Short-Term Effects of a Multimodal 3-Week Inpatient Pulmonary Rehabilitation Programme for Patients with Sarcoidosis: The ProKaSaRe Study.

BACKGROUND: Real-world data on the effects of a multicomponent pulmonary rehabilitation (PR) for patients with sarcoidosis are scarce. OBJECTIVE: To describe characteristics of patients with sarcoidosis referred for a 3-week inpatient PR, to assess the effects of PR on their quality of life (QoL) and clinical outcomes, and to investigate whether there are specific subgroups who particularly benefit from PR. METHODS: Using a prospective multicentre study design, data regarding 6-min walking distance (6MWD), QoL (Saint George's Respiratory Questionnaire, SGRQ), and the secondary outcomes of dyspnoea and psychological burden (fatigue, anxiety, and depression) were collected. RESULTS: We included 296 patients in the study (average age 49.1 ± 9.7 years, 47% female, average vital capacity 3.5 ± 1.0 L [87.0 ± 20.6 predicted]). The 6MWD improved by the end of the rehabilitation by 39.8 m on average (p < 0.0001; standardised response mean, SRM = 0.61), SGRQ showed significant improvements in all 3 domains, and the total score (p < 0.001) improved by 5.69-8.28 points (SRM 0.46-0.62). For the secondary outcomes, significant improvement (p < 0.001) was seen for all measured parameters, e.g., dyspnoea (modified Medical Research Council Scale, mMRC), fatigue (Fatigue Assessment Scale [FAS]; SRM = -0.71), anxiety and depression (Hospital Anxiety and Depression Scale [HADS]; SRM -0.58/-0.38), and generic QoL (measured by the SF-36 scales of physical and mental health; SRM 0.31/0.55). CONCLUSIONS: Our results provide the first documented evidence that PR is a promising complementary therapy option for sarcoidosis patients who remain subjectively symptomatic despite optimised outpatient medical treatment.

Preferences of patients with asthma or COPD for treatments in pulmonary rehabilitation.

INTRODUCTION: Pulmonary rehabilitation (PR) aims to improve disease control in patients with chronic obstructive pulmonary disease (COPD) and asthma. However, the success of PR-programs depends on the patients' participation and willingness to cooperate. Taking the patients' preferences into consideration might improve both of these factors. Accordingly, our study aims to analyze patients' preferences regarding current rehabilitation approaches in order to deduce and discuss possibilities to further optimize pulmonary rehabilitation. METHODS AND ANALYSIS: At the end of a 3 weeks in-house PR, patients' preferences concerning the proposed therapies were assessed during two different time slots (summer 2015 and winter 2015/2016) in three clinics using a choice-based conjoint analysis (CA). Relevant therapy attributes and their levels were identified through literature search and expert interviews. Inclusion criteria were as follows: PR-inpatient with asthma and/or COPD, confirmed diagnosis, age over 18 years, capability to write and read German, written informed consent obtained. The CA analyses comprised a generalized linear mixed-effects model and a latent class mixed logit model. RESULTS: A total of 542 persons participated in the survey. The most important attribute was sport and exercise therapy. Rehabilitation preferences hardly differed between asthma and COPD patients. Health-related quality of life (HRQoL) as well as time since diagnosis were found to have a significant influence on patients' rehabilitation preferences. CONCLUSIONS: Patients in pulmonary rehabilitation have preferences regarding specific program components. To increase the adherence to, and thus, the effectiveness of rehabilitation programs, these results must be considered when developing or optimizing PR-programs.

ProKaSaRe Study Protocol: A Prospective Multicenter Study of Pulmonary Rehabilitation of Patients With Sarcoidosis.

BACKGROUND: Available data assessing the efficacy of pulmonary rehabilitation for patients with chronic sarcoidosis are scant; for Germany, there are none at all. OBJECTIVE: To gain information about the benefit of in-house pulmonary rehabilitation for patients with chronic sarcoidosis and for the health care system, we intend to collect data in a prospective multicenter "real-life" cohort trial. METHODS: ProKaSaRe (Prospektive Katamnesestudie Sarkoidose in der pneumologischen Rehabilitation) [Prospective Catamnesis Study of Sarcoidosis in Pulmonary Rehabilitation] will assess a multimodal 3-week inpatient pulmonary rehabilitation program for adult patients with chronic sarcoidosis over a 1-year follow-up time. Defined specific clinical measurements and tests will be performed at the beginning and the end of the rehabilitation. In addition, questionnaires concerning health-related quality of life and the patients' symptoms will be provided to all patients. Inclusion criteria will be referral to one of the 6 participating pulmonary rehabilitation clinics in Germany for sarcoidosis and age between 18 and 80 years. Patients will only be excluded for a lack of German language skills or the inability to understand and complete the study questionnaires. To rule out seasonal influences, the recruitment will take place over a period of 1 year. In total, at least 121 patients are planned to be included. A descriptive statistical analysis of the data will be performed, including multivariate analyses. The primary outcomes are specific health-related quality of life (St George's Respiratory Questionnaire) and exercise capacity (6-minute walk test). The secondary outcomes are several routine lung function and laboratory parameters, dyspnea scores and blood gas analysis at rest and during exercise, changes in fatigue, psychological burden, and generic health-related quality of life (36-item Short Form Health Survey). RESULTS: Funding was obtained on October 12, 2010; enrollment began on January 15, 2011 and was completed by January 14, 2012. Results are anticipated late summer 2015. CONCLUSIONS: Due to the large number of participants, we expect to obtain representative findings concerning the effectiveness of pulmonary rehabilitation for patients with sarcoidosis and to provide a dataset of assessed objective and subjective short- and long-term changes due to pulmonary rehabilitation. The results should form the basis for the planning of a randomized controlled trial. TRIAL REGISTRATION: German Clinical Trials Register: DRKS00000560; https://drks-neu.uniklinik-freiburg.de/ drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00000560 (Archived by WebCite® at http://www.webcitation.org/6dKb5X87R).

The effect of amlodipine on exercise-induced pulmonary hypertension and right heart function in patients with chronic obstructive pulmonary disease.

The aim of the study was to investigate the pulmonary vasodilator effect of the dihydropyridine calcium channel blocker amlodipine in patients with clinically stable chronic obstructive pulmonary disease (COPD) and pulmonary hypertension (PH). Many patients with COPD develop chronic PH and this may predict mortality in this disorder. The treatment with calcium channel blockers is accepted as a therapeutic strategy for primary pulmonary hypertension. In twenty male patients (mean age 57+/-7 years) with clinically stable COPD and PH, we investigated whether amlodipine could effectively decrease pulmonary vascular resistance (PVR) and pulmonary arterial pressure (PAP) and improve right heart function. PAP was recorded by a balloon-tipped thermodilution catheter and cardiac output was determined in triplicate by thermodilution at rest and during exercise. In addition, blood gas values were determined from the capillary blood of the earlobe. All measurements were done under identical conditions before and after 18 days of chronic treatment: with 10 mg amlodipine once daily starting with 5mg in the first week. At a mean maximal achieved workload of 71.3+/-20 Watts, amlodipine achieved a significant reduction in PVR (-13.4%; p<0.01) and PAP (-12.1%; p<0.001) implying an improved right heart function assessed by a significant reduction in mean right atrial pressure (-20.6%; p<0.05). During the action of amlodipine there were no significant changes in pulmonary gas exchange and pulmonary capillary wedge pressure. Amlodipine given as a single daily oral dose of 10mg is a safe and effective pulmonary vasodilator in COPD patients with PH and leads to an improvement in right heart function.