scholarly journals Cross-sectoral rehabilitation intervention for patients with intermittent claudication versus usual care for patients in non-operative management - The CIPIC Rehab study: study protocol for a randomised controlled trial

2019 ◽  
Author(s):  
Maj Siercke ◽  
Lise Pyndt Jørgensen ◽  
Malene Missel ◽  
Lau Caspar Thygesen ◽  
Pernille Peppercorn Blach ◽  
...  
Keyword(s):  
Cardiac Rehabilitation ◽  
Usual Care ◽  
Intermittent Claudication ◽  
Mixed Method ◽  
Operative Management ◽  
Treadmill Walking ◽  
Rehabilitation Programme ◽  
Walking Distance ◽  
Walking Test ◽  
Non Operative Management

Abstract Introduction: Intermittent claudication (IC) caused by Peripheral Artery Disease (PAD) is a common cardiovascular disease. Patients with IC have reduced walking capacity, restricted activity levels and mobility, and reduced health-related quality of life. The disease leads to social isolation, the risk of cardiovascular morbidity, and mortality. Non-operative management of IC requires exercise therapy and studies show that supervised exercise training is more effective than unsupervised training, yet many patients with IC lack motivation for changes in health behavior. No studies investigating the effects of existing cardiac rehabilitation targeted patients with IC have been published. The aim of this paper is to present the rationale and design of the CIPIC Rehab Study, which examines the effect of a cross-sectoral rehabilitation programme versus usual care for patients in non-operative management for IC. Methods and analysis: A randomised clinical trial aims to investigate whether cardiac rehabilitation for patients with IC in non-operative management versus usual care is superior to treatment as usual. The trial will allocate 118 patients, 1:1 individual randomisation to either the intervention or control group. The primary outcome is maximal walking distance measured by the standardised treadmill walking test. The secondary outcome is pain-free walking distance measured by the standardised treadmill walking test, healthy diet measured by a fat-fish-fruit-green score, and level of physical activity measured by activity score within official recommendations. Statistical analyses will be blinded. Several exploratory analyses will be performed. A mixed-method design is used to evaluate qualitative and quantitative findings. A qualitative and a survey-based complementary study will be undertaken to investigate patients’ post-discharge experiences. A qualitative post-intervention study will explore experiences of participation in rehabilitation. Discussion: The study is the first to assess the effect of a cardiac rehabilitation programme designed for patients with intermittent claudication. The study will describe how to monitor and improve rehabilitations programme for patients with intermittent claudication in a real-world setting. Mixed method strategies can allow for both exploration and generalization in the same study, but the research design is a complex intervention and any effects found can not be awarded a specific component.

scholarly journals Cross-sectoral rehabilitation intervention for patients with intermittent claudication versus usual care for patients in non-operative management.   - The CIPIC Rehab study: study protocol for a randomised controlled trial

2019 ◽  
Author(s):  
Maj Siercke ◽  
Lise Pyndt Jørgensen ◽  
Malene Missel ◽  
Lau Caspar Thygesen ◽  
Pernille Peppercorn Blach ◽  
...  
Keyword(s):  
Cardiac Rehabilitation ◽  
Usual Care ◽  
Intermittent Claudication ◽  
Mixed Method ◽  
Operative Management ◽  
Treadmill Walking ◽  
Rehabilitation Programme ◽  
Walking Distance ◽  
Walking Test ◽  
Non Operative Management

