity of both cardiovascular and strength training would be assigned on an individual basis based on personal factors (eg, physical condition at baseline, experience). Participants were subsequently asked specific questions (Table 1) to evaluate the program and provide feedback based on their own experiences with exercise.
Figure 1. Program description provided to participants in the survey.
Detailed description of the exercise program provided to participants within the survey. Participants were provided this figure alongside the relevant questions about the program for ease of identifying the exercise program components for feedback purposes. Blue boxes indicate examples of cardiovascular exercise scheduled activities and green indicates strength training scheduled activities as a part of the program.
Table 1.
Survey items examining components of an exercise program in adults with restless legs syndrome.
| Perceptual Component | Survey Question | Response Options |
|---|---|---|
| Necessity | “Do you think people with RLS need an exercise program specifically made for people with RLS?” | Yes or no |
| Interest | “Is this an exercise program that you would be interested in?” | Yes or no |
| “If this exercise program was available to you locally, how likely would you be to participate in the program?” | Extremely unlikely to extremely likely | |
| Modifications | “Why is this program of interest/not of interest to you? What changes would you like to see?” | Open-ended |
| Barriers | “What would prevent you from participating in this exercise program? [No word limit] | Open-ended |
| Feasibility/tolerability | “Based on your own experience with exercise, do you think this exercise program would be well tolerated by people with RLS?” | Yes, maybe, no |
| Efficacy | “Based on your own experience with exercise, do you think this program would make RLS symptoms worse or better?” | Range 1 (much worse) to 5 (much better) |
RLS = restless legs syndrome.
Demographic and clinical characteristics
Participants completed items for assessing age, sex, race, height, and weight. Several questions were included to examine RLS-specific clinical characteristics, including previous diagnosis of RLS, age at diagnosis, type of physician to provide diagnosis, bilateral or unilateral symptomology, duration of RLS symptoms, and time of symptom onset on a typical day/night (eg, 2 am). Female participants were also asked if symptoms began during pregnancy and stopped after pregnancy. Participants were further asked questions regarding current RLS-specific treatments, including the responsiveness of symptoms to the treatment as well as treatment type, dosage, timing, and regularity of administration. We further examined the presence of conditions highly associated with RLS, including periodic limb movements, iron-deficiency anemia, renal disease, diabetes, radiculopathy, peripheral edema, and peripheral neuropathy.
Statistical analyses
Quantitative analyses
All quantitative analyses were conducted using Python 3.7.4 in Jupyter Notebook (version 6.0.1) using the statsmodels package (version 0.10.1).24 Descriptive statistics are reported as mean and standard deviation (SD) for continuous variables and number and percentage for dichotomous variables. The perceptions of exercise program necessity, interest, tolerability, and efficacy are presented as the percentage of respondents in each category.
Conceptual analysis of open-ended responses
Conceptual content analysis was applied to open-ended narrative responses, wherein responses are coded within predefined categories (eg, Barriers, Recommend Modifications, and Interest).25,26 Conceptual content analyses were conducted by identifying themes as the initial level of analysis, as opposed to individual words or phrases, and inclusion based on the existence of a theme rather than frequency of mentions. As such, a theme may be mentioned as many times as desired by participants and will still be included in analyses. This inclusion of all reported themes, rather than those with an arbitrary number of mentions, allows for a more thorough and rich description of the participant responses. During initial thematic analysis, content was organized into overarching themes, and then further analyzed for emergence of codes. Data were reread in their entirety after coding, and no new themes or codes emerged. Data were then summarized into a cohesive story for reporting in the present manuscript.
RESULTS
Participant characteristics
The summary of demographic and clinical characteristics for the final sample of participants completing the survey (n = 513) is presented in Table 2. The sample had a mean age of 68 ± 10 years and were primarily White (97%) female (64%), and with an average body mass index of 26.5 ± 5.8 kg/m2. With regard to RLS characteristics, participants reported experiencing RLS symptoms for an average of 30 ± 18 years, with an average RLS severity of 20.0 ± 8.3 (ie, moderate RLS) and a median RLS peak onset time of 19:00 (ie, 7:00 pm). Most participants reported symptoms bilaterally (96%) and symptoms were mostly unrelated to pregnancy (91%). Most participants (91%) were taking medications on a regular basis to manage their symptoms, with 98% reporting that medications either partially or completely relieved symptoms. Interestingly, RLS severity was similar for people on medication (20.0 ± 8.4) compared with people not on medication (19.3 ± 6.8), possibly due to treatment response heterogeneity, different treatment modalities, or issues with augmentation. Only 27% of participants reported a concomitant, secondary condition that could cause secondary RLS (eg, iron-deficiency anemia) or mimic RLS symptoms (eg, peripheral neuropathy), but most participants (63%) reported the presence of periodic limb movements in addition to having RLS.
