Dataset Information

Remotely monitored Baduanjin exercise in moderate-to-severe chronic obstructive pulmonary disease patients (BROCADE): A study protocol.

ABSTRACT:

Background

Baduanjin is a traditional Chinese exercise regimen used to treat various chronic illnesses and is associated with both psychological and physical benefits. However, its benefits for patients suffering from chronic obstructive pulmonary disease (COPD) are unclear. This study aims to assess the efficacy, safety, and underlying mechanisms of Baduanjin exercise in patients with moderate-to-severe COPD (BROCADE) by remote monitoring.

Methods

This study protocol describes a multicenter, open-label, prospective randomized computed tomography. A total of 150 individuals who meet the inclusion criteria after the screening and consent processes will take part in the study. All participants will be provided routine medication and lifestyle interventions. They will be randomly assigned to a control group, a classical pulmonary rehabilitation group, or a Baduanjin group, which will undergo remotely monitored Baduanjin exercises for a cumulative duration of 1 hour per day, three times per week for 12 weeks. The participants will be followed for 24 weeks. The primary outcomes will be a 6-minutes walking distance and St. George's Respiratory Questionnaire index. The secondary outcomes will be lung function, cross-sectional area of the pectoralis major and subcutaneous fat, modified Medical Research Council score, COPD assessment test questionnaire results, extremity muscle strength, and quality of life. Any adverse events that may occur will be monitored and recorded.

Results

This study is ongoing and will be submitted to a peer-reviewed journal for publication once completed.

Conclusion

A novel neutrophil-related inflammatory mechanism will potentially be identified. In addition, the study results will provide a safe, effective, simple and operational Baduanjin exercise protocol for moderate-to-severe COPD patients aimed at improving prognosis and quality of life.

SUBMITTER: Xu S

PROVIDER: S-EPMC9803505 | biostudies-literature | 2022 Dec

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Remotely monitored Baduanjin exercise in moderate-to-severe chronic obstructive pulmonary disease patients (BROCADE): A study protocol.

Xu Shuanglan S Yin Zhifei Z Chen Zi Z Zhang Dandan D Ye Sheng S Zhou Ping P Chen Aiping A Wu Di D Liu Weihua W Zhang Liuchao L Guo Liquan L Xu Guangxu G Zhou Linfu L

Medicine 20221201 52

<h4>Background</h4>Baduanjin is a traditional Chinese exercise regimen used to treat various chronic illnesses and is associated with both psychological and physical benefits. However, its benefits for patients suffering from chronic obstructive pulmonary disease (COPD) are unclear. This study aims to assess the efficacy, safety, and underlying mechanisms of Baduanjin exercise in patients with moderate-to-severe COPD (BROCADE) by remote monitoring.<h4>Methods</h4>This study protocol describes a ...[more]

PMID: 36596062

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Project description:BackgroundPediatric applications of non-invasive brain stimulation using transcranial direct current stimulation (tDCS) have demonstrated its safety with few adverse events reported. Remotely monitored tDCS, as an adjuvant intervention to rehabilitation, may improve quality of life for children with cerebral palsy (CP) through motor function improvements, reduced treatment costs, and increased access to tDCS therapies. Our group previously evaluated the feasibility of a remotely monitored mock tDCS setup in which families and children successfully demonstrated the ability to follow tDCS instructional guidance.Methods and designHere, we designed a protocol to investigate the feasibility, safety, and tolerability of at-home active transcranial direct current stimulation in children with CP with synchronous supervision from laboratory investigators. Ten participants will be recruited to participate in the study for 5 consecutive days with the following sessions: tDCS setup practice on day 1, sham tDCS on day 2, and active tDCS on days 3-5. Sham stimulation will consist of an initial 30-second ramp up to 1.5 mA stimulation followed by a 30-second ramp down. Active stimulation will be delivered at 1.0 - 1.5 mA for 20 minutes and adjusted based on child tolerance. Feasibility will be evaluated via photographs of montage setup and the quality of stimulation delivery. Safety and tolerability will be assessed through an adverse events survey, the Box and Blocks Test (BBT) motor assessment, and a setup ease/comfort survey.DiscussionWe expect synchronous supervision of at-home teleneuromodulation to be tolerable and safe with increasing stimulation quality over repeated sessions when following a tDCS setup previously determined to be feasible. The findings will provide opportunity for larger clinical trials exploring efficacy and illuminate the potential of remotely monitored tDCS in combination with rehabilitation interventions as a means of pediatric neurorehabilitation. This will demonstrate the value of greater accessibility of non-invasive brain stimulation interventions and ultimately offer the potential to improve care and quality of life for children and families with CP.Trial registrationOctober 8, 2021( https://clinicaltrials.gov/ct2/show/NCT05071586 ).

