6-minute Walk Distance Research Articles

Comparison of in-clinic assessment of 6MWT by conventional method and using wearable sensors for patients with ATTR-CM.

The 6-minute walk test (6MWT) is used to assess submaximal exercise capacity in clinical trials. Conducting the 6MWT can be challenging when patients cannot visit the clinic due to physical/travel limitations. This pilot study assessed the feasibility of conducting the 6MWT using wearable sensors for patients with transthyretin amyloid cardiomyopathy. Participants were enrolled in the phase 3 ATTRibute-CM trial. Sensors were positioned on patients' feet and lower back during the 6MWT. The 6-minute walk distance (6MWD) was compared with the distance measured by a trained observer during a concurrent conventional test. Pearson and concordance correlation coefficients were estimated. Twelve participants from five centers participated; 11had evaluable data. Mean 6MWD was 330.3 m (conventional method) and 335.1 m (wearable sensors); mean difference (SD) was 4.7 m (10.95). Pearson and concordance correlation coefficients for 6MWD were 0.998 (95% CI: 0.992-0.999) and 0.997 (95% CI: 0.991-0.999), respectively. The 6MWD measured using wearable sensors and by the conventional method were closely correlated. Conducting the 6MWT with wearable sensors may be feasible and as reliable as the conventional method in a monitored clinic setting. Whether at-home 6MWD measured by wearable sensors correlates with in-clinic monitoring deserves further study. ClinicalTrials.gov identifier is NCT03860935.

Jinbei oral liquid for idiopathic pulmonary fibrosis: a randomized placebo-controlled trial

The traditional Chinese medicine compound preparation known as Jinbei Oral Liquid (JBOL) consists of 12 herbs, including Astragalus membranaceus (Fisch.) Bge, Codonopsis pilosula (Franch.) Nannf, et al. Having been used for over 30 years in the treatment of pulmonary diseases, JBOL was evaluated in this study in order to assess its effect on idiopathic pulmonary fibrosis as well as its safety (ChiCTR2000035351, Chictr.org.cn.09/08/2020). A double-blind, multicenter, randomized, proof-of-concept trial was conducted to assess the efficacy of oral JBOL 40 ml and Corbrin Capsules 1 g compared to a placebo and Corbrin Capsules in patients with idiopathic pulmonary fibrosis (IPF). Over a 26-week period, patients received the active treatment or placebo three times daily, in a 1:1 ratio. This clinical study uses a randomized method, with a cycle of every 4 patients. TCM doctors at or above the deputy director level of the research center conduct TCM dialectics on IPF patients. To assess efficacy, over the duration of the trial, we measured serial changes in a composite indicator encompassing time to first acute exacerbation of IPF (first hospitalization or death due to respiratory cause), total lung capacity (TLC) (mL), predicted forced vital capacity (FVC%), forced vital capacity (FVC) (mL), predicted diffusing capacity of the lungs for carbon monoxide (predicted DLco%), 6-minute walk distance (6MWD), St. George’s Respiratory Questionnaire (SGRQ) total score, and arterial oxygen partial pressure (PaO2) from baseline to week 26 versus placebo. A total of 103 patients were screened, and 72 received the study medication. Of these, 68 patients were included in the analysis set, with 34 receiving JBOL and 34 receiving a placebo. After 26 weeks, a statistically significant reduction in total lung capacity (TLC) was observed for the JBOL group, with a change of 136 mL compared to -523 mL for the placebo group (difference 659 mL, 95% CI -1215 to -104 mL, p = 0.02). The study found that the change in FVC% predicted was − 1.48% and − 3.58% for the JBOL and placebo groups, respectively (difference of 2.10%, 95% CI -7.13 to 2.93, p = 0.41). Additionally the differences between the two groups in changes in FVC (mL), DLCO % predicted, PaO2 (mmHg) measures were − 67 mL (95% CI -238 to 104), -7.74% (95% CI -17.26 to 1.79), and − 3.57 mmHg (95% CI -10.02 to 2.87), respectively. Treatment with JBOL compared to placebo resulted in sequential changes in acute exacerbation, with no significant difference in SGRQ scores. It was not found that there was a statistically significant difference between the JBOL and placebo groups in TEAE reporting and serious TEAE reporting. Compared to the placebo group, there was a statistically significant reduction (p < 0.021) in TLC (mL) after 26 weeks for JBOL. The rates of FVC % predicted, FVC, DLCO % predicted, and PaO2 in the group treatment with JBOL were numerically lower than those in the placebo treatment group, although these differences did not reach statistical significance. JBOL exhibited comparable safety to placebo. This study has preliminarily shown the efficacy and safety of JBOL for IPF, but this is an exploratory clinical trial, more patient-involved studies should be needed in the near future.Trial registration: Chictr.org.cn ChiCTR2000035351; the trial was prospective clinical studies registered on August 9, 2020.

