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Effect of Sitting Baduanjin exercise on early rehabilitation of sepsis patients with non-invasive ventilation : a randomized controlled trial

BMC Complementary Medicine and Therapies volume 24, Article number: 330 (2024) Cite this article

Abstract

Background

For patients with sepsis receiving non-invasive ventilation (NIV), early rehabilitation is crucial. The Sitting Baduanjin (SBE) is an efficient early rehabilitation exercise suitable for bed patients. There is no consensus about the effect of SBE on the early rehabilitation of septic patients with NIV. This study focused on how the SBE affected the early rehabilitation of sepsis patients with NIV.

Methods

96 sepsis patients with NIV were randomly assigned to either an Baduanjin group that received the SBE based on the routine rehabilitation exercise (n = 48) or a control group (n = 48) that received routine rehabilitation exercise. The primary outcome was the Medical Research Council(MRC)score, and the Barthel Index score, the duration of NIV, length of ICU stay, length of total stay, hospitalization expense as secondary outcomes.

Results

A total of 245 sepsis patients were screened, with 96 randomly assigned. The study was completed by 90 patients out of the 96 participants.Results revealed that the MRC score increased in both groups, but the improvement of muscle strength in Baduanjin group was more obvious, with statistical significance (p < 0.001).There was statistically significantly difference between the two groups in Barthel Index at the day of transfer out of ICU(P = 0.028).The patients in the Baduanjin group had an average reduction of 24.09 h in the duration of NIV and 3.35 days in total length of hospital stay compared with the control group (p < 0.05).Of note, the Baduanjin group had significantly reduction the total hospitalization expense. No serious adverse events occurred during the intervention period.

Conclusions

In patients with sepsis, the SBE appears to improve muscle strength and activities of daily living (ADL), and lowed the duration of NIV, the length of the total stay, and the hospitalization expense.

Trial registration

The study registered on the Chinese Clinical Trial Registry (www.chictr.org.cn), Clinical Trials identifier ChiCTR1800015011 (28/02/2018).

Peer Review reports

Introduction

Sepsis is one of the most common causes of death among hospitalized patients in the intensive care unit (ICU) [1]. It affects more than 1 million patients in the United States annually and more than 30 million adults worldwide [2, 3].In the management of sepsis, clinicians usually focus on treatment of circulatory, renal and respiratory function. In addition, most patients receive sedative and analgesic drugs to help with pain and oxygen consumption [4]. Thus, this treatment regimen result in prolonged periods of unconsciousness and immobility. It affects the normal physiological function of critically ill patients and induces complications such as atelectasis, ICU-acquired weakness (ICU-AW) [5]. In recent years, rehabilitation has been important for the prevention and treatment of muscle atrophy and has become an important field of critical care [4, 6].Therefore, the rehabilitation treatment has become a routine treatment method in ICU sepsis patient management. It is safe and effective for patients to implement early rehabilitation exercises [7].

A randomized study showed that early mobilization, which promotes early and progressive activity (from exercise in bed to sitting, standing, and ultimately walking), reduced the duration of physical therapy, time to ambulation during hospitalization [5]. Some studies also suggest that early mobility intervention is associated with improved physical function at hospital discharge [7, 8]. Baduanjin, as a traditional Chinese medicine exercise therapy, is an effective early exercise rehabilitation method [9,10,11]. It can systematically mobilize the active joints and muscles, and modulate mind and spirit at the same time, ultimately achieving the integration of the mind and body [10, 12]. The Sitting Baduanjin exercise (SBE) is an improved rehabilitation exercise suitable for bed patients as shown. In our department, we have successfully implemented the SBE into the rehabilitation training in a patient with acute myocardial infarction or Dysfunctional ventilatory weaning response and achieved a better effect [13, 14]. However, the effect of rehabilitation in sepsis patients with Non-invasive ventilation(NIV)has not been evaluated until now. Therefore, we tried to evaluate whether the SBE in this study would affect the clinical outcome of sepsis patients with NIV.

Materials and methods

Trial design

This was a parallel, randomized controlled trial (RCT) in which participants were randomly allocated into either the Baduanjin group or the control group with an equal allocation ratio. Our study strictly complies with the guidelines of the CONSORT 2010 checklist [15].

Ethical approval and registration

The Guangdong Provincial Hospital of Chinese Medicine’s Human Research Ethics Committee approved this study(B2017-139-01). Also, we registered the study on the Chinese Clinical Trial Registry (Registration No.ChiCTR1800015011). It complies with the principles outlined in the Helsinki Declaration and the relevant regulations of the national regulatory agency.