Table 2.
Summary of demographic and clinical characteristics in the final sample (n = 513).
| Values | |
|---|---|
| Age, mean (SD) [range], y | 68.2 (10.0) [18–89] |
| Sex (female), n (%) | 329 (64%) |
| Race (White), n (%) | 497 (97%) |
| BMI, mean (SD) [range], kg/m2 | 26.5 (5.8) [16.1–53.2] |
| RLS duration, mean (SD) [range], y | 30.0 (18.3) [1.0–81.0] |
| RLS severity, mean (SD) [range] | 20.0 (8.3) [0.0–39.0] |
| No symptoms (IRLS = 0), n (%) | 13 (3%) |
| Mild (IRLS 1–10), n (%) | 55 (11%) |
| Moderate (IRLS 11–20), n (%) | 192 (37%) |
| Severe (IRLS 21–30), n (%) | 207 (40%) |
| Very severe (IRLS > 30), n (%) | 46 (9%) |
| RLS onset time, median (IQR) [range] | 19:00 (15:00–21:00) [1:00–24:00] |
| Bilateral vs unilateral (bilateral), n (%) | 491 (96%) |
| Pregnancy-related (yes), n (%) | 31 (9%) |
| RLS medication use (yes), n (%) | 465 (91%) |
| Nonresponsive to RLS medications, n (%) | 8 (2%) |
| Medication frequency (regularly), n (%) | 440 (95%) |
| Secondary conditions (yes), n (%) | 140 (27%) |
| Presence of PLMs, n (%) | 323 (63%) |
BMI = body mass index, IQR = interquartile range, IRLS = International Restless Legs Syndrome Study Group Scale, PLM = periodic limb movement, RLS = restless legs syndrome, SD = standard deviation.
Perceptions of the value of an exercise program for RLS
The summary of responses for the usefulness of the proposed exercise program for people with RLS is presented in Figure 2. Two-thirds of respondents (n = 343, 67%) indicated that there was a need for an RLS-specific exercise program. Most respondents (n = 330, 64%) indicated that they would be interested in participating in the proposed program and more than half (n = 296, 58%) indicated that they would be somewhat or extremely likely to participate in the proposed program if it was available to them locally. On the other hand, 36% (n = 183) responded that they would not be interested in the proposed program and 32% (n = 165) of respondents indicated that they would be somewhat or extremely unlikely to participate in the program if it was available to them. About half of respondents (n = 286, 56%) indicated that they thought the program would be well tolerated by people with RLS, with 51% (n = 260) indicating that they thought the proposed program would improve symptoms. Only 6% (n = 33) thought the proposed program would not be well tolerated by people with RLS, with only 6% (n = 28) indicating that they thought the proposed program would worsen symptoms.
Figure 2. Summary of responses to quantitative questions regarding the utility of an evidence-based exercise program for people with restless legs syndrome.
Response frequency to questions regarding participant perceptions of need, interest, tolerability, likelihood to participate and program efficacy.
Perceived barriers to participating in the exercise program
Self-reported barriers to participation in the proposed program were organized into 4 main categories: (1) concerns regarding accessibility, (2) personal factors, (3) concerns regarding trustworthiness, and (4) fear of illness, injury, and symptom exacerbation.
Accessibility
In terms of accessibility, participants described financial costs of gym membership, equipment, and personal trainers as potential barriers to participation (quotes 1–3), access to the specific program location (quotes 4, 5), and timing of scheduled exercise sessions (quotes 6, 7).
1. “If there is a fee for working with someone to exercise, I cannot afford it.”
2. “There are financial… barriers that affect the frequency with which I could access this service.”
3. “Who can afford a personal trainer 3 times a week!!!”
4. “Need something close to me—within reasonable driving distance.”
5. “I would like a program I can do at home and without an exercise specialist.”
6. “I’m not sure that I could find time to add more exercise to my schedule.”
7. “I currently work 4 days a week so would have to fit around that.”
Personal factors
An additional barrier to participation described by participants included personal factors such as current program interference (quote 8), preference for different types of activities (quote 9), and personality characteristics hindering engagement (quote 10). Further, instances of inability to exercise, or preference to avoid exercise due to various factors (eg, pain), were described by some participants as a major barrier (quotes 11, 12).