The role of exercise-based prehabilitation in enhancing surgical outcomes for patients with digestive system cancers: a meta-analysis

BackgroundPrehabilitation is a crucial component of tumor rehabilitation that attempts to improve patients’ preoperative health, although its efficacy in treating patients with cancers of the digestive system is still up for debate.MethodsThe records from PubMed (MEDLINE), Embase, Web of Science, Cochrane Library, EBSCO, Scopus, CNKI and Wan fang database up to November 2024 were systematically searched. The Cochrane Collaboration tool was employed for evaluating the risk of bias in each study, and the PRISMA 2020 checklist provided by the EQUATOR network was utilized.ResultsThrough quality analysis, 20 articles were included, involving 1719 patients. Although its effect on severe complications is still unknown, the prehabilitation significantly decreased overall postoperative complications when compared to standard care, with a risk ratio (RR) of 0.74 (95% CI: 0.65 to 0.84). Despite not shortening the postoperative hospital stay (MD: -0.13, 95% CI: -0.29 to 0.03), prehabilitation demonstrated notable improvements in the 6-minute walk distance (6MWD), with preoperative gains (MD: 25.87, 95% CI: 14.49 to 37.25) and sustained benefits at 4 weeks postoperatively (MD: 22.48, 95% CI: 7.85 to 37.12). However, no significant differences in 6MWD were observed at 6 or 8 weeks postoperatively. The average improvement in 6MWD from baseline to preoperative was 28.99 (95% CI: 10.89 to 47.08, P = 0.002), and from 4 weeks postoperative to baseline, it was 25.95 (95% CI: 6.84 to 45.07, P = 0.008), with no significant change at 8 weeks. The acceptance and completion rates of prehabilitation were commendably high at 61% (95% CI: 47–75%) and 90% (95% CI: 87–93%), respectively, alongside a relatively low dropout rate of 10% (95% CI: 7% to13%).ConclusionsPrehabilitation reduces postoperative complications and improves short-term physical function in digestive surgery patients, with good patient acceptance; however, the long-term effects are unknown due to a lack of follow-up data.RegistrationIt was registered with the International Prospective Register of Systematic Reviews (PROSPERO) with the identification code CRD42022361100.

Effect of short-term exercise-based prehabilitation program for patients undergoing liver cancer surgery: A randomized controlled trial.

Patients with liver cancer usually experience postoperative complications and reduced perioperative functional capacity. This study aimed to assess the effect of a short-term, exercise-based prehabilitation program on postoperative clinical outcomes and perioperative functional capacity in patients with liver cancer undergoing hepatectomy. This single-center, prospective, open-labeled randomized controlled trial was conducted with 205 patients. Patients in the prehabilitation group (n= 104) received a 1-week exercise intervention program before surgery, including aerobic and resistance exercises, and respiratory training. Patients in the control group (n= 101) received the usual clinical care. The assessors were blinded to the patient allocation. The primary outcome was the incidence of postoperative pulmonary complication during hospitalization, which the multivariate logistic regression model analyzed. Other outcomes included functional capacity measured as the 6-minute walk distance, postoperative complications, length of stay, hospital readmissions, hospitalization cost, and patient-reported outcomes. Post hoc subgroup analyses were performed. The median duration of prehabilitation was 8days. There was no between-group difference in the incidence of postoperative pulmonary complication (adjusted odds ratio, 0.70; 95% confidence interval, 0.37-1.29; P=.249). There were no differences in postoperative clinical outcomes and patient-reported outcomes, except for 6-minute walk distance (33.36m higher in the prehabilitation group, 95% CI, 22.02-44.70; P<.001). This exercise prehabilitation program did not affect postoperative clinical outcomes or patient-reported outcomes of patients with liver cancer, but it showed improvement in preoperative functional capacity.

Pulmonary Hemodynamic Correlates and Prognostic Value of the Cardiopulmonary Exercise Score in Patients With Left Heart Failure