Participants

From November 2017 to May 2019, participants were recruited from hospitalized patients in the ICU of The Second Clinical College of Guangzhou University of Chinese Medicine Eligibility criteria included patients who were diagnosed with sepsis, aged 18 to 80 years, and they were given NIV on admission; The delirium assessment (CAM-ICU) was normal. Inhalation oxygen concentration (FiO2) < 0.60; Respiratory rate < 30 bpm; Muscle strength ≥ 4; The primary disease and treatment plan were clear, and endotracheal intubation was not expected; Sepsis diagnostic criteria was a reference to the Third International Consensus Definitions for Sepsis and Septic Shock [16]. Exclusion criteria included participants with prior neuromuscular disease, including severe heart failure (NYHA cardiac function class IV or LVEF ≤ 35%), Guillain-Barre syndrome, muscle weakness, cardiogenic shock, and poor compliance. Written informed consent was obtained before the start of the study.

Randomization and masking

In a 1:1 allocation ratio, patients were randomly assigned to either the Baduanjin or the control groups. Biostatisticians used the R statistical programme to produce a random sequence to allocate assignments. These assignments were placed in sealed, opaque envelopes with date and signature labels placed over the seals. The trial coordinator unsealed the sequential randomization envelopes and informed the people of their group assignments following the baseline evaluation of patients. In our study, participants could not be blinded, but the researchers who collected the data and statistics were independent and uninformed.

Intervention

The control group was given routine rehabilitation exercises in the ICU, including the passive movement of limbs, active activities, and functional training. The participants were instructed to do bed activities, including forwarding bending, backward stretching, adduction, abduction, and pronation, for 15–20 min every day.

Participants in the Baduanjin group were given SBE on the base of the control group until they were transferred out of the ICU. The SBE has been developed by our team based on the characteristics of patients with Severe patients in ICU (Supplementary Appendix Video 1). It is composed of 8 types. Each type is done 4–8 times for 12 min each time. Patients exercise daily at 09:00 and 16:00 for 15–20 min each time depending on their physical strength. Two certified instructors were engaged to provide instruction and supervise the participants’ training.

Treatment will be discontinued if any of the following occurs: (1) The patient felt laborious, dizziness, sweating, fatigue and severe dyspnea, SpO2 < 90%; (2) Systolic blood pressure < 90 or > 200mmHg, mean arterial pressure < 65mmHg; (3) The FiO2 of NIV was greater than 60%;(4) The patient’s respiratory rate was greater than 35 times /min.

Outcome measures

The primary outcome was the Medical Research Council (MRC) score. Secondary outcomes included changes in Barthel Index (BI), the duration of NIV, length of ICU stay, length of total stay, ICU hospitalization expense, Total hospitalization expense.

MRC score

Muscle strength was evaluated by the MRC score which was measured at baseline, the 3rd and the day of transfer out of ICU. The MRC score is a 6-level muscle strength assessment method, with a score of 0 to 5 in each level. Muscle strength of bilateral upper limbs (wrist extension, elbow flexion, shoulder joint abduction), and bilateral lower limbs (dorsiflexion, knee extension, hip flexion) were evaluated [17].

Barthel index

The Barthel Index is an interview-based method for assessing to assess participants’ activities of daily living (ADL) [18]. It consists of ten items: feeding, bathing, grooming, clothing, bladder control, bowel control, toilet usage, moving, transferring, and stair climbing [19, 20].The full score is 100 points, < 20 points mean serious functional impairment, life is completely dependent; A score of 20–40 indicates a great need for help in life; A score of 41 ~ 60 indicates life needs; >60 points means basic self-care.

Calculation of sample size

MRC score was used as the primary outcome in this study.According to previous research [21], the control group can increase the average score of MRC by 12 points. Baduanjin can increase the average score of MRC by 24.5 points, and the standard deviation is about 20. According to the formula, \(\text{N}=[(\text{Z}^{1-\alpha} + \text{Z}^{1-\beta})(\text{S}/\Delta)]^2\). Each group’s sample size is around 41 cases for a total of 82 cases in the two groups. Given the dropout and loss of follow-up situation, it is projected that a 15% dropout (loss of follow-up) will necessitate 96 instances.

