Effectiveness, safety, and cost-utility of a knee brace in medial knee osteoarthritis: the ERGONOMIE randomized controlled trial.

OBJECTIVE: This pragmatic, multicenter, open-label, randomized controlled trial (RCT) aimed to compare the effectiveness, safety, and cost-utility of a custom-made knee brace versus usual care over 1 year in medial knee osteoarthritis (OA). DESIGN: 120 patients with medial knee OA (VAS pain at rest >40/100), classified as Kellgren-Lawrence grade II-IV, were randomized into two groups: ODRA plus usual care (ODRA group) and usual care alone (UCA group). The primary effectiveness outcome was the change in VAS pain between M0 and M12. Secondary outcomes included changes over 1 year in KOOS (function) and OAKHQOL (quality of life) scores. Drug consumption, compliance, safety of the knee brace, and cost-utility over 1 year were also assessed. RESULTS: The ODRA group was associated with a higher improvement in: VAS pain (adjusted mean difference of -11.8; 95% CI: -21.1 to -2.5); all KOOS subscales (pain: +8.8; 95% CI: 1.4-16.2); other symptoms (+10.4; 95% CI: 2.7-18); function in activities of daily living (+9.2; 95% CI: 1.1-17.2); function in sports and leisure (+12.3; 95% CI: 4.3-20.3); quality of life (+9.9; 95% CI: 0.9-15.9), OAKHQOL subscales (pain: +14.8; 95% CI: 5.0-24.6); and physical activities (+8.2; 95% CI: 0.6-15.8), and with a significant decrease in analgesics consumption at M12 compared with the UCA group. Despite localized side-effects, observance was good at M12 (median: 5.3 h/day). The ODRA group had a more than 85% chance of being cost-effective for a willingness-to-pay threshold of €45 000 per QALY. CONCLUSIONS: The ERGONOMIE RCT demonstrated significant clinical benefits of an unloader custom-made knee brace in terms of improvements in pain, function, and some aspects of quality of life over 1 year in medial knee OA, as well as its potential cost-utility from a societal perspective.

The effects of mirror therapy on pain and motor control of phantom limb in amputees: A systematic review.

BACKGROUND AND OBJECTIVE: Phantom limb pain (PLP) is a major problem after limb amputation. Mirror therapy (MT) is a non-pharmacological treatment using representations of movement, the efficacy of which in reducing PLP remains to be clarified. Here, we present the first systematic review on MT efficacy in PLP and phantom limb movement (PLM) in amputees (lower or upper limb). METHODS: A search on Medline, Cochrane Database and Embase, crossing the keywords "Phantom Limb" and "Mirror Therapy" found studies which were read and analyzed according the PRISMA statement. RESULTS: Twenty studies were selected, 12 on the subject of MT and PLP, 3 on MT and PLM, 5 on MT and both (PLP and PLM). Among these 20 studies, 5 were randomized controlled trials (163 patients), 6 prospective studies (55 patients), 9 case studies (40 patients) and methodologies were heterogeneous. Seventeen of the 18 studies reported the efficacy of MT on PLP, but with low levels of evidence. One randomized controlled trial did not show any significant effect of MT. As to the effect of MT on PLM, the 8 studies concerned reported effectiveness of MT: 4 with a low level of evidence and 4 with a high level of evidence. An alternative to visual illusion seems to be tactile or auditory stimulation. CONCLUSION: We cannot recommend MT as a first intention treatment in PLP. The level of evidence is insufficient. Further research is needed to assess the effect of MT on pain, prosthesis use, and body representation, and to standardize protocols.

Clinical effectiveness and safety of a distraction-rotation knee brace for medial knee osteoarthritis.

OBJECTIVE: Evaluation of the clinical effectiveness and safety of a new custom-made valgus knee brace (OdrA) in medial knee osteoarthritis (OA) in terms of pain and secondary symptoms. METHODS: Open-label prospective study of patients with symptomatic medial knee OA with clinical evaluation at 6 and 52 weeks (W6, W52). We systematically assessed pain on a visual analog scale (VAS), Knee injury and Osteoarthritis Outcome Score (KOOS), spatio-temporal gait variables, use of nonsteroidal anti-inflammatory drugs (NSAIDs) and analgesic-sparing effects of the brace and tolerance. Mean scores were compared at baseline, W6 and W52 and the effect size (ES) and 95% confidence intervals (95% CIs) were calculated. RESULTS: We included 20 patients with knee OA (mean age 64.2±10.2 years, mean body mass index 27.2±5.4 kg/m2). VAS pain and KOOS were improved at W6 and W52: pain (ES=0.9 at 1 year), amelioration of other symptoms (ES=0.4), and function in activities of daily living (ES=1.1), sports and leisure (ES=1.5), quality of life (ES=0.9) and gait speed (ES=0.41). In total, 76% of patients showed clinical improvement at 1 year. Analgesic and NSAIDs consumption was significantly decreased at W6 and W52. One serious adverse effect noted was lower-limb varices, and observance was deemed satisfactory at 1 year. CONCLUSION: This new unloader brace appeared to have good effect on medial knee OA, with an acceptable safety profile and good patient compliance.