Abstract Introduction: Intermittent claudication (IC) caused by Peripheral Artery Disease (PAD) is a common cardiovascular disease. Patients with IC have reduced walking capacity, restricted activity levels and mobility, and reduced health-related quality of life. The disease leads to social isolation, the risk of cardiovascular morbidity, and mortality. Non-operative management of IC requires exercise therapy and studies show that supervised exercise training is more effective than unsupervised training, yet many patients with IC lack motivation for changes in health behavior. No studies investigating the effects of existing cardiac rehabilitation targeted patients with IC have been published. The aim of this paper is to present the rationale and design of the CIPIC Rehab Study, which examines the effect of a cross-sectoral rehabilitation programme versus usual care for patients in non-operative management for IC. Methods and analysis: A randomised clinical trial aims to investigate whether cardiac rehabilitation for patients with IC in non-operative management versus usual care is superior to treatment as usual. The trial will allocate 118 patients, 1:1 individual randomisation to either the intervention or control group. The primary outcome is maximal walking distance measured by the standardised treadmill walking test. The secondary outcome is pain-free walking distance measured by the standardised treadmill walking test, healthy diet measured by a fat-fish-fruit-green score, and level of physical activity measured by activity score within official recommendations. Statistical analyses will be blinded. Several exploratory analyses will be performed. A mixed-method design is used to evaluate qualitative and quantitative findings. A qualitative and a survey-based complementary study will be undertaken to investigate patients’ post-discharge experiences. A qualitative post-intervention study will explore experiences of participation in rehabilitation. Discussion: The study is the first to assess the effect of a cardiac rehabilitation programme designed for patients with intermittent claudication. The study will describe how to monitor and improve rehabilitations programme for patients with intermittent claudication in a real-world setting. Mixed method strategies can allow for both exploration and generalization in the same study, but the research design is a complex intervention and any effects found can not be awarded a specific component.

scholarly journals Improving Rehabilitation for Patients with Intermittent Claudication: A Randomized Controlled Trial with a Mixed-Methods Evaluation (The CIPIC Rehab Study)

2021 ◽  
Author(s):  
Maj Siercke ◽  
Sanne Pagh Moller ◽  
Lau Caspar Thygesen ◽  
Henrik Sillesen ◽  
Dorthe Overgaard
Keyword(s):  
Quality Of Life ◽  
Physical Activity ◽  
Clinical Trial ◽  
Mixed Methods ◽  
Usual Care ◽  
Randomized Clinical Trial ◽  
Intermittent Claudication ◽  
Walking Distance ◽  
Significant Difference

Aim: This study aimed to explore how qualitative data about rehabilitation for patients with intermittent claudication do provide an enhanced understanding of the quantitative experimental results. Background: The study was a randomized clinical trial comparing a rehabilitation intervention with usual care. A statistically significant difference between rehabilitation and usual care was found in walking distance, physical activity, quality of life and diet. The findings from the quantitative and qualitative analyses were analysed separately on their own tradition. In this study, mixed methods address whether the qualitative results could help explain the quantitative results and bring forward additional information. Design: Complex mixed-method intervention design with a convergent questionnaire variant. Methods: From April 2017- May 2019, patients diagnosed with intermittent claudication were included in a randomized clinical trial (N=118). In addition, qualitative interview informants from the intervention group were sampled from the quantitative study population for a survey (N=43) and focus group interviews (N=10). Interviews were conducted from April 2018-August 2019. Results: Integrated analyses identified how improvement in walking distance, physical activity, diet and quality of life was affected by team spirit, pedometer, education and fun exercise in a local setting. Quantitative and qualitative findings primarily confirmed and expanded each other; however, two discordant results were also evident. Conclusion: Our study adds empirical evidence regarding how a mixed-methods study can be used to obtain a more nuanced understanding of complex healthcare problems. The study provides new knowledge concerning how to set up a rehabilitation programme for patients with intermittent claudication.

scholarly journals Motivating Structured walking Activity in people with Intermittent Claudication (MOSAIC): protocol for a randomised controlled trial of a physiotherapist-led, behavioural change intervention versus usual care in adults with intermittent claudication

BMJ Open ◽  
2019 ◽  
Vol 9 (8) ◽  
pp. e030002 ◽  
Author(s):  
Lindsay Bearne ◽  
Melissa Galea Holmes ◽  
Julie Bieles ◽  
Saskia Eddy ◽  
Graham Fisher ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Usual Care ◽  
Intermittent Claudication ◽  
Controlled Trial ◽  
Behavioural Change ◽  
Walking Distance ◽  
Walking Ability ◽  
Walking Activity ◽  
Walking Exercise ◽  
Randomised Controlled

