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Activity for Diabetic Polyneuropathy (ADAPT): Study Design and Protocol for a 2-Site Randomized Controlled Trial.

ABSTRACT: Background:Half of all patients with diabetes develop diabetic peripheral neuropathy (DPN), a complication leading to reduced mobility and quality of life. Although there are no proven pharmacologic approaches to reduce DPN risk or slow its progression, evidence suggests that physical activity may improve symptoms and enhance peripheral nerve regeneration. Objective:The aim of the study will be to determine the impact of an intense lifestyle intervention on neuropathy progression and quality of life in individuals with DPN. Design:The study will be a randomized controlled trial. Setting:The study will be conducted at 2 academic medical centers. Participants:The participants will be 140 individuals with type 2 diabetes and mild to moderate DPN. Intervention:The intervention group will receive 18 months of supervised exercise training, actigraphy-based counseling to reduce sedentary behavior, and individualized dietary counseling. Control group participants will receive diet and activity counseling at baseline and at 9 months. Measurements:The primary outcomes are neuropathy progression as measured by intraepidermal nerve fiber density in a distal thigh skin biopsy and the Norfolk Quality of Life-Diabetic Neuropathy score. Secondary outcomes include pain, gait, balance, and mobility measures. Limitations:Due to the combined intervention approach, this protocol will not be able to determine which intervention components influence outcomes. There also may be difficulty with participant attrition during the 18-month study intervention. Conclusions:The Activity for Diabetic Polyneuropathy (ADAPT) protocol resulted from a collaboration between physical therapists and neurologist researchers that includes as primary outcomes both a quality-of-life measure (NQOL-DN) and a physiologic biomarker (IENFD). It has the potential to demonstrate that an intensive lifestyle intervention may be a sustainable, clinically effective approach for people with DPN that improves patient outcomes and can have an immediate impact on patient care and future clinical trials.

SUBMITTER: Kluding PM

PROVIDER: S-EPMC6257067 | biostudies-literature | 2017 Jan

REPOSITORIES: biostudies-literature

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Activity for Diabetic Polyneuropathy (ADAPT): Study Design and Protocol for a 2-Site Randomized Controlled Trial.

Kluding Patricia M PM Singleton J Robinson JR Pasnoor Mamatha M Dimachkie Mazen M MM Barohn Richard J RJ Smith A Gordon AG Marcus Robin L RL

Physical therapy 20170101 1

<h4>Background</h4>Half of all patients with diabetes develop diabetic peripheral neuropathy (DPN), a complication leading to reduced mobility and quality of life. Although there are no proven pharmacologic approaches to reduce DPN risk or slow its progression, evidence suggests that physical activity may improve symptoms and enhance peripheral nerve regeneration.<h4>Objective</h4>The aim of the study will be to determine the impact of an intense lifestyle intervention on neuropathy progression ...[more]

PMID: 27417167

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Project description:BackgroundDiabetic peripheral neuropathy (DPN) is the most common complication of type 2 diabetes mellitus (T2DM); its diagnosis and treatment are based on symptomatic improvement. However, as pharmacological therapy causes multiple adverse effects, the implementation of acupunctural techniques, such as electroacupuncture (EA) has been suggested as an alternative treatment. Nonetheless, there is a lack of scientific evidence, and its mechanisms are still unclear. We present the design and methodology of a new clinical randomized trial, that investigates the effectiveness of EA for the treatment of DPN.MethodsThis study is a four-armed, randomized, controlled, multicenter clinical trial (20-week intervention period, plus 12 weeks of follow-up after concluding intervention). A total of 48 T2DM patients with clinical signs and symptoms of DPN; and electrophysiological signs in the Nerve Conduction Study (NCS); will be treated by acupuncture specialists in outpatient units in Mexico City. Patients will be randomized in a 1:1 ratio to one of the following four groups: (a) short fibre DPN with EA, (b) short fibre DPN with sham EA, (c) axonal DPN with EA and (d) axonal DPN with sham EA treatment. The intervention will consist of 32 sessions, 20 min each, per patient over two cycles of intervention of 8 weeks each and a mid-term rest period of 4 weeks. The primary outcome will be NCS parameters, and secondary outcomes will include DPN-related symptoms and pain by Michigan Neuropathy Screening Instrument (MNSI), Michigan Diabetic Neuropathy Score (MDNS), Dolour Neuropatique Score (DN-4), Semmes-Westein monofilament, Numerical Rating Scale (NRS) for pain assessment, and the 36-item Short Form Health Survey (SF-36). To measure quality of life and improve oxidative stress, the inflammatory response; and genetic expression; will be analysed at the beginning and at the end of treatment.DiscussionThis study will be conducted to compare the efficacy of EA versus sham EA combined with conventional diabetic and neuropathic treatments if needed. EA may improve NCS, neuropathic pain and symptoms, oxidative stress, inflammatory response, and genetic expression, and it could be considered a potential coadjutant treatment for the management of DPN with a possible remyelinating effect.Trial registrationClinicalTrials.gov. NCT05521737 Registered on 30 August 2022. International Clinical Trials Registry Platform (ICTRP) ISRCTN97391213 Registered on 26 September 2022 [2b].