Abstract Objective: Pulmonary hypertension secondary to left heart failure is associated with an abnormal response to exercise and poor prognosis. The objective of this study is to develop an algorithm by using data from cardiopulmonary exercise testing (CPET) to assess the severity of pulmonary hemodynamics and predict clinical worsening and mortality in patients with heart failure. Methods: From April 2017 to December 2018, a total of 102 patients with heart failure who underwent CPET and invasive right heart catheterization participated in this prospective study. All enrolled patients had their clinical characteristics, hemodynamic parameters, and CPET results. Based on the CPET data namely peak oxygen uptake, the minute ventilation/carbon dioxide production slope, resting end-tidal carbon dioxide, oxygen uptake/work rate flattening, exercise oscillatory ventilation, and oxygen uptake efficiency slope, a Heart Failure Cardiopulmonary Exercise (HFCE) score was developed. The total score was then calculated to categorize patients into 3 groups: low score (0–3) (n = 31), intermediate score (4–7) (n = 45), and high score (8–14) (n = 26). Clinical events were defined as all-cause death and rehospitalization for heart failure, which were recorded and tracked for at least 12 months. Pearson’s correlation coefficients were calculated to assess the relationship between the HFCE score and hemodynamic parameters, 6-minute walk distance, and N-terminal-pro hormone brain natriuretic peptide. Cox proportional hazards regression analysis was used to identify independent predictors of clinical events. Survival curves for clinical events were generated using the Kaplan-Meier method and compared among the 3 groups with different HFCE scores with a log-rank test. Results: The high HFCE score group had a higher prevalence of New York Heart Association class Ⅲ–Ⅳ (high score vs. intermediate score vs. low score: 85% (22/26) vs. 56% (25/45) vs. 45% (14/31), P = 0.008), higher N-terminal-pro hormone brain natriuretic peptide levels (high score vs. intermediate score vs. low score: (3,039 ± 2,171) ng/L vs. (2,039 ± 2,353) ng/L vs. (1,438 ± 947) ng/L, P = 0.035), lower 6-minute walk distance (high score vs. intermediate score vs. low score: (312 ± 79) m vs. (362 ± 84) m vs. (363 ± 76) m, P = 0.042) compared to intermediate score or low score. The high HFCE score correlated well with high levels of pulmonary vascular resistance (r = 0.539, P &lt; 0.01), pulmonary artery wedge pressure (r = 0.292, P &lt; 0.01), and mean pulmonary artery pressure (r = 0.474, P &lt; 0.01), as well as low levels of cardiac output (r = –0.357, P &lt; 0.01). Moreover, 46 patients developed composed clinical events at 12 months. In the multivariate model, the HFCE score was an independent predictor of composed clinical events (hazard ratio = 1.142, 95% confidence interval: 1.041–1.253, P = 0.005). Kaplan-Meier analysis showed a significantly higher probability of composed clinical events in patients with a higher HFCE score (P log-rank = 0.004). Conclusion: The HFCE score—obtained through CPET—provides valuable prognostic information by indicating the severity of hemodynamics in patients with pulmonary hypertension secondary to left heart failure. It can likely serve as a reliable predictor for clinical worsening and mortality.

Association between preoperative exercise tolerance and unplanned readmission in patients who underwent pancreatectomy for pancreatic ductal adenocarcinoma: a retrospective analysis

BackgroundDespite advances in treatment, the incidence of postoperative complications following pancreatectomy remains high, leading to frequent hospital readmissions. Therefore, this study aimed to investigate the relationship between preoperative exercise tolerance and the likelihood of unplanned readmission in patients with pancreatic ductal adenocarcinoma.MethodsThis retrospective analysis included 88 patients who underwent pancreatectomy at a single institution between July 2019 and September 2022 and focused on patients with pancreatic ductal adenocarcinoma. Patients’ preoperative exercise tolerance was assessed using the 6-minute walk distance (6 MWD).ResultsThe study found a 22.7% readmission rate within 1 year, with the median 6 MWD being significantly lower in readmitted patients than in those who were not readmitted (390.0 m versus 436.5 m; p < 0.01). A 6 MWD cut-off of 425 m was a strong predictor of readmission, with lower preoperative exercise tolerance associated with a higher risk of readmission.ConclusionsEnhancing preoperative physical reserves through exercise therapy may reduce readmission rates and improve patient outcomes. Further research with larger sample sizes is required to confirm these findings.

Longitudinal changes in the 6-minute walk test and the Glittre-activities of daily living test in adults with cystic fibrosis.

With the increasing use of highly effective modulator therapy (HEMT) in adults with cystic fibrosis (awCF), it is necessary to determine the evolution of the most dynamic physiological markers of this disease, such as the 6-minute walk test (6MWT) and the Glittre-activities of daily living test (TGlittre). The present study aimed to evaluate the 1-year changes in the 6- minute walking distance (6MWD), TGlittre time, and quality of life (QoL) in awCF before the initiation of HEMT and to determine the impact of habitual physical activity (HPA) and chest physiotherapy (CP). This longitudinal study enrolled 24 awCF who completed the 6MWT and TGlittre. Pulmonary function tests, handgrip strength (HGS), and the Cystic Fibrosis Questionnaire-Revised (CFQ-R) were conducted. Measurements were collected at baseline (T1) and 1 year later (T2). The median body mass index increased between T1 and T2 [19.8 (18-24) vs. 21.4 (19-24) kg/m2, p=0.038]. TGlittre time decreased both in relation to the absolute values [3.10 (2.52-3.39) vs. 2.40 (2.00-3.00) minutes, p=0.001] and in relation to the predicted values [127 (116-150) vs. 108 (102-140) % predicted, p=0.001]. Although there was no increase in 6MWD relative to the predicted values, it increased relative to the absolute values [545 (463-654) vs. 617 (540-658) meters, p=0.041]. In relation to the group that did not engage in HPA, individuals who had HPA showed an increase in HGS between T1 and T2 [7.1 (0-20) vs. 0 (-12-3) kgf, p=0.031]. In relation to the group that did not undergo CP, individuals undergoing CP showed an increase in the 'treatment burden'-CFQ-R between T1 and T2 [16.1 (-3-18) vs. -11.2 (-28-1) points, p=0.049]. In conclusion, awCF performed better on TGlittre than on 6MWT. They experienced an improvement in body composition. HPA was correlated with peripheral muscle strength, as were CP and QoL.

