Testing the effectiveness of a self-efficacy based exercise intervention for inactive people with type 2 diabetes mellitus: design of a controlled clinical trial

<p>Abstract</p> <p>Background</p> <p>Sufficient exercise is important for people with Type 2 Diabetes Mellitus (T2DM), as it can prevent future health problems. Despite, it is estimated that only 30-40% of people with T2DM are sufficiently active. One of the psychosocial constructs that is believed to influence physical activity behaviour, is exercise self-efficacy. The goal of this study is to evaluate a patient-tailored exercise intervention for people with T2DM that takes exercise self-efficacy into account.</p> <p>Methods/Design</p> <p>This study is conducted as a non-randomized controlled clinical trial. Patients are eligible when they are diagnosed with T2DM, exercise less than advised in the ADA guideline of 150 min/week of moderate-intensity aerobic physical activity, have an BMI >25 and are between 18 and 80 years old. Recruitment takes place at a Primary care organization of general practitioners and practice nurses in the south of the Netherlands.</p> <p>Participants are allocated to three groups: An <it>advice intervention</it> -for participants with a high exercise self-efficacy score- in which participants receive a patient-tailored exercise intervention, an <it>intensive intervention</it> -for participants with a low exercise self-efficacy score- in which participants receive a patient-tailored exercise intervention accomplished by a group based intervention, and a <it>control group</it> in which participants receive regular Dutch diabetes care. The primary outcome measure of this study is physical activity. Secondary outcome measures are health status, (symptoms of) depression, exercise self-efficacy, Body Mass Index (BMI), blood pressure and glycemic control.</p> <p>Discussion</p> <p>We aimed to design an intervention that can be implemented in Primary care, but also to design an easy accessible program. This study is innovative as it is -to our best knowledge- the first study that takes level of exercise self-efficacy of people with T2DM into account by means of giving extra support to those with the lowest exercise self-efficacy. If the program succeeds in increasing the amount of physical activity it can be implemented in regular primary care.</p> <p>Trial registration</p> <p>Dutch Trial Register NTR2734</p

All-arthroscopic versus mini-open repair of small or moderate-sized rotator cuff tears: A protocol for a randomized trial [NCT00128076]

BACKGROUND: Rotator cuff tears are the most common source of shoulder pain and disability. Only poor quality studies have compared mini-open to arthroscopic repair, leaving surgeons with inadequate evidence to support optimal, minimally-invasive repair. METHODS/DESIGN: This randomized, multi-centre, national trial will determine whether an arthroscopic or mini-open repair provides better quality of life for patients with small or moderate-sized rotator cuff tears. A national consensus meeting of investigators in the Joint Orthopaedic Initiative for National Trials of the Shoulder (JOINTS Canada) identified this question as the top priority for shoulder surgeons across Canada. The primary outcome measure is a valid quality-of-life scale (Western Ontario Rotator Cuff (WORC)) that addresses 5 domains of health affected by rotator cuff disease. Secondary outcomes will assess rotator cuff functionality (ROM, strength, Constant score), secondary dimensions of health (general health status (SF-12) and work limitations), and repair integrity (MRI). Outcomes are measured at baseline, at 6 weeks, 3, 6, 12, and 24 months post-operatively by blinded research assistants and musculoskeletal radiologists. Patients (n = 250) with small or medium-sized cuff tears identified by clinical examination and MRI who meet eligibility criteria will be recruited. This sample size will provide 80% power to statistically detect a clinically important difference of 20% in WORC scores between procedures after controlling for baseline WORC score (α = 0.05). A central methods centre will manage randomization, data management, and monitoring under supervision of experienced epidemiologists. Surgeons will participate in either conventional or expertise-based designs according to defined criteria to avoid biases from differential surgeon expertise. Mini-open or all-arthroscopic repair procedures will be performed according to a standardized protocol. Central Adjudication (of cases), Trial Oversight and Safety Committees will monitor trial conduct. We will use an analysis of covariance (ANCOVA), where the baseline WORC score is used as a covariate, to compare the quality of life (WORC score) at 2 years post-operatively. As a secondary analysis, we will conduct the same statistical test but will include age and tear size as covariates with the baseline score. Enrollment will require 2 years and follow-up an additional 2 years. The trial will commence when funding is in place. DISCUSSION: These results will have immediate impact on the practice behaviors of practicing surgeons and surgical trainees at JOINTS centres across Canada. JOINTS Canada is actively engaged in knowledge exchange and will publish and present findings internationally to facilitate wider application. This trial will establish definitive evidence on this question at an international level

Predictors of adherence to a physical activity counseling intervention delivered by exercise physiologists: secondary analysis of the NewCOACH trial data