Statistical analyses

Data were reported as mean and standard deviation for continuous variables and as percentages for categorical variables. All data were analyzed by a blinded statistician using SPSS 22.0 software with significance set at an alpha level of 0.05. Independent t-tests, chi-square(χ2) tests and Kruskal-Wallis tests were used to examine the homogeneity of demographic and clinical information between the two groups at baseline.Repeated measures analysis of variance (ANOVA) was used to test for change over time (i.e.,baseline, Day3, and Out of ICU) in the MRC for the Baduanjin group and control group.Group comparisons were made by the Mann–Whitney U test for continuous variables and the chi-square test for categorical variables.

Results

Characteristics at baseline between the two groups

Totally 245 sepsis patients were screened, and 96 underwent randomization, including 48 and 48 in the Baduanjin group and the control group, respectively. During the study, 3 participants in the intervention group dropped out due to they could not insist on doing SBE every day. In the control group, 3 participants withdrew because of the deterioration of his condition, and his family abandoned treatment. The rest of the participants completed the whole study as required. Of the 96 participants, 90 total participants completed the entire study, yielding an attrition rate of 6.25%.

We obtained complete data from 90 cases as shown in Table 1. Table 1 shows the baseline characteristics of the study population. There was no significant difference between the two groups about baseline characteristics, including age, sex, BMI, Hypertension, History of diabetes, History of the smoker, History of drinking, LVEF, APACHE-II, SOFA, WBC, oxygenation index, Lactic acid, etc. (p > 0.05 ) (See Fig. 1).

Table 1 Baseline demographic characteristics of participants in two groups
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Fig. 1
figure 1

Inclusion and exclusion criteria for this study

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The participants’ performance of muscle strength and ADL

The participants’ performance of muscle strength was evaluated by MRC score, and the ADL was evaluated by Barthel Index as shown in Table 2. The MRC score of the Baduanjin group and the control group was baseline [49.60 (95% CI, 47.27–51.93) vs. 51.47 (95% CI, 48.80–54.13), p = 0.126], the 3rd day [52.38 (95% CI, 50.27–54.49] vs. 52.31 (95% CI, 49.55–55.07, p = 0.768], the transfer out of ICU [56.96 (95% CI, 55.69–58.22] vs. 53.49 (95% CI, 51.29– 55.68, p = 0.025]. A significant difference was found in the increase of the MRC score in the Baduanjin group (p < 0.001). However, there was a nonsignificant difference in the control group (p = 0.247). The result display that there was no significant difference in Barthel Index between the two groups on the baseline [40.78 (95%CI, 37.40–44.15] vs. 35.78 (95%CI, 30.90–40.66,p = 0.068]. However, the difference between the two groups was statistically significant at the day of transfer out of ICU [62.22 (95% CI, 59.36–69.09] vs. 55.00 (95% CI, 49.44–60.56, p = 0.028] (Fig. 2).

Table 2 The changes in participants ' performance of muscle strength and ADL
Full size table
Fig. 2
figure 2

The participants ' performance of muscle strength and ADL. Values are presented as median with the interquartile range.(A)The change of MRC score from baseline, Day3 and out of ICU. Intragroup comparison, ##P < 0.001,ns = no significance; Comparison among groups,*P<0.05,ns = no significance. (B) Barthel Inedex score between the two groups on the baseline and out of ICU.Comparison among groups,*P<0.05,ns = no significance

Full size image

The duration of NIV, length of ICU stay, and length of total stay between two group

In Table 3, the median time of Duration of NIV was 24.09 h shorter in the Baduanjin group than the control group [60.33 (95%CI, 52.66–68.00) vs. 84.42 (95%CI, 70.94–97.91), respectively,p = 0.038].Regarding the Length of stay, although the two groups had no statistically significant in the Length of ICU stay [5.07 (95%CI, 4.67–5.46) vs. 5.87(95%CI,5.16–6.57), respectively,p = 0.248], there was a considerable reduction in the Baduanjin group compared with the control group Length of total stay [7.82 (95%CI, 6.57–9.07) vs. 11.17(95%CI,9.28–13.07), respectively,p = 0.003](Fig. 3).

