A randomized controlled trial of supplemental oxygen versus air in cancer patients with dyspnea

2003 ◽  
Vol 17 (8) ◽  
pp. 659-663
Author(s):  
Eduardo Bruera ◽  
Catherine Sweeney ◽  
Jie Willey ◽  
J Lynn Palmer ◽  
Florian Strasser ◽  
...  
Keyword(s):  
Controlled Trial ◽  
Treatment Phase ◽  
Supplemental Oxygen ◽  
Comprehensive Cancer Center ◽  
Cancer Center ◽  
Walk Test ◽  
Shortness Of Breath ◽  
Double Blind ◽  
6 Minute Walk Test ◽  
Minute Walk

Context: The symptomatic benefits of oxygen in patients with cancer who have nonhypoxic dyspnea are not well defined. Objective: To determine whether or not oxygen is more effective than air in decreasing dyspnea and fatigue and increasing distance walked during a 6-minute walk test. Patients and methods: Patients with advanced cancer who had no severe hypoxemia (i.e., had an O2 saturation level of] / 90%) at rest and had a dyspnea intensity of] / 3 on a scale of 0–10 (03/4/no shortness of breath, 103/4/worst imaginable shortness of breath) were recruited from an outpatient thoracic clinic at a comprehensive cancer center. This was a double-blind, randomized crossover trial. Supplemental oxygen or air (5 L/min) was administered via nasal cannula during a 6-minute walk test. The outcome measures were dyspnea at 3 and 6 minutes, fatigue at 6 minutes, and distance walked. We also measured oxygen saturation levels at baseline, before second treatment phase, and at the end of study. Results: In 33 evaluable patients (31 with lung cancer), no significant differences between treatment groups were observed in dyspnea, fatigue, or distance walked (dyspnea at 3 minutes: P = 0.61; dyspnea, fatigue, and distance walked at 6 minutes: P = 0.81, 0.37, and 0.23, respectively). Conclusions: Currently, the routine use of supplemental oxygen for dyspnea during exercise in this patient population cannot be recommended.

scholarly journals Feasibility and Acceptability of a Physical Activity Tracker and Text Messages to Promote Physical Activity During Chemotherapy for Colorectal Cancer: Pilot Randomized Controlled Trial (Smart Pace II)

JMIR Cancer ◽  
10.2196/31576 ◽  
2022 ◽  
Vol 8 (1) ◽  
pp. e31576
Author(s):  
Erin L Van Blarigan ◽  
Anand Dhruva ◽  
Chloe E Atreya ◽  
Stacey A Kenfield ◽  
June M Chan ◽  
...  
Keyword(s):  
Physical Activity ◽  
Digital Health ◽  
Controlled Trial ◽  
Text Message ◽  
Text Messages ◽  
Walk Test ◽  
Randomized Controlled ◽  
6 Minute Walk Test ◽  
Minute Walk

