Exercise Rehabilitation for People with Postural Tachycardia Syndrome at Two Secondary Care Centres in the UK: the PULSE Feasibility Randomised Controlled Trial

Overview

Journal BMJ Open

Specialty General Medicine

Date 2025 Feb 22

PMID 39987007

Authors

Gordon McGregor

Becky Evans

Harbinder Kaur Sandhu

Julie Bruce

Gita Devi

Sajad Hayat

Siew Wan Hee

Peter Heine

Nikki Holliday

Shivam Joshi

Lesley Kavi

Lim Boon

Angela Noufaily

Nicholas Parsons

Shilpa Patel

Gemma Pearce

Richard Powell

Eva Schultz

Jane Simmonds

Albiona Zhupaj

Helen Eftekhari

Sandeep Panikker

Affiliations

Soon will be listed here.

Abstract

Objectives: The aim of the study was to assess the feasibility of conducting a definitive multicentre randomised controlled trial (RCT) testing an online exercise rehabilitation and behavioural/motivational support intervention for people with postural tachycardia syndrome (PoTS).

Design: Feasibility RCT.

Setting: Two secondary care centres.

Participants: Adults aged 18 to 60 years with PoTS. Exclusions were serious mental health/cognitive problem preventing safe participation; currently undertaking physical activity equivalent to the Chief Medical Officer guidelines; pregnancy.

Interventions: Participants were randomly assigned (1:1) to best-practice usual care (a single 1:1 session of advice) or the 'postural tachycardia syndrome exercise' (PULSE) intervention: (1) individual online consultation, (2) 12 weeks of supervised online group exercise and behavioural/motivational support, and (3) home exercise programme with recumbent exercise bike.

Outcomes: The primary outcome was feasibility: (1) patients screened, eligible, recruited, randomised, withdrawn; (2) adherence; (3) physiological, clinical and patient-reported outcomes (4 and 7 months); and (4) embedded qualitative study to evaluate acceptability.

Results: 209 patients screened between 5 May 2021 and 1 December 2022, 44 (female 98%; age 29.9 SD, 7.5) were randomised to usual care (n=21) or PULSE (n=23) (71% of target). Follow-up at 4 months was n=12 and n=17 respectively (66% of target). Median live exercise/support session attendance was 15 (IQR 12 to 17) of 18 sessions. Home exercise bike usage was highly variable. There were two serious adverse events in each treatment arm, both unrelated to the trial. Exercise rehabilitation was considered important by participants, and trial procedures, outcomes and interventions were acceptable.

Conclusions: The PULSE trial procedures and interventions were acceptable, and important design considerations were identified. A definitive RCT testing a remotely supervised exercise rehabilitation and behavioural/motivational support intervention for people with PoTS is feasible in the UK National Health Service.

Trial Registration Number: ISRCTN45323485.

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