Patient Characteristics and Outcomes by Sex and Smoking Status in Pulmonary and Cardiac Rehabilitation.

Those with established symptomatic cardiopulmonary disease should attend secondary prevention programs. Attendance at these programs is known to differ by sex and by smoking status, with females and those who smoke being less likely to attend. However, little is known about whether the risk factors of being female and smoking are cumulative, and how outcomes from secondary prevention differ by these subgroups. Accordingly, we sought to examine patient characteristics at entry and outcomes of those attending pulmonary (PR) and cardiac rehabilitation (CR) by sex and smoking status. Data were from patients enrolled in programs participating in a national registry between 2013-2021 (PR) or 2012-2021 (CR). Variables examined included: age, sex, race, educational attainment, insurance coverage, qualifying diagnosis, BMI, number of PR/CR sessions attended, and baseline, and change in, psychosocial (depression and anxiety symptoms) and physical function and fitness measures (6-minute walk distance [6MWD]/metabolic equivalents [METs]). Analyses included 41,087 PR and 447,921 CR patients. Current smoking was reported in 14.3% (PR) and 8.4% (CR) of patients. Across PR/CR, at baseline, current smoking and female sex were both associated with higher depression scores, lower fitness/function measures, and completing fewer sessions. Both current smoking and female sex were significantly associated with less improvement in 6MWD, METs and depression scores within CR. Both sex and smoking status are important risk factors for those entering secondary prevention programs. Females who smoke have higher risk factors at entry, attend fewer sessions, and, within CR, improve less in fitness/function. This study uses large national registries to replicate and expand upon prior findings that both female sex and current smoking are associated with higher-risk profiles when entering secondary prevention programs. Additionally, this study demonstrates that current smoking and female sex are also associated with less improvement during secondary prevention, especially within cardiac rehabilitation.

Rehabilitation at Home Using Mobile Health for Older Adults Hospitalized for Ischemic Heart Disease

Among older adults with ischemic heart disease, participation in traditional ambulatory cardiac rehabilitation (CR) remains low. While mobile health CR (mHealth-CR) provides a novel opportunity to deliver care, age-specific impairments to technology use may limit uptake, and efficacy data are currently lacking. To test whether mHealth-CR improves functional capacity in older adults. The RESILIENT phase 2, multicenter, randomized clinical trial recruited patients aged 65 years or older with ischemic heart disease (defined as a hospital visit for myocardial infarction or coronary revascularization) from 5 academic hospitals in New York, Connecticut, and Massachusetts between January 9, 2020, and April 22, 2024. Participants were randomized 3:1 to mHealth-CR or usual care. mHealth-CR consisted of commercially available software delivered on a tablet computer, coupled with remote monitoring and weekly exercise therapist telephone calls, delivered over a 3-month duration. As RESILIENT was a trial conducted in a routine care setting to inform decision-making, participants in both arms were also allowed to receive traditional CR at their cardiologist's discretion. The primary outcome was change from baseline to 3 months in functional capacity, measured by 6-minute walk distance (6MWD). Secondary outcomes were health status (12-Item Short Form Health Survey [SF-12]), residual angina, and impairment in activities of daily living. A total of 400 participants (median age, 71.0 years [range, 65.0-91.0 years]; 291 [72.8%] male) were randomized to mHealth-CR (n = 298) or usual care (n = 102) and included in the intention-to-treat analysis. Of those, 356 participants (89.0%) returned in person for 6MWD assessment at 3 months. For the primary outcome, there was no adjusted difference in 6MWD between participants receiving mHealth-CR vs usual care (15.6 m; 95% CI, -0.3 to 31.5 m; P = .06). Among subgroups, there was an improvement in 6MWD among women (36.6 m; 95% CI, 8.7-64.4 m). There were no differences in any secondary outcomes between groups (eg, adjusted difference in SF-12 physical component scores at 3 months: -1.9 points; 95% CI, -3.9 to 0.2 points). Based on inverse propensity score weighting, there was no effect of mHealth-CR on 6MWD among those who did not attend traditional CR (25.7 m; 95% CI, -8.7 to 60.2 m). In this randomized clinical trial of mHealth-CR vs usual care, mHealth-CR did not significantly increase 6MWD or result in improvements in secondary outcomes. The findings suggest the older adult population may require more age-tailored mHealth strategies to effectively improve outcomes. ClinicalTrials.gov Identifier: NCT03978130.