Are first ventilatory threshold and 6-minute walk test heart rate interchangeable? A pilot study in healthy elderlies and cardiac patients.

BACKGROUND: Heart rate (HR) at the ventilatory threshold (VT) is often used to prescribe exercise intensity in cardiac rehabilitation. Some studies have reported no significant difference between HR at VT and HR measured at the end of a 6-min walk test (6-MWT) in cardiac patients. The aim of this work was to assess the potential equivalence between those parameters at the individual level. METHOD: Three groups of subjects performed a stress test and a 6-MWT: 22 healthy elderlies (GES, 77 ± 3.7 years), 10 stable coronary artery disease (CAD) patients (GMI, 50.9 ± 4.2 years) and 30 patients with chronic heart failure (GHF, 63.3 ± 10 years). We analyzed the correlation, mean bias, 95% confidence interval (95% CI) of the mean bias and the magnitude of the bias between 6-MWT-HR and VT-HR. RESULTS: There was a significant difference between 6-MWT and VT-HR in GHF (99.1 ± 8.8 vs 91.6 ± 18.6 bpm, P=0.016) but not in GES and GMI. The correlation between those 2 parameters was high for GMI (r=0.78, P<0.05), and moderate for GES and GHF (r=0.48 and 0.55, respectively, P<0.05). The 95% CI of bias was large (>30%) in GES and GHF and acceptable in GMI (8-12%). CONCLUSION: 6-MWT-HR and VT-HR do not appear interchangeable at the individual level in healthy elderlies and CHF patients. In CAD patients, further larger studies and/or the development of other walk tests could help in confirming the interest of a training prescription based on walking performance, after an exhaustive study of their cardiometabolic requirements.

Walking tests during the exercise training: specific use for the cardiac rehabilitation.

Walk tests, principally the six-minute walk test (6mWT), constitute a safe, useful submaximal tool for exercise tolerance testing in cardiac rehabilitation (CR). The 6mWT result reflects functional status, walking autonomy and efficacy of CR on walking endurance, which is more pronounced in patients with low functional capacity (heart failure - cardiac surgery). The 6mWT result is a strong predictor of mortality. However, clinically significant changes and reliability are still subject to debate - probably because of the ambiguity in terms of the target speed (either comfortable or brisk walking). Of the other time-based walk tests, the 2-minute-walk test is the only one applicable during CR, reserved for patients with severe disabilities by its psychometric properties. Fixed-distance tests (principally the 200m fast walk test) and incremental shuttle walking, tests explore higher levels of effort and may represent a safe and inexpensive alternative to laboratory-based tests during CR. These walking tests may be useful for personalizing prescription of training programs. However, the minimum clinically significant difference has not yet been determined. Lastly, walking tests appear to be potential useful tools in promoting physical activity and behavioural changes at home. Thus, validation of other walk tests with better psychometric properties will be necessary.

Eccentric training in chronic heart failure: feasibility and functional effects. Results of a comparative study.

OBJECTIVES: To evaluate, in chronic heart failure (CHF) patients, feasibility, safety, compliance and functional improvements of an eccentric (ECC) cycle training protocol personalized by the rate of perceived exertion (RPE; 9-11 Borg Scale), compared to concentric (CON) training at workload corresponding to the first ventilatory threshold. METHODS: Thirty patients were randomly allocated to ECC or CON training (20 sessions). Compliance was evaluated with RPE, visual analog scale for muscle soreness and monitoring of heart rate (HR). Functional parameters were measured by the distance walked and the VO(2) uptake during the 6-minute walk test (6MWT) before and after training. RESULTS: Two patients were excluded due to adverse effects in each group. RPE was 9-11 in ECC training while it reached 12-14 in CON training. HR remained stable in ECC group during exercise whereas it increased during CON exercise. 6MWT distance improved in both group (ECC: +53 m; CON: +33 m). 6MWT VO(2) uptake remained stable in ECC group whereas it increased in CON group. CONCLUSION: ECC training tailored by RPE appears to be an efficient and safe alternative for CHF patients. Indeed, it induces functional improvement similar to conventional CON training with lower demand on the cardiovascular system during exercise.