Background We conducted a pilot 2-arm randomized controlled trial to assess the feasibility of a digital health intervention to increase moderate-to-vigorous physical activity in patients with colorectal cancer (CRC) during chemotherapy. Objective This study aimed to determine whether a digital health physical activity intervention is feasible and acceptable during chemotherapy for CRC. Methods Potentially eligible patients with CRC expected to receive at least 12 weeks of chemotherapy were identified in person at the University of California, San Francisco, and on the web through advertising. Eligible patients were randomized 1:1 to a 12-week intervention (Fitbit Flex, automated SMS text messages) versus usual care. At 0 and 12 weeks, patients wore an Actigraph GT3X+ accelerometer for 7 days and completed surveys, body size measurements, and an optional 6-minute walk test. Participants could not be masked to their intervention arm, but people assessing the body size and 6-minute walk test outcomes were masked. The primary outcomes were adherence (eg, Fitbit wear and text response rate) and self-assessed acceptability of the intervention. The intervention would be considered feasible if we observed at least 80% complete follow-up and 70% adherence and satisfaction, a priori. Results From 2018 to 2020, we screened 240 patients; 53.3% (128/240) of patients were ineligible and 26.7% (64/240) declined to participate. A total of 44 patients (44/240, 18%) were randomized to the intervention (n=22) or control (n=22) groups. Of these, 57% (25/44) were women; 68% (30/44) identified as White and 25% (11/44) identified as Asian American or Pacific Islander; and 77% (34/44) had a 4-year college degree. The median age at enrollment was 54 years (IQR 45-62 years). Follow-up at 12 weeks was 91% (40/44) complete. In the intervention arm, patients wore Fitbit devices on a median of 67 out of 84 (80%) study days and responded to a median of 17 out of 27 (63%) questions sent via SMS text message. Among 19 out of 22 (86%) intervention patients who completed the feedback survey, 89% (17/19) were satisfied with the Fitbit device; 63% (12/19) were satisfied with the SMS text messages; 68% (13/19) said the SMS text messages motivated them to exercise; 74% (14/19) said the frequency of SMS text messages (1-3 days) was ideal; and 79% (15/19) said that receiving SMS text messages in the morning and evening was ideal. Conclusions This pilot study demonstrated that many people receiving chemotherapy for CRC are interested in participating in digital health physical activity interventions. Fitbit adherence was high; however, participants indicated a desire for more tailored SMS text message content. Studies with more socioeconomically diverse patients with CRC are required. Trial Registration ClinicalTrials.gov NCT03524716; https://clinicaltrials.gov/ct2/show/NCT03524716

scholarly journals Treatment with human umbilical cord-derived mesenchymal stem cells for COVID-19 patients with lung damage: a randomised, double-blind, placebo-controlled phase 2 trial

2020 ◽  
Author(s):  
Lei Shi ◽  
Hai Huang ◽  
Xuechun Lu ◽  
Xiaoyan Yan ◽  
Xiaojing Jiang ◽  
...  
Keyword(s):  
Lung Lesion ◽  
Lung Damage ◽  
Human Umbilical Cord ◽  
Lesion Volume ◽  
Walk Test ◽  
Double Blind ◽  
Phase 2 Trial ◽  
6 Minute Walk Test ◽  
To Receive ◽  
Minute Walk

AbstractBACKGROUNDTreatment of severe Corona Virus Disease 2019 (COVID-19) is challenging. We performed a phase 2 trial to assess the efficacy and safety of human umbilical cord-mesenchymal stem cells (UC-MSCs) to treat severe COVID-19 patients with lung damage, based on our phase 1 data.METHODSIn this randomized, double-blind, and placebo-controlled trial, we recruited 101 severe COVID-19 patients with lung damage. They were randomly assigned to receive either UC-MSCs (4 × 107 cells per infusion) or placebo on day 0, 3, and 6. The primary endpoint was an altered proportion of whole lung lesion volumes from baseline to day 28. Other imaging outcomes, 6-minute walk test, maximum vital capacity, diffusing capacity, and adverse events were recorded and analysed.RESULTS100 COVID-19 patients were finally recruited to receive either UC-MSCs (n = 65) or placebo (n = 35). UC-MSCs administration exerted numerical improvement in whole lung lesion volume from baseline to day 28 compared with the placebo (the median difference was -13.31%, 95%CI -29.14%, 2.13%, P=0.080). UC-MSCs significantly reduced the proportions of solid component lesion volume compared with the placebo (median difference: -15.45%; 95% CI -30.82%, -0.39%; P=0.043). The 6-minute walk test showed an increased distance in patients treated with UC-MSCs (difference: 27.00 m; 95% CI 0.00, 57.00; P=0.057). The incidence of adverse events was similar in the two groups.CONCLUSIONSUC-MSCs treatment is a safe and potentially effective therapeutic approach for COVID-19 patients with lung damage. (Funded by The National Key R&D Program of China and others. ClinicalTrials.gov number, NCT04288102.)