Effects of Acute Phase Intensive Exercise Training in Patients With Acute Decompensated HeartFailure.

Acute decompensated heart failure (ADHF) leads to hospitalizations and functional decline in older adults. Although cardiac rehabilitation (CR) is effective for stable heart failure, its impact on ADHF patients, particularly those without frailty, is unclear. The goal of this study was to evaluate the efficacy and safety of early in-hospital CR for patients hospitalized with ADHF who are not frail. In this multicenter trial (ACTIVE-ADHF [Effects of Acute Phase Intensive Exercise Training in Patients with Acute Decompensated HeartFailure]), ADHF patients without physical frailty were randomized 2:1 to undergo either exercise-based CR or standard care. The intervention included early mobilization and structured exercise training. The primary outcome was the change in 6-minute walk distance (6MWD) from baseline to discharge. Secondary outcomes assessed physical and cognitive function, quality of life, and safety. A total of 91 patients were randomized to treatment, with 59 allocated to the intervention group and 32 to the control group. The primary outcome, 6MWD, improved significantly more in the intervention group, with a mean increase of 75.0 ± 7.8m vs 44.1 ± 10.2m in the control group, with an effect size of 30.9 ± 13.1m (95%CI: 4.8-57.0; P= 0.021). The intervention group showed favorable results in secondary efficacy outcomes, including physical and cognitive function, physical activity, and quality of life. Safety outcomes were similar between groups, except for a greater reduction in B-type natriuretic peptide levels at 90days' postdischarge in the intervention group. In patients with ADHF without physical frailty, in-hospital exercise-based CR led to significant improvements in 6MWD at 2weeks after randomization without compromising safety. (ACTIVE-ADHF [Effects of Acute Phase Intensive Exercise Training in Patients with Acute Decompensated HeartFailure]; UMIN000020919).

Impact of pulmonary rehabilitation on survival in people with Interstitial lung disease.

Pulmonary rehabilitation (PR) is a beneficial intervention for people with interstitial lung disease (ILD), however the effect of PR on survival is unclear. This study compared the survival outcomes in people with ILD who were allocated to PR versus those who were allocated to control in two published randomised controlled trials (RCTs). Does participation in PR impact survival among people with ILD? The combined data from the two previous RCTs of PR in ILD were included. Time from start of PR until date of death, lung transplantation or censoring was calculated. Kaplan-Meir and Cox proportional hazard regression analysis were used to assess the impact of PR on survival. Baseline variables of age at time of PR, gender, FVC, 6-minute walk distance (6MWD), exertional nadir SpO2 and diagnosis of idiopathic pulmonary fibrosis (IPF) were included as covariates. Of the 182 participants with ILD (87 IPF, 109 males, mean (SD) age 69(10), FVC%pred 76(19), TLCO%pred 48(16)), death occurred in 62%, 6% were transplanted, 20% were alive and 12% were lost to follow-up. Median survival for those who completed PR was 6.1 years (95% CI 4.4 to 7.9) compared to 4.7 years (95%CI 3.4 to 6.0) for those in the control group, however this was not significantly different (log rank p=0.7). After adjusting for baseline variables, at 5 years, completion of PR was associated a 44% lower risk of mortality (HR 0.56 (0.36-0.88), p=0.01). At 10 years, no difference in survival was observed between the PR and control group. Participation in PR among people with ILD may impact survival at 5 years. Along with clinical improvements following PR, the potential for a survival benefit further strengthens the importance of PR in the standard care of people with ILD.

Associations Between Upper Extremity Function, Activities of Daily Living, and Functional Capacity in Patients with Heart Failure with Reduced Ejection Fraction.

Limited information is available regarding the associations between upper extremity function, activities of daily living (ADLs), and functional capacity in patients with heart failure with reduced ejection fraction (HFrEF). This study aimed to investigate the associations between upper extremity function, ADLs, and functional capacity in patients with HFrEF. This cross-sectional study included 31 patients with HFrEF. Demographic, anthropometric, and clinical data were recorded. Upper extremity function and ADLs were evaluated using the 6-Minute Pegboard and Ring Test (6PBRT) and the Glittre Activities of Daily Living Test (TGlittre), respectively. The 6-Minute Walk Test (6MWT) was administered to measure functional capacity. Heart rate (HR), systolic blood pressure (SBP), diastolic blood pressure (DBP), peripheral oxygen saturation (SpO2), dyspnea, and fatigue were assessed at the beginning and end of each test. The 6PBRT was significantly correlated with TGlittre (rho = -0.718, P < 0.001) and 6-minute walk distance (6MWD) (r = 0.546, P = 0.001). A significant correlation was also found between TGlittre and 6MWD (rho = -0.810, P < 0.001). Changes in HR, SBP, and dyspnea were significantly different across the 6PBRT, TGlittre, and 6MWT (P < 0.05). This study indicates that upper extremity function is associated with ADLs and functional capacity in patients with HFrEF. The 6PBRT requires lower cardiopulmonary demand than TGlittre and 6MWT in this patient population.