Table 3 The duration of NIV, length of ICU stay, and length of total stay between two group
Full size table
Fig. 3
figure 3

The duration of NIV, length of ICU stay, and length of total stay between two group. Values are presented as median with the interquartile range.NIV: non-invasive ventilation. (A)The Duration of NIV.*P<0.05; (B) Comparison of length of stay and total length of stay between the two groups.*P<0.05,**P<0.01,ns = no significance

Full size image

Hospitalization expenses between two group

In Table 4, compared with the control group, there were no statistical difference in the ICU hospitalization expenses [31201.71 (95%CI, 16112.43–39094.05) vs. 45947.47 (95%CI, 19012.08–77252.82), respectively, p = 0.058]. However, there was an effective reduction in the Baduanjin group compared with the control group in the total hospitalization expenses [41615.10 (95%CI, 32114.46–51115.75) vs.66206.45 (95%CI, 53168.52– 79244.38), respectively, p = 0.002] (Fig. 4).

Table 4 The duration of hospitalization expense between two group
Full size table
Fig. 4
figure 4

Hospitalization expense between two group. Values are presented as median with the interquartile range.Comparison of the ICU hospitalization expenses and the total hospitalization expense between the two groups.**P<0.01,ns = no significance

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Adverse event

During the observation period, 1 participant in the Baduanjin group died of the relapse of pneumonia after being transferred out of the ICU. In the control group, 3 patients died of worsening infections during their ICU stay, and 1 patient died of heart failure after being transferred out of the ICU. None of these events could be related to the interventions.

Discussion

The results of this study showed that the SBE was effective for improving the muscle strength and ADL in patients with sepsis. It could also significantly decrease the duration of NIV, the length of total stay, and hospitalization expense. No serious adverse events were observed during the SBE exercise, indicating the safety and usefulness of early intervention for patients of sepsis with NIV.

Sepsis is a serious disease, which affects more than 19 million people each year [1]. Prompt identification, treatment with broad-spectrum antibiotics, and elimination of the source of infection are key to the early care of sepsis, as well as resuscitation with intravenous fluids and vasopressors in patients with hypotension or elevated lactate [22]. However, after hospitalization for sepsis, the patient’s independent mobility often decreases. Patients often develop physical weakness after a critical illness, which may be due to myopathy, neuropathy, cognitive impairment, or a combination of these conditions [23]. The National Institute for Health and Care Excellence’s Guidelines on Rehabilitation after Critical illness recommend multiprotection rehabilitation after critical Illness, starting in the ICU and continuing in the ward [7]. At present, early rehabilitation programs include passive motion in bed, active motion, and Neuromuscular electrical stimulation, et al. [5, 24]. Yet, weakness is the most common outcome of sepsis [25].

As far as we know, this study is the first RCT to investigate the effect of the SBE in sepsis patients with NIV. There have been studies that have demonstrated benefits of Baduanjin exercise, including improving balance, muscle strength, psychological illness, pulmonary function, and quality of life for patients with chronic diseases [9, 18, 27]. Liu, X and his colleagues had indicated that Baduanjin was safe and feasible for pre-frail/frail community-dwelling older people with the potential to reduce fall risk and reverse frailty status [28]. Yuen, M and his team showed that the Baduanjin exercise was effective in improving leg strength, and mobility [26]. It was a safe and sustainable form of home-based exercise for people with chronic stroke. However, there is no significant outcome on the patient’s Barthel index. In our research, we found that SBE exercise can improve Muscle strength and Barthel index in patients with sepsis at the time of transfer out of the ICU. The possible reason for this was that our study was conducted on patients with mild sepsis using NIV, while Yuen, M and his colleagues [26] were studying stroke patients, whose recovery of daily self-care functions was slower.

As we have known, Baduanjin is a moderate-intensity physical activity that combines meditation and body awareness and is effective in improving overall health [12]. The SBE, which combined with the modern medical concept and the rehabilitation characteristics of severe patients, is a kind of improved rehabilitation exercise suitable for bedridden patients based on the traditional Baduanjin. Our team has shown in a previous study that the SBE is an adjunctive therapy for ventilatory dysfunctional weaning responses and is effective in relieving cardiopulmonary function and reducing anxiety and ventilator use time [13]. Previous studies have confirmed the safety and efficacy of SBE for post-reperfusion rehabilitation in patients with acute myocardial infarction. Its safety and efficacy have been clinically affirmed [14]. Although 1 patient in the Baduanjin group died in this study, the patient died of lung infection after being transferred out of the ICU. This event had nothing to do with the Baduanjin intervention. Furthermore, we found that there was no significant difference in the length of ICU stay and ICU hospitalization expense (yuan) between the two groups. The reason for this result may be the sample size is not large enough. However, the participants in the Baduanjin group had a mean decrease of 24.09 h in the duration of NIV and 3.35 days in the length of total stay compared with the control group, which was consistent with a study by Schaller and his colleagues, who had indicated that early and progressive activity could shorten the patient length of stay in the SICU [5].The total hospitalization expense of the SBE was also significantly reduced. The results of the analysis indicated that the SBE was of a benefice to the early rehabilitation of sepsis patients with NIV.