Project description:Baduanjin has been shown to be an effective method of exercise for promoting body function in patients with chronic obstructive pulmonary disease (COPD). However, this method is rarely used by rural doctors in rural communities. The aim of this study was to compare the therapeutic effects of Baduanjin exercise with those of conventional pulmonary rehabilitation (CPR) implemented by rural doctors in patients with COPD. A total of 472 COPD patients from 18 village clinics were randomly allocated to the Baduanjin group (n = 158), CPR group (n = 154), or control group (n = 160). The Baduanjin group received six months of Baduanjin training, the CPR group received six months of rehabilitation training, and the control group received usual care. The primary outcomes were changes in health status, as measured by the COPD Assessment Test (CAT), and dyspnoea, as assessed via the modified Medical Research Council (mMRC) dyspnoea scale. The secondary outcomes included six-minute walking distance (6MWD) performance and anxiety and depression scores on the Hospital Anxiety and Depression Scale (HADS-A and HADS-D, respectively). Baseline data were collected before randomization, and outcomes were ascertained at the six-month follow-up by blinded assessors. After six months of training, compared with the control group, the Baduanjin group presented significant improvements in CAT scores (t = 5.121, P < 0.001), mMRC scale scores (t = 5.719, P < 0.001), 6MWD performance (t = 12.608, P < 0.001), HADS-A scores (t = 6.210, P < 0.001), and HADS-D scores (t = 2.945, P = 0.010). The CPR group also presented significant improvements in CAT scores (t = 4.725, P < 0.001), mMRC scale scores (t = 5.499, P < 0.001), 6MWD performance (t = 11.662, P < 0.001), HADS-A scores (t = 5.697, P < 0.001), and HADS-D scores (t = 2.671, P = 0.023). In contrast, the control group participants showed no significant changes in CAT scores (t = -0.252, P = 0.801), mMRC scale scores (t = -0.085, P = 0.932), 6MWD performance (t = -0.463, P = 0.644), HADS-A scores (t = -2.75, P = 0.783), or HADS-D scores (t = -0.281, P = 0.779). No adverse events were reported during the study. The positive effects of Baduanjin exercise on the subjective symptoms of COPD patients are similar to those of CPR. The trial was registered with the Chinese Clinical Trials Registry (reference: ChiCTR-TRC-12001958) (22/02/2012).

