Comparison of home-based rehabilitation and a centre-based exercise in terms of functional capacity, muscle oxygenation and quality of life in people with peripheral arterial disease: a protocol for a randomised controlled trial.

INTRODUCTION: Peripheral arterial disease (PAD) is increasingly prevalent, and supervised physical exercise programmes are recommended as the first-line treatment. However, these programmes are underused. Alternative delivery models may be able to expand treatment coverage. The objective of this study was to compare a home-based exercise programme (HBEP) and a centre-based exercise (CBE) in terms of their effects on functional capacity, peripheral muscle oxygenation and quality of life in individuals with PAD. METHODS AND ANALYSIS: This single-blind, parallel randomised clinical trial will consist of two groups: HBEP and CBE. A qualitative analysis will be carried out to investigate acceptability and satisfaction. The primary outcome will be functional capacity, assessed by the incremental shuttle walk test. Secondary outcomes will include functional capacity, assessed by a treadmill walking test; peripheral muscle oxygenation and quality of life; and self-reported functional impairment, risk factors, morbidity, level of physical activity, adherence, acceptability and satisfaction. The intervention protocols will consist of 12 weeks of intermittent walking until claudication symptoms, three times a week. Participants randomly assigned to the CBE group will participate in supervised face-to-face sessions. The HBEP group will perform exercises at home with remote supervision, monitored by a pedometer and heart rate monitor, and subjective perception of effort during each session will be recorded by participants in a training diary; follow-up will be conducted by telephone calls. Statistical analyses will follow the intention-to-treat principle. Participants allocated to the HBEP group will be interviewed about their experience of remote treatment using a qualitative approach. ETHICS AND DISSEMINATION: Ethics approval was obtained from the Ethics Committee of the Universidade Federal de Minas Gerais. The results will be disseminated in a peer-reviewed journal and presented at international congresses. This research has the potential to improve the care of people with PAD because if home-based rehabilitation demonstrates effectiveness, it could be considered an alternative or support resource to the usual centre-based treatment models, expanding access, coverage and participation in vascular physiotherapy TRIAL REGISTRATION: https://ensaiosclinicos.gov.br/rg/RBR-97vy9n7 on 14 April 2022.

Evaluation of functional capacity and muscle metabolism in individuals with peripheral arterial disease with and without diabetes.

OBJECTIVE: Peripheral arterial disease (PAD) is characterized by intermittent claudication, which interferes with walking and leads to worsening of functional capacity. This mechanism has not been clearly defined in PAD. Thus, the aim of our study was to identify the muscular metabolism and vascular function variables using near-infrared spectroscopy (NIRS) and their possible associations with functional capacity in individuals with PAD and secondly to verify the differences in these variables between persons with PAD and diabetes mellitus (DM) and those with PAD without DM. METHODS: A total of 39 participants with intermittent claudication were enrolled, 14 of whom had DM. They were assessed for functional capacity by the total distance covered in the treadmill test with the speed and grade constant and for muscle function and metabolism using near-infrared spectroscopy at rest and during the treadmill test. The Spearman correlation coefficient was computed to assess the presence of an association between the variables, and multiple linear regression analysis was performed, considering the total test distance as the dependent variable. The assessment between groups was performed using the independent t test or Mann-Whitney U test. RESULTS: The near-infrared spectroscopy variables related to tissue oxygen saturation in the test recovery phase were correlated with the functional performance during the treadmill test. Thus, those with a longer or slower recovery time and those with greater tissue deoxygenation had walked a shorter distance. A significant difference (P = .049) was noted between those with PAD stratified by DM in the reoxygenation time required for an occlusion. CONCLUSIONS: These findings reinforce the hypothesis that peripheral factors related to vascular function and muscular metabolism can affect the walking capacity of persons with PAD and that microvascular dysfunction is more prevalent among those with PAD and DM.

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.

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).

Effects of physical exercise on plasma levels of brain-derived neurotrophic factor and depressive symptoms in elderly women--a randomized clinical trial.

OBJECTIVES: To investigate the effect of 2 standardized exercise programs, muscle strength exercises (SE) and aerobic exercises (AE), on the plasma levels of brain-derived neurotrophic factor (BDNF) and depressive symptoms in 451 elderly women. DESIGN: A randomized controlled trial. SETTING: Belo Horizonte/MG-Brazil. PARTICIPANTS: Community-dwelling older women (N=451; age, 65-89y). INTERVENTION: The participants were divided into 2 groups: SE and AE. Both protocols lasted 10 weeks, and 30 sessions (1-h sessions) in total were performed 3 times a week under the direct supervision of physical therapists. MAIN OUTCOME MEASURES: Plasma levels of BDNF (enzyme-linked immunosorbent assay) and depressive symptoms (Geriatric Depression Scale). RESULTS: There was a significant difference for BDNF plasma levels between the SE and AE groups (P=.009). Post hoc analysis revealed a pre-post intervention difference in BDNF levels only for the SE group (P=.008). A statistically significant difference was found for the pre- and postintervention Geriatric Depression Scale scores in both groups (P=.001), showing that the effects of both exercise protocols were comparable regarding depressive symptoms (P=.185). CONCLUSIONS: The present findings have demonstrated the positive effect of muscle strengthening and aerobic intervention on depressive symptoms in community-dwelling elderly women. Interestingly, only SE significantly increased the plasma levels of BDNF in our sample. The positive effects of physical exercise on depressive symptoms in the elderly were not mediated by BDNF.