ABSTRACT
Background: Guidelines recommend walking trainings for peripheral arterial disease (PAD) management. Supervised walking training is superior to walking advise to improve the walking distance. Telehealth service with nurse support may close this gap. Patients and methods: This study introduces a telehealth service, "Keep pace!", which has been developed for patients with symptomatic PAD (Fontaine stage IIa and IIb), enabling a structured home-based walking training while monitoring progress via an app collecting unblinded account of steps and walking distance in self-paced 6-minute-walking-tests by geolocation tracking to enhance intrinsic motivation. Supervision by nurses via telephone calls was provided for 8 weeks, followed by 4 weeks of independent walking training. Patient satisfaction, walking distance and health-related quality of life were assessed. Results: 19 patients completed the study. The analysis revealed an overall high satisfaction with the telehealth service (95.4%), including system quality (95.1%), information quality (94.4%), service quality (95.6%), intention to use (92.8%), general satisfaction with the program (98.4%) and health benefits (95.8%). 78.9% asserted that the telehealth service lacking nurse calls would be less efficacious. Pain-free walking distance (76.3±36.8m to 188.4±81.2m, +112.2%, p<0.001) as well as total distance in 6-minute-walking test (308.8±82.6m to 425.9±107.1m, +117.2%, p<0.001) improved significantly. The telehealth service significantly reduced discomfort by better pain control (+15.5%, p=0.015) and social participation (+10.5%, p=0.042). Conclusions: In conclusion, patients were highly satisfied with the telehealth service. The physical well-being of the PAD patients improved significantly post vs. prior the telehealth program.
ABSTRACT
BACKGROUND: Auricular nerve stimulation has been proven effective in different diseases. We investigated if a conservative therapeutic alternative for claudication in peripheral arterial occlusive disease (PAD) via electroacupuncture of the outer ear can be established. PATIENTS AND METHODS: In this prospective, double-blinded trial an ear acupuncture using an electroacupuncture device was carried out in 40 PAD patients in Fontaine stage IIb. Twenty patients were randomized to the verum group using a fully functional electroacupuncture device, the other 20 patients received a sham device (control group). Per patient, eight cycles (1 cycle = 1 week) of electroacupuncture were performed. The primary endpoint was defined as a significantly more frequent doubling of the absolute walking distance after eight cycles in the verum group compared to controls in a standardized treadmill testing. Secondary endpoints were a significant improvement of the total score of the Walking Impairment Questionnaire (WIQ) as well as improvements in health related quality of life using the Short Form 36 Health Survey (SF-36). RESULTS: There were no differences in baseline characteristics between the two groups. The initial walking distance significantly increased in both groups (verum group [means]: 182 [95 % CI 128-236] meters to 345 [95 % CI 227-463] meters [+ 90 %], p < 0.01; control group [means]: 159 [95 % CI 109-210] meters to 268 [95 % CI 182-366] meters [+ 69 %], p = 0.01). Twelve patients (60 %) in the verum group and five patients (25 %) in controls reached the primary endpoint of doubling walking distance (p = 0.05). The total score of WIQ significantly improved in the verum group (+ 22 %, p = 0.01) but not in controls (+ 8 %, p = 0.56). SF-36 showed significantly improvements in six out of eight categories in the verum group and only in one of eight in controls. CONCLUSIONS: Electroacupuncture of the outer ear seems to be an easy-to-use therapeutic option in an age of increasingly invasive and mechanically complex treatments for PAD patients.