Effects of a home-based rehabilitation program in obese type 2 diabetics.

OBJECTIVE: To assess, in obese type 2 diabetics (T2D), the impact of a home-based effort training program and the barriers to physical activity (PA) practice. METHOD: Twenty-three obese T2D patients (52.7 ± 8.2 years, BMI = 38.5 ± 7.6 kg/m(2)) were randomized to either a control group (CG), or an intervention group (IG) performing home-based cyclergometer training during 3 months, 30 min/day, with a monthly-supervised session. The initial and final measurements included: maximal graded effort test on cyclergometer, 6-minute walk test (6MWT) and 200-meter fast walk test (200mFWT), quadriceps maximal isometric strength, blood tests and quality of life assessment (SF- 36). A long-term assessment of the amount of physical activity (PA) and the barriers to PA practice was conducted using a questionnaire by phone call. RESULTS: Patients in the CG significantly improved the maximal power developed at the peak of the cyclergometer effort test (P < 0.05) as well as the quadriceps strength (P < 0.01). There were no significant changes in the other physical and biological parameters, neither in quality of life. At a mean distance of 17 ± 6.4 months, the PA score remained low in the two groups. The main barriers to PA practice identified in both groups were the perception of a low exercise capacity and a poor tolerance to effort, lack of motivation, and the existence of pain associated to PA. CONCLUSION: This home-based intervention had a positive impact on biometrics and physical ability in the short term in obese T2D patients, but limited effects in the long term. The questionnaires completed at a distance suggest considering educational strategies to increase the motivation and compliance of these patients.

Therapeutic education in cardiovascular diseases: state of the art and perspectives.

OBJECTIVE: To assess the impact of therapeutic education programmes for Coronary Artery Disease (CAD) and Chronic Heart Failure (CHF), as well as patients' expectations and education needs, tips to improve adherence to lifestyle modifications, and education materials. METHOD: We conducted a systematic review of the literature from 1966 to 2010 on Medline and the Cochrane Library databases using following key words: "counselling", "self-care", "self-management", "patient education" and "chronic heart failure", "CAD", "coronary heart disease", "myocardial infarction", "acute coronary syndrome". Clinical trials and randomized clinical trials, as well as literature reviews and practical guidelines, published in English and French were analysed. RESULTS: Therapeutic patient education (TPE) is part of the non-pharmacological management of cardiovascular diseases, allowing patients to move from an acute event to the effective self-management of a chronic disease. Large studies clearly showed the efficacy of TPE programmes in changing cardiac patients' lifestyle. Favourable effects have been proved concerning morbidity and cost-effectiveness even though there is less evidence for mortality reduction. Numerous types of intervention have been studied, but there are no recommendations about standardized rules and methods to deliver information and education, or to evaluate the results of TPE. The main limit of TPE is the lack of results for adherence to long-term lifestyle modifications. CONCLUSION: The efficacy of TE in cardiovascular diseases could be improved by optimal collaboration between acute cardiac units and cardiac rehabilitation units. The use of standardized rules and methods to deliver information and education and to assess their effects could reinforce this collaboration. Networks for medical and paramedical TPE follow-up in tertiary prevention could be organized to improve long-term results.

Evaluation of medical students' expectations for multimedia teaching materials: Illustration by an original method using the evaluation of a web site on cardiovascular rehabilitation.

INTRODUCTION: Different multimedia tools have been developed to help medical students prepare for the National Ranking Examination (NRE), rendering their choice quite difficult. No study has specifically evaluated students' expectations regarding these materials. OBJECTIVES: To learn how medical students in Dijon assessed a website dedicated to cardiovascular rehabilitation, and collecting their suggestions in order to meet their expectations and the goals of second cycle medical studies. METHODS: Eighteen second-cyle students were evaluated in a semi-directed manner and in ecological situation, a website specifically designed for the national curricula on cardiovascular rehabilitation for obtaining the Diploma of Specialty Studies (DES) for physical medicine and rehabilitation (PM&R) residents. Students also had to fill out a pretest and a posttest (5 MCQs). RESULTS: The overall quality of the site was deemed satisfactory (65.6 ± 7.7 points/100). Medical information was considered better than non-medical data and site's design (respectively 84.8 ± 8.1, 61.1 ± 20 and 64.4 ± 14.9/100). Students found the site useful in terms of understanding the items related to cardiovascular rehabilitation, although they judged it not completely in line with the NRE goals. The average score increased significantly between the pre-and post-test (6.8 ± 0.8 vs. 5 ± 1.5/8, p<0.05). CONCLUSION: This site appears to be significantly useful for short-term knowledge improvement, but only partially meeting the expectations of second-cycle students. It seems relevant to study further possibilities for customizing and providing summarized learning for the NRE. These elements could serve as building grounds for the future version of this website.