Natalie A Johnson,1&ndash;4 Ben Ewald,1&ndash;4 Ronald C Plotnikoff,3 Fiona G Stacey,1&ndash;4 Wendy J Brown,5 Mark Jones,1,4 Elizabeth G Holliday,1,4 Erica L James1&ndash;4 1School of Medicine and Public Health, Faculty of Health and Medicine, University of Newcastle, Callaghan, NSW, Australia; 2Priority Research Centre in Health Behaviour, University of Newcastle, NSW, Australia; 3Priority Research Centre in Physical Activity and Nutrition, University of Newcastle, NSW, Australia; 4Hunter Medical Research Institute, New Lambton Heights, NSW, Australia; 5Centre for Research on Exercise, Physical Activity and Health, School of Human Movement and Nutrition Sciences, The University of Queensland, Brisbane, QLD, Australia Background: General practitioners (GPs) cite time as a barrier to physical activity counseling. An alternative for time-poor GPs in Australia is the referral of insufficiently active patients to exercise physiologists (EPs). As data on the predictors of adherence to physical activity counseling interventions are limited, this study aimed to identify the sociodemographic, medical, health, and psychological characteristics of insufficiently active primary care patients who adhered to a physical activity counseling intervention delivered by EPs. Methods: This secondary analysis of data from the NewCOACH randomized trial used logistic regression to identify predictors of adherence, defined as patient participation in at least four of the five physical activity counseling sessions. EPs provided information about the number of sessions, while other potential predictors were obtained from the self-administered baseline questionnaire and medical summary sheets provided by the GPs. Results: Of the 132 patients referred to an EP, 102 (77%) were adherent: 91 (69%) and eleven (8.3%) participated in all, or all but one, of the sessions, respectively. Of the remainder, seven (5.3%) patients participated in three sessions, seven (5.3%) participated in two sessions, five (3.8%) participated in one session, and eleven (8.3%) did not participate in any session. The odds of being adherent were 5.84 (95% CI 1.46&ndash;23.4, P&le;0.05) times higher among retired participants than in those who were not in paid employment. The odds of being adherent 1) increased as the positive outcome expectation score increased (OR 1.89, 95% CI 1.12&ndash;3.18, P&le;0.05) and 2) decreased as the duration (days) between referral and the initial counseling session increased (OR 0.95, 95% CI 0.92&ndash;0.98, P&lt;0.01). Conclusion: More than three quarters of the patients participated in all, or all but one, of the sessions. Being retired, positive outcome expectations, and having a shorter wait between referral and the initial appointment predicted adherence. Keywords: insufficiently active, adherence, predictors, primary care, exercise physiologist, patient

Convergent Validity of the Constant-Murley Outcome Measure in Patients with Rotator Cuff Disease

Purpose: Despite the popularity of the Constant-Murley score (CMS), a combined patient-report and objective (health professional administered) shoulder outcome measure, minimal information exists on its reliability or validity. The purpose of this study was to examine (1) internal consistency and convergent validity of the CMS and (2) the degree to which other shoulder measures explain variation in range of motion and strength components of the CMS

Engineering online and in-person social networks to sustain physical activity: application of a conceptual model

BACKGROUND: High rates of physical inactivity compromise the health status of populations globally. Social networks have been shown to influence physical activity (PA), but little is known about how best to engineer social networks to sustain PA. To improve procedures for building networks that shape PA as a normative behavior, there is a need for more specific hypotheses about how social variables influence PA. There is also a need to integrate concepts from network science with ecological concepts that often guide the design of in-person and electronically-mediated interventions. Therefore, this paper: (1) proposes a conceptual model that integrates principles from network science and ecology across in-person and electronically-mediated intervention modes; and (2) illustrates the application of this model to the design and evaluation of a social network intervention for PA. METHODS/DESIGN: A conceptual model for engineering social networks was developed based on a scoping literature review of modifiable social influences on PA. The model guided the design of a cluster randomized controlled trial in which 308 sedentary adults were randomly assigned to three groups: WalkLink+: prompted and provided feedback on participants’ online and in-person social-network interactions to expand networks for PA, plus provided evidence-based online walking program and weekly walking tips; WalkLink: evidence-based online walking program and weekly tips only; Minimal Treatment Control: weekly tips only. The effects of these treatment conditions were assessed at baseline, post-program, and 6-month follow-up. The primary outcome was accelerometer-measured PA. Secondary outcomes included objectively-measured aerobic fitness, body mass index, waist circumference, blood pressure, and neighborhood walkability; and self-reported measures of the physical environment, social network environment, and social network interactions. The differential effects of the three treatment conditions on primary and secondary outcomes will be analyzed using general linear modeling (GLM), or generalized linear modeling if the assumptions for GLM cannot be met. DISCUSSION: Results will contribute to greater understanding of how to conceptualize and implement social networks to support long-term PA. Establishing social networks for PA across multiple life settings could contribute to cultural norms that sustain active living. TRIAL REGISTRATION: ClinicalTrials.gov NCT0114280