Challenges in recruitment and adherence to a randomized clinical trial in Brazil on the effects of transcutaneous nervous electrical stimulation on individuals with peripheral arterial disease: A feasibility study
| Autor: | Plinio dos Santos Ramos, Bruno Rabite Dornelas, Ana Paula Ferreira, Djalma Rabelo Ricardo, Danielle Aparecida Gomes Pereira, Ana Flávia Ferreira |
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| Rok vydání: | 2020 |
| Předmět: |
Male
medicine.medical_specialty Referral Walking 030204 cardiovascular system & hematology Transcutaneous electrical nerve stimulation law.invention 03 medical and health sciences Peripheral Arterial Disease 0302 clinical medicine Randomized controlled trial Double-Blind Method law Heart Rate medicine Aerobic exercise Humans Prospective Studies 030504 nursing business.industry Patient Selection Cardiorespiratory fitness Intermittent Claudication Middle Aged Intermittent claudication Work release Exercise Therapy Clinical trial Medical–Surgical Nursing Physical therapy Transcutaneous Electric Nerve Stimulation Feasibility Studies Patient Compliance Female medicine.symptom 0305 other medical science business Brazil |
| Zdroj: | Journal of vascular nursing : official publication of the Society for Peripheral Vascular Nursing. 38(4) |
| ISSN: | 1532-6578 |
| Popis: | Objective Describe the feasibility, barriers during the recruitment and intervention period, recruitment rate (success and efficiency), and the level of participation and adherence in the randomized clinical trial to verify the effects of transcutaneous electrical nerve stimulation (TENS) for the symptoms of intermittent claudication (IC) and its repercussions on functional capacity, cardiorespiratory fitness and cardiovascular autonomic function in individuals with sta II Fontaine classification, residing in Brazil. Design Prospective, double-blind, randomized clinical trial. Setting Level secondary. Participants A total of 63 participants were screened, of which 12.6% were included. Eight individuals with peripheral arterial disease (PAD) and IC underwent a protocol that lasted 8 weeks. Interventions. The experimental group received 45 minutes TENS 10 Hz, followed by 30 minutes of aerobic exercise, and the control group received a placebo TENS also followed by 30 minutes of exercise. Incremental walking test, gait impairment questionnaire, treadmill test, heart rate variability, and 4-second test were applied, considering adherence, success, and efficiency. Results The most efficient recruitment sources were as follows: 1) referral by physician and 2) referral by a physiotherapist. Out of 63 participants, 8 (12.6%) were included in the clinical trial. Participants were excluded due to the following reasons: not meeting the criteria (41 participants (65%)), locomotion (6 participants (9.5%)), transportation (5 participants (7.9%)), work release (1 participant (1.6%)), and interest (2 participants (3.2%)). The overall participation was 99 participants (51.6%) in a total of 192 sessions offered. Conclusion It was not possible to succeed in recruitment and adherence rates. The results of this clinical trial reinforce that PAD is neglected, and strategies including a multidisciplinary approach with the effective participation of nursing, physiotherapy, medicine, and nutrition professionals, are necessary to optimize care for individuals with PAD need to be strengthened. Brazilian Registry of Clinical Trials (RBR-8RTZFN). |
| Databáze: | OpenAIRE |
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