Multicenter randomized clinical trial of supervised exercise therapy with or without feedback versus walking advice for intermittent claudication

ObjectiveThe initial treatment for intermittent claudication is supervised exercise therapy (SET). Owing to limited capacity and patient transports costs of clinic-based SET, a concept of SET provided by local physiotherapists was developed. We hypothesized that provision of daily feedback with an accelerometer in addition to SET would further increase walking distance.MethodsThis multicenter randomized trial was set in vascular surgery outpatient clinics and included 304 patients with intermittent claudication. Patients were randomized to exercise therapy in the form of “go home and walk” advice (WA), SET, or SET with feedback. Local physiotherapists provided SET. The primary outcome measure was the change in absolute claudication distance. Secondary outcomes were the change in functional claudication distance and results on the Walking Impairment Questionnaire (WIQ) and Short-Form 36 (SF-36) Health Survey after 12 months.ResultsIn 11 centers, 102, 109, and 93 patients were included, respectively, in the WA, SET, and SET with feedback groups, and data for 83, 93, and 76, respectively, could be analyzed. The median (interquartile range) change in walking distance between 12 months and baseline in meters was 110 (0-300) in the WA group, 310 (145-995) in the SET group, and 360 (173-697) in the SET with feedback group (P < .001 WA vs SET). WIQ scores and relevant domains of the SF-36 improved statistically significantly in the SET groups.ConclusionsSET is more effective than WA in improving walking distance, WIQ scores, and quality of life for patients with intermittent claudication. Additional feedback with an accelerometer did not result in further improvement. SET programs should be made available for all patients with intermittent claudication

Extending the Range of Treadmill Testing for Patients with Intermittent Claudication

NICOLAI, S. P. A., P. LEFFERS, L. M. KRUIDENIER, R. A. DE BIE, M. H. PRINS, and J. A. W. TEIJINK. Extending the Range of Treadmill Testing for Patients with Intermittent Claudication. Med. Sci. Sports Exerc., Vol. 42, No. 4, pp. 640-645, 2010. Purpose: There is a need to evaluate patients with peripheral arterial disease (PAD) with a limited or extended walking distance. We aimed to enable an estimation of walking distance as measured on a frequently used "standard" graded (3.2 km.h(-1), 2% increase per 2 min) protocol for walking distances measured on protocols with a lower or higher workload. Methods: Patients with PAD and an absolute claudication distance (ACD) o

Ginkgo biloba for intermittent claudication

Background People with intermittent claudication (IC) suffer from pain in the muscles of the leg occurring during exercise which is relieved by a short period of rest. Symptomatic relief can be achieved by (supervised) exercise therapy and pharmacological treatments. Ginkgo biloba is a vasoactive agent and is used to treat IC. Objectives To assess the effect of Ginkgo biloba on walking distance in people with intermittent claudication. Search methods For this update the Cochrane Peripheral Vascular Diseases Group Trials Search Co-ordinator searched the Specialised Register (March 2013) and CENTRAL (2013, Issue 2). Selection criteria Randomised controlled trials of Ginkgo biloba extract, irrespective of dosage, versus placebo in people with IC. Data collection and analysis Two authors independently assessed trials for selection, assessed study quality and extracted data. We extracted number of patients, mean walking distances or times and standard deviations. To standardise walking distance or time, caloric expenditures were used to express the difference between the different treadmill protocols, which were calculated from the speed and incline of the treadmill. Main results Fourteen trials with a total of 739 participants were included. Eleven trials involving 477 participants compared Ginkgo biloba with placebo and assessed the absolute claudication distance (ACD). Following treatment with Ginkgo biloba at the end of the study the ACD increased with an overall effect size of 3.57 kilocalories (confidence interval (CI) -0.10 to 7.23, P = 0.06), compared with placebo. This translates to an increase of just 64.5 (CI -1.8 to 130.7) metres on a flat treadmill with an average speed of 3.2 km/h. Publication bias leading to missing data or "negative" trials is likely to have inflated the effect size. Authors' conclusions Overall, there is no evidence that Ginkgo biloba has a clinically significant benefit for patients with peripheral arterial disease