8. “I think my existing exercise program for my whole body is adequate.”
9. “I would rather go to a swimming pool and do water aerobics.”
10. “No interest. Hate lifting weights and know that will not change.”
11. “I am physically unable to do some of these exercises.”
12. “Pain worsens with exercise. Five spine fusions, total hip replacement.… Forget it…. Sorry!”
Trustworthiness
In regard to the emergent theme of trustworthiness, participants described a lack of evidence about the efficacy of exercise for individuals with RLS as a barrier to program participation (quotes 13–16).
13. “I would still need to be convinced by research. My RLS is so severe that I’m not willing to make changes because what I’m doing makes it more manageable.”
14. “If there was scientific evidence that supported a specific program to reduce RLS, I would try it.”
15. “I need data that shows why it would be relevant to me.”
16. “…I would only be interested if there was some unique exercise found to be helpful to RLS patients.”
Fear
The fourth theme that emerged during analysis of the “barriers” data was fear. Some participants expressed fear regarding exposure to illness (particularly, COVID-19 [coronavirus disease 2019]–related illness) (quotes 17, 18) and RLS exacerbation or worsening (quotes 19, 20).
17. “Even though I am vaccinated, including a booster shot, I probably would not be willing to go into an indoor exercise facility that would expose me to others who are also working out….”
18. “I can’t attend the local gym as I’m on immunosuppressants and risk of COVID is high in the gym….”
19. “I’m getting along with my current home grown program and can’t risk making a change—This stuff is ugly.”
20. “It would exacerbate my symptoms.”
Recommended modifications to the exercise program
Participants provided multiple aspects of change to the proposed program for consideration by researchers. These changes are organized below into 4 main categories: (1) additional considerations/modifications for comorbidities, disabilities, age differences, and RLS-specific impairments (eg, inability to sleep/daytime sleepiness) (quotes 21–24); (2) inclusion or exclusion of specific exercise modalities (quotes 25–30); (3) modifications to intensity, frequency, duration, or scheduling of proposed program (quotes 30–32); and (4) individualization of program components (quotes 33–35).
21. “I would like to see this later in the day as I struggle to get up some mornings due to sleeplessness.”
22. “I think it should be age appropriate….I’m 80 so I think my program might be [different] than a young persons.”
23. “Some of us are developing balance issues related to falls.”
24. “Missing the mobility exercises to increase strength at end of range of motion and to increase flexibility.”
25. “I would like to see some stretching as well as light yoga incorporated into an exercise program.”
26. “Stretching seems to help. I would like a regular exercise program that deals with proper stretching techniques.”
27. “I think it would be good to add stretching/yoga, even though research has shown it does not have a significant benefit.”
28. “I would like to know how you feel about water aerobics? I must be careful with my back.”
29. “A specific program for Pilates may be helpful.”
30. “I sort of wonder if maybe not enough strength training, and maybe that should be 3 days/week too?”
31. “There is not nearly enough cardio to be useful. It would not improve your health nearly enough and probably would make me go backwards. I would like at least an hour of cardio or more.”
32. “I would not recommend doing cardio so much. I personally have bad experiences with cardio, as it has worsened my RLS symptoms before.”
33. “… the program needs to be individualized to build up weight or speed SLOWLY.”
34. “Program needs to be designed for the individual’s physical responses. Exercises need to change with body responses. Person needs to be instructed and trained to listen and experiment with body responses.”
35. “I think rather than a fixed program, some thoughtful and educated consultation might be better given the wide range of both motivation and physical abilities of people.”
Specific interest in the exercise program
Participants were thorough in their description of factors influencing interest in participation. Some of the factors influencing their level of interest included RLS-educated providers (quotes 36, 37), desire to reduce need for medications (quotes 38–40) to manage and/or reduce RLS symptoms, and ultimately improve quality of life (quotes 41–42).
36. “[Interested] because it’s designed for RLS.”
37. “[Interested] because I’m assuming it’s designed by a physiologist who understands the mysterious nature of RLS.”
38. “A non-medicinal method to reduce RLS severity is of great interest.”
39. “I just need something other than meds to relieve this irritation.”
40. “Am desperate to try anything which might relieve the symptoms without resorting to more and more scary medication.”
41. “It interests me because I am willing to try anything that can provide relief from the symptoms of RLS.”
42. “I need something as RLS is ruining my life.”