COMPLEX ESTIMATE OF THE TEST OF A 6-MINUTE WALK IN PATIENTS WITH CHRONIC OBSTRUCTIVE LUNG DISEASE

2021 ◽  
pp. 146-149
Author(s):  
Андрей Петрович Бабкин
Keyword(s):  
The Body ◽  
Pulmonary Diseases ◽  
Physical Work ◽  
Control Group ◽  
Chronic Obstructive ◽  
Walk Test ◽  
Shortness Of Breath ◽  
Chronic Pulmonary Diseases ◽  
6 Minute Walk Test ◽  
Minute Walk

Одним из важных проявлений большинства хронических легочных заболеваний является одышка, которая, в свою очередь, становится основной причиной ограничения переносимости физических нагрузок. Снижение физической толерантности у больных, страдающих хроническими легочными заболеваниями, обусловлено неспособностью организма обеспечивать необходимое поступление кислорода во время нагрузки, а в клиническом отношении - с невозможностью для пациента выполнять ту физическую работу, которую мог выполнять ранее. Среди методов оценки переносимости физических нагрузок используют кардиопульмонарное тестирование на велоэргометре, тредмиле, которое требует обязательного присутствия врача, что не всегда возможно в амбулаторных условиях. В ряде работ показана достаточная эффективность для диагностики состояния больного и оценки переносимости нагрузки использование для этой цели теста 6-минутный ходьбы. Это тест с ходьбой в произвольном темпе в течение 6 мин. Результатом теста является расстояние, которое больной может быстро пройти по ровной твердой поверхности за 6 мин. Расстояние, пройденное в тесте 6-минутной ходьбы, имеет прогностическое значение при многих заболеваниях, включая ХОБЛ. В данной статье оценивается комплексная оценка модифицированного теста 6-минутной ходьбы у больных ХОБЛ с использованием динамической пульcоксиметрии, которая расширяет диагностические возможности нагрузочного тестирования. Показано, что параллельно нарастанию выраженности одышки у больных снижается сатурация кислорода с постепенным восстановлением в покое. В контрольной группе, несмотря на сопоставимую с больными ХОБЛ одышку, оцениваемую по шкале Борга, насыщение крови кислородом не менялось. Комплексная оценка теста 6-минутной ходьбы поможет объективизировать эффективность проводимых лечебных и профилактических мероприятий у больных с ХОБЛ One of the important manifestations of most chronic pulmonary diseases is a shortness of breath, which, in turn, becomes the main reason for the restability of physical exertion. A decrease in physical tolerance in patients suffering from chronic pulmonary diseases is due to the inability of the body to provide the necessary flow of oxygen during the load, and in the clinical terms - with the impossibility of the patient to carry out that physical work that could be performed earlier. Among the methods for estimating the tolerability of physical loads, cardiopulmonary testing on the bikergometr, tredmil, which requires the mandatory presence of a doctor, which is not always possible in the outpatient conditions. A number of work shows sufficient efficiency for the diagnostic of the patient's condition and the use of load portability to use for this purpose a 6-minute walk. This is a walking speed in an arbitrary pace for 6 minutes. The result of the test is the distance that the patient can quickly go through a smooth solid surface for 6 minutes. The distance traveled in a 6-minute walk test is prognostic in many diseases, including COPD. This article is estimated to be an integrated assessment of a 6-minute walk test using a dynamic pulse oximetry, which expands the diagnostic capabilities of load testing. It has been shown that in parallel increasing the severity of shortness of breath in patients decreases the saturation of oxygen with gradual restoration alone. In the control group, despite comparable with sickness patient with COPD, the oxygen saturation estimated on the Borg scale did not change. A comprehensive test assessment of a 6-minute walk will help to facility the effectiveness of therapeutic and preventive measures to patients with COPD

scholarly journals A secondary analysis of data from the OPTICARE randomized controlled trial investigating the effects of extended cardiac rehabilitation on functional capacity, fatigue, and participation in society