IntroductionWalking exercise is a recommended but underused treatment for intermittent claudication caused by peripheral arterial disease (PAD). Addressing the factors that influence walking exercise may increase patient uptake of and adherence to recommended walking. The primary aim of this randomised controlled trial (RCT) is to evaluate the efficacy of a physiotherapist-led behavioural change intervention on walking ability in adults with intermittent claudication (MOtivating Structured walking Activity in people with Intermittent Claudication (MOSAIC)) in comparison with usual care.Methods and analysisThe MOSAIC trial is a two-arm, parallel-group, single-blind RCT. 192 adults will be recruited from six National Health Service Hospital Trusts. Inclusion criteria are: aged ≥50 years, PAD (Ankle Brachial Pressure Index ≤0.90, radiographic evidence or clinician report) and intermittent claudication (San Diego Claudication Questionnaire), being able and willing to participate and provide informed consent. The primary outcome is walking ability (6 min walking distance) at 3 months. Outcomes will be obtained at baseline, 3 and 6 months by an assessor blind to group allocation. Participants will be individually randomised (n=96/group, stratified by centre) to receive either MOSAIC or usual care by an independent randomisation service. Estimates of treatment effects will use an intention-to-treat framework implemented using multiple regression adjusted for baseline values and centre.Ethics and disseminationThis trial has full ethical approval (London—Bloomsbury Research Ethics Committee (17/LO/0568)). It will be disseminated via patient forums, peer-reviewed publications and conference presentations.Trial registration numberISRCTN14501418

scholarly journals The Impact of Walking Exercises and Resistance Training upon the Walking Distance in Patients with Chronic Lower Limb Ischaemia

2016 ◽  
Vol 2016 ◽  
pp. 1-8 ◽  
Author(s):  
Maria Szymczak ◽  
Grzegorz Oszkinis ◽  
Marian Majchrzycki
Keyword(s):  
Resistance Training ◽  
Intermittent Claudication ◽  
Rehabilitation Program ◽  
Lower Limbs ◽  
Walking Distance ◽  
Group Training ◽  
Limb Ischaemia ◽  
Walking Test ◽  
Resistance Exercises ◽  
The Impact

Objective. The objective of this paper is to compare the impact of supervised walking and resistance training upon the walking distance in PAD patients. Materials and Methods. The examination involved 50 PAD patients at the 2nd stage of the disease according to Fontaine’s scale. The participants were randomly allocated to two groups: one exercising on the treadmill (n=24) and one performing resistance exercises of lower limbs (n=26). Results. The 12-week program of supervised rehabilitation led to a significant increase in the intermittent claudication distance measured both on the treadmill and during the 6-minute walking test. The group training on the treadmill showed a statistically significant increase of the initial claudication distance (ICD) and the absolute claudication distance (ACD) measured on the treadmill, as well as of ICD and the total walking distance (TWD) measured during the 6-minute walking test. Within the group performing resistance exercises, a statistically significant improvement was observed in the case of parameters measured on the treadmill: ICD and ACD. Conclusions. The supervised rehabilitation program, in the form of both walking and resistance exercises, contributes to the increase in the intermittent claudication distance. The results obtained in both groups were similar.

The test to retest reproducibility of walking test for intermittent claudication associated with lumbar spinal stenosis

2020 ◽  
Author(s):  
Shinji Tanishima ◽  
Hu Jianzhong ◽  
Zhao Jie ◽  
Yang Huilin ◽  
Hideki Nagashima ◽  
...  
Keyword(s):  
Intermittent Claudication ◽  
Spinal Stenosis ◽  
Lumbar Spinal Stenosis ◽  
Lower Limb ◽  
Cauda Equina ◽  
Walking Distance ◽  
Walking Test ◽  
Lower Limb Pain ◽  
Significant Difference ◽  
Lumbar Spinal

Abstract Background The walking test is useful to evaluate leg numbness and pain caused by cauda equina symptoms in patients with lumbar spinal stenosis but there are few reports described about reproducibility. The study aim was to evaluate the reproducibility of the walking test for lumbar spinal stenosis Methods Seventy patients with lumbar spinal stenosis who had intermittent claudication symptoms at a multicenter outpatient clinic were examined prospectively. A walking test was performed at 0 and 4 weeks. We investigated walking distance and lower limb pain and numbness in this study. Pain and numbness were evaluated by using the Visual Analog Scale (VAS) immediately after the walking test for the hip and outside, inside, front, and posterior sides of the lower legs. Cohen’s kappa analysis and interphase correlation coefficients (ICCs) were used to evaluate reproducibility. The Swiss Spinal Stenosis Questionnaire (SSS) was used to evaluate stenosis severity. Results The mean SSS was 30.2 ± 5.5 initially and 29.2 ± 5.2 at week 4, with no significant difference in severity ( P = 0.10). The walking distance ICC between baseline and 4 weeks was 0.670. The interobserver reliabilities for lower limb ache and numbness in both legs were acceptable. The average VAS for lower leg pain was 23.2 ± 25.2 mm at baseline and 27.4 ± 28.8 mm at week 4. The ICC was 0.668. The average VAS for leg numbness was 23.4 ± 26.7 mm at baseline and 24.8 ± 25.2 mm at week 4. The ICC was 0.683. Conclusions The walking test walking distance and symptomatic site results were reproducible.