DISCUSSION
This is the first study to include feedback from people with RLS as key stakeholders to optimize and refine an exercise program. Most respondents (67%) expressed a need for an exercise program designed specifically for people who have RLS and 64% of respondents were interested in the program if it was proposed. Interest in the program was primarily driven by (1) the desire to reduce the need for medications, (2) the desire to improve overall quality of life, and (3) the idea that the program was designed by educated/informed RLS providers. However, only 58% of respondents indicated that they would participate in the proposed program if it was available to them, suggesting that there are areas of the exercise program that could be improved to increase program participation and efficacy.
Despite most respondents expressing interest in the exercise program, 32% reported that they would be unlikely to participate even if it was available to them locally and 36% were not interested in the program as proposed. Considering the relatively low completion rates seen in exercise studies17 and the fact that RLS can be aggravated by certain features of exercise, it is important to consider barriers to participation in the development of an exercise program. One emerging barrier was accessibility of the program (ie, cost, location/proximity). Although we did not state that the exercise sessions needed to occur at a specific time of day, a re-occurring barrier that emerged in data analysis was that people would not be able to participate if the sessions occurred at a specific time of day (eg, 8:30 am). Participants also expressed that they would be less likely to participate due to personal factors (ie, current program in place, lack of personal interest, personal preferences, health/chronic condition). These barriers are like those previously reported for older adults without RLS,27–29 including lack of time, potential for injury, physical or mental health, individual preferences, and inconvenience.
Another important concern of participants was fear of exposure to illnesses, notably COVID-19, as well as fear of RLS symptom exacerbations. Despite current evidence for the benefit of exercise for RLS symptoms,10–16,30,31 there are anecdotal reports of certain parameters of exercise (eg, high-intensity) exacerbating symptom of RLS. Respondents stressed that appropriately educated and trained exercise providers who are knowledgeable about the potential for symptom exacerbations with exercise are integral to buy-in from stakeholders. Accordingly, we provide recommendations for exercise specialists to consider when creating and implementing exercise programs for people with RLS (Table 3) based on our results.
Table 3.
Exercise programming considerations for restless legs syndrome.
| Considerations | |
|---|---|
| Multimodal program | Provide multimodal exercise programs (aerobic, anaerobic, and flexibility) based on current exercise guidelines. Stretching should be conducted regularly in addition to as needed during symptomatic episodes. Provide stretching routine focused on major muscle groups of the affected limbs that can be used during symptomatic episodes. |
| Progression | Programs should progress in 3 areas based on the client’s individual response. Each case should be evaluated and once deemed necessary, progression through intensity, volume, and complexity in movements should be implemented. A simple joint-by-joint movement approach (segmenting movements by adding complexity or total joints used to create more diverse movement) is an effective way to progress individuals. Starting with base movement patterns and progressing in frequency and intensity slowly depending on person’s baseline activity levels. Remain at lower intensities than commonly recommended for the first 1–2 weeks and depending on the comfort and response of the client. |
| Program flexibility | Include exercise prescription focused on the interests and needs of the person. Exercise sessions should remain flexible regarding location (eg, more home-based participation) as well as with exercise parameters (ie, frequency, intensity, duration, type, and time of day). |
| Individualization (frequency, intensity, type, duration, and time of day) | Program should be individualized based on person’s physical abilities and should be modified based on individual response to the program. If symptom exacerbations regularly occur with a specific exercise, modify the exercise type, frequency, and/or intensity (eg, decrease intensity and increase frequency). Individualize routines for time-of-day considerations, understanding that some people experience great benefits at specific times of the day whereas others experience symptom exacerbations. |
| Avoid symptom exacerbation | Continuously monitor and assess symptom response to exercise program including RLS symptom severity, sleep quality, daytime sleepiness, and fatigue related to sleep dysfunction. Readjust programming frequency, intensity, and/or duration, as necessary, to avoid symptom exacerbations and improve sleep quality. |
| Maintain expectations | Educate clients of the benefits of long-term exercise to improve RLS and that short-term symptom exacerbations can occur but should not be normal or regular. |
| Comorbid conditions | Consider additional chronic health conditions, disabilities, and/or older age that are common in adults with RLS. |
RLS = restless legs syndrome.