2019 ◽  
Vol 33 (8) ◽  
pp. 1355-1366
Author(s):  
Nienke ter Hoeve ◽  
Madoka Sunamura ◽  
Henk J Stam ◽  
Ron T van Domburg ◽  
Rita JG van den Berg-Emons
Keyword(s):  
Cardiac Rehabilitation ◽  
Functional Capacity ◽  
Controlled Trial ◽  
Secondary Analysis ◽  
Walk Test ◽  
Face To Face ◽  
Randomized Controlled ◽  
After Care ◽  
6 Minute Walk Test ◽  
Minute Walk

Objective: In this secondary analysis of data from the OPTICARE trial, we compared the effects of two behavioral interventions integrated into cardiac rehabilitation to standard rehabilitation with regard to functional capacity, fatigue, and participation in society. Design: This is a randomized controlled trial. Setting: This study was conducted in a cardiac rehabilitation setting. Subjects: A total of 740 patients with acute coronary syndrome were recruited for this study. Interventions: Patients were randomized to (1) three months of standard rehabilitation; (2) cardiac rehabilitation plus nine months after-care with face-to-face group lifestyle counseling; or (3) cardiac rehabilitation plus nine months after-care with individual lifestyle telephone counseling. Main measures: Functional capacity (6-minute walk test), fatigue (Fatigue Severity Scale), and participation in society (Utrecht Scale for Evaluation of Rehabilitation-Participation) were measured at randomization, 3, 12, and 18 months. Results: Additional face-to-face sessions resulted at 12 months in 12.49 m more on the 6-minute walk test compared to standard rehabilitation ( P = .041). This difference was no longer present at 18 months. Prevalence of fatigue decreased from 30.2% at baseline to 11.9% at 18 months compared to an improvement from 37.3% to 24.9% after standard rehabilitation (between-group difference: odds ratio = 0.47; P = .010). The additional improvements in functional capacity seemed to be mediated by increases in daily physical activity. No mediating effects were found for fatigue. No additional improvements were seen for participation in society. Additional telephonic sessions did not result in additional intervention effects. Conclusion: Extending cardiac rehabilitation with a face-to-face behavioral intervention resulted in additional long-term improvements in fatigue and small improvements in functional capacity up to 12 months. A telephonic behavioral intervention provided no additional benefits.

scholarly journals Feasibility and Acceptability of a Physical Activity Tracker and Text Messages to Promote Physical Activity During Chemotherapy for Colorectal Cancer: Pilot Randomized Controlled Trial (Smart Pace II) (Preprint)

2021 ◽  
Author(s):  
Erin L Van Blarigan ◽  
Anand Dhruva ◽  
Chloe E Atreya ◽  
Stacey A Kenfield ◽  
June M Chan ◽  
...  
Keyword(s):  
Physical Activity ◽  
Digital Health ◽  
Controlled Trial ◽  
Text Message ◽  
Text Messages ◽  
Walk Test ◽  
Randomized Controlled ◽  
6 Minute Walk Test ◽  
Minute Walk