scholarly journals A cilostazol hatékony és biztonságos lehetőség a claudicatio intermittens kezelésére. A NOCLAUD vizsgálat eredményei

2017 ◽  
Vol 158 (4) ◽  
pp. 123-128 ◽  
Author(s):  
Katalin Farkas ◽  
Zoltán Járai ◽  
Endre Kolossváry
Keyword(s):  
Quality Of Life ◽  
Side Effects ◽  
Adverse Events ◽  
Intermittent Claudication ◽  
Walking Distance ◽  
Claudicatio Intermittens ◽  
Efficacy And Safety ◽  
Walking Test ◽  
Efficacy Analysis

Abstract: Intermittent claudication can seriously impair the patients’ quality of life. Cilostazol was registered in Hungary in 2014. This study aimed to evaluate the efficacy and safety of cilostazol in patients with intermittent claudication. 1405 patients were enrolled to the 6 months, multicenter, non-interventional trial. From the 1331 patients, who completed the study, the data of 674 patients were subjected to efficacy analysis. Pain free and maximal walking distance and the 6 minute walking test improved significantly at 3 months (78.65%, 65.23%, 56.09%; respectively, p<0.001), and a further increase was observed after 6 months treatment (129.74%, 107.2, 80.38% respectively, p<0.001). Adverse events occured in 7.26% of the patients. The most frequent adverse events were headache, diarrhea, dizziness, tachycardia or palpitation. 24 patients (1.7%) stopped cilostazol treatment because of side effects. 6 month cilostazol treatment significantly increased the walking distance in patients with intermittent claudication, without important safety problems. Orv. Hetil., 2017, 158(4), 123–128.

scholarly journals Improving Rehabilitation for Patients with Intermittent Claudication: A Randomized Controlled Trial with a Mixed-Methods Evaluation (The CIPIC Rehab Study)

2021 ◽  
pp. 1-13
Author(s):  
Maj Siercke ◽  
Maj Siercke ◽  
Sanne Pagh Moller ◽  
Lau Caspar Thygesen ◽  
Henrik Sillesen ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Physical Activity ◽  
Clinical Trial ◽  
Mixed Methods ◽  
Usual Care ◽  
Randomized Clinical Trial ◽  
Intermittent Claudication ◽  
Walking Distance ◽  
Significant Difference

Aim: This study aimed to explore how qualitative data about rehabilitation for patients with intermittent claudication do provide an enhanced understanding of the quantitative experimental results. Background: The study was a randomized clinical trial comparing a rehabilitation intervention with usual care. A statistically significant difference between rehabilitation and usual care was found in walking distance, physical activity, quality of life and diet. The findings from the quantitative and qualitative analyses were analysed separately on their own tradition. In this study, mixed methods address whether the qualitative results could help explain the quantitative results and bring forward additional information. Design: Complex mixed-method intervention design with a convergent questionnaire variant. Methods: From April 2017- May 2019, patients diagnosed with intermittent claudication were included in a randomized clinical trial (N=118). In addition, qualitative interview informants from the intervention group were sampled from the quantitative study population for a survey (N=43) and focus group interviews (N=10). Interviews were conducted from April 2018-August 2019. Results: Integrated analyses identified how improvement in walking distance, physical activity, diet and quality of life was affected by team spirit, pedometer, education and fun exercise in a local setting. Quantitative and qualitative findings primarily confirmed and expanded each other; however, two discordant results were also evident. Conclusion: Our study adds empirical evidence regarding how a mixed-methods study can be used to obtain a more nuanced understanding of complex healthcare problems. The study provides new knowledge concerning how to set up a rehabilitation programme for patients with intermittent claudication.

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