Project description:Rationale: Physical exercise is an essential adjunct to the management of patients with type 2 diabetes mellitus. Therapeutic interventions that improve blood flow to peripheral nerves, such as exercise, may slow the progression of neuropathy in the diabetic patient. Aims: This randomized clinical trial was conducted to determine whether a structured program of aerobic, isokinetic strength, or the combination of aerobic-isokinetic strength exercise intervention alters peripheral nerve function in glycemic-controlled diabetic patients with advanced length-dependent distal symmetric polyneuropathy. Methods: Forty-five patients with type 2 diabetes mellitus exhibiting tight glycemic control (HbA1c intergroup range 7.2-8.0%) were randomized by block design across four experimental groups: sedentary controls (n = 12), aerobic exercise (n = 11), isokinetic strength (n = 11), or the combination of aerobic-isokinetic strength training (n = 11). Patients randomized to training groups exercised 3× per week for 12 weeks, whereas patients randomized to the sedentary control group received standard of care. To minimize attention and educational bias, all patients attended a 12-session health promotion educational series. At baseline, immediately following intervention, and again at 12-week post-intervention, detailed nerve conduction studies were conducted as a primary outcome measure. At these same intervals, all patients completed as secondary measures quantitative sensory testing, symptom-limited treadmill stress tests, and a Short-Form 36-Veterans Questionnaire (SF-36V). Results: Of the 45 patients randomized into this study, 37 (82%) had absent sural nerve responses, 19 (42%) had absent median sensory nerve responses, and 17 (38%) had absent ulnar sensory nerve responses. By comparison, responses from tibial nerves were absent in only three (7%) subjects while responses from peroneal nerves were absent in five (11%) subjects. Eleven (92%) of 12 patients that had volunteered to be biopsied exhibited abnormal levels of epidermal nerve fiber densities. Exercise, regardless of type, did not alter sensory or motor nerve electrodiagnostic findings among those patients exhibiting measurable responses (ANOVA). There was, however, a modest (p = 0.01) beneficial effect of exercise on sensory nerve function (Fisher's Exact Test). Importantly, the beneficial effect of exercise on sensory nerve function was enhanced (p = 0.03) during the post-intervention interval. In addition, three of six patients that had undergone exercise intervention exhibited a marked 1.9 ± 0.3-fold improvement in epidermal nerve fiber density. By comparison, none of three sedentary patients whom agreed to be biopsied a second time showed improvement in epidermal nerve fiber density. Compared to baseline values within groups, and compared with sedentary values across groups, neither aerobic, isokinetic strength, or the combination of aerobic-isokinetic strength exercise intervention altered peak oxygen uptake. Patients that underwent aerobic or the combined aerobic-isokinetic strength exercise intervention, however, demonstrated an increase in treadmill test duration that was sustained over the 12-week post-intervention period. Conclusion: A 12-week course of physical exercise, regardless of type, does not alter sensory or motor nerve electrodiagnostic findings. In a subset of patients, a short-term structured program of aerobic exercise may selectively improve sensory nerve fiber function. Large-scale exercise lifestyle intervention trials are warranted to further evaluate the impact of aerobic exercise on sensory nerve fiber function in diabetic neuropathic patients. Clinical Trial Registration: www.ClinicalTrials.gov, identifier NCT00955201.

