Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Randomized Controlled Trial
. 2025 Nov 17;25(1):469.
doi: 10.1186/s12883-025-04423-x.

Heart rate variability biofeedback in adults with chronic spinal cord injury: a randomised feasibility study

Jacob Schoffl  1   2 , Mohit Arora  3   4 , Ilaria Pozzato  3   4 , Candice McBain  3   4 , Dianah Rodrigues  3   4 , Elham Vafa  3   4   5 , James W Middleton  3   4 , Glen M Davis  5 , John Bourke  3   4 , Andrei Krassioukov  6 , Ian D Cameron  3   4 , Ashley Craig  3   4
Affiliations
Randomized Controlled Trial

Heart rate variability biofeedback in adults with chronic spinal cord injury: a randomised feasibility study

Jacob Schoffl et al. BMC Neurol. .

Abstract

Background: Heart rate variability biofeedback (HRV-F) is a neurocardiac self-regulation therapy, that has been shown to improve cardiac autonomic regulation, emotional regulation, and cognitive function in various clinical populations. Despite this, there is little evidence for the benefit of HRV-F in adults with spinal cord injury (SCI).

Methods: This study evaluated the feasibility of conducting a parallel randomised controlled trial (RCT) to evaluate the effectiveness of a 10-week HRV-F intervention for adults with chronic SCI. Individuals with SCI (irrespective of level and completeness), at least 12 months after diagnosis due to any traumatic or non-traumatic and non-progressive cause, and aged between 18 and 70 years of age were eligible to participate. Feasibility was evaluated in terms of six primary outcomes: (i) randomisation and blinding, (ii) participant safety, (iii) recruitment, (iv) retention, (v) adherence to the intervention, and (vi) primary outcome data collection methods (heart rate variability [HRV] and cerebral blood velocity [CBv]). Participants' satisfaction, impression of change, and technological issues were assessed as secondary outcomes.

Results: The first 10 participants of the RCT (n = 120) were studied in the 10-week feasibility study. No serious adverse events occurred during the study activities (assessment or intervention sessions). While there were no withdrawals and high adherence to the intervention, the recruitment rate was below the target. There were no missing HRV data; however, missing data for CBv was higher than anticipated based on the literature (35% vs. 20%). A few minor connectivity issues occurred with the technology used for home training by participants. Modifications to the RCT protocol, including adjusting the eligibility criteria, recalculating the sample size, conducting interventions in participants' homes, and altering the CBv assessment protocol, were proposed to address these issues.

Conclusions: With the proposed modifications implemented, the RCT is deemed feasible for investigating the effectiveness of a 10-week HRV-F intervention for adults with chronic SCI.

Trial registration: Australian and New Zealand Clinical Trial Registry (ACTRN12621000870853). Registered on July 6, 2021.

Keywords: Autonomic nervous system; Biofeedback; Feasibility studies; Randomised controlled trials; Spinal cord injuries.

PubMed Disclaimer

Conflict of interest statement

Declarations. Ethics approval and consent to participate: The study was conducted in accordance with the National Health and Medical Research Council’s National Statement on Ethical Conduct in Human Research (2007) and the Note for Guidance on Good Clinical Practice (CPMP/ICH-135/95). This feasibility study was approved by the Northern Sydney Local Health District Human Research Ethics Committee (2020/ETH02554, 02/12/2020). Informed consent was obtained from all subjects involved in the study. Consent for publication: Written informed consent was obtained from the patients to publish this paper. Competing interests: The authors declare no competing interests.

Figures

Fig. 1
Fig. 1
An overview of the trial. The feasibility study aims to evaluate the practicality of undertaking the randomised control trial (RCT), focusing on the first 10 RCT participants from baseline to 10-weeks. The RCT investigates the effectiveness of heart rate variability biofeedback (HRV-F) on autonomic and neural function
Fig. 2
Fig. 2
CONSORT flow diagram
See this image and copyright information in PMC

References

    1. Hou S, Rabchevsky AG. Autonomic consequences of spinal cord injury. Compr Physiol. 2011;4(4):1419–53. - PubMed
    1. Wecht JM, Krassioukov AV, Alexander M, Handrakis JP, McKenna SL, Kennelly M, et al. International standards to document autonomic function following SCI (ISAFSCI): second edition. Top Spinal Cord Injury Rehabilitation. 2021;27(2):23–49. - PMC - PubMed
    1. Simpson LA, Eng JJ, Hsieh JT, Wolfe DL. The health and life priorities of individuals with spinal cord injury: a systematic review. J Neurotrauma. 2012;29(8):1548–55. - PMC - PubMed
    1. Barker RN, Kendall MD, Amsters DI, Pershouse KJ, Haines TP, Kuipers P. The relationship between quality of life and disability across the lifespan for people with spinal cord injury. Spinal Cord. 2009;47(2):149–55. - PubMed
    1. Cao Y, Krause JS. The association between secondary health conditions and indirect costs after spinal cord injury. Spinal Cord. 2021;59(3):306–10. - PubMed

Publication types

LinkOut - more resources