Satisfaction and Acceptability of Telemonitored Home-Based Exercise in Patients With Intermittent Claudication: Pragmatic Observational Pilot Study

Abstract

Background Current guidelines recommend supervised exercise training (SET) as a first-line treatment in patients with intermittent claudication (IC). SET has been shown to be more effective than home-based exercise therapy (HBET). However, the lack of available SET programs hampers broad SET implementation in clinical practice. Objective The aim of this study is to assess patient satisfaction and acceptability of a structured HBET program using wearable technology and elastic band resistance exercises. Methods A total of 20 patients with IC (Rutherford 1-3) with internet access and currently not engaged in structured exercise training were recruited in a pragmatic observational pilot study. Participants were instructed to complete 3 walking sessions and 2 elastic band resistance exercise sessions per week in their home environment during a 4-week period. Patient satisfaction and acceptability were assessed using a 5-point Likert scale questionnaire (1-2=very unsatisfied, 3=neutral, and 4-5=very satisfied) evaluating the materials and intervention content. Secondary outcomes were evaluated at baseline and at completion of the 4-week intervention and included maximal walking distance (MWD) and pain-free walking distance (PFWD), physical fitness, and patient-reported outcomes on quality of life, walking capacity, levels of kinesiophobia, and self-efficacy. Statistically significant changes were tested using paired t tests or Wilcoxon signed-rank tests. Results All patients (15 men, 5 women; mean age 64.6, SD 10.6 years; range 41-81 years) completed the 4-week intervention and were highly satisfied with the program (mean overall score 4.5, SD 0.5). Patients’ questionnaire responses documented willingness to recommend the exercise program to other patients (mean 4.5, SD 0.5; median 4.5) and preference for continuing the intervention (mean 4.3, SD 0.5; median 4). Furthermore, participants endorsed the use of the sports watches to track walking sessions (mean 4.25, SD 0.6; median 4), felt safe (mean 4.4, SD 0.6; median 4), and appreciated personal feedback (mean 4.55, SD 0.5; median 5) and flexibility of training (mean 4.1, SD 0.7; median 4). Resistance training was not preferred over walking training (mean 2.65, SD 0.8; median 3). In addition, PFWD (+89 m; P=.001), MWD (+58 m; P=.03), Walking Impairment Questionnaire distance score (+0.18; P=.01), activity-related scores (+0.54; P<.001), and total quality of life (+0.36; P=.009) improved following the intervention. Other patient-related outcomes, physical fitness, and physical activity remained to be statistically unaltered. Conclusions Patients with IC were satisfied and accepted technology to monitor and guide HBET, with observed short-term effectiveness regarding walking capacity and quality of life. However, elastic band resistance exercises as a part of HBET were not preferred over progressive walking. Trial Registration ClinicalTrials.gov NCT04043546; https://clinicaltrials.gov/ct2/show/NCT04043546

Safety of home-based exercise for people with intermittent claudication: A systematic review

“…Exercise programmes in all the included studies consisted of walking, with one utilising music to guide participants, 34 one using walking poles, 33 and one using resistance band exercises in addition to walking. 35 The description of exercise location was varied, including at home, an unsupervised setting, in the community, a self-chosen environment, an outdoor track, or was not specifically stated. Exercise intensity was generally prescribed via claudication pain.…”

“… 26 , 28 , 32 , 33 , 42 – 45 , 47 Nine studies included exercise to moderate pain levels. 27 , 29 , 30 , 35 – 38 , 40 , 41 Two studies did not provide a clear description of the degree of claudication pain 22 , 34 and two did not report this information. 31 , 48 …”

“… 22 , 23 , 25 , 26 , 28 , 31 – 33 , 36 , 39 , 41 – 43 , 46 The remaining 13 studies reported no events. 24 , 27 , 29 , 30 , 34 , 35 , 37 , 38 , 40 , 44 , 45 , 47 , 48 Four related adverse events occurred in total (three cardiac and one noncardiac in origin) resulting in a total all-cause event rate of one event per 36,953 patient-hours ( Table 2 ). The total cardiac and noncardiac event rates were one per 49,270 and one per 147,810 patient-hours, respectively ( Table 2 ).…”

“…32 Five studies raised some concerns over the possibility of measurement of the outcome being influenced by knowledge of group allocation, as they required judgements from participants aware of their intervention. 32 , 35 , 41 , 43 , 47 Three studies were deemed at high risk of bias due to selective reporting, with two missing questionnaire data 22 , 23 and one not reporting all time points for treadmill data. 41 One study was deemed at high risk of bias due to unclear group definition, 44 and another raised some concerns as groups were created retrospectively.…”

“…Twelve of the included studies were randomised controlled trials, [22][23][24][25][26][27][28][29][30][31][32][33] and the remaining 15 were nonrandomised. [34][35][36][37][38][39][40][41][42][43][44][45][46][47][48] The included studies comprised a total of 2351 participants, 1642 of whom received a home-based intervention, representing a total of 147,810 patient-hours.…”