BACKGROUND We conducted a pilot 2-arm randomized controlled trial to assess the feasibility of a digital health intervention to increase moderate-to-vigorous physical activity in patients with colorectal cancer (CRC) during chemotherapy. OBJECTIVE This study aimed to determine whether a digital health physical activity intervention is feasible and acceptable during chemotherapy for CRC. METHODS Potentially eligible patients with CRC expected to receive at least 12 weeks of chemotherapy were identified in person at the University of California, San Francisco, and on the web through advertising. Eligible patients were randomized 1:1 to a 12-week intervention (Fitbit Flex, automated SMS text messages) versus usual care. At 0 and 12 weeks, patients wore an Actigraph GT3X+ accelerometer for 7 days and completed surveys, body size measurements, and an optional 6-minute walk test. Participants could not be masked to their intervention arm, but people assessing the body size and 6-minute walk test outcomes were masked. The primary outcomes were adherence (eg, Fitbit wear and text response rate) and self-assessed acceptability of the intervention. The intervention would be considered feasible if we observed at least 80% complete follow-up and 70% adherence and satisfaction, a priori. RESULTS From 2018 to 2020, we screened 240 patients; 53.3% (128/240) of patients were ineligible and 26.7% (64/240) declined to participate. A total of 44 patients (44/240, 18%) were randomized to the intervention (n=22) or control (n=22) groups. Of these, 57% (25/44) were women; 68% (30/44) identified as White and 25% (11/44) identified as Asian American or Pacific Islander; and 77% (34/44) had a 4-year college degree. The median age at enrollment was 54 years (IQR 45-62 years). Follow-up at 12 weeks was 91% (40/44) complete. In the intervention arm, patients wore Fitbit devices on a median of 67 out of 84 (80%) study days and responded to a median of 17 out of 27 (63%) questions sent via SMS text message. Among 19 out of 22 (86%) intervention patients who completed the feedback survey, 89% (17/19) were satisfied with the Fitbit device; 63% (12/19) were satisfied with the SMS text messages; 68% (13/19) said the SMS text messages motivated them to exercise; 74% (14/19) said the frequency of SMS text messages (1-3 days) was ideal; and 79% (15/19) said that receiving SMS text messages in the morning and evening was ideal. CONCLUSIONS This pilot study demonstrated that many people receiving chemotherapy for CRC are interested in participating in digital health physical activity interventions. Fitbit adherence was high; however, participants indicated a desire for more tailored SMS text message content. Studies with more socioeconomically diverse patients with CRC are required. CLINICALTRIAL ClinicalTrials.gov NCT03524716; https://clinicaltrials.gov/ct2/show/NCT03524716

Direct Myocardial Implantation of Human Fetal Stem Cells in Heart Failure Patients: Long-term Results

2010 ◽  
Vol 13 (1) ◽  
pp. 31 ◽  
Author(s):  
Federico Benetti ◽  
Ernesto Pe�herrera ◽  
Teodoro Maldonado ◽  
Yan Duarte Vera ◽  
Valvanur Subramanian ◽  
...  
Keyword(s):  
Heart Failure ◽  
Stem Cells ◽  
Cardiac Function ◽  
Nyha Class ◽  
Left Ventricular ◽  
Long Term Results ◽  
Walk Test ◽  
The Mean ◽  
6 Minute Walk Test ◽  
Minute Walk

Background: End-stage heart failure (HF) is refractory to current standard medical therapy, and the number of donor hearts is insufficient to meet the demand for transplantation. Recent studies suggest autologous stem cell therapy may regenerate cardiomyocytes, stimulate neovascularization, and improve cardiac function and clinical status. Although human fetal-derived stem cells (HFDSCs) have been studied for the treatment of a variety of conditions, no clinical studies have been reported to date on their use in treating HF. We sought to determine the efficacy and safety of HFDSC treatment in HF patients.Methods and Results: Direct myocardial transplantation of HFDSCs by open-chest surgical procedure was performed in 10 patients with HF due to nonischemic, nonchagasic dilated cardiomyopathy. Before and after the procedure, and with no changes in their preoperative doses of medications (digoxin, furosemide, spironolactone, angiotensin-converting enzyme inhibitors, angiotensin receptor blockers, betablockers), patients were assessed for New York Heart Association (NYHA) class, performance in the exercise tolerance test (ETT), ejection fraction (EF), left ventricular end-diastolic dimension (LVEDD) via transthoracic echocardiography, performance in the 6-minute walk test, and performance in the Minnesota congestive HF test. All 10 patients survived the operation. One patient had a stroke 3 days after the procedure, and although she later recovered, she was unable to perform the follow-up tests. Another male patient experienced pericardial effusion 3 weeks after the procedure. Although it resolved spontaneously, the patient abandoned his control tests and died 5 months after the procedure. An autopsy of the myocardium suggested that new young cells were present in the cardiomyocyte mix. At 40 months, the mean (SD) NYHA class decreased from 3.4 0.5 to 1.33 0.5 (P = .001); the mean EF increased 31%, from 26.6% 4% to 34.8% 7.2% (P = .005); and the mean ETT increased 291.3%, from 4.25 minutes to 16.63 minutes (128.9% increase in metabolic equivalents, from 2.46 to 5.63) (P < .0001); the mean LVEDD decreased 15%, from 6.85 0.6 cm to 5.80 0.58 cm (P < .001); mean performance in the 6-minute walk test increased by 43.2%, from 251 113.1 seconds to 360 0 seconds (P = .01); the mean distance increased 64.4%, from 284.4 144.9 m to 468.2 89.8 m (P = .004); and the mean result in the Minnesota test decreased from 71 27.3 to 6 5.9 (P < .001).Conclusion: Although these initial findings suggest direct myocardial implantation of HFDSCs is feasible and improves cardiac function in HF patients at 40 months, more clinical research is required to confirm these observations.