Project description:BackgroundDiabetic polyneuropathy (DPN) negatively affects foot and ankle function (strength and flexibility), which itself affects the daily physical activity and quality of life of patients. A physical therapy protocol aiming to strengthen the intrinsic and extrinsic foot muscles and increase flexibility may be a promising approach to improve lower-extremity function, prevent further complications, and improve autonomy for daily living activities in these patients. Thus, the inclusion of a specific foot-related exercises focused on the main musculoskeletal impairments may have additional effects to the conventional interventions in the diabetic foot.Methods/designA prospective, parallel-group, outcome-assessor blinded, randomized controlled trial (RCT) will be conducted in 77 patients with DPN who will be randomly allocated to usual care (control arm) or usual care with supervised foot-ankle exercises aiming to increase strengh and flexibility twice a week for 12 weeks and remotely supervised foot-ankle exercises for a year through a web software. Patients will be evaluated 5 times in a 1 year period regarding daily physical activity level, self-selected and fast gait speeds (primary outcomes), foot ulcer incidence, ulcer risk classification, neuropathy testing, passive ankle range of motion, quality of life, foot health and functionality, foot muscle strength, plantar pressure, and foot-ankle kinematics and kinetics during gait.DiscussionThis study aims to assess the effect of a foot-ankle strength and flexibility program on a wide range of musculoskeletal, activity-related, biomechanical, and clinical outcomes in DPN patients. We intend to demonstrate evidence that the year-long training program is effective in increasing gait speed and daily physical activity level and in improving quality of life; foot strength, functionality, and mobility; and biomechanics while walking. The results will be published as soon as they are available.Trial registrationThis study has been registered at ClinicalTrials.gov as NCT02790931 (June 6, 2016) under the name "Effects of foot muscle strengthening in daily activity in diabetic neuropathic patients".

Project description:BackgroundThere are a growing number of mHealth tools for breast cancer patients but a lack of scientific evidence for their effects. Recent studies have shown a mix of positive and negative impacts on users. Here we will assess the impact of OWise Breast Cancer, a mobile application for self-monitoring symptoms and managing care, on the process of self-management.MethodsThis randomized controlled trial with early stage breast cancer patients will assess the effect of OWise use on patient activation at 3 months from diagnosis measured by the PAM-13 questionnaire. We will also assess differences in changes in health-related quality of life, psychological distress, health status, and National Health Service (NHS) health resource utilization over the first year from diagnosis. Participants will be randomly allocated (1:1) to standard care or standard care plus OWise. Participants will complete questionnaires before starting anti-cancer treatment and at 3, 6, and 12 months from diagnosis. Clinical and patient-reported outcome data will be linked to health resource utilization data from Discover, an integrated care record of primary, secondary, and social care in North West London. We will measure contamination in the control group and adjust the sample size to mitigate the dilution of effect estimates. A per-protocol analysis will be conducted as a sensitivity analysis to assess robustness of the primary results.DiscussionThis study aims to generate evidence for the effectiveness of OWise at improving patient activation for women with early-stage breast cancer. The results will show the impact of using the tool at the patient level and the NHS health system level. The outcomes of the study will have implications for the application of OWise across the NHS for breast cancer patients and expansion into other tumor types. Assessing publicly available mHealth tools poses a challenge to trialists due to the risk of contamination. Here we apply various methods to measure, mitigate, and assess the effects of contamination.Trial registrationThe study was registered at clincaltrials.gov (NCT03866655) on 7 March 2019.

Project description:To evaluate the efficacy and safety of 18 months of tafamidis treatment in patients with early-stage V30M transthyretin familial amyloid polyneuropathy (TTR-FAP).In this randomized, double-blind trial, patients received tafamidis 20 mg QD or placebo. Coprimary endpoints were the Neuropathy Impairment Score-Lower Limbs (NIS-LL) responder analysis (<2-point worsening) and treatment-group difference in the mean change from baseline in Norfolk Quality of Life-Diabetic Neuropathy total score (TQOL) in the intent-to-treat (ITT) population (n = 125). These endpoints were also evaluated in the efficacy-evaluable (EE; n = 87) population. Secondary endpoints, including changes in neurologic function, nutritional status, and TTR stabilization, were analyzed in the ITT population.There was a higher-than-anticipated liver transplantation dropout rate. No differences were observed between the tafamidis and placebo groups for the coprimary endpoints, NIS-LL responder analysis (45.3% vs 29.5% responders; p = 0.068) and change in TQOL (2.0 vs 7.2; p = 0.116) in the ITT population. In the EE population, significantly more tafamidis patients than placebo patients were NIS-LL responders (60.0% vs 38.1%; p = 0.041), and tafamidis patients had better-preserved TQOL (0.1 vs 8.9; p = 0.045). Significant differences in most secondary endpoints favored tafamidis. TTR was stabilized in 98% of tafamidis and 0% of placebo patients (p < 0.0001). Adverse events were similar between groups.Although the coprimary endpoints were not met in the ITT population, tafamidis was associated with no trend toward more NIS-LL responders and a significant reduction in worsening of most neurologic variables, supporting the hypothesis that preventing TTR dissociation can delay peripheral neurologic impairment.This study provides Class II evidence that 20 mg tafamidis QD was associated with no difference in clinical progression in patients with TTR-FAP, as measured by the NIS-LL and the Norfolk QOL-DN score. Secondary outcomes demonstrated a significant delay in peripheral neurologic impairment with tafamidis, which was well tolerated over 18 months.