Baseline NT-proBNP Non-Response Score and Health Status Measures in Assessing Treatment Responses in Heart Failure with Reduced Ejection Fraction.

We aim to validate NT-proBNP nonresponse score (NNRS) previously derived from the PROTECT and BATTLESCARRED studies in comparison with standard health status measures in predicting natriuretic peptide responses in patients with heart failure with reduced ejection fraction. Data on the GUIDE-IT trial were used to derive the NNRS based on 4 predictors including baseline NT-proBNP, heart rate, NYHA functional class, and history of atrial fibrillation. The discriminative capacity of the NNRS and health status measures for having NT-proBNP >1,000 pg/mL at 12 months was assessed and compared with baseline or follow-up health status measures including Kansas City Cardiomyopathy Questionnaire Overall Summary Score (KCCQ-OSS), Duke Activity Status Index (DASI), and 6-minute walk distance. Multivariable logistic regression analysis was used to determine the predictive value of the score and health status measures greater than the median values for NT-proBNP response with adjustment for age, sex, body mass index, comorbidities, baseline creatinine and NT-proBNP levels. Among 877 patients, 252 (28.7%) patients had NT-proBNP >1,000 pg/mL at 12 months. The discriminative capacity of the NT-proBNP non-response score was 0.72 (95% CI 0.67-0.77). After adjusting for covariates, only NNRS (P=.044) and KCCQ-OSS (P=.002) remained predictive for NT-proBNP non-response at 12 months. NT-proBNP non-response score and KCCQ-OSS was associated with persistently elevated NT-proBNP 12 months independently of baseline NT-proBNP levels.

Echocardiography Findings for Pulmonary Hypertension During Workup for Bronchoscopic Lung Volume Reduction.

Bronchoscopic lung volume reduction (BLVR) is a minimally invasive intervention that improves dyspnea and quality of life in select individuals with emphysema. Echocardiography is the initial screening tool for pulmonary hypertension (PH) in patients evaluated for BLVR. Multiple BLVR and lung volume reduction surgery (LVRS) trials have used and right ventricular systolic pressure (RVSP) of 45mmHg as a cutoff for potential significant PH. However, PH is established hemodynamically by right heart catheterization (RHC), not echocardiography due to notoriously inaccurate RSVP values in patients with lung disease, especially those with COPD and suboptimal acoustic imaging windows. Over a 5-year period, all patients who met PFT criteria for BLVR underwent a routine screening echocardiogram for PH. Twenty-four patients with a RVSP >45mmHg or suspicion of significant PH on echocardiography were subjected to RHC. Twenty-one (88%) with suspicion for significant PH based on echocardiography did not have significant PH on RHC. Three patients (12%) had significant PH based on RHC precluding them from BLVR. Ten of the 21 patients with echo suspected PH, but RHC negative PH qualified for BLVR. Twelve-month follow-up data was available for 7 of these patients post-BLVR that included change in forced expiratory volume in 1 second (FEV1), 6-minute walk distance (6MWD), and St. George's Respiratory Questionnaire (SGRQ). The mean change in FEV1 showed an increase of 0.154L, 6MWD increase of 42m, and SGRQ decrease of 11.5 points. On the basis of results from this study, all patients being evaluated for BLVR found to have a RVSP over 45mmHg on echocardiography should undergo RHC to confirm significant PH.

HEPATOCYTE GROWTH FACTOR FOR WALKING PERFORMANCE IN PERIPHERAL ARTERY DISEASE.