Prognostic role of results of dynamic capnography in integral assessment of parameters of respiratory system in 6-minute walk test in patients with chronic heart failure

2020 ◽  
Vol 28 (3) ◽  
pp. 290-299
Author(s):  
Kira A. Ageeva ◽  
Evgenii V. Filippov
Keyword(s):  
Respiratory System ◽  
Prognostic Significance ◽  
Left Ventricular ◽  
Left Ventricular Ejection ◽  
Control Group ◽  
Walk Test ◽  
Ventricular Ejection Fraction ◽  
6Mwt Distance ◽  
6 Minute Walk Test ◽  
Minute Walk

Aim. To study the prognostic value of the results of dynamic capnography in the complex assessment of parameters of the respiratory system in 6-minute walk test in patients with chronic heart failure (CHF). Materials and Methods. 73 Patients were examined: the group of study included 48 patients with IIA or IIB stage CHF (mean age 57.94.6 years, 23 men), the control group included 25 practically healthy volunteers (mean age 47.63.5 years, 9 men). The patients were conducted complex determination of parameters of the respiratory system: clinical scaling before and after 6-minute walk test (6MWT), instrumental examinations including spirometry, capnography and pulse oximetry before, during and after physical activity. The analysis of survival was conducted on the basis of the dynamic follow-up of patients within 5 years (60 months). Results. In the analysis of parameters of dyspnea at rest, all the parameters were higher in the group of patients with CHF (р0.05). The distance walked by the patients with CHF in 6 minutes was 488.2390.84 m, which was significantly less than in the control group (815.6053.89 m, р=0.009). Dyspnea as the cause of stoppage/slowing down of walking in 6MWT, was also more often recorded in patients with CHF (93.83.0% and 48.05.1%, р=0.049). Besides, in 6MWT the patients noted: weakness in legs (50.15.0% in the group of CHF and 40.05.0% in the control group, р=0.014), palpitation (29.04.6% and 20.04.1%, respectively, р=0.004). Worsening of dyspnea parameters in 6MWT was more evident in patients with CHF than in the control group (р0.01). In the CHF group, hypocapnic type of ventilation was revealed in 6MWT, analysis of РЕТСО2 trend graphs revealed a wave-like increase in the parameters, the so called periodic breathing (PB). CO2 trend was recorded in CHF group in 58.31.0% of cases (the difference with the control group with р=0.046), the trend of heart rate in 18.80.3% of cases (р=0.027). Cox proportional hazards regression analysis of mortality in patients with CHF showed a prognostic significance of a complex model comprising the following parameters of a patient: body mass index (р=0.005), left ventricular end-diastolic dimension (р=0.034), left ventricular end-systolic dimension (р=0.002), left ventricular ejection fraction (р=0.041), 6MWT distance (р=0.004), desaturation (р=0.009), and the presence of signs of PB during 6MWT (р=0.005). Model coefficients were statistically significant at р0.0001. Conclusions. Dynamic capnography and pulse oximetry allow to identify signs of PB in patients with CHF during 6MWT which may deepen a complex assessment of parameters of the cardio-respiratory system in patients with CHF in order to determine tolerance to physical exercise as well as the effectiveness of the conducted treatment. Complex assessment of survival of patients with CHF showed prognostic significance of the following parameters of a patient: body mass index, left ventricular end-diastolic dimension, left ventricular end-systolic dimension, left ventricular ejection fraction, 6MWT distance, desaturation, PB during 6MWT.

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