Project description:BackgroundTraumatic brain injury (TBI) may impact an individual physically, cognitively, socially, and emotionally. Poor balance, reduced mobility, and low daily physical activity often will require ongoing physical rehabilitation intervention. However, face-to-face specialized physiotherapy is not always accessible for individuals living in rural settings.ObjectiveWe will answer four questions: (1) What is the feasibility of a remotely supervised, home-based, intensive exercise intervention with survivors of moderate and severe TBI? (2) Does the frequency of remote supervision have an impact on the feasibility of completing a home-based intensive exercise program? (3) Does the frequency of remote supervision impact balance, functional mobility, and physical activity? (4) What is the lived experience of remote supervision for both survivors and caregivers?MethodsFour participants will complete two intensive, 4-week (five days per week) home-based exercise interventions remotely supervised via synchronous videoconference. Each exercise intervention will have a goal of 160 to 300 repetitions or 60 minutes of tailored exercises to promote neuroplasticity and be defined as an intensive home-based exercise intervention. An alternating single-subject design will allow for the comparison between two frequencies of remote supervision, once weekly and five times weekly. Daily repeated outcome measures, pre- and postintervention outcome measures, and 1-month follow-up outcome measures will be collected to explore the effect on feasibility and physical variables. Daily outcome measures include step count and Five Times Sit-to-Stand test. Pre-post measures include assessment of quiet stance and the Community Balance and Mobility Scale. A semistructured interview will be completed at the end of each intervention segment to document the lived experience of both survivors and their study partners. Finally, five questionnaires will be used to understand the overall experience: the Mayo-Portland Adaptability Inventory-4 Participation Index, Satisfaction With Life Scale, Fall Efficacy Scale-International, Interpersonal Behavior Questionnaire, and System Usability Scale. Data will be analyzed following traditional single-subject methods of analysis.ResultsEthics approval was received from both the Bruyère Research Institute and University of Ottawa review boards in March 2019. Recruitment is underway.ConclusionsThe proposed intervention is complex in nature due to the involvement of multiple technology sources and the inclusion of a complex dyad (survivors and caregivers) in a community setting. This type of research is timely given that alternative methods of physical intervention delivery are needed to facilitate gains in balance, mobility, physical activity among TBI survivors with limited access to clinical care, and the quality of the patients' experience.International registered report identifier (irrid)PRR1-10.2196/14867.

Project description:BACKGROUND:Revefenacin is a long-acting muscarinic antagonist that was recently approved for the nebulized treatment of chronic obstructive pulmonary disease (COPD). Although shorter duration studies have documented the efficacy of revefenacin in COPD, longer-term efficacy has not been described. In a recent 52-week safety trial, revefenacin was well tolerated and had a favorable benefit-risk profile. Here we report exploratory efficacy and health outcomes in patients receiving revefenacin 175 μg or 88 μg daily during the 52-week trial. METHODS:In this randomized, parallel-group, 52-week trial (NCT02518139), 1055 participants with moderate to very severe COPD received revefenacin 175 μg or 88 μg in a double-blind manner, or open-label active control tiotropium. RESULTS:Over the 52-week treatment period, both doses of revefenacin, as well as tiotropium, elicited significant (all p < 0.0003) improvements from baseline in trough forced expiratory volume in 1 s (FEV1). The trough FEV1 profile (least squares mean change from baseline) for revefenacin 175 μg ranged from 52.3-124.3 mL and the trough FEV1 profile for tiotropium ranged from 79.7-112.8 mL. In subgroup comparisons, the effect of revefenacin on trough FEV1 was comparable in patients taking concomitant long-acting β-agonists, with or without inhaled corticosteroids, with patients who were not taking these medications. There were statistically significant (p < 0.05) improvements in all measured health status outcomes (evaluated using St. George's Respiratory Questionnaire, COPD Assessment Test, Clinical COPD Questionnaire and Baseline and Transition Dyspnea Index) from 3 months onward, in all treatment arms. CONCLUSIONS:Significant sustained improvements from baseline in trough FEV1 and respiratory health outcomes were demonstrated for 175-μg revefenacin over 52 weeks, further supporting its use as a once-daily bronchodilator for the nebulized treatment of patients with COPD. TRIAL REGISTRATION:NCT02518139 ; Registered 5 August 2015.

Dataset Information

Remotely monitored Baduanjin exercise in moderate-to-severe chronic obstructive pulmonary disease patients (BROCADE): A study protocol.

Background

Methods

Results

Conclusion

Publications

Remotely monitored Baduanjin exercise in moderate-to-severe chronic obstructive pulmonary disease patients (BROCADE): A study protocol.

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