Project description:BackgroundRetarded task-oriented gait, balance performance and increased fall risk are among the most debilitating problems in patients with diabetic polyneuropathy (DPN). The lower body positive pressure (LBPP) training was recently introduced in the field of rehabilitation, but evaluating the effects of the LBPP on gait, balance and fall risk in patients with DPN has not been thoroughly investigated.AimThe aim of this study was to evaluate the effect of LBPP treadmill training program on task-oriented gait, balance performance and fall risk in patients with DPN.DesignSingle-blinded, randomized-controlled trial.SettingRehabilitative outpatient unit.PopulationSixty-two patients with DPN were randomly assigned into 5-groups; group-A (100% weight-bearing; N.=12), group-B (75% weight-bearing; N.=13), group-C (50% weight-bearing; N.=13), group-D (25% weight-bearing; N.=12) and group-E (control group; N.=12).MethodsThe intervention groups (A, B, C, D) received moderate intensity aerobic exercise training (AET) program (30-45 minutes, 50-70% heart rate reserve) on the AlterG (AlterG, Inc., Fremont, CA, USA) treadmill for 12-weeks. Task-oriented gait, balance performance and the fall risk were evaluated at baseline (evaluation-1), after 12-weeks (evaluation-2) and 12-weeks poststudy cessation (evaluation-3; follow-up) for all groups using the Tinetti balance assessment tool.ResultsAt evaluation-2, there were significant "within-groups" increases in the balance, gait and fall risk scores. There were significant "between-groups" differences in the same evaluated variables, with the highest increases were in group-B (P<0.05). At evaluation-3, there was a decline in the mean values of the evaluated variables, but still significant increases in the mean values of balance, gait and fall risk compared to the baseline mean values. There were significant "between-groups" differences in all variables, with the highest increases were in group-B (P<0.05).ConclusionsModerate intensity LBPP treadmill training program can effectively improve task-oriented gait, balance performance, and fall risk scores in patients with DPN. The 25% off-loading weight percentage during the LBPP treadmill training program yielded the most favorable short and long-term improvements compared to the other weight off-loading percentages in patients with DPN.Clinical rehabilitation impactThe LBPP aerobic training program is an effective rehabilitation procedure in patients with DPN especially when utilizing the 25% off-loading weight percentage during the LBPP treadmill training program.

Project description:Background and motivationThe effectiveness of using acupuncture to treat migraine is rarely and even suspectedly reported in the literature. In this article, we report the design and the protocol of a randomized controlled large-scale trial to treat migraine using acupuncture, aiming at testifying it is effective to use acupuncture to treat migraine. We demonstrate also that the effectiveness of the treatment may vary due to using acupoints of different meridians or different acupoints of one meridian.Methods and designA multi-center randomized controlled trial is currently undergoing, with three acupoints treatment groups and one non-acupoints control group. The acupuncture treatment consists of 20 sessions per patient with a observation period of 20 weeks. In total, 480 patients with migraine are registered in this study within 8 hospitals in China from March 2008 to June 2009. These patients are randomly assigned to receive one of the following four acupoints treatment groups, i.e. 1) specific acupoints of Shaoyang meridians (120 patients), 2) non-specific acupoints of Shaoyang meridians (120 patients), 3) acupoints of other meridians (120 patients); or 4) non-acupoints control group (120 patients). The main outcome measurement in this trial is the effect comparison achieved among these four groups in terms of number of days with migraine and intensity of migraine during and after the baseline phase, i.e. the first 4 weeks before randomization and 4, 8 and 16 weeks after randomization. The intensity of headache including headache intensity grade (0-3) and visual analogue scale (VAS) score will also be used in this study. In addition, the differences of Migraine-Specific Quality-of-Life Questionnaire (MSQ) and Transcranial Doppler Sonography (TCD) before and after randomization are also used as the secondary outcome measurement.DiscussionThe result of this trial (which will be available in 2009) will demonstrate the efficacy of using acupuncture to treat migraine, and verify whether the specific effect of acupoints exists and whether this specific effect of acupoints is related to meridian and a collection of meridian Qi.Trials registrationClinical Trials.gov NCT00599586.

Dataset Information

Activity for Diabetic Polyneuropathy (ADAPT): Study Design and Protocol for a 2-Site Randomized Controlled Trial.

Publications

Activity for Diabetic Polyneuropathy (ADAPT): Study Design and Protocol for a 2-Site Randomized Controlled Trial.

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