Ginkgo biloba for intermittent claudication

Background People with intermittent claudication (IC) suffer from pain in the muscles of the leg occurring during exercise which is relieved by a short period of rest. Symptomatic relief can be achieved by (supervised) exercise therapy and pharmacological treatments. Ginkgo biloba is a vasoactive agent and is used to treat IC. Objectives To assess the effect of Ginkgo biloba on walking distance in people with intermittent claudication. Search methods For this update the Cochrane Peripheral Vascular Diseases Group Trials Search Co-ordinator searched the Specialised Register (March 2013) and CENTRAL (2013, Issue 2). Selection criteria Randomised controlled trials of Ginkgo biloba extract, irrespective of dosage, versus placebo in people with IC. Data collection and analysis Two authors independently assessed trials for selection, assessed study quality and extracted data. We extracted number of patients, mean walking distances or times and standard deviations. To standardise walking distance or time, caloric expenditures were used to express the difference between the different treadmill protocols, which were calculated from the speed and incline of the treadmill. Main results Fourteen trials with a total of 739 participants were included. Eleven trials involving 477 participants compared Ginkgo biloba with placebo and assessed the absolute claudication distance (ACD). Following treatment with Ginkgo biloba at the end of the study the ACD increased with an overall effect size of 3.57 kilocalories (confidence interval (CI) -0.10 to 7.23, P = 0.06), compared with placebo. This translates to an increase of just 64.5 (CI -1.8 to 130.7) metres on a flat treadmill with an average speed of 3.2 km/h. Publication bias leading to missing data or "negative" trials is likely to have inflated the effect size. Authors' conclusions Overall, there is no evidence that Ginkgo biloba has a clinically significant benefit for patients with peripheral arterial disease

Identifying the Need to Discuss Infertility Concerns Affecting Testicular Cancer Patients: An Evaluation (INDICATE Study)

Men with testicular cancer (TC) risk impaired fertility. Fertility is a major concern for TC patients due to diagnosis in almost always reproductive ages and high overall survival. This study assessed counselling in regards to the risk of impaired fertility and sperm cryopreservation. A cross-sectional survey was performed on 566 TC patients diagnosed between 1995–2015. Of the 566 survivors, 201 questionnaires were completed (35.5%). Eighty-eight percent was informed about possible impaired fertility, 9.5% was not informed. The majority (47.3%) preferred the urologist to provide information. Collecting sperm was troublesome but successful for 25.6%, 4.8% did not succeed in collecting sperm. The reasons were high pressure due to disease, pain after surgery and uncomfortable setting. Due to impaired fertility, 19% of the respondents reported grief and 9.3% stated as being less satisfied in life. Sperm cryopreservation was performed by 41.3% (n = 83). One third (n = 63, 31.3%) had children after treatment, of which 11.1% made use of preserved sperm (n = 7). The results of this survey indicate the importance of timely discussion of fertility issues with TC patients. While being discussed with most men, dissatisfaction and grief may occur as a result of impaired fertility and a lack of counselling. Overall, 6.5% made use of cryopreserved sperm (n = 13). Men prefer their urologist providing counselling on fertility

Identifying the Need to Discuss Infertility Concerns Affecting Testicular Cancer Patients: An Evaluation (INDICATE Study)

Men with testicular cancer (TC) risk impaired fertility. Fertility is a major concern for TC patients due to diagnosis in almost always reproductive ages and high overall survival. This study assessed counselling in regards to the risk of impaired fertility and sperm cryopreservation. A cross-sectional survey was performed on 566 TC patients diagnosed between 1995–2015. Of the 566 survivors, 201 questionnaires were completed (35.5%). Eighty-eight percent was informed about possible impaired fertility, 9.5% was not informed. The majority (47.3%) preferred the urologist to provide information. Collecting sperm was troublesome but successful for 25.6%, 4.8% did not succeed in collecting sperm. The reasons were high pressure due to disease, pain after surgery and uncomfortable setting. Due to impaired fertility, 19% of the respondents reported grief and 9.3% stated as being less satisfied in life. Sperm cryopreservation was performed by 41.3% (n = 83). One third (n = 63, 31.3%) had children after treatment, of which 11.1% made use of preserved sperm (n = 7). The results of this survey indicate the importance of timely discussion of fertility issues with TC patients. While being discussed with most men, dissatisfaction and grief may occur as a result of impaired fertility and a lack of counselling. Overall, 6.5% made use of cryopreserved sperm (n = 13). Men prefer their urologist providing counselling on fertility