VM202 is a plasmid encoding two isoforms of hepatocyte growth factor (HGF). In preclinical studies, HGF stimulated angiogenesis and muscle regeneration. This preliminary clinical trial tested the hypothesis that VM202 injections in gastrocnemius muscle would improve walking performance in people with mild to moderate and symptomatic lower extremity peripheral artery disease (PAD). In a double-blind clinical trial, people with PAD were randomized to gastrocnemius muscle injections of either 4 mgs of VM202 or placebo every 14 days for four doses. The primary outcome was 6-month change in 6-minute walk distance. Secondary outcomes included 3-month change in treadmill walking time and gastrocnemius muscle biopsy measures. In this preliminary trial, statistical significance was pre-specified as a one-sided P value <0.10. 39 participants with PAD (64.1% Black, 28.2% female) were randomized. Adjusting for age, race, smoking, and baseline performance, VM202 did not improve 6-minute walk at 6-month follow-up, compared to placebo (-13.5 meters, 90% confidence interval (CI): -38.5,+∞). At 3-month follow-up, VM202 improved maximum treadmill walking time (+2.38 minutes (90% CI: +1.08, +∞), P=0.014) and increased central nuclei abundance in gastrocnemius muscle (+5.86, 90% CI: +0.37,+∞, P=0.088), compared to placebo. VM202 did not significantly improve pain-free walking distance (difference: +0.30 minutes, 90% CI:-1.10,+∞, P=0.39), calf muscle perfusion (difference: +1.80 ml/minute per 100 g tissue, 90% CI: -3.80,+∞, P=0.33), or the WIQ distance score (difference: +2.02, 90% CI: -8.11,+∞, P=0.40). In post-hoc analyses, VM202 significantly improved 6-minute walk in PAD participants with diabetes mellitus at 6-month follow-up (+34.19 (90% CI: 4.04,+∞), P=0.075), but had no effect in people without diabetes (interaction P value=0.079). These data do not support gastrocnemius injections of VM202 to improve 6-minute walk in PAD. Secondary outcomes suggested potential benefit of VM202 on skeletal muscle measures and treadmill walking, while post-hoc analyses suggested benefit in PAD participants with diabetes.

Riociguat in pulmonary arterial hypertension: Application of the 4-strata COMPERA 2.0 risk assessment tool in the PATENT studies.

Risk stratification is an essential part of evaluating disease severity in patients with pulmonary arterial hypertension (PAH). This study applied the 4-strata COMPERA 2.0 risk model to the Phase 3 PATENT-1/2 studies of riociguat. This was a post hoc analysis of PATENT-1 and PATENT-2. Log-rank tests of Kaplan-Meier curves were performed to compare the risk strata at PATENT-1 baseline and Week 12 regarding time to clinical worsening and survival at 2 years in the PATENT-2 population. Data on COMPERA 2.0 status at baseline were available for 214 patients with riociguat and 100 with placebo; overall, 120 patients were identified as intermediate-low risk and 96 as intermediate-high risk. At PATENT-1 Week 12, improvements in COMPERA 2.0 risk strata and median 6-min walk distance were seen with riociguat vs placebo in patients assessed as intermediate-low risk and intermediate-high risk at baseline by COMPERA 2.0. More patients improved their COMPERA 2.0 risk status with riociguat vs placebo in the intermediate-low (38 % vs 22 %) and intermediate-high risk groups (42 % vs 31 %). COMPERA 2.0 assessed at PATENT-1 baseline and Week 12 discriminated between risk strata for survival and clinical worsening in PATENT-2 at 2 years (p≤.001 for all analyses). In conclusion, this analysis supports the risk-reduction benefits of riociguat in patients with PAH at intermediate-low risk and intermediate-high risk, and externally validated the utility of COMPERA 2.0 in the long-term risk assessment of patients from a clinical trial population.

Comparative breakthrough: Umbilical cord mesenchymal stem cells vs bone marrow mesenchymal stem cells in heart failure treatment.

In this article, we evaluate the comparative efficacy and safety of mesenchymal stem cells (MSCs) derived from bone marrow (BM-MSCs) and umbilical cord (UC-MSCs) in the treatment of heart failure and myocardial infarction. MSCs have gained importance as living bio drug due to their regenerative potential, with BM-MSCs being the most extensively studied. However, UC-MSCs offer unique advantages, such as noninvasive collection and fewer ethical concerns. This systematic review and meta-analysis summarizes data from 13 randomized controlled trials, which included a total of 693 patients. Their study shows that UC-MSCs significantly improved left ventricular ejection fraction by 5.08% at 6 months and 2.78% at 12 months compared with controls, while BM-MSCs showed no significant effect. Neither cell type showed significant changes in 6-minute walk distance. In addition, UC-MSCs and BM-MSCs had comparable safety profiles, with no significant differences in major adverse cardiac events, except for a lower rehospitalization rate observed with BM-MSCs. These results position UC-MSCs as a promising alternative in MSC-based therapies for cardiac disease, offering potential improvements in cardiac function while maintaining a favorable safety profile. Future research should focus on optimizing administration protocols and further exploring the long-term benefits and mechanisms of UC-MSCs in cardiac repair.

