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Table 1 World Health Organization trial registration data set

From: Protocol for a randomised controlled feasibility trial of exercise rehabilitation for people with postural tachycardia syndrome: the PULSE study

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