In this study, only 56% of respondents thought the program would be well tolerated by people with RLS and 53% thought it would be likely to improve symptoms of RLS. Another important barrier that emerged in the present study was the lack of evidence about the efficacy of exercise in RLS, whereby additional research is necessary to identify specific exercise prescription parameters that can improve symptoms without increasing the risk for symptom exacerbation in people with RLS. Although a similar program demonstrated overall improvements in RLS with a 41% reduction in symptoms after 12 weeks,10 that study only had a 53% completion rate, collectively suggesting that this program may not work for everyone with RLS. Therefore, there are specific modifications that should be incorporated into the exercise program that may reduce barriers and increase the program’s feasibility and efficacy to engage more people with RLS.
Respondents with RLS recommended several modifications to consider in the design of the exercise program to improve feasibility and mitigate the barriers identified above (Table 3), such as individualization (ie, adapting the program to specific needs of the participant) of exercise parameters, including modified intensity, type of exercises (eg, walking vs water aerobics), duration of exercise sessions, and time of day to complete exercise sessions. Participants further emphasized that modification of exercise parameters should be considered for personal factors, such as concomitant comorbidities, chronic health conditions, disability, and/or older age. RLS-specific factors, such as RLS severity and daytime sleepiness, should also be a consideration for exercise prescription. Participants further suggested that exercise sessions be more flexible with regard to location (ie, more home-based exercise participation). Last, participants strongly suggested the inclusion of flexibility (eg, stretching, yoga, Pilates) and balance exercises for a well-rounded program, especially considering the prominence of fear of falling as a primary barrier to exercise participation in the older adult population.27–29
The present study has important limitations that should be considered when interpreting our results. As we sought to describe perceptions of an exercise program based on personal experiences, all outcomes are subjective in nature, thus increasing risk of recall bias. Selection and confirmation bias should also be considered as most people understand that exercise is good for overall health, and responses may have been tailored to the perceived expectation of researchers. Although we recruited from an RLS-specific organization and we utilized the validated RLS-SFDQ1320 in assessing the presence of RLS, we did not include a physician confirmation of RLS diagnosis. Almost half of participants reported severe RLS notwithstanding the regular use of medications; however, we did not assess for augmentation related to long-term use of dopaminergic medications. Also, the mean age of the study population was older and these factors could impact the characteristics of physical activity participation and the perceived interaction between exercise and RLS. The survey was conducted through Qualtrics using the “Anonymize responses” mode, whereby we did not record respondents’ IP (Internet Protocol) address, location data, or contact information; therefore, we were unable to contact participants for missing data or unclear responses. Last, our cohort was primarily White, limiting the generalizability to people of different racial and ethnic backgrounds who have different prevalence estimates and may experience RLS differently.32,33
This is the first study, to our knowledge, to include people with RLS as key stakeholders in the design of an RLS-specific exercise program. Our results indicated that people with RLS express a need for an RLS-specific exercise program designed by informed RLS providers and that appropriately educated and trained exercise providers who are knowledgeable about RLS are integral to buy-in from stakeholders. Although most respondents expressed interest in the exercise program as is, participants presented several important modifications to consider that could reduce perceived barriers and improve the feasibility of the exercise program. Such results are imperative to increase success of subsequent implementation efforts and will accelerate adoption of any exercise program into practice.
DISCLOSURE STATEMENT
All authors have reviewed and approved this manuscript for submission. Work for this study was performed at the Department of Psychiatry and Behavioral Sciences, Stanford University School of Medicine, Palo Alto, CA. This study was funded, in part, by the National Heart, Lung, and Blood Institute (T32HL110952). The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health. The funding sources were not involved in (1) the study design; (2) data collection, analysis, or interpretation; (2) in writing of the report; or in the decision to submit the article for publication. Data can be made available upon reasonable request by the corresponding author. Drs. Katie Cederberg and E. Morghen Sikes declare that they have no competing interest. Dr. Emmanuel Mignot consults and has received contracts from Jazz Pharmaceuticals, Orexia/Centessa, Takeda, Dreem, and ActiGraph; has received grant/clinical trial funding from Harmony, Takeda, Apple, Humani, Sunovion, Indorsia, and Eisai; is and has been a Principal Investigator on clinical trials using orexin agonists from Takeda and sodium oxybate and Solriamfetol, Jazz Pharmaceutical products, for the treatment of type 1 narcolepsy; all outside the scope of this work.
ACKNOWLEDGMENTS
The authors thank the Restless Legs Syndrome Foundation, the Northern California Restless Legs Syndrome Support Group, and study participants for their contribution to this manuscript.
ABBREVIATIONS
- RLS
restless legs syndrome
- SD
standard deviation
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