PULSE
Research type
Research Study
Full title
PostUraL tachycardia Syndrome Exercise (PULSE): a randomised feasibility study
IRAS ID
266145
Contact name
Gordon McGregor
Contact email
Sponsor organisation
University Hospitals Coventry & Warwickshire NHS Trust
ISRCTN Number
ISRCTN45323485
Duration of Study in the UK
2 years, 4 months, 1 days
Research summary
Research Summary
Postural Orthostatic Tachycardia Syndrome (POTS) can seriously effect well-being and quality of life, due to its many disabling symptoms. The condition mostly (but not only) affects women aged 13 to 50. People with POTS have an abnormal heart rate rise when they stand up, with symptoms including palpitations, dizziness, fainting, and long-lasting fatigue. Attending education, earning a living, and caring for dependants can be severely affected, and the impact on the healthcare system is significant.Medical treatment is not always effective for POTS, but lifestyle interventions like exercise may help some people. We aim to find out if people with POTS will enrol on, and complete, a supervised exercise programme. First, we will run discussion groups with people affected by POTS, to help us better understand their needs, and refine an exercise intervention. At two hospitals, we will then invite people with POTS onto a study comparing a supervised exercise and motivational support intervention, with usual care (no supervised exercise). We will test whether people want to be involved, can tolerate the exercise, and if symptoms and quality of life improve over time.
Lay summary of study results
Postural Tachycardia Syndrome (PoTS) can seriously affect wellbeing and quality of life. Symptoms include palpitations, dizziness, fainting, and long-lasting fatigue. Medical treatment is not always effective, but exercise and support programmes may help. We ran discussion groups with people affected by PoTS to help us design an online exercise and wellbeing support programme. We then enrolled 44 people from two hospitals onto a small research study (a feasibility study) comparing a 12-week supervised online home-based exercise and wellbeing support programme (PULSE) with a one-off session of advice. The study was not big enough to test if the PULSE programme helped people feel better, but we wanted to see if it was possible to run a big research study in the future. People with PoTS found that being involved in the research project was acceptable. Some people felt better after the PULSE programme, and nobody felt worse. We found that it was possible to run the research project with very few problems. We learnt a lot about how to do this safely and efficiently. This means that we can now test if the PULSE programme works in a big research project across the UK.REC name
East Midlands - Nottingham 2 Research Ethics Committee
REC reference
20/EM/0077
Date of REC Opinion
1 Apr 2020
REC opinion
Favourable Opinion