The performance of SBE can systematically improve muscle strength and ADL in patients with sepsis.Because when practicing SBE, the body maintains a steady gravity center. With the lumbar spine as the axis, the movement of the four limbs is driven. The muscle tension and relaxation are alternating at different parts of the body.This may be the reason why SBE can bring benefits to sepsis patients.However, the molecular mechanisms behind the therapeutic changes are still not well understood and will require further research in the future.

This study has some limitations. First, this is a single-center study. Second, the duration of our intervention was limited to the period of hospitalization, with a lack of long-term follow-up intervention. Moreover, we cannot describe the definitive physiological mechanism of the SBE. Nonetheless, this study offers the first clinical data from sepsis patients with NIV.

Conclusions

The SBE appears to improve muscle strength and ADL in patients with sepsis, with additional benefits of lowed the length of the total stay, the duration of NIV, and the hospitalization expense.

Data availability

The datasets used and analyzed during the current study are available from the corresponding author upon reasonable request.

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Acknowledgements

Not applicable.

Funding

This work was funded by The scientific and technological research of traditional Chinese medicine, Guangdong Provincial Hospital of Chinese Medicine (No.YN2016HL03,YN2020HL03,YN2020HL14,YN2022HL06,YN2023HL04,YN2023HL13),Guangzhou Science and Technology Bureau (No.202102010242), Guangdong Provincial Administration of Traditional Chinese Medicine(No.20212072).

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Author notes

  1. Liheng Guo and Xiaoxuan Zhang contributed equally to this work and share the corresponding authors of this paper.

Authors and Affiliations

  1. Intensive Care Unit, The Second Clinical College of Guangzhou University of Chinese Medicine, No 111 Dade Road, Guangzhou, 510120, China

    Ming-Gui Chen, Fangfang Wang, Lixia Huang, Tingjie Qi, Hanhua Guo, Rui-Xiang Zeng, Xiaoyan Li, Haizhen Chen, Min-Zhou Zhang, Liheng Guo & Xiaoxuan Zhang

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Contributions

All authors contributed to data collection, and reviewed and approved the final manuscript. Xiaoxuan Zhang is the guarantor of the paper, taking responsibility for the integrity of the work, from inception to published article. Ming-Gui Chen wrote the main manuscript text. Lixia Huang, Tingjie Qi, Hanhua Guo collected the cases. Xiaoyan Li, Haizhen Chen，Fangfang Wang, Rui-Xiang Zeng, and Min-Zhou Zhang carried out data collection and revision of the manuscript. Liheng Guo carried out study design and revision of the manuscript.

Corresponding authors

Correspondence to Liheng Guo or Xiaoxuan Zhang.

Ethics declarations

Ethics approval and consent to participate

The Guangdong Provincial Hospital of Chinese Medicine’s Human Research Ethics Committee approved this study(B2017-139-01).Written informed consent was obtained from each patient or their parents or guardians.

Consent for publication

A written consent for publication was obtained from each patient or their parents or guardians.

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The authors declare no competing interests.

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Supplementary Material 1: The introduction of the Sitting Baduanjin exercises by the intensive care unit of Guangdong provincial hospital of Chinese medicine. A: Prop up the sky with both hands to regulate the internal organs. B: Slap wrist and elbow by using another hand to relieve stress. C: Clasp hands and hit the chest area about per second a time. D: Sway head to expel sickness. E, F: Hands on your head, then raise your head and stretch your elbows. G: Rub the waist with hands to strengthen the kidneys. H: Punch with Clench fists and circle left and right. I: Stretch arms back like an eagle to cure all diseases.

Supplementary Material 2: (The introduction of the Sitting Baduanjin exercises).

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Chen, MG., Wang, F., Huang, L. et al. Effect of Sitting Baduanjin exercise on early rehabilitation of sepsis patients with non-invasive ventilation : a randomized controlled trial. BMC Complement Med Ther 24, 330 (2024). https://doi.org/10.1186/s12906-024-04626-8

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  • DOI: https://doi.org/10.1186/s12906-024-04626-8

Keywords

BMC Complementary Medicine and Therapies

ISSN: 2662-7671

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