Reproducibility, validity and responsiveness of the 200-metre fast walk test in patients undergoing cardiac rehabilitation.

OBJECTIVE: To investigate the reliability, validity and responsiveness of the 200-metre fast walk test in patients with coronary artery disease engaged in a cardiac rehabilitation programme. DESIGN: Descriptive study. SETTING: Tertiary care hospital. SUBJECTS: Thirty stable patients with coronary artery disease (51.9 ± 8.7 years), referred to the cardiac rehabilitation department after an acute coronary syndrome. INTERVENTION: Not applicable. MAIN MEASURES: Six-minute walk test distance, time to perform the 200-m fast walk test, peak power output of the graded maximal exercise test, before and after the programme; SF-36 quality of life questionnaire at baseline. Walk tests were performed twice at baseline to assess reliability. RESULTS: The 200-m fast walk test was highly reliable (ICC = 0.97). It was significantly correlated with the graded maximal exercise test peak power and the 6-minute walk test at baseline (r = -0.417; P < 0.05; and r = -0.566; P < 0.01, respectively) and after the training programme (r = -0.460, P < 0.05; and r = -0.926; P < 0.01, respectively). At baseline, there was a strong correlation between the 200-m fast walk test time and the physical component score of the SF-36 (r = -0.77; P < 0.01), but not between the 200-m fast walk test time and the SF-36 mental component score. Mean 200-m fast walk test time was significantly different between the patients performing ≤90 W (n = 11) or ≥100 W (n = 19) at the baseline graded maximal exercise test (121.7 ± 13.6 vs. 115.5 ± 10.1 seconds; P < 0.05). The responsiveness was strong with a standardized response mean at 1.11. CONCLUSION: The 200-m fast walk test is a reliable, valid and responsive high-intensity walk test in patients with coronary artery disease after an acute coronary syndrome. It can thus give additional information to that given by the 6-minute walk test and the graded maximal exercise test.

Rehabilitation in patients with peripheral arterial disease.

Rehabilitation is a recommended first-line therapy for patients with peripheral arterial disease (PAD) and consists of supervised exercise training and therapeutic education. Proved benefits are significant: improve pain-free walking distance, functional status and quality of life; reduce cardiovascular risk factors and mortality. At least three sessions weekly are recommended during 3 months. Exercise conditioning (global training and lower limb resistance training) is tailored by the preliminary evaluation of walking ability (free walking test, treadmill tests, 6-min walk test) and of the cardiac tolerance (maximal effort tests). Then the exercise workload is progressively improved. The four main goals of therapeutic education are: smoking cessation, prolonged physical activity, Mediterranean diet and observing pharmacological therapies. The limited compliance of the patients with PAD is often an obstacle for educational needs. The chronic patients with important functional limitations and unchecked risk factors will be preferentially enrolled in such programs. When a revascularization is discussed, rehabilitation can serve as trial treatment. Despite its efficacy, rehabilitation is still underutilized in clinical practice and should be promoted.

Usefulness of the 6-minute walk test and the 200-metre fast walk test to individualize high intensity interval and continuous exercise training in coronary artery disease patients after acute coronary syndrome: a pilot controlled clinical study.

