Table 1 World Health Organization trial registration data set
| Data category | Information |
|---|---|
| Primary registry and trial identifying number | ISRCTN45323485 |
| Date of registration in primary registry | 7 April 2020 |
| Secondary identifying numbers |
REC reference: 20/EM/0077 BHF reference: PG/19/22/34203 |
| Source(s) of monetary or material support | British Heart Foundation Project Grant |
| Primary sponsor |
UHCW NHS Trust University Hospital Clifford Bridge Rd., Coventry CV2 2DX Tel: 02476 966195 Email: R&DSponsorship@uhcw.nhs.uk |
| Secondary sponsor(s) |
Coventry University Richard Crossman Building Jordon Well Coventry University CV1 5RW Email: cdu141@coventry.ac.uk |
| Contact for public queries |
Coventry University Richard Crossman Building Jordon Well Coventry University CV1 5RW Email: cdu141@coventry.ac.uk |
| Contact for scientific queries |
Dr Gordon McGregor Coventry University/UHCW NHS Trust Tel: 024 76150285 Email: gordon.mcgregor@coventry.ac.uk |
| Public title | Supervised exercise rehabilitation for people with postural tachycardia syndrome |
| Scientific title | PostUraL tachycardia Syndrome Exercise (PULSE): a randomised controlled feasibility study |
| Countries of recruitment | England |
| Health condition(s) or problem(s) studied | Postural orthostatic tachycardia syndrome |
| Intervention(s) |
Intervention group: (1) individual assessment, (2) supervised out-patient exercise programme, (3) behavioural and motivational support, (4) guided lifestyle physical activity. Control intervention: best-practice usual care |
| Key inclusion and exclusion criteria |
Inclusion: adults (18–40 years) with confirmed diagnosis of POTS and attending syncope out-patient clinics; able to attend a PULSE centre; able to provide informed consent. Exclusion: absolute contraindications to exercise; currently achieving CMO physical activity guidelines; mental health issue preventing engagement with trial procedures; pregnant at time of recruitment; previous randomisation in PULSE; unable to attend a PULSE centre; took part in PULSE intervention co-creation. |
| Study type |
Type: feasibility, interventional, two-centre Allocation: randomised Assignment: parallel Masking: outcomes assessors, chief investigator, statistician |
| Date of first enrolment | TBC |
| Target sample size | 62 |
| Recruitment status | Ready to start recruitment (on hold due to Covid-19) |
| Primary outcome(s) | Feasibility and process indicators: number of patients screened, eligible, recruited, randomised, withdrawn and retained; adherence to exercise rehabilitation programme; length of time to complete each outcome assessment and the whole outcome assessment appointment; willingness of participants to join non-POTS specific exercise rehabilitation programmes; physiological, clinical, patient-reported outcomes to identify a primary outcome for a definitive trial; acceptability of the interventions and the trial (qualitative interviews) |
| Key secondary outcomes |
At 4 and 7 months: exercise capacity—graded recumbent cycle ergometer test; autonomic function—increase in heart rate from supine to 10-min stand; symptom burden—COMPASS 31 dysautonomia scale and fatigue severity scale; HRQoL—EQ-5D-5L; self-efficacy—general self-efficacy scale; exercise tolerability—continuous heart rate monitoring and symptoms during exercise; adverse events. At baseline and 7 months: semi-structured interviews with participants |