The Role of Kinesiotherapy in Enhancing Physical Performance and Self-Esteem: A Prospective Observational Study in Obese Adolescents

Obesity is a multifactorial chronic condition characterized by excessive fat accumulation, which adversely affects health and quality of life. This prospective observational study aimed to evaluate the impact of a 9-month tailored kinesiotherapy program on physical performance, body composition, and self-esteem in overweight and obese adolescents. Participants were divided into a study group (SG, n=40) and a control group (CG, n=40). The SG engaged in individualized kinesiotherapy sessions, while the CG maintained their usual activities. Both groups received education on the 5-2-1-0 rule for obesity prevention and management. Results indicated significant improvements in the SG, including enhancements in the 6-minute walk distance (6MWD), Timed Up-and-Go test (TUG), and Rosenberg Self-Esteem Scale (all p &lt; 0.001). Notably, BMI and body fat percentage decreased significantly in the SG compared to the CG. Regression analysis revealed strong correlations between body composition, physical performance, and self-esteem improvements, particularly in girls and rural participants, highlighting the intervention's adaptability and effectiveness. Although limited by a relatively small sample size, short duration, and variability in adherence tracking, the study highlights the essential role of individualized physical activity programs in improving health outcomes. In conclusion, the findings from our study emphasize the significant role of individualized kinesiotherapy programs in improving physical and psychological health outcomes in overweight/obese adolescents. By integrating instrumental assessments, such as the BTS system, with subjective evaluations like PAQ-A and the Rosenberg scale, our study high-lights the multifaceted impact of physical activity on this vulnerable population.

Longitudinal anemia status and risk for adverse outcomes in former smokers with COPD

BackgroundAnemia is a prevalent comorbidity in COPD associated with increased morbidity. However, the significance of longitudinal anemia status and variation in anemia status trends over time in COPD are not known. Furthermore, individuals with COPD and smoking history often have multiple comorbidities, in particular cardiovascular disease. The objective of this study was to evaluate the association between longitudinal anemia status and COPD outcomes, accounting for comorbid cardiovascular disease.MethodsSerial hemoglobin measures and clinical outcomes were obtained in former smokers with moderate to severe COPD from two clinical studies over a 6-to-9-month period. In the first analysis, the association between repeated measures of time-varying anemia status and outcomes was assessed by generalized estimating equations adjusted for covariates including cardiovascular disease. In the second analysis, each participant’s anemia risk profile during the study period was characterized as high versus low anemia risk-growth rate. Mean differences in the progression of COPD outcomes over time between the two groups were assessed using a generalized linear mixed model. Effect modification by baseline coronary artery calcium (CAC) burden was explored.ResultsThere were 159 individuals with mean age of 66.5 years (± 8.3) and mean FEV1% predicted of 51.4% (± 17.0), of which 41% were ever-anemic during the study period. Repeated measures of anemia status were associated with higher St. George’s Respiratory Questionnaire (SGRQ) scores (β 2.5, 95% CI: 0.1,4.8, p = 0.04), lower 6-minute walk distance (6MWD) (β -38.6, 95% CI: -67.7,-7.4, p = 0.02), and higher rate of moderate-to-severe exacerbations over the prospective follow-up period (IRR 1.8, 95% CI: 1.1,2.8, p = 0.02). There was effect modification by CAC burden such that with higher burden the mean difference in COPD outcome by anemia status was greater for a subset of symptom scores. Participants with profiles of increasing anemia risk had higher estimated rates of decline in the FEV1% predicted and 6MWD and increase in SGRQ scores compared to those with stable or decreasing anemia risk.ConclusionsLongitudinal anemia status trends may be predictive of COPD disease trajectory. Anemia status by repeated measures analysis is associated with COPD morbidity with potentially stronger associations in the setting of high CAC burden.

Comparison of Physical Activity Level and Functional Capacity in Patients with Type 2 Diabetes Mellitus and Healthy Controls.

Background: Physical activity improves glycemic control in T2DM. It may also influence functional capacity and thus improve quality of life. Despite evidence of exercise benefits, majority of people with type 2 diabetes are physically inactive and are less likely to meet the recommendations for physical activity. However, there is no readily available literature demonstrating the functional capacity in Indian subjects diagnosed with T2DM. Purpose: The aim of this study was to compare physical activity level and functional capacity in patients with Type 2 Diabetes Mellitus (T2DM) and healthy controls. Materials and Methods: In this study, 30 patients with T2DM and 30 age, gender and BMI matched healthy controls who met the inclusion criteria were recruited for the study after taking a written consent. The physical activity level was assessed using International Physical Activity Questionnaire (IPAQ) and functional capacity was assessed with 6 Minute Walk Distance (6MWD). The IPAQ score, IPAQ sitting hours and 6MWD were compared between the 2 groups. Data was tested for normality. Unpaired t test was used to compare Age and BMI between groups for matching. Unpaired t test was used to compare 6MWD between both the groups and Mann Whitney U test was used to compare IPAQ score and IPAQ sitting hours between both the groups. Results: The study demonstrates T2DM patients have reduced functional capacity as compared to control group. A difference of 68.4 meters in 6MWD [p=0.000] was observed with no difference in physical activity levels between the two groups. Conclusion: T2DM patients have reduced functional capacity as compared to control group. The mechanism of impaired functional capacity appears to be associated with the disease process. Therefore, early exercise prescription and physical fitness for improving glycemic control and functional capacity in T2DM patients is essential.