OBJECTIVE: To study the effects of three individualized exercise training prescriptions using either a percentage of maximal heart rate (HR), maximal 6-minute walk test (6MWT) HR, or maximal 200-metre fast walk test (200-mFWT) HR, on walking performance and exercise capacity in coronary artery disease (CAD) patients. DESIGN: Controlled clinical study. PARTICIPANTS: Twenty-seven outpatients enrolled in a rehabilitation programme after an acute coronary syndrome. SETTING: Cardiac rehabilitation unit. INTERVENTIONS: Three groups: (A): moderate intensity continuous exercise (MICE) at 70% of the maximal HR of the graded maximal exercise test (n = 10); (B): MICE at the maximal 6MWT HR (n = 8); (C): high intensity interval training (HIIT) based on the 6MWT and the 200-mFWT maximal HR (n = 9). Group B and C performed walk tests every 2 weeks, to readjust training HR (THR) if needed. MEASURES: 6MWT and 200-mFWT performances, peak VO(2) and peak power (Pmax). RESULTS: 6MWT and 200-mFWT performances improved significantly and similarly in all groups (P < 0.05). Peak VO(2) improved significantly in all groups (P < 0.05), this improvement being higher in group C (HIIT) versus A (P < 0.05). Group B was closer to the recommended THR during exercise sessions compared to group A. CONCLUSION: This pilot study showed that using the 6MWT and 200-mFWT HR to individualize MICE or HIIT prescription is feasible in CAD patients, and could lead them closer to THR objective, to similar improvements in walking performance, and greater peak VO(2) increase for HIIT. Future randomised studies should investigate long-term effects of programmes prescribed from walk tests HR, especially for HIIT modality.

Does eccentric endurance training improve walking capacity in patients with coronary artery disease? A randomized controlled pilot study.

OBJECTIVE: To examine the effect of eccentric endurance training on exercise capacities in patients with coronary artery disease. DESIGN: Randomized parallel group controlled study. SETTING: Cardiac rehabilitation unit, Dijon University Hospital. PARTICIPANTS: Fourteen patients with stable coronary artery disease after percutaneous coronary intervention. INTERVENTION: Patients followed 15 sessions of training (1 session per day, 3 days a week), either in the concentric group, following a standard programme, or in the eccentric group, performing eccentric resistance exercises using both lower limbs on a specifically designed ergometer. MAIN OUTCOMES MEASURED: Symptom-limited Vo2, peak workload, isometric strength of leg extensor and ankle plantar flexors, distance covered during the 6-minute walk test and time to perform the 200-m fast walk test in both groups, before and after the training period. RESULTS: Patients did not report any adverse effects and were highly compliant. All measured parameters improved in eccentric and concentric group, except for 200-m fast walk test: symptom-limited Vo2 (+14.2% versus +4.6%), peak workload (+30.8% versus +19.3%), 6-minute walk test distance walked (+12.6% versus +10.1%) and leg extensor strength (+7% versus +13%) improved to a similar degree in both groups (P < 0.01); ankle plantar flexor strength improved in both groups with a significantly greater increase in the eccentric group (+17% versus +7%, P < 0.05). CONCLUSION: Patients with stable coronary artery disease can safely engage in eccentric endurance training, which appears to be as efficient as usual concentric training, with reduced oxygen consumption.

The 200-m fast-walk test compared with the 6-min walk test and the maximal cardiopulmonary test: a pilot study.

OBJECTIVE: The 200-m fast-walk test has been proposed as a high- intensity performance test in healthy, elderly subjects. Adaptation of low-risk coronary artery disease patients during this test were compared with those in a 6-min walk test and a maximal cardiopulmonary exercise test. DESIGN: Thirty patients with stable coronary artery disease (51.9 +/- 8.7 yrs), referred to the cardiac rehabilitation department, performed a cardiopulmonary exercise test, then a 200-m fast-walk test and a 6-min walk test in a random order, before and after the training period (6 wks, 3 days per week). Heart rate was monitored during each test. Peak workload of cardiopulmonary exercise test, distance walked on the 6-min walk test, and time to perform the 200-m fast-walk test were measured. A subsample of ten patients performed the exercise test with gas exchange measurements, with ventilatory threshold determination. RESULTS: All subjects completed walk tests without complaint or incidents. Compared with the cardiopulmonary exercise test, the cardiac relative intensity was higher during the 200-m fast-walk test than during the 6-min walk test, both before (89.6% vs. 78.1% of cardiopulmonary exercise test maximal heart rate; P < 0.05) and after (83.8% vs. 74.3%; P < 0.05) training. Among the subsample of ten patients, the 200-m fast-walk test heart rate was significantly higher than the ventilatory threshold heart rate, which did not differ from the 6-min walk test heart rate. The 200-m fast-walk test time significantly decreased after training (-9.1%, P < 0.01). CONCLUSION: In patients with coronary artery disease at low risk, the 200-m fast-walk test explores higher levels of cardiorespiratory capacity than the 6-min walk test. Thus, this could be a useful field test in complement to the cardiopulmonary exercise test to assess functional capacity improvement and update training targets regularly during the course of high-intensity rehabilitation programs in this population.