Heart Rate Variability Reflects the Natural History of Physiological Development in Healthy Children and Is Not Associated with Quality of Life

Abstract Background Non-dystrophic myotonias (NDMs) comprise muscle chloride and sodium channelopathies due to genetic defects of the CLCN1- and SCN4A-channels. No licensed antimyotonic treatment has been available until approval of mexiletine (NaMuscla®) for adult patients by the EMA in December 2018. This Delphi panel aimed to understand how outcomes of the pivotal phase III Mexiletine study (MYOMEX) translate to real world practice and investigate health resource use, quality of life and the natural history of NDM to support economic modelling and facilitate patient access. Methods Nine clinical experts in treating NDM took part in a two-round Delphi panel. Their knowledge of NDM and previous use of mexiletine as an off-label treatment prior to NaMuscla’s approval ensured they could provide both qualitative context and quantitative estimates to support economic modelling comparing mexiletine (NaMuscla) to best supportive care. Consensus in four key areas was sought: healthcare resource utilization (HRU), treatment with mexiletine (NaMuscla), patient quality of life (QoL), and the natural history of disease. Concept questions were also asked, considering perceptions on the feasibility of mapping the validated Individualized Neuromuscular Quality of Life (INQoL) instrument to the generic EQ-5D™, and the potential impact on caregiver QoL. Results Consensus was achieved for key questions including the average long-term dosage of mexiletine (NaMuscla) in practice, the criteria for eligibility of myotonia treatment, the clinical importance of QoL outcomes in MYOMEX, the higher proportion of patients with increased QoL, and the reduction in the need for mental health resources for patients receiving mexiletine (NaMuscla). While consensus was not achieved for other questions, the results demonstrated that most experts felt mexiletine (NaMuscla) reduced the need for HRU and was expected to improve QoL. The QoL mapping exercise suggested that it is feasible to map domains of INQoL to EQ-5D. Points of interest for future research were identified, including that mexiletine (NaMuscla) may slow the annual decrease in QoL of patients over their lifetime, and a significant negative impact on QoL for some caregivers. Conclusions This project successfully provided data from an informed group of clinical experts, complementing the currently available clinical trial data for mexiletine (NaMuscla) to support patient access decisions.

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Mind–body interactive qigong improves physical and mental aspects of quality of life in inpatients with stroke: A randomized control study

European Journal of Cardiovascular Nursing ◽

10.1177/1474515119860232 ◽

2019 ◽

Vol 18 (8) ◽

pp. 658-666 ◽

Cited By ~ 7

Author(s):

Ching-Hsiang Chen ◽

Kuo-Sheng Hung ◽

Yu-Chu Chung ◽

Mei-Ling Yeh

Keyword(s):

Quality Of Life ◽

Heart Rate ◽

Heart Rate Variability ◽

High Frequency ◽

Standard Care ◽

Low Frequency ◽

Control Group ◽

Subacute Stroke ◽

Interactive Exercise

Background: Stroke, a medical condition that causes physical disability and mental health problems, impacts negatively on quality of life. Post-stroke rehabilitation is critical to restoring quality of life in these patients. Objectives: This study was designed to evaluate the effect of a mind–body interactive qigong intervention on the physical and mental aspects of quality of life, considering bio-physiological and mental covariates in subacute stroke inpatients. Methods: A randomized controlled trial with repeated measures design was used. A total of 68 participants were recruited from the medical and rehabilitation wards at a teaching hospital in northern Taiwan and then randomly assigned either to the Chan-Chuang qigong group, which received standard care plus a 10-day mind–body interactive exercise program, or to the control group, which received standard care only. Data were collected using the National Institutes of Health Stroke Scale, Hospital Anxiety and Depression Scale, Short Form-12, stroke-related neurologic deficit, muscular strength, heart rate variability and fatigue at three time points: pre-intervention, halfway through the intervention (day 5) and on the final day of the intervention (day 10). Results: The results of the mixed-effect model analysis showed that the qigong group had a significantly higher quality of life score at day 10 ( p<0.05) than the control group. Among the covariates, neurologic deficit ( p=0.04), muscle strength ( p=0.04), low frequency to high frequency ratio ( p=0.02) and anxiety ( p=0.04) were significantly associated with changes in quality of life. Conversely, heart rate, heart rate variability (standard deviation of normal-to-normal intervals, low frequency and high frequency), fatigue and depression were not significantly associated with change in quality of life ( p >0.05). Conclusions: This study supports the potential benefits of a 10-day mind–body interactive exercise (Chan-Chuang qigong) program for subacute stroke inpatients and provides information that may be useful in planning adjunctive rehabilitative